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FAT1 Multi-Function Device
FAT1 Multi-Function Device
FAT1 Multi-Function Device
FAT1 Multi-Function Device

FAT1 Multi-Function Device

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The First Artificially Intelligent Combination Tonometer, Tonographer, and Ophthalmodynamometer  

Why Choose the FAT1 Multifunction Device?

  • Performs Three Novel FDA PMA Cleared Tests
  • Three Second Measurement Time
  • Three Separate CPT Codes
  • Affordable. Lease or Purchase
  • Section 179

The New Standard. Your Choice for Precision and Accuracy

Features

Tonometry Study Summary:

In a clinical trial comparing of the Falck Medical Multifunction Device  (FAT1) in 205 eyes the following results were obtained:

  • No statistical relationship found between FAT1 readings and corneal curvature or thickness, r2 < 0.05.

Manometric Study Summary:

In a comparative study of the FAT1 readings to a reference u-tube mercury manometer using human eye bank eyes, the following results were obtained:

  • Average Coefficient of Variation: 2.6% +/- 0.10 (5 to 50mmHg).
  • Average Standard Deviation: 0.7 mmHg +/- 0.4 (5 to 50mmHg).

Clinical Tonography Trial Summary:

In a clinical trial comparing the FAT1 to a reference indentation tonographer for the measurement of conventional outflow facility in 91 eyes from 91 subjects the following results were obtained:

  • The mean conventional outflow facility (C) difference between the FAT1 and the reference Indentation Tonographer over a range of 0.01 to 0.70 ul/min/mmHg was 0.0043 ul/min/mmHg ( 95% CI, 0.001 to 0.0076 ), n= 182.
  • Average FAT1 conventional outflow facility measurement in the glaucoma group was 0.09 +/- 0.05 and in the non-glaucoma group was 0.31 +/- 0.12 ul/min/mmHg, p < 0.0001, n = 182.
  • Average FAT1 IOP measurement in the glaucoma group was 20.02 +/- 5.5 and in the non-glaucoma group was 18.6 +/- 2.4, p = 0.01, n = 182.
  • In the High outflow facility group (C > 0.18) (non-glaucoma, 28/30 eyes) 93.3% of the paired differences were within +/- 1.96 standard deviations of the mean difference between the FAT1 and the reference Indentation Tonographer, n=60.
  • In the Medium outflow facility group (C >0.09 < 0.18) (glaucoma, 29/31 eyes) 95.2% of the paired differences were within +/- 1.96 standard deviations of the mean difference, n=62.
  • In the Low outflow facility group (C < 0.09) (glaucoma, 30/30 eyes) 96.7% of the paired differences were within +/- 1.96 standard deviations of the mean difference, n=60.

Tonographic Laboratory Study Summary:

In a comparative tonographic laboratory study using freshly enucleated preserved eye bank eyes, the following results were obtained:

  • For every 10 mmHg change in IOP average anterior chamber fluid volume change was 3.22 ul/minute, for a 20 mmHg change in IOP average anterior fluid volume change was 7.027 ul/minute and for 30 mmHg change in IOP average anterior fluid volume change was 11.75 ul/minute, r2 = 0.99.
  • The correlation coefficient for volume decrease and corneal indentation was 0.999. 
  • The correlation coefficient for volume decrease and applanation diameter was 0.997.

Clinical Ophthalmodynamometry (OPH) Study Summary:

In a clinical trial involving 42 adult eyes where ipsi-lateral OPH force, brachial artery blood pressure and IOP were recorded, the following results were obtained:

  • The average OPH estimated Central Retinal Artery Force was 59.73 +/- 11.10 mmHg.
  • The Mean Brachial Artery Blood Pressure (MBAP) was 93.16 +/- 8.32 mmHg.
  • The average IOP was 15.72 +/- 3.04 mmHg.
  • The average calculated Ocular Perfusion Pressure was 44.01 mmHg.

*Results on file with the Food and Drug Administration

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