The Falck Medical Applanation Tonometer (FAT 2) measures the intraocular pressure by applanation of the cornea uses a disposable sterile plastic prism. It is used as an accessory to a slit lamp microscope. Internal software is used for error checking and calibration. The disposable prism is mounted on a free floating counterweighted arm. When the prism comes into contact with the cornea, the initial applanation area is determined by the biomechanics of the cornea. Force is then actively applied to the cornea and measurements are taken every 13.8 milliseconds. Multiple readings are taken and statistical analysis is performed to ensure repeatability. The measurement principle is the same as the Goldmann, but adjustments are reade for variations in surface wetness and corneal resistance. The size of the applanation area is objectively determined by using visible light and the principle of total internal reflectance (TIR). A new sterile disposable prism is required prior to each new patient. In addition to intraocular pressure, the device also measures ocular pulsatile amplitude by recording the change in the applanation signal that occurs with the cardiac cycle. The measurement of ocular pulsatile amplitude is similar to the Langham methodology.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Falck Medical Applanation Tonometer (FAT 2), based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner. Instead, performance is demonstrated through comparison to a reference standard (Goldmann applanation tonometer) and an in-vitro manometric study. The implicit acceptance is that the device's performance is comparable or superior to these standards.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (FAT 2)
Intraocular Pressure (IOP) Measurement vs. Goldmann	Demonstrate high correlation and low average mean difference compared to the Goldmann Applanation Tonometer.	Average Mean Difference: 0.7 mmHg (SD=2.0)
		r² = 0.93 (indicating strong positive correlation)
		Range: 9 to 56 mmHg
Manometric Study (In-vitro accuracy)	Demonstrate low coefficient of variation and standard deviation against a reference mercury manometer.	Average Coefficient of Variation: 2.6% +/- 0.10 (5 to 50 mmHg)
		Average Standard Deviation: 0.7 mmHg +/- 0.4 (range 0.09-1.26, 5 to 50 mmHg)
Biocompatibility	Non-toxic to ocular and systemic tissues.	All testing found to be non-toxic to ocular and systemic tissues.

2. Sample Size Used for the Test Set and Data Provenance

Clinical Trial (IOP measurement):
- Sample Size: 205 eyes (number of patients is not specified, but typically one patient has two eyes)
- Data Provenance: Not explicitly stated, but the "Clinical Trial Summary" implies prospective human clinical data. The country of origin is not specified.
Manometric Study (In-vitro accuracy):
- Sample Size: Not specified beyond "human eye bank eyes." The number of individual eyes or measurements is not provided.
- Data Provenance: Retrospective for the usage of "eye bank eyes," as these would be from deceased donors. The country of origin for the eye bank is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Clinical Trial (IOP measurement): The ground truth was established by a "reference Goldmann applanation tonometer." This implies expert operation of the Goldmann tonometer, but the number of operators/experts or their specific qualifications are not mentioned. The expertise is assumed to be inherent in the recognized performance of the Goldmann device.
Manometric Study (In-vitro accuracy): The ground truth was established by a "reference u-tube mercury manometer." This is a physical standard, not requiring expert consensus in the same way clinical ground truth does. The operators' qualifications are not specified.

4. Adjudication Method for the Test Set

Clinical Trial: Not applicable as the Goldmann tonometer serves as the single reference (ground truth). No explicit mention of independent adjudication of readings from the Goldmann or FAT 2 beyond basic statistical comparison.
Manometric Study: Not applicable; the mercury manometer provides a physical reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs. without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. This device is a measurement instrument, and the studies focused on its direct measurement accuracy compared to established methods, not on how it assists human readers in making diagnoses or interpretations in an MRMC setting. Therefore, an effect size for human reader improvement with AI assistance is not relevant or reported here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was effectively done. The Falck Applanation Tonometer (FAT 2) is a device that directly measures IOP. The clinical trial compared its measurements directly to a Goldmann tonometer, and the manometric study compared its measurements to a mercury manometer. These are direct, standalone performance assessments of the device's output. The "Internal software is used for error checking and calibration," which implies algorithmic processing for the final output.

7. The Type of Ground Truth Used

Clinical Trial (IOP measurement): Reference standard measurements from a Goldmann Applanation Tonometer. This is a widely accepted clinical standard.
Manometric Study (In-vitro accuracy): Reference measurements from a u-tube mercury manometer. This is a physical, highly accurate, and established in-vitro standard for pressure.

8. The Sample Size for the Training Set

The 510(k) summary does not provide specific information about a "training set" in the context of machine learning. The device contains "Internal software" for error checking and calibration, but details on how this software was developed or if it involved a distinct supervised learning "training set" are not disclosed. Typically, applanation tonometers rely on physical principles (Imbert-Fick Law) and calibration rather than complex machine learning models that require large training datasets in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

As a "training set" is not explicitly mentioned or detailed for a machine learning model, the method for establishing its ground truth is also not provided. The device likely relies on engineering and calibration data for its internal software rather than ground truth labels from a training dataset.

