The Diaton Tonometer is intended to measure intraocular pressure (IOP). The device is intended for use as an aid in the diagnosis of glaucoma and for monitoring IOP.

Device Description

Tonometer diaton. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Diaton Tonometer, focusing on acceptance criteria and the study that proves the device meets those criteria:

Diaton Tonometer Acceptance Criteria and Performance Study

The provided document describes the predicate device comparison and technological characteristics but does not explicitly define quantitative acceptance criteria for the Diaton Tonometer's performance in a standalone study. Instead, the "Conclusion" section states that the "results of the comparison medical tests of Tonometer diaton and Goldmann tonometer demonstrated their high coincidence degree in the whole range with the compared devices." This suggests that the acceptance criteria were based on demonstrating substantial equivalence to the predicate device (Goldmann Manual Tonometer) in terms of IOP measurement accuracy.

Given the information, we can infer the reported device performance and the implicit acceptance criteria based on its equivalence to the Goldmann Tonometer.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter/Criteria	Acceptance Criteria (Inferred from Substantial Equivalence to Goldmann Tonometer)	Reported Device Performance
IOP Measurement Accuracy	High coincidence with Goldmann Manual Tonometer across its measurement range.	"The results of the comparison medical tests of Tonometer diaton and Goldmann tonometer demonstrated their high coincidence degree in the whole range with the compared devices. We achieved the same results from all devices." (This implies a level of accuracy comparable to the Goldmann Tonometer, which is the gold standard).
Measurement Range	Comparable to or suitable for clinical needs (5-60 mmHg specified).	5-60 mm Hg
Time of Single Measurement	Efficient for clinical use.	3 seconds (not more)
Painless diagnostics	Yes	Achieved without anesthetics and antiseptics
Elimination of infection risk	Yes	Achieved
Independence from cornea's crookedness	Yes	Achieved
Evaluation of IOP in patients after corneal operations	Yes	Achieved
IOP measurement in children	Yes	Achieved
Monitoring of Glaucoma treatment	Yes	Achieved

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

The document does not explicitly state the sample size of patients or eyes used in the "comparison medical tests." It vaguely refers to "medical tests."

Data Provenance: The company is based in Ryazan, Russia (Ryazan State Instrument-Making Enterprise), so it's highly probable the study data originated from Russia. The document does not specify if the study was retrospective or prospective, but clinical comparison tests are typically prospective.

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

The document refers to "comparison medical tests" where the Diaton Tonometer was compared to the Goldmann Tonometer. The Goldmann Tonometer is considered the clinical gold standard for IOP measurement. While it doesn't explicitly state "experts" establishing ground truth, the comparison implies that the Goldmann measurements served as the reference standard, which would typically be performed by trained ophthalmologists or technicians.

Qualifications of Experts: Not specified. However, for a Goldmann Tonometer, the measurements are performed by trained personnel, likely ophthalmologists, optometrists, or ophthalmic technicians.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. It simply states that the results of the Diaton Tonometer were compared to those of the Goldmann Tonometer.

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

No, an MRMC comparative effectiveness study is not mentioned. The study described is a comparison study between the Diaton Tonometer and a predicate device (Goldmann Tonometer) for direct measurement. It does not evaluate how human readers improve with or without AI assistance, as the Diaton Tonometer itself is a measurement device, not an AI-assisted diagnostic tool for human readers.

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

Yes, the study described is essentially a standalone performance assessment of the Diaton Tonometer. It measures the device's ability to determine IOP independently and then compares those measurements to a predicate device. The device provides an objective reading on an LCD screen without requiring human interpretation other than reading the displayed value.

7. The Type of Ground Truth Used

The ground truth used was the measurement obtained from the Goldmann Manual Tonometer. The Goldmann Tonometer is widely considered the clinical gold standard for intraocular pressure measurement. Therefore, the ground truth is based on a clinical gold standard measurement.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" or "training data." As this is a medical device for direct measurement rather than an AI/machine learning algorithm requiring training, the concept of a training set is not applicable in the context described. The focus is on the performance of the device itself (hardware and its embedded algorithm, if any) against a known standard.

