The Canon Full Auto Tonometer TX-20 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

The provided text is a 510(k) summary for the Canon Full Auto Tonometer TX-20. It states that the device is substantially equivalent to a predicate device (Canon Full Auto Tonometer TX-F) and details its intended use, but it does not contain specific acceptance criteria, a detailed study design with sample sizes, expert qualifications, or comparative effectiveness results. The document emphasizes substantial equivalence based on performance testing (electrical safety, electromagnetic compatibility) and design control activities, rather than a clinical study establishing new performance metrics.

Therefore, for aspects of your request related to specific acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC study), the provided text does not contain this information. The response will reflect the information that is present in the document.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., accuracy, precision targets) for the Canon Full Auto Tonometer TX-20, nor does it report detailed performance data against such criteria. Instead, it relies on demonstrating substantial equivalence to an existing predicate device (Canon Full Auto Tonometer TX-F, K023816). The "Performance testing" section vaguely states that "Evaluation performed on the TX-20 demonstrated that it's safe and effective."

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of specific performance metrics (e.g., accuracy, precision, sensitivity, specificity).	Substantially equivalent to predicate device Canon Full Auto Tonometer TX-F (K023816) in terms of intended use, safety, and effectiveness.
Compliance with applicable electrical safety and electromagnetic compatibility standards and guidances.	The TX-20 complies with applicable standards and guidances.
Demonstrates safety and effectiveness.	Evaluation performed on the TX-20 demonstrated that it's safe and effective.

Study Information

The document does not describe a clinical study in the traditional sense with a test set, training set, or ground truth data. Instead, it refers to "Performance testing" to demonstrate substantial equivalence.

Sample size used for the test set and the data provenance: Not specified. The document mentions "Performance testing" but does not detail the sample size (e.g., number of subjects or measurements) used for any such testing. No data provenance (e.g., country of origin, retrospective/prospective) is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth establishment for a test set is described. The device's performance is asserted through comparison to a predicate and compliance with technical standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study or ground truth establishment requiring adjudication is described.
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. The device is a tonometer, which directly measures intraocular pressure, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The TX-20 is described as a "Full Auto Tonometer," implying standalone (automated) operation to measure intraocular pressure. However, no specific standalone performance metrics (e.g., accuracy against a gold standard) are detailed beyond the claim of substantial equivalence to the predicate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For a tonometer, "ground truth" would typically refer to measurements taken by a highly accurate reference method, but no such reference or ground truth method is detailed in this submission. The basis for safety and effectiveness is substantial equivalence to the predicate.
The sample size for the training set: Not applicable. This document pertains to a medical device (tonometer) which does not appear to involve machine learning models that require a "training set" in the context of data-driven AI.
How the ground truth for the training set was established: Not applicable, for the reason stated above.

Summary

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Section 5: 510(k) Summary 510(k) Summary

SEP 2 0 2011

Prepared:

June 17, 2011

New Model

Submitter/Holder:

Company Name: Company Address: Contact Person: Phone Number: Fax Number:

CANON INC. 30-2 Shimomaruko 3-chome, Ohta-ku, Tokyo 146-8501, Japan Naoyasu Asaka (81)3-3758-2111 (81)3-5482-3960

Proposed Device:

Reason For 510(k): Trade Name: Model Name: Classification Name: FDA 510(k) #:

Predicate Device:

Trade Name: Model Name: Classification Name: FDA 510(k) #:

CANON INC. Full Auto Tonometer TX-20P HKX, Tonometer and accessories. To be assigned

CANON INC. Canon Full Auto Tonometer TX-F HKX, Tonometer and accessories. K023816

Description of Device:

The Canon Full Auto Tonometer TX-20 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-20 is intended to be used for the measurement of intraocular pressure of the human eye.

Comparison to Predicate:

The TX-20 is substantially equivalent to the predicate device identified previously with regard to intended use, safety and effectiveness.

Performance testing:

The Electrical safety, Electromagnetic compatibility and other performance testings were performed on the TX-20 and the TX-20 complies with applicable standards and guidances. Evaluation performed on the TX-20 demonstrated that it's safe and effective.

Conclusion:

The Performance Data demonstrate that TX-20 is as safe and effective as predicate device, Canon Full Auto Based on the information in this submission, similarity to predicate device, and the results Tonometer TX-F. of our design control activities and non-clinical testing, it is the opinion of CANON INC. that the Full Auto Tonometer TX-20 described in this submission is substantially equivalent to predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10905 New Hampshire Avenue Document Control Room WO66-G609 Silver Spring, MI) 20993-0002

Canon, Inc. - Medical Equipment Group c/o Mr. Koji Kubo Manager Cosmos Corporation 6-5-3 Beaune Honkomagome 2F, Honkomagome, Bunkyo-ku Tokyo. 113-0021 Japan

SEP 2 0 2011

Re: K111710

Trade/Device Name: Canon TX-20 Full Auto Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HKX Dated: August 30. 2011 Received: August 31, 2011

Dear Mr. Kubo:

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.

ff 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.

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Page 2 -- Mr. Koji Kubo

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 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,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Fesia Alexander

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Malvina B. Eydelman. M.D. Director Division of Ophthalmic. Neurological. 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): Kl(17170 Full Auto Tonometer TX-20 Device Name: Indications for Use: The Canon Full Auto Tonometer TX-20 is intended to be used for the measurement of intraccular pressure of the human eye. Prescription Use OR × Over-The-Counter Use (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

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(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111710

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.