The Falck Medical Multi-function Tonometer (FAT1) is indicated for the measurement of intraocular pressure, ocular pulsatile amplitude, force (Ophthalmodynamometry) and estimating conventional outflow facility with calibrated force application (Indentation Tonography).

Device Description

The Falck Medical Multi-function Tonometer (FAT1) mounts on the slit lamp microscope. The device has a floating prism arm which holds a disposable plastic prism. The device has a detection system located in the prism arm head that prevents re-use of the prism.

The prism optical system uses the principle of total internal reflectance. Sampling is every 7 milliseconds and multiple samples are obtained for each measurement. Each measurement is statistically analyzed for repeatability and accuracy. Intraocular pressure is measured using the Imbert-Fick method of applanation. Force application is controlled by the microprocessor. The ocular pulsatile amplitude and central retinal artery pulsation with force application is optically captured. Indentation tonography methodology using calibrated force application is used to measure conventional outflow facility.

AI/ML Overview

This document does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria values and a comprehensive study report. However, I can extract and infer information based on the provided text.

Here's an analysis of the acceptance criteria and study that demonstrates the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the Falck Medical Multifunction Tonometer, FAT1, is substantially equivalent to two predicate devices: Falck Medical, Inc. FAT2 (K071755) and Model 30 Classic Pneumatonometer with Tonography Option (K002395). This implies that the FAT1's performance is expected to be comparable to or within established ranges of these predicate devices, which would have their own acceptance criteria.

However, specific quantitative acceptance criteria for the FAT1 itself (e.g., "IOP measurement accuracy within X mmHg of gold standard") and the corresponding reported performance values are not explicitly stated in this document. The document primarily focuses on establishing substantial equivalence based on technical equivalence and prior testing of the predicate device (FAT2) and a separate IDE study for tonography.

Here's a table based on the information provided, with inferred criteria where direct values are missing:

Measurement Parameter	Acceptance Criteria (Inferred from Substantial Equivalence and Prior Approvals)	Reported Device Performance
Intraocular Pressure (IOP)	Substantially equivalent to FAT2 (K071755). Expected to meet the accuracy and precision demonstrated by FAT2 in its performance testing (K071755) and subsequent FDA correspondence (11/03/2009 & 01/10/2010).	"The FAT1 device is technically and functionally equivalent to the FAT2 device for the measurement of intraocular pressure... The accuracy and safety of the FAT2 device... was demonstrated in performance testing in 510(k) K071755 and in additional correspondence with the Food and Drug Administration, Office of Device Evaluation dated 11/03/2009 and 01/10/2010 -FMI."
Ocular Pulsatile Amplitude	Substantially equivalent to FAT2 (K071755). Expected to meet the accuracy and precision demonstrated by FAT2 in its performance testing.	"The FAT1 device is technically and functionally equivalent to the FAT2 device for the measurement of... ocular pulsatile amplitude... The accuracy and safety of the FAT2 device... was demonstrated in performance testing in 510(k) K071755..."
Force (Ophthalmodynamometry)	Substantially equivalent to FAT2 (K071755). Expected to meet the accuracy and precision demonstrated by FAT2 in its performance testing for observing pulsation of the central retinal artery.	"The FAT1 device is technically and functionally equivalent to the FAT2 device for the measurement of... the force required to observe pulsation of the central retinal artery. The accuracy and safety of the FAT2 device... was demonstrated in performance testing in 510(k) K071755..."
Conventional Outflow Facility (Indentation Tonography)	Substantially equivalent to Model 30 Classic Pneumatonometer with Tonography Option (K002395). Expected to demonstrate safety, repeatability, precision, and accuracy comparable to or better than this predicate.	"Bench testing and clinical testing done under FDA guidance with IDE (1080757) for the measurement of conventional outflow facility demonstrated the safety, repeatability, precision and accuracy of the FAT1."
Biocompatibility of Disposable Prism	Non-toxic and safe (cytotoxicity, systemic toxicity, ocular irritation).	"The prism and prism material in cyto-toxicity, systemic toxicity and ocular irritation testing was found to be non-toxic and safe."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

For IOP, Ocular Pulsatile Amplitude, and Ophthalmodynamometry (based on FAT2 equivalence): The document refers to validation data for the predicate device, FAT2 (K071755), and additional correspondence (11/03/2009 and 01/10/2010). The sample sizes and exact data provenance (country, retrospective/prospective) for the FAT2's testing are not provided in this document.
For Conventional Outflow Facility (IDE 1080757): "Bench testing and clinical testing done under FDA guidance with IDE (1080757) for the measurement of conventional outflow facility demonstrated the safety, repeatability, precision and accuracy of the FAT1." The sample size, country of origin, and whether it was retrospective or prospective for this specific IDE study are not provided in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish ground truth for any of the performance tests mentioned (either for FAT2 or the IDE study for FAT1's tonography).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication method used for establishing ground truth or evaluating device performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The device is a tonometer, a measurement device, not an image-reading AI system where "human readers improve with AI vs without AI assistance" would be a relevant concept. Therefore, an MRMC comparative effectiveness study of this nature was not done, nor would it be applicable.