Summary

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K07/755

510(k) SUMMARY

JUN - 3 2008

1.	Submitter Information:
	A.	Company Name/Address:	Falck Medical, Inc.35 Washington Street, Suite 2Mystic, CT 06355(860) 536-9000(860) 536-9000 FAX
	B.	Contact Person:	Francis Falck, Jr., M.D., PhD, M.S.CEO and President
	C.	Manufacturing Location:	To be determined
2.	Device Information:
	A.	Device Trade Name:	Falck Medical Applanation Tonometer (FAT 2)
	B.	Classification Name:	tonometer
	C.	Classification Panel:	86: ophthalmic
	D.	Device Classification Number:	886.1930
	E.	Product Codes:	HKY, HKX
3.	Substantial Equivalence:

The Falck Applanation Tonometer Model 2 (FAT 2) is substantially equivalent to the Goldmann Applanation Tonometer SL 900, (K981432). The device is based on the Imbert -Fick Law and uses applanation of the cornea to measure the intraocular pressure.

Additionally, the FAT 2 is substantially equivalent to the Langham Model 201 Tonograph/Tonometer (K010998) for the measurement of ocular pulsatile amplitude.

The list of equivalent devices follows:

K981432	1/12/1999	Goldmann Tonometer	Golden Vision, Inc.
K010998	6/27/2001	Model 201 Tonograph/Tonometer	Langham OphthalmicTechnologies

Intended use: ধা

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The Falck Medical Applanation Tonometer (FAT 2) is indicated in the measurement of intraocular pressure and ocular pulsatile amplitude.

Device Description: ട്.

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area is objectively determined by using visible light and the principle of total internal reflectance (TIR).

A new sterile disposable prism is required prior to each new patient. In addition to intraocular pressure, the device also measures ocular pulsatile amplitude by recording the change in the applanation signal that occurs with the cardiac cycle. The measurement of ocular pulsatile amplitude is similar to the Langham methodology.

Performance Testing റ്.

Biocompatibility and Toxicity Testing

The disposable prism is designed to come into contact with the cornea for a short period of time. Biocompatibility testing was performed on the prism material to establish a safety profile for the device. Toxicity testing included cytotoxicity, ocular irritation, and systemic toxicity. All testing was found to be non-toxic to ocular and systemic tissues.

Manometric Study Summary

In a comparative study of Falck Applanation Tonometer 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, range 0.09 1.26, (5 to 50mmHg). .

Clinical Trial Summary

In a clinical trial comparing the Falck Applanation Tonometer to a reference Goldmann applanation tonometer for IOP measurement in 205 eyes, the following results were obtained:

Average Mean Difference between Falck Applanation Tonometer and the Goldmann ◆ Applanation Tonometer: 0.7mmHg, SD=2.0, r2= 0.93, (9 to 56mmHg).

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Function	Falck(FAT 2)Subject of510(k)	Goldmann SL900 TonometerK981432	Langham OcularBlood Flow (OBF)Tonograph-TonometerK010998
Measurement independentof corneal resistance	Yes	No	No
Topical anesthetic use	Yes	Yes	Yes
Fluorescein use required	No	Yes	No
Measures ocular pulse	Yes	No	Yes
Ocular Pulsatile Amplitude	Yes	No	Yes
Patient position during test	Sitting only	Sitting only	Sitting / Supine
Force application oftonometer arm	Automatic	Manual	Pneumatic
Skill level required	TrainedAssistant	TrainedAssistant	TrainedAssistant
Requires slit lamp	Yes	Yes	No
Sampling Frequency	145 samplesper second	60 seconds	100 samplesper second
Electronic	Yes	No	Yes
Data capture	Yes	No	Yes
Data communication	Yes	No	No

7. Device Comparisons (Similarities and Differences) to Predicate Devices

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 : 2008

Falck Medical, Inc c/o Richard E. Lippman O.D., F.A.A.O. VP Ophthalmic Product Regulatory Affairs R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Rd., Suite 30 Rockville, MD 20850

Re: K071755

Trade Name: Falck Applanation Tonometer (FAT 2) Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HKY, HPK, NJJ Dated: May 19, 2008 Received: May 19, 2008

Dear Dr. Lippman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Malvina B. Reynolds, and

Malvina B. Eydelman, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K071755

Device Name: Falck Medical Applanation Tonometer Model 2 (FAT 2)

Indications for Use:

The Falck Medical Applanation Tonometer Model 2 (FAT 2) is indicated in the measurement of intraocular pressure and ocular pulsatile amplitude.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ( 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dacoulus 5/30/2008

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

Page 1 of

510(k) Number K071755

Regulation Number and Section

§ 886.1930 Tonometer and accessories.

(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.