The iCare Tonometer TA01i is a portable, handheld, battery operated tonometer, which measures intraocular pressure (IOP). To measure IOP, a very light (26.5 mg) and a slow moving (0.25-0.30 m/s) probe makes momentary contact with the cornea of the eye. The device measures the speed of the probe during the time probe is in contact with cornea. Resulting IOP is displayed on a liquid crystal display (LCD). The force used for the measurement which is directed onto the eye is extremely small, because of the low weight and slow speed of the probe.

AI/ML Overview

The iCare Tonometer TA01i is a device intended for measuring intraocular pressure (IOP) of the human eye. The provided text, a 510(k) summary, details the device's characteristics and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like "sensitivity ≥ X%" or "specificity ≥ Y%". Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technological features, and overall performance.

The qualitative acceptance criteria can be inferred as:

Operating Range, Accuracy, and Repeatability: The device must meet acceptance criteria for these aspects.
Substantial Equivalence to Predicate Devices: The device's performance, safety, and effectiveness must be comparable to previously cleared devices.
Biocompatibility: The patient-contacting probe must be biocompatible.
Electromagnetic Compatibility & Electrical Safety: The device must conform to relevant standards.

Here's a summary of the stated performance relative to these inferred criteria:

Acceptance Criteria (Inferred)	Reported Device Performance
Operating Range	Met: Evaluated in bench testing. Range: 7-50 mmHg (display range 1-99 mmHg)
Accuracy	Met: Evaluated in bench testing. Performance compared to predicate devices (including Goldmann type) in clinical evaluation.
Repeatability	Met: Evaluated in bench testing.
Substantial Equivalence in Performance, Safety, and Effectiveness to Predicate Devices (e.g., Goldmann Tonometer, Tono-Pen XL, Pascal DCT, TGUc-01 "PRA")	Achieved: "Based on the results of non-clinical and clinical testing, the performance of iCare Tonometer TA01i is judged to be substantially equivalent to predicate devices." Specific comparisons highlight: - Rebound measurement technique (different from applanation for some predicates, but validated). - No maintenance calibration required. - Lightweight, disposable, single-use, sterilized probe. - Probe briefly touches the eye, low force (8-16 mN). - No anesthesia required. - Can be used in any position (with horizontal orientation).
Biocompatibility of Patient-Contacting Probe	Met: "The patient contacting probe is considered biocompatible. The appropriate tests for biocompatibility were performed according to "ISO 10993-1:2003, Biological evaluation of medical devices - Part 1 Evaluation and Testing"."
Electromagnetic Compatibility (EMC) and Electrical Safety	Met: "The electromagnetic compatibility and electrical safety of the iCare Tonometer TA01i was tested and found to conform to the requirements of IEC 60601-1 and IEC 60601-1-2."

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

The document states: "In clinical evaluation, the performance of iCare Tonometer TA01i was compared to predicate devices, including Goldmann type tonometer." However, it does not specify the sample size (number of patients or measurements) used for this clinical evaluation.

Data provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only mentions "clinical evaluation."

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. It mentions comparison "to predicate devices, including Goldmann type tonometer," which implies that the predicate device's measurement served as the reference.

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

The document does not describe any adjudication method for the test set clinicians or measurements. The comparison is stated as being against predicate devices.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This device is a standalone tonometer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed, and there is no information about an effect size for human reader improvement.

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

Yes, a standalone performance evaluation of the device itself was performed. The "bench testing" evaluated the device's operating range, accuracy, and repeatability, which are characteristics of the device's standalone performance. The "clinical evaluation" also assessed the iCare Tonometer TA01i's performance independently, comparing its measurements to those of predicate devices. The device is a measurement tool, not an assistive AI.

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

The primary ground truth or reference standard used for the clinical evaluation was measurements from predicate devices, specifically noted to include "Goldmann type tonometer." Goldmann applanation tonometry is widely considered the gold standard for IOP measurement.

8. The sample size for the training set

This device is a physical medical device (tonometer), not a machine learning or AI algorithm that requires a "training set" in the computational sense. Therefore, there is no concept of a training set sample size for this device.

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

As noted above, this device does not use a "training set" in the context of AI/ML. The device's underlying physics and calibration are based on rebound tonometry principles, rather than learned patterns from a dataset.

