The TGDc-01 "PRA" is a portable tonometer that measures IOP through the eyelid in the sclera area. It has a measurement range of 5-60 mm Hg, a single measurement time of not more than 3 seconds, and uses 2 CR2032 batteries. It weighs not more than 79 g and has dimensions of 173.5 x 25.5 x 19.5 mm. It displays the IOP measurement on an LCD screen.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Tonometer TGDc-01 "PRA", based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a formal study with statistical targets for performance. Instead, it relies on a qualitative comparison to predicate devices and highlights the device's technological characteristics.

However, based on the narrative, the implicit acceptance criteria are that the TGDc-01 "PRA" performs equivalently to the predicate devices (Goldmann Tonometer and Canon T-2 Non-Contact Tonometer) in terms of IOP measurement, particularly demonstrating "high coincidence degree in the whole range."

Acceptance Criteria (Inferred from Narrative)	Reported Device Performance
IOP Measurement Equivalence to Predicate Devices	"high coincidence degree in the whole range with the compared devices."
Measurement Range: 5-60 mm Hg	5-60 mm Hg
Single Measurement Time: <= 3 sec	3 sec.
Autonomous Power Supply with 2 CR2032 batteries	2 feed elements CR2032
Number of Measurements per Battery Set: >= 1500	1500 (not less)
Serviceability: >= 8 years	8 years (not less)
Weight: <= 79 g	79 g (not more)
Dimensions: <= 173.5 x 25.5 x 19.5 mm	173.5 x 25.5 x 19.5 mm (not more)
No direct effect on the cornea	+ (Yes)
Portability	+ (Yes)
Independence from cornea's crookedness	+ (Yes)
Digital IOP indication	+ (Yes)
Measurement in sitting position	+ (Yes)
Measurement in supine position	+ (Yes)
Short-time measurement	+ (Yes)
Sterilization not required	+ (Yes)
Anesthesia not required	+ (Yes)

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

The document does not explicitly state the sample size used for the comparison medical tests.
The data provenance is from Russia, as the manufacturer is the "Ryazan State Instrument-Making Enterprise" in Ryazan, Russia.
The study appears to be retrospective in the context of summarizing existing comparison medical tests, although the tests themselves would have been prospective.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The statement "We achieved the same results from all devices" suggests a direct comparison rather than a consensus-based adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done with human readers improving with AI vs. without AI assistance. The Tonometer TGDc-01 "PRA" is a medical device for measuring Intraocular Pressure (IOP), not an AI-powered diagnostic system requiring human reader interaction for interpretation.

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

The device itself is a standalone measurement tool. The "comparison medical tests" inherently evaluate its standalone performance against other standalone tonometers. There is no "algorithm" in the modern AI sense that would have a separate standalone evaluation beyond the device's primary function. The device's output (IOP measurement) is a direct reading.

7. The Type of Ground Truth Used

The ground truth for the comparison medical tests was established by measurements from legally marketed predicate devices, specifically the Goldmann Tonometer and the Canon T-2 Non-Contact Tonometer. These devices are considered the established standard for IOP measurement. Since the document states "We achieved the same results from all devices," this implies the predicate device readings served as the reference.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a measurement instrument, not a learning algorithm that requires a training set.

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

As there is no mention of a training set, there is no ground truth establishment method described for one. The device's functionality is based on its physical measurement principles, not on learned patterns from a dataset.

Summary

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KO21937

10. 510 (k) Summary

10.1. Common

OCT 11 2002

10.1.1. Requlatory Code

Code of Federal Regulations Title 21, Volume 8: Revised as of April 1, 2001 21CFR886.1930

10.1.2. Company Name/Contact

Distributor in USA: Ralf Thomaier Truevision Instruments 4220 Cesar Chavez #536 San Francisco, CA94131 Tel: (415)-643 98 38 Fax: (415)-643 98 39

Manufacturer: Ryazan State Instrument-Making Enterprise 32 Kalvaev St. Ryazan, 390 000 Russia

10.1.3. Medical Specialty

Ophthalmic

10.1.4. Name of Device

Trade name: Common Name: Tonometer TGDc-01"PRA" Tonometer and accessories subpart B - Diagnostic devices

10.1.5. Product Code

HKX

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10.1.6. Device Class

Class II

10.1.7. Regulation Number

886.1930

10.1.8. Predicate Devices

The TGDc-01 "PRA" is substantially equivalent to the following legally marketed devices:

