The Canon FULL AUTO TONOMETER TX-F is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure with the help of a full auto-alignment system.

AI/ML Overview

This is a 510(k) premarket notification for a medical device submitted to the FDA. Such submissions focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a PMA (Pre-Market Approval) or de novo submission might for novel devices.

Therefore, the provided document does not contain the specific information requested in your prompt regarding acceptance criteria and a detailed study proving device performance as typically expected for advanced AI/ML models.

Here's a breakdown of why and what information can be inferred from the document:

Why the requested information is not present:

Type of Device: The Canon FULL AUTO TONOMETER TX-F is a tonometer, a physical medical device for measuring intraocular pressure. It's not described as an AI/ML powered device or software.
Regulatory Pathway: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device (in this case, the Canon TX-10 Tonometer). This pathway generally focuses on comparing technical characteristics, materials, and intended use, rather than extensive clinical efficacy studies with predefined acceptance criteria for novel performance metrics.
Date: The submission is from 2002, long before the widespread use and regulatory guidelines for AI/ML in medical devices became common.

Based on the provided text, the following specific questions cannot be answered:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth.
Adjudication method.
MRMC comparative effectiveness study results or effect size.
Standalone performance in the context of an algorithm.
Type of ground truth used in the context of image interpretation or complex diagnostic algorithms.
Sample size for the training set.
How ground truth for the training set was established.

What can be extracted or inferred from the document about "acceptance criteria" and "study":

While not explicitly called "acceptance criteria" in the AI/ML sense, the core of this 510(k) is demonstrating performance equivalent to the predicate device. The "study" here is essentially the comparison itself, showing that the new device measures intraocular pressure effectively and safely, similar to its predecessor.

1. A table of acceptance criteria and the reported device performance:

Inferred "Acceptance Criteria": The primary "acceptance criteria" for a 510(k) device like this is demonstrating substantial equivalence to the predicate device (Canon TX-10 Tonometer) in terms of safety and effectiveness. This is achieved by showing that the new device performs its intended function (measurement of intraocular pressure) within similar parameters and doesn't raise new questions of safety or effectiveness.
Reported Device Performance: The primary "performance" reported is through the "CANON TONOMETER COMPARISON CAHRT" included in the document. This chart compares technical specifications, implying that similar specifications and functionality demonstrate equivalent performance.

Category	Predicate Device (CANON TONOMETER TX-10)	Proposed Device (CANON TONOMETER TX-F)	Implied Equivalence/Performance
Measuring Range	0-30/0-60mmHg (Automatic setting)	Same as TX-10	Equivalent
Alignment Method	Auto Mode (Monitor and auto alignment), Manual Mode (Monitor with 2 dots)	Full Auto Mode (Monitor and auto alignment, Change R/L position), Auto Mode (Same as TX-10), Manual Mode (Same as TX-10)	Equivalent/Enhanced Functionality
Increment	1mmHg	Same as TX-10	Equivalent
Measuring Time	3 milliseconds (0.003 second)	Same as TX-10	Equivalent
Fixation Target	LED (green)	Same as TX-10	Equivalent
Chin Rest	Power assisted (driving at controller)	Same as TX-10	Equivalent
Safety Mechanism	Software Controlled Stopper	Same as TX-10	Equivalent
Printout Format	R/L, Date, time, average, ID, 3 or 10 data for each eye	Same as TX-10	Equivalent
Display	4" (inch) Color LCD	5" (inch) B/W CRT	Different (larger, B/W vs Color but deemed equivalent for function)
Dimensions (mm)	Body: 299x340x177, Controller: 170x183x177	280x540x480±15 (Note: This combines body and controller dimensions into one unit, implying a design change, but overall functionality deemed equivalent)	Different (design), but functionally equivalent
Weight (kg)	Body: 16.0, Controller: 1.5	20.5	Different (total weight), but functionally equivalent

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

Not provided. For a 510(k) of this nature, clinical study data with specific patient sample sizes, if any, would be presented in a separate section if required for demonstrating equivalence beyond technical specifications, or would be part of internal testing not explicitly detailed in the public 510(k) summary. The comparison chart indicates technical equivalence.

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

Not applicable/Not provided. This is a physical measurement device, not an interpretive AI system. "Ground truth" would refer to the true intraocular pressure, typically measured by a gold standard method. Clinical studies, if performed, would compare the device's measurements against such a standard, but details are not in this summary.