Summary

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063873

5. 510(k) Summary

MAY 2 3 2007

Summary prepared:

December 21, 2006

Submitted by

Company name: Company address:

Contact person: Phone number: Fax number:

Tiolat Oy Nuijamiestentie 5 B 00400 Helsinki Finland Kari Serjamaa, CEO +358 9 8775 1150 +358 9 728 6670

US Agent to respond to FDA requests:

Contact person: Company name: Company address:

Phone number:

Fax number:

Nelson Tobin Diagnostic Instrument Group 8404 Sunstate Street Tampa, FL 33634 (813) 926-3447 (813) 926-7954

Proposed Device

Tiolat Oy Manufacturer: Device name: iCare Tonometer Model name: TA01i Classification name: 86HKX Regulation number: 886.1930 Device class: Class II

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5.1 Intended Use

The iCare Tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.

5.2 Device Description

5.3 Predicate Devices

The iCare Tonometer TA01 is judged to be substantially equivalent in safety, effectiveness and intended use to the following legally marketed devices:

Manufacturer:	HAAG-STREIT
Device name:	APPLANATION TONOMETER AT 900
Classification name:	86HK Y
Regulation number:	886.1930
Device class:	Class II
510(k) number:	K981432

Manufacturer:	MEDTRONIC
Device name:	MEDTRONIC TONO-PEN XL
Classification name:	86HK Y
Regulation number:	886.1930
Device class:	Class II
510(k) number:	K053430

Manufacturer:	SMT SWISS MICROTECHNOLOGY AG
Model name:	PASCAL DYNAMIC CONTOUR TONOMETER
Classification name:	86HKY
Regulation number:	886.1930
Device class:	Class II
510(k) number:	K032967

Manufacturer:	RYAZAN STATE INSTRUMENT-MAKING
	ENTERPRISE
Model name:	Tonometer TGDc-01 "PRA"
Classification name:	86HKX
Regulation number:	886.1930
Device class:	Class II
510(k) number:	K021937

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5.4 Substantial Equivalence Comparison

In Tables 5.1, 5.2, 5.3 and 5.4 the iCare Tonometer TA01i is compared to predicate devices to show the equivalence. The comparison of intended use and technological features of iCare Tonometer TA01 indicate that the device is substantially equivalent to legally marketed predicate devices.

Table 5.1. iCare Tonometer TA01i vs. Haag-Streit Applanation Tonometer AT-900 (Goldmann type) . .

	iCare Tonometer TA01i	Haag-Streit AT-900
Indication	Intraocular pressure (IOP)measurement	Same
Design	Hand-held microprocessorbased	Slit lamp mounted manual dial
Measurement technique	Rebound	Applanation
Calibration	No maintenance calibrationrequired
Contact tip	Lightweight, disposable, singleuse, plastic probe (26.5mg)	Prism as applanation surface
Contact tip sterilization	Sterilized, disposable, singleuse	Prisms need to be disinfectedafter each patient
Patient interface	Probe briefly touches the eye	Held on patient's eye whiledial is adjusted
Force caused to eye bymeasurement	8-16 mN	10-50 mN (1g = 1/100N=10mN)
Display	4 digit LCD (2 digit reading)	Scribed dial
Range of measurement	7-50 mmHg (display range 1-99 mmHg)	0-80
Versatility	Patient can be measured in anyposition, but the tonometermust be oriented horizontally	Patient can be measured insitting position
Anesthesia required	No	Yes
Weight	5.47 oz. without batteries(155 g)	1.10 lb(0.5 kg)
Dimensions	1.26" × 3.15" × 9.06"(32 mm × 80 mm × 230 mm)	(250 mm × 115 mm × 89 mm)
Power source	4 × 1.5 Volt AA batteries

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	iCare Tonometer TA0li	Tono-Pen XL
Indication	Intraocular pressure (IOP) measurement	Same
Design	Hand-held microprocessor based	Same
Measurement technique	Rebound	Applanation
Calibration	No maintenance calibration required	Same
Contact tip	Light weight, disposable, single use, plastic probe with tip radius of 0.9 mm	1.0 mm transducer tip, applanation surface approximately 3 mm
Contact tip sterilization	Sterilized, disposable, single use	Sanitized natural latex tip covers
Patient interface	Probe briefly touches eye	Briefly touched against eye
Force caused to eye by measurement	8-16 mN	Depending on user, uncontrolled
Display	4 digit LCD (2 digit reading)	Same
Range of measurement	7-50 mmHg (display range 1-99 mmHg)	5-80 mmHg
Versatility	Patient can be measured in any position, but the tonometer must be oriented horizontally	Patient can be measured in any position
Anesthesia required	No	Same
Weight	5.47 oz. without batteries (155 g)	2.25 oz. (64 g)
Dimensions	1.26" × 3.15" × 9.06" (32 mm × 80 mm × 230 mm)	7 1/4" × 1" × 7/8" (184.2 mm × 25.4 mm × 22.2 mm)
Power source	4 × 1.5 Volt AA batteries	2 × OCU-CELTM XL batteries

Table 5.2. iCare Tonometer TA01i vs. Tono-Pen XL

. .

