The Keeler Applanation Tonometer is a screening device used to measure intraocular pressure which is one of the factors considered in diagnosing glaucoma. The product is a non-active medical device and is completely mechanical, therefore without electrical components. The operation principal is based on Goldmann applanation method. The product is installed on a special support on the slit lamp and is used in conjunction with commercially available slit lamps.

AI/ML Overview

Let's break down the information provided about the Keeler Applanation Tonometer (KAT) and its performance study.

Based on the provided K093445 submission, the Keeler Applanation Tonometer is a manual contact tonometer and its submission is based on substantial equivalence to predicate devices, rather than a standalone clinical study with defined acceptance criteria and specific performance metrics in the way one might see for an AI/software device. For mechanical devices like this, the 'acceptance criteria' are typically met by demonstrating that the device functions identically or equivalently to legally marketed devices, and passes relevant engineering standards.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" for a diagnostic accuracy as seen in AI or complex diagnostic devices isn't directly applied here. Instead, the "acceptance criteria" are implied by substantial equivalence to predicate devices and adherence to relevant standards. The performance is assessed by comparison.

Criterion Type	Acceptance Criteria (Implied)	Reported Device Performance (Keeler Applanation Tonometer)
Technological Equivalence (Bench Testing)	Device must possess comparable technological characteristics (type, indication, design, prism material, measurement range, measurement technique, measurement method, calibration, intended use) to predicate devices. Device must meet nominal requirements of Tonometer Standard BSENISO 8612:2001. The KAT has identical technological characteristics to both predicate devices (CSO F900/A900 and Haag-Streit AT 900) across all listed criteria. Bench testing verified KAT units against the nominal requirements of Tonometer Standard BSENISO 8612:2001. Comparative bench study showed KAT and predicate devices were "substantially equivalent" when subjected to the same nominal standard requirements.
Clinical Equivalence (Field Trial)	Device performance in a clinical setting should be comparable to predicate devices. The field test, conducted by an ophthalmic professional, confirmed that the findings with the KAT were "comparable" to its predicate device.
Safety and Effectiveness	Device is as safe and effective as predicate devices.	Based on all performance testing (bench and field), the Keeler Applanation Tonometer is "judged to be as safe, as effective and performs as well as the predicate devices."

Study Information & Data Provenance

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size for patients or measurements in the provided document. The "bench testing" would involve a sample of the manufactured devices, and the "field trial" would involve some number of patients/eyes tested by an ophthalmic professional. However, specific numbers are not given.
- Data Provenance: The bench testing and field trial were likely conducted by the manufacturer or on their behalf. The country of origin of the data is implied to be within the UK (where the manufacturer is located), but this is not explicitly stated for the studies themselves. The studies appear to be prospective in nature, as they were conducted to test the performance of the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The field test was conducted by "an ophthalmic professional." This implies at least one expert, but doesn't specify if it was a single individual or a group, nor are their specific qualifications (e.g., years of experience, sub-specialty) detailed.
- Qualifications of Experts: Described as "ophthalmic professional." No further detail (e.g., ophthalmologist, optometrist, specific experience) is provided.
Adjudication method for the test set:
- Not applicable/Not explicitly stated in the context of this submission. For substantial equivalence of a general-purpose mechanical device, an adjudication method for ground truth is typically not required as it would be for a complex diagnostic algorithm. The comparison is against established, legally marketed devices.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant to evaluating AI (artificial intelligence) systems or other diagnostic aids where human interpretation is assisted. The Keeler Applanation Tonometer is a purely mechanical device, not an AI system. Therefore, this question is not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This question is also not applicable as the Keeler Applanation Tonometer is a manual, mechanical device and does not involve an algorithm or AI. Its operation inherently requires a human operator ("manual contact tonometer").
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the "ground truth" was adherence to the Tonometer Standard BSENISO 8612:2001 and direct comparison of measurements against the predicate devices.
- For the field trial, the "ground truth" was likely the intraocular pressure (IOP) readings obtained by the "ophthalmic professional" using both the Keeler Applanation Tonometer and the predicate device(s) on actual patients, with comparability being the key outcome. It's not based on pathology or outcomes data in the sense of disease progression, but on the agreement of the measurement value itself.
The sample size for the training set:
- Not applicable. The Keeler Applanation Tonometer is a mechanical device, not a machine learning model. Therefore, it does not have a "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth for a training set.

Summary

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K093445

Abbreviated 510(k) Summary

Manufacturer's information

Company Name: Keeler Ltd

Company Address: Clewer Hill Road

Windsor

SL4 4AA

Contact Person: Neil Atkins

Telephone: +44 (0)1753 857177 +44 (0)1753 827145 · Fax:

Submitter's information

The submitter of this pre-market notification is:

Mr. Eugene VanArsdale (Marketing Manager). Keeler Instruments Inc 456. Parkway, Broomall, PA 19008 Company Phone No: (610) 353 4350 Company Fax No: (610) 353 7814

Date summary prepared: January 04, 2010

Proposed Device Identification

Device Trade Name:	Keeler Applanation Tonometer
Common Name:	Goldmann Tonometer
Class:	2
Classification Panel:	86
Product Code:	HKY
Regulation Number:	886.1930

Indications for Use

The Keeler Applanation Tonometer is indicated for measuring intraccular pressure to aid in the screening and diagnosis of Glaucoma.