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

Not applicable/Not provided.

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:

Not applicable. This device is not an AI-assisted diagnostic tool involving human readers interpreting cases.

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

Not applicable. This is a standalone tonometer, a physical device, not an algorithm. Its performance is its ability to measure IOP. The comparison chart serves as the "standalone" performance assessment by comparing its specifications to a predicate device.

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

Not explicitly stated in the summary. For a tonometer, the "ground truth" would implicitly be the actual intraocular pressure, potentially verified by a reference tonometer or a more invasive gold standard (e.g., manometry in a research setting) if clinical accuracy studies were conducted. However, the FDA found substantial equivalence based on the technical comparison.

8. The sample size for the training set:

Not applicable/Not provided. This is not an AI/ML device that undergoes "training."

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

Not applicable/Not provided.

Summary

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K023816

510(k) Summary

NOV 2 6 2002

Prepared: August 22, 2002

Submitter:

Company Name:	Canon USA, Inc. (U.S. agent/official correspondent for Canon Inc.)
Company Address:	One Canon PlazaLake Success, NY 11042 U.S.A.
Contact Person:	Sheila Driscoll, Senior Product Safety Engineer
Phone Number:	(516) 328-5602
Fax Number:	(516) 328-5169

Proposed Device:

Reason For 510(k):	New Model
Manufacturer:	Canon Inc.
Trade Name:	Canon
Model Name:	FULL AUTO TONOMETER TX-F
Classification Name:	86HKX, Tonometer, AC powered
Classification #:	886.1930
FDA 510(k) #:	To be assigned

Predicate Device:

Manufacturer:	Canon Inc.
Trade Name:	Canon
Model Name:	TX-10 Tonometer
Classification Name:	86HKX, Tonometer, AC powered
Classification #:	886.1930
FDA 510(k) #:	K963079

Description Of Device:

The Canon FULL AUTO TONOMETER TX-F is a tonometer designed using a non-contact measurement system.

Air puff gently measures the intraocular pressure with the help of a full auto-alignment system.

Intended Use:

The Canon FULL AUTO TONOMETER TX-F is intended to be used for the measurement of intraocular pressure of the human eye.

Technical Characteristics:

Please refer to the attached COMPARISON CHART.

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	Model	CANON TONOMETER TX-10	CANON TONOMETER TX-F
Specification	Measuring RangeSetting	0-30/0-60mmHg(Automatic)	Same as TX-10
	Alignment Method	Auto ModeMonitor and auto alignment	Full Auto ModeMonitor and auto alignmentand Change R/L positionAuto Mode
			Same as TX-10
	Manual Mode	Manual ModeMonitor with two dots	Same as TX-10
	Increment	1mmHg	Same as TX-10
	Measuring Time	3 millisecond(0.003 second)	Same as TX-10
	Fixation Target	LED(green)	Same as TX-10
	Chin Rest	Power assisted(driving at controller)	Same as TX-10
	Safety Mechanism	Software Controlled Stopper	Same as TX-10
Printout Format		R/L,Date,time,avarage,ID,3 or 10 data for each eye	Same as TX-10
	Display	4"(inch)Color LCD	5"(inch)B/W CRT
Dimentions(with×depth×height)mm		Body299×340×177Controller170×183×177	280×540×480±15
Weight(kg)		Body16.0Controller1.5	20.5

CANON TONOMETER COMPARISON CAHRT

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Canon USA. Inc. Underwriters Laboratories Inc. B c/o Mr. Kent Donhue 1285 Walt Whitman Road Melville, NY 11747

Re: K023816

Trade Name: Canon "Full Auto Tonometer TX-F" Classification Regulation Number: 886.1930 Regulatory Class: II Product Code: HKX Dated: November 1, 2002 Received: November 15, 2002

Dear Mr. Donhue:

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. Kent Donhu

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 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 http://www.fda.gov/cdrlv/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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K023816

Indications Statement

of l

510(K)Number(if known):

Device Name: FULL AUTO TONOMETER TX-F

Indications for Use:

The Canon FULL AUTO TONOMETER TX-F is intended to be used for the measurement of intraocular pressure of the human eye.

LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use	✓ OR Over-The-Counter Use
(Per 21 CFR 801.109)	(Optional Format 1-2-96)

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

510(k) Number	K023816
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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.