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	iCare Tonometer TA0li	Pascal DCT
Indication	Intraocular pressure (IOP) measurement	Same
Design	Hand-held microprocessor based	Slit lamp mounted microprocessor based
Measurement technique	Rebound	Dynamic contour
Calibration	No maintenance calibration required	Self calibrating
Contact tip	Light weight, disposable, single use, plastic probe with tip radius of 0.9 mm	Sensor tip 7 mm, pressure sensor 1.2 mm
Contact tip sterilization	Sterilized, disposable, single use	Sterile, single use disposable tip cover
Patient interface	Probe briefly touches the eye
Force caused to eye by measurement	8-16 mN	10 mN (constant 1 gram)
Display	4 digit LCD (2 digit reading)	LCD display
Range of measurement	7-50 mmHg (display range 1–99 mmHg)	5-200 mmHg
Versatility	Patient can be measured in any position, but the tonometer must be oriented horizontally	Same
Anesthesia required	No	Yes
Weight	5.47 oz. without batteries (155 g)	7.41 oz. (210 g)
Dimensions	1.26" × 3.15" × 9.06" (32 mm × 80 mm × 230 mm)	6.69" × 3.46" × 1.57" (170 mm × 88 mm × 40 mm)

Table 5.3. iCare Tonometer TA01i vs. Pascal dynamic contour tonometer (DCT)

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	iCare Tonometer TA01i	Tonometer TGDc-01 "PRA"
Indication	Intraocular pressure (IOP) measurement	Same
Design	Hand-held microprocessor based	Hand-held microprocessor based
Measurement technique	Rebound	Same, but measurement to upper eyelid
Calibration	No maintenance calibration required	No maintenance calibration required
Contact tip	Light weight, disposable, single use, plastic probe with tip radius of 0.9 mm	–
Contact tip sterilization	Sterilized, disposable, single use	–
Patient interface	Probe briefly touches the eye	Touches the upper eyelid
Display	4 digit LCD (2 digit reading)	4 digit LCD (2 digit reading)
Range of measurement	7-50 mmHg (display range 1–99 mmHg)	0-60
Versatility	Patient can be measured in any position, but the tonometer must be oriented horizontally	Patient can be measured in any position, but the tonometer must be oriented downwards
Anesthesia required	No	No
Weight	5.47 oz. without batteries (155 g)	2.79 oz. (79g)
Dimensions	1.26" × 3.15" × 9.06" (32 mm × 80 mm × 230 mm)	6.83" × 1.00" × 0.77" (173.5mm × 25.5mm × 19.5mm)
Power source	4 × 1.5 Volt AA batteries	4 × 1.5 Volt batteries (CR2032)

Table 5.4. iCare Tonometer TA01ivs Tonometer TGDc-01 "PRA"

5.5 Summary of Non-Clinical and Clinical Testing

The performance of iCare Tonometer TA01i has been evaluated in bench testing. The units under test met the acceptance criteria of the operating range, accuracy and repeatability.

In clinical evaluation, the performance of iCare Tonometer TA01i was compared to predicate devices, including Goldmann type tonometer.

Based on the results of non-clinical and clinical testing, the performance of iCare Tonometer TA01i is judged to be substantially equivalent to predicate devices. The patient contacting probe is considered biocompatible. The appropriate tests for biocompatibility were performed according to "ISO 10993-1:2003, Biological evaluation of medical devices - Part 1 Evaluation and Testing".

The electromagnetic compatibility and electrical safety of the iCare Tonometer TA01i was tested and found to conform to the requirements of IEC 60601-1 and IEC 60601-1-2.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tiolat Oy c/o Mr. Nelson Tobin Diagnostic Instrument Group 8404 Sunstate Street Tampa, Fl 33634

MAY 2 3 2007

Re: K063873

Trade/Device Name: iCare Tonometer TA01i Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer Regulatory Class: Class II Product Code: HKX Dated: May 9, 2007 Received: May 10, 2007

Dear Mr. Tobin:

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. Nelson Tobin

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egelman, M.D.

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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4. Indications for Use Statement

Indications for Use

510(k) Number (if known): not assigned yet

Device Name: iCare Tonometer TA01i

Indications for Use:

The iCare Tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.

Prescription Use __ X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Dan L. Kautz

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

510(k) Number K063873

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.