GOLDMAN MANUALTONOMETERproduced byGOLDEN VISION, INC.7436 S.W. 117THAVE.,SUITE 103MIAMI, FL 33183 3816	510(k) Number:K981432
CANONNON-CONTACTTONOMETER T-2produced byCANON, INC.30-2SHIMOMARUKO3-CHOMEOHTA-KU,TOKYO, JAPAN,JA 146	510(k) Number:K943939

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10.2. Intended Use

Quick and accurate measurement of IOP in various situations independent of place and time is the dream of every ophthalmologist. Today the portable tonometer TGDc-01 "PRA" gives you that capability. This new IOP measuring method through the eyelid in the sclera area, unique to our device, eliminates completely any effect on the mucous eye membrane.

Painless diagnostics without anesthetics and antiseptics .
Elimination of infection risk .
Measuring results independent of cornea's crookedness .
Evaluation of IOP in patients after any operations on cornea .
IOP measurement in children .
Monitoring of Glaucoma treatment .

10.3. Technological Characteristics

Measurement range	5-60 mm Hg
The time of a single measurement, not more	3 sec.
Autonomous power supply: 2 feed elements CR2032"VARTA" or similar. Supply voltage	3 V
Number of measurements using one set of feed elements, 1500not less
Serviceability, not less	8 years
Weight, not more	79 g
Dimensions, not more	173,5 õ 25,5 õ 19,5 mm

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FEATURES	TGDc-01	GoldmannTonometer	ShiotzTonometer	Air-jet	Tono Pen
No direct effect on the cornea	+
Portability	+		+		+
Displays independence fromcornea's crookedness.	+		+	+
Digital IOP indication	+	+		+	+
Measurement in sitting position	+	+		+	+
Measurement in supine position	+		+	+	+
Short-time measurement	+			+	+
Sterilization is not required	+			+	+
Anesthesia is not required	+			+

10.4. Conclusion

The results of the comparison medical tests of Tonometer TGDc-01 "PRA" and Goldmann tonometer as well as Canon Tonometer T-2 demonstrated their high coincidence degree in the whole range with the compared devices. We achieved the same results from all devices.

Taking into account the comparison medical tests findings as well as tonometer TGDc-01 "PRA" advantages (anesthetics and antiseptics are not necessary; elimination of infection risk; short-time measurement; results independent of cornea's crookedness) its wide application in ophthalmology is recommended alongside with Goldmann tonometer and Canon tonometer, especially while carrying out mass examination of population. Also, it is recommended for use at home to control ophthalmotonus condition under drugs and medical treatment.

Tonometer TGDc-01 "PRA" represents new technology to ophthalmology. It is compact, handy, and can be easily placed in a smock pocket or in a handbag.

Portability, safety and simplicity make tonometer TGDc-01 "PRA" ideal for a wide range of application:

· for mass examination of the population
· at the patient's bedside

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in geriatrics homes .
· in children hospitals
· at the army
at home. .

Tonometer TGDc-01 "PRA" is not only good for determining the potential for glaucoma onset. It can also be used for monitoring treatement effectiveness throughout the day. Unlike other Tonometers, TGDc-01 "PRA" can be used repeatedly during the day with no effect on the eye.

Tonometer TGDc-01 "PRA" is easy to use. A simple operating manual will be provided with each device. It takes only some seconds to measure the IOP, with the patient in a sitting or supine position. The IOP measurement is displayed on an LCD screen of the device. To test the tonometer's operational integrity there is a pressure control device provided.

Tonometer TGDc-01 "PRA" uses the latest technologies which provide it high reliability, quality and longevity.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

OCT 1 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Truevision Instruments c/o Mr. Ralf Thomaier 4220 Cesar Chavez #536 San Francisco, CA 94131

Re: K021937

Trade Name: Tonometer TGDc-01 "PRA" Classification Regulation Number: 886.1930 Regulatory Class: II Product Code: HKX Dated: September 19, 2002 Received: September 23, 2002

Dear Mr. Thomaier:

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.

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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Page 2 - Mr. Ralf Thomaier

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 proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address littp://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATION FOR USE FORM

FDA/CDRH/510K PROGRAM

510(k) Number (if known): K 02i 937 TONO METE -01 PRA Device Name: 760c Indications For Use:

The TGDC - 01 PRA Tonometer is isseel to ineasur ocular pressure ( 10P) in the diagnosis for use The tended clevictis 0, 1101

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

James L Mc Carthy
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K021937

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.