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

As noted in point 8, there is no mention of a "training set" in the context of this device. Therefore, how its ground truth was established is not applicable. The device's measurement mechanism and calibration would have been established during its development and manufacturing, but this is distinct from establishing ground truth for a dataset used to train an AI model.

Summary

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K060780 2. 510 (k) Summary

6 2006 APR

2.1. Common

2.1.1. Regulatory Code

21 CFR 886.1930

2.1.2. Company Name/Contact

510(k) owner/holder:

Ryazan State Instrument-Making Enterprise 32 Kalyaev St. Ryazan, 390 000 Russia

Agent for Ryazan and Contact Person:

Boris Kun Bicom, Inc. 151 East Walnut Street Long Beach, NY 11561

phone: 516-431-3859 facsimile: 888-260-0606

2.1.3. Medical Specialty

Ophthalmic

2.1.4. Name of Device

Trade name: Common Name: Tonometer diaton Tonometer and accessories subpart B - Diagnostic devices

2.1.5. Product Code

HKX

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2.1.6. Device Class

Class II

2.1.7. Regulation Number

21 C.F.R. § 886.1930

2.1.8. Predicate Devices

Diaton is substantially equivalent to the following legally marketed devices:

Goldman Manual Tonometer(Golden Vision, Inc.)	510(k) Number:K981432
TGDC-01 "PRA"(Truevision Instruments)	510(k) Number:K021937

2.2. 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 diaton 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.

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

2.3. Technological Characteristics

Measurement range, mm Hg	5-60
The time of a single measurement, sec., not more	3
Autonomous power supply: feed element CR2032 “VARTA” or
similar. Supply voltage, V	3
Number of measurements using one feed element, not less	1500
Serviceability, years	5
Weight, g, not more	89
Dimensions, mm, not more	173,5x25,5x19,5

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2.4. Conclusion

The results of the comparison medical tests of Tonometer diaton and Goldmann tonometer 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 diaton advantages (anesthetics and antiseptics are not necessary; elimination of infection risk; shorttime measurement; results independent of cornea's crookedness) its wide application in ophthalmology is recommended alongside with Goldmann tonometer, esvecially 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 diaton represents an improvement to existing 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 diaton ideal for a wide range of application:

1 for mass examination of the population
1 at the patient's bedside
1 in geriatrics homes
10 in children hospitals
10 at the army
10 at home.

Tonometer diaton is not only good for determining the potential for glaucoma onset. It can also be used for monitoring treatment effectiveness throughout the day. Unlike other Tonometers, diaton can be used repeatedly during the day with no effect on the eve,

Tonometer diaton 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 non ition. The IOP measurement is displayed on an LCD screen of the device. To test the tonomoneters operational integrity there is a pressure control device provided.

Tonometer diaton uses the latest technologies, which provide it high reliability, quality and longevity.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 6 2006

Ryazan State Instrument-Making Enterprise c/o Mr. Neil E. Devine Jr. Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087

Re: K060780

Trade/Device Name: Diaton Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer & Accessories Regulatory Class: Class II Product Code: HKX Dated: March 21, 2006 Received: March 22, 2006

Dear Mr. Devine:

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. Neil E. Devine Jr.

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 Office of Compliance at (301) 827-8910. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

MB Eychhus - MD

Malvina B. Eydelman, M.D. Division 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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Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Diaton Tonometer

Indications for Use:

The Diaton Tonometer is intended to measure intraocular pressure (IOP). The device is intended for use as an aid in the diagnosis of glaucoma and for monitoring IOP.

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 A NOTHER PAGE IF NEEDED) www.rada.com/w/index.com/w/index.com/w/index.php?title=1900","includes":nullance":nullance.com

Concurrence of CDRH, Office of Device Evaluation (ODE)

Denis L. McCarthy

510(k) Number K060780

Page 1 of 1

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.