Device Description and intended use

JAN 1 9 2010

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The operation principal is based on Goldmann applanation method.

The product is installed on a special support on the slit lamp and is used in conjunction with commercially available slit lamps.

Predicated Devices

Keeler Applanation Tonometer is judged to be substantially equivalent in safety, effectiveness and intended use to the following legally marketed devices:

Substantial Equivalence 1:

Predicate Device:	F900 and A900, CSO
510(k) No:	K022054
Manufacturer:	CSO S.R.L

Substantial Equivalence 2:
Predicate Device:	Haag Streit AT 900
510(k) No:	K981432
Manufacturer:	Haag-Streit

Substantial Equivalence Comparison

Table below shows the comparison of Keeler Applanation Tonometer to predicate devices. The comparison of intended use and technological features of KAT indicate that the device is substantially equivalent to legally marketed predicate devices.

Comparison of Goldmann Tonometer Technological CharacteristicsKeeler Applanation Tonometer vs. CSO Tonometer
Criteria	Predicate DeviceF900 and A900,CSO Tonometers(Re:510(k)K022054)	Keeler Applanation Tonometer (KAT)
Type	Manual contactTonometer	Manual contact Tonometer
Indication	Intraocular Pressure(IOP) measurement	Intraocular Pressure (IOP)measurement
Design	Slit lamp mountedmanual dial	Slit lamp mounted manual dial
Prism Material	Acrylic (PMMA)	Acrylic (PMMA)
Measurement Range	0-80mmHg	0-80mmHg
Measurementtechnique	Applanation	Applanation
Measurement Method	Direct reading ofIOP in mmHg (eachdivision on dial ofmeasuring drum isequal to 0.2gmf(1.96mN))	Direct reading of IOP in mmHg (eachdivision on dial of measuring drum isequal to 0.2gmf (1.96mN))
Calibration	Maintenance and	Maintenance and calibration required

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	calibration required
Intended use	Instrument isintended to measurepressure byapplanation(applying a small flatdisc to cornea)	Instrument is intended to measurepressure by applanation (applying asmall flat disc to cornea)

Comparison of Goldmann Tonometer Technological CharacteristicsKeeler Applanation Tonometer vs. Haag-Streit AT 900
Criteria	Predicate DeviceHaag-Streit AT 900(Re:510(k)K0981432)	Keeler Applanation Tonometer (KAT)
Type	Manual contactTonometer	Manual contact Tonometer
Indication	Intraocular Pressure(IOP) measurement	Intraocular Pressure (IOP)measurement
Design	Slit lamp mountedmanual dial	Slit lamp mounted manual dial
Measurement Range	0-80mmHg	0-80mmHg
Measurementtechnique	Applanation	Applanation
Measurement Method	Direct reading ofIOP in mmHg (eachdivision on dial ofmeasuring drum isequal to 0.2gmf(1.96mN))	Direct reading of IOP in mmHg (eachdivision on dial of measuring drum isequal to 0.2gmf (1.96mN))
Calibration	Maintenance andCalibration required	Maintenance and calibration required
Intended use	Instrument isintended to measurepressure byapplanation(applying a small flatdisc to cornea)	Instrument is intended to measurepressure by applanation (applying asmall flat disc to cornea)

Note: There is no difference between Predicate devices and Keeler Applanation
Tonometer.

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Summary of Performance Testing

The performance of Keeler Applanation Tonometer has been evaluated in bench testing, comparative study with its predicative devices and field trial.

Bench testing was carried out using arrangement as per Tonometer Standard BSENISO 8612: 2001. Keeler Applanation Tonometer units under test are verified against the nominal requirements of Tonometer standard.

Bench testing arrangement was also used to carry out comparative study, i.e. comparing Keeler Applanation Tonometer with its predicate devices. Keeler Applanation Tonometer and its predicate devices were subject to the same nominal requirements as set by the Tonometer standard and the results demonstrate that they are substantially equivalent.

Field test was conducted by ophthalmic professional to compare Keeler Applanation Tonometer with its predicate device and the findings are comparable.

Based on the results of the performance testing, the Keeler Applanation Tonometer is iudged to be as safe, as effective and performs as well as the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Keeler Instruments, Inc. c/o Mr. Eugene R. VanArsdale Marketing Director 456 Parkway Broomall, PA 19008

JAN 1 9 2010

Re: K093445

Trade/Device Name: Keeler Applanation Tonometer, T-Type KAT, K-Type KAT; (KAT) Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: II Product Code: HKY Dated: October 19, 2009 Received: October 21, 2009

Dear Mr. VanArsdale:

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 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); medical device reporting (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.

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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/ucm115809.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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Kesia Alexander for

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):

Device Name: Keeler Applanation Tonometer (KAT)

Indications for Use:

The Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.

Prescription Use V (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 ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Danl Kauk

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

510(k) Number K093445

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.