The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

Device Description

The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of the human eye.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TOMEY NON-CONTACT TONOMETER FT-1000. This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics of the new device itself.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, expert qualifications, and detailed performance metrics cannot be found in the provided text. The document's purpose is to demonstrate that the new device is as safe and effective as a legally marketed predicate, not to report on an independent clinical trial meeting specific quantitative acceptance criteria for the new device's performance.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria in the quantitative sense (e.g., "sensitivity must be > X%, specificity > Y%"). Instead, it relies on a comparison table to establish equivalence in technical characteristics and indication for use with the predicate device.

Feature	Predicate Device (CANON TONOMETER TX-F)	TOMEY NON-CONTACT TONOMETER FT-1000	"Acceptance" (Equivalence Claim)
Device Type	Non-contact (air-puff) type	Same as TX-F	Equivalent
Indication for Use	For measurement of intraocular pressure.	For measurement of intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.	Equivalent (expanded for screening/diagnosis)
Measurable Range	0 to 60 mmHg (auto shifting)	0 to 60 mmHg (manual changing)	Equivalent (range)
Measuring Increment	1 mmHg	Same as TX-F	Equivalent
Measuring Unit	mmHg	mmHg / hPa	Equivalent (with added unit)
Operation Distance	11.3mm	11.0mm	Similar
Safety Mechanism	Software Controlled Stopper	Software Controlled Stopper (Same as TX-F), Touch Sensor	Equivalent (with added feature)
Memory	Max. 10 measurements for each eye	Same as TX-F	Equivalent
Data Output	RS232C	Same as TX-F	Equivalent
Power-saving	Available	Same as TX-F	Equivalent
Printer	Thermal line printer	Same as TX-F	Equivalent
Chin Rest	Power assisted	Same as TX-F	Equivalent
Power Supply	AC100-240V, 50/60Hz, 0.4-0.8A, Approx.80VA	AC100-240V, 50/60Hz, 85-110VA	Similar

2. Sample size used for the test set and the data provenance:

The provided text does not include information on a specific test set, its sample size, or data provenance for proving the device's performance against defined acceptance criteria. The submission focuses on technical and functional comparison to a predicate device.

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

This information is not available in the provided document. As no specific test set is described, there's no mention of experts establishing ground truth.

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

This information is not available in the provided document.

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:

This information is not available and is not relevant to this submission, which is for a standalone measurement device rather than an AI-assisted diagnostic tool for human readers.

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

The device described is a standalone measurement device (a tonometer) that measures intraocular pressure. Its performance is inherent to the device itself. The primary "study" presented is the comparison to the predicate device, demonstrating that its technical characteristics and function are substantially equivalent. The 510(k) process often relies on such comparisons rather than new, large-scale clinical trials if substantial equivalence can be demonstrated through technical and functional grounds.

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

The concept of "ground truth" in the diagnostic sense (e.g., for sensitivity/specificity) is not explicitly addressed as no diagnostic performance study of the new device is detailed. For a measurement device like a tonometer, the "truth" would typically relate to the accuracy and precision of its IOP measurements compared to a gold standard tonometry method (e.g., Goldmann applanation tonometry) if a clinical study were performed to establish these. However, this level of detail for a new study is not present. The submission relies on the predicate's established performance as a reference.

8. The sample size for the training set:

This information is not available. The device is an electro-mechanical measurement device, and the concept of a "training set" in the context of an algorithm or AI model does not apply here.

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

This information is not available for the reason stated in point 8.

Summary

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K073087

1. Company Identification

TOMEY CORP. 2-11-33 Noritakeshinmachi, Nishi-ku, Nagoya, Aichi, JAPAN 451-0051 Tel: +81-52-581-5592 Fax: +81-52-581-5955

2. Official Correspondent

Tomoko Watanabe (Ms.) International Dept.

NOV 1 8 2008

1. Date of Submission October 31, 2007

4. Device Trade name NON-CONTACT TONOMETER FT-1000

5. Common/Usual Name

Tonometer and accessories

6. Classification Number

Class II, 86HKX, 21 CFR 886.1930 - Tonometer AC-Powered

7. Predicate Device

Manufacturer : Canon Inc. : FULL AUTO TONOMETER TX-F Trade Name 510(k) No. : K023816

8. Description of Device

The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of the human eye.

9. Indication for use

The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraccular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

10. Technical Characteristics

Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are equivalent in the areas of fechnical characteristics, general functions.

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Appendix 1: Comparison Table with Predicate Device

Manufacturer/ Model	CANON TONOMETER TX-F(K023816)	TOMEYNON-CONTACT TONOMETERFT-1000
Type	Non-contact (air-puff) type	Same as TX-F
Indication for Use	The Canon FULL AUTOTONOMETER TX-F is intended tobe used for the measurement ofintraocular pressure of the humaneye.	The NON-CONTACTTONOMETER FT-1000 isindicated for the measurement ofintraocular pressure withoutcontacting the eye to aid in thescreening and diagnosis ofglaucoma.
Measurable range	0 to 60 mmHgIncludes automatic shiftingbetween 30/60 mmHg	0 to 60 mmHg(manually changing between 30/60mmHg)
Measuring increment	1 mmHg	Same as TX-F
Measuring unit	mmHg	mmHg / hPa
Fixation Target	LED(green)	LED(orange)
Operation distance	11.3mm	11.0mm
Observation range	Approx. 15 x 12 mm	Approx. 15 x 9 mm
Alignment	Full Auto/Auto/ManualFull auto R/L, Alignment, ShotAuto Alignment, Shot	Auto alignmentAuto shot(These are set independently)Touch alignment
Safety Mechanism	Software Controlled Stopper	Software Controlled Stopper(Sameas TX-F)Touch Sensor
Memory	Max. 10 measurements for eacheye	Same as TX-F
Data output	RS232C	Same as TX-F
Power-saving system	Available	Same as TX-F
Display	5-inch monochrome CRT monitor	5.7-inch color LCD monitor
Printer	Thermal line printer	Same as TX-F
Chin Rest	Power assisted	Same as TX-F
Power Supply	AC100-240V,50/60Hz,0.4-0.8A,Approx.80VA	AC100-240V,50/60Hz,85-110VA
Operating range(Movable range)	Front/back: 40mmLeft/right: 90mmUp/Down: 30mm	Front/back: 40mmLeft/right: 88mmUp/Down: 45mm
Dimensions	280(W)x520(D)x495(H)mm	306(W)x493(D)x463(H)mm
Wight	20.5kg(45.2lbs.)	Approx. 18kg

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tomey Corporation c/o Kojo Kubo Comos Corporation 3F, 2-17 Akebono-cho. Tachikawa Tokyo 190-0012 Japan

NOV 1 8 2008

Re: K073087

Trade Device Name: Non-Contact Tonometer FT-1000 Regulation Number: 21 CFR 886.1930 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: HKX Dated: November 7, 2008 Received: November 10, 2008

Dear Mr. Kubo:

This letter corrects our substantially equivalent letter of November 18, 2008.

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 (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 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Malina Berglund

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): K073087

Device Name : NON-CONTACT TONOMETER, FT-1000

Indications For Use:

The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am I right

Division Sign-Off)
Division of Ophthalmic and Ear,
Nose and Throat Devices

510(k) Number K073087

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.