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

This device is a physical instrument for measuring physiological parameters, operated by a human. The concept of "standalone algorithm only" is not applicable in the context of this tonometer. However, the device itself performs the measurement calculations automatically (e.g., using the Imbert-Fick method, statistical analysis of multiple samples). The closest equivalent would be the accuracy of the device's measurement output compared to a reference standard, which is implied by the performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used. However, for a tonometer, the ground truth for intraocular pressure measurement would typically involve a reference standard tonometer known for its accuracy (e.g., Goldmann applanation tonometer, or other highly calibrated master tonometers). For biocompatibility, the ground truth is established through standard biocompatibility testing methodologies (cytotoxicity, systemic toxicity, ocular irritation assessments) as per ISO standards.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning, as this device's function is explained based on physical principles (Imbert-Fick applanation, optical systems) and specific methodologies for tonography. Therefore, the concept of a "training set" is not directly applicable as described in modern AI/ML development. The device's calibration and validation would involve engineering specifications and clinical performance data, but not a "training set" in the AI sense.

9. How the ground truth for the training set was established

As the concept of a "training set" as understood in machine learning is not applicable to this device, the method for establishing its ground truth is not provided and not relevant in this context.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 15, 2016

Falck Medical, Inc. Francis Y. Falck, Jr., M.D., Ph.D., M.S. Chair, Scientific Advisory Board 35 Washington Street Mystic, CT 06355

Re: K151491

Trade/Device Name: Falck Medical Multifunction Tonometer, FAT1 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKY, HPK, NJJ Dated: December 7, 2015 Received: December 14, 2015

Dear Dr. Falck:

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, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

-(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation

(21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -A

for 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) K151491

Device Name

Falck Medical Multifunction Tonometer, FAT1

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Information:

1. Company Name/Address:	Falck Medical, Inc.35 Washington StreetMystic, CT 06355860-536-9000
2. Contact Information:	Francis Y. Falck, Jr., M.D., Ph.D., M.S.CEO, Chair Scientific Advisory Board
3. Manufacturing Location:	VR Industries, 333 Strawberry Field Road,Warwick, RI 02886

Device Information:

1. Device Trade Name: Falck Medical Multi-Function Tonometer (FAT1)
1. Classification Name: Tonometer
1. Classification Panel: 86 (Ophthalmic)
1. Classification Number: 886.1930
1. Product Codes: HKY, HPK, NJJ

Substantial Equivalence:

The Falck Medical Multi-Function Tonometer, (FATI) is substantially equivalent to the FAT2 device (K071755) for the measurement of intraccular pressure, ocular pulsatile amplitude and the force required to observe pulsation of the central retinal artery (Ophthalmodynamometry). The FAT1 device is technically and functionally equivalent to the Falck Medical, Inc. FAT2 device. The FAT1 device is also substantially equivalent to the Model 30 Classic Pneumatonometer with Tonography Option (K002395) for measuring the change in intraocular pressure with force application from the outflow of aqueous humor through the conventional outflow system (indentation Tonography).

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Intended Use:

Device Description:

Performance Testing:

The disposable prism was tested for biocompatibility. The prism and prism material in cyto-toxicity, systemic toxicity and ocular irritation testing was found to be non-toxic and safe. The FAT1 device is technically and functionally equivalent to the FAT2 device for the measurement of intraocular pressure, ocular pulsatile amplitude and the force required to observe pulsation of the central retinal artery. The accuracy and safety of the FAT2 device for the measurement of intraocular pressure, ocular pulsatile amplitude and the amount of force required to observe pulsation of the central retinal artery was demonstrated in performance testing in 510(k) K071755 and in additional correspondence with the Food and Drug Administration, Office of Device Evaluation dated 11/03/2009 and 01/10/2010 -FMI.

Bench testing and clinical testing done under FDA guidance with IDE (1080757) for the measurement of conventional outflow facility demonstrated the safety, repeatability, precision and accuracy of the FAT1.

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.