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The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

The Icare HOME Tonometer is a home-use handheld, battery operated device. The Icare HOME tonometer technology is based on the previously cleared Icare tonometer model TA011 (K063873), which has been commercially distributed in the United States, Europe and many other countries worldwide. The measurement method, the measurement algorithm and technology of the two models are identical and both models use the same disposable probe tip. The Icare HOME tonometer utilizes the rebound method to measure intraocular pressure. A small (1.8 mm diameter), light (26.5 mg), sterile, single-use probe tip makes brief and gentle contact with the eye. The device measures the deceleration of the magnetized probe and the rebound time during contact with the eye and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP. A single measurement sequence includes six measurements for both measurement modes. The probe moves to the cornea and returns to the neutral position during each of the six measurements. After the six measurements the tonometer calculates the final IOP and stores it with other information in the tonometer's memory, including date, time, eye identification (right or left) and measurement quality i.e., the standard deviation of the six individual measurements. The Icare HOME Tonometer can record over one thousand measurement results. The physician can transfer this recorded measurement information to a computer through a USB cable.

Here's an analysis of the provided text, extracting information related to acceptance criteria and the study proving the device meets them:

Device: Icare HOME Tonometer (K163343/S001)
Intended Use: Prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a tabulated format with pass/fail. Instead, it describes various tests and their "acceptable" outcomes. I've extrapolated these into a table based on the success statements. Note that some criteria are qualitative (e.g., "acceptable", "meets standards"), reflecting the regulatory language.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Performance Testing):

  • Sample Size: 460 participants enrolled across 5 US sites. 385 eyes of 385 participants found eligible. Data from 376 eyes included in effectiveness analyses.
  • Data Provenance: Prospective, observational, multi-center clinical trial conducted in the U.S.

• Human Factors Testing:

  • Sample Size: 18 patients (17 completed all scenarios successfully, 1 did not pass certification in Phase 1 and was excluded).
  • Data Provenance: Actual-Use HFE Validation Test conducted in the U.S.

• Bench Testing: No specific sample size of "data points" is given, but it involved three Icare HOME tonometer units and two operators.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Clinical Performance Testing:

  • The ground truth for IOP was established using Goldmann Applanation Tonometry (GAT) measurements, which are considered the clinical standard. These were performed by an "eye care professional" (implied subject matter expert).
  • Qualifications: "eye care professional" is stated, specifics like years of experience or board certification are not provided in this document.
  • Other Ground Truth: Corneal epithelial defects were assessed using the Oxford Scheme grading, and discomfort via Visual Analog Scale (VAS) questionnaire.

• Human Factors Testing:

  • Training and re-certification were conducted by a "qualified HCP trainer (ophthalmologist, optometric technician)."
  • The certification process for the device (determining proficiency) involved "Icare Home tonometer readings did not sufficiently agree with the GAT measurement" for one participant. This suggests GAT was part of their certification ground truth.

4. Adjudication Method for the Test Set

• Clinical Performance Testing (GAT ground truth): An eye care professional took two GAT measurements, with a third if the first two were not within 2 mmHg of each other. This is a form of internal consistency/adjudication for the GAT reading itself, but not for discrepancies between the device and the GAT.
• Human Factors Testing (Device Proficiency): Certification involved comparison of Icare HOME readings with GAT measurements. No explicit multi-reader adjudication process for the outcomes is described for either the clinical or human factors studies.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, a traditional MRMC comparative effectiveness study where multiple human readers interpret cases with and without AI assistance to measure improvement in human performance was not described.
• The study design was to compare the Icare HOME device's performance (self-measured IOP) against established clinical methods (GAT and Icare TA01i, both performed by healthcare professionals), and to assess human factors for home use. It was not designed to show how human readers improve their interpretation with AI assistance, as the device itself is a measurement tool, not an interpretative AI.

6. Standalone (Algorithm Only) Performance

• Was standalone performance done? Yes, the "Bench Performance Testing" section describes the device's accuracy and precision measured against a manometer-controlled model, which is an assessment of the device's inherent measurement capability independent of human operation.
• The entire "Clinical Performance Testing" section also evaluates the device's measurements (Icare Home device measurements) compared to gold standard measurements (GAT, TA01i measurements) in a clinical setting, though it emphasizes self-measurement by patients. This can be considered assessing the device's standalone accuracy in the hand of a lay user versus clinical ground truth.

7. Type of Ground Truth Used

The ground truth used for performance evaluation was primarily:

• Manometer-controlled model values: For bench testing of accuracy.
• Goldmann Applanation Tonometry (GAT): Considered the clinical gold standard for IOP measurement in the clinical performance study.
• Icare TA01i tonometer measurements: Also used as a reference point in the clinical study, as it's the predicate device with the same measurement technology.
• Expert assessment/observation: For human factors testing, observing user interactions and their ability to follow instructions.
• Clinical outcomes/observations: For safety, including adverse events, corneal staining, and patient-reported discomfort (VAS).

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the device's algorithm. The device (Icare HOME tonometer) uses a "rebound method to measure intraocular pressure" and its "measurement method, the measurement algorithm and technology... are identical" to the predicate Icare TA01i tonometer. This suggests the core algorithm for IOP calculation was already established and validated with the predicate device, or developed using other data not detailed as part of the submission. The current submission focuses on validating the new device (Icare HOME) for its specific use case (home use by patients) against predicate devices and clinical standards.

9. How the Ground Truth for the Training Set Was Established

As a training set for the device's algorithm is not explicitly mentioned (due to the device using an established algorithm from a predicate), how such ground truth was established is not detailed within this submission document. The focus is on the performance testing of the device for its intended use.

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The Icare ic100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

The Icare ic100 (TA011) tonometer is a hand-held, battery operated device which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic100 (TA011) tonometer is fundamentally the same as the predicate Icare tonometer model TA01i (cleared by FDA under K063873). The measurement method, the IOP measurement algorithm and rebound technology (including disposable probe) are identical for both models. The Icare ic100 (TA011) tonometer utilizes the rebound method to measure intraocular pressure. A small (1.8 mm diameter), light (26.5 mg), sterile, single-use probe makes brief and gentle contact with the eye. The tonometer measures the deceleration of the magnetized probe and the rebound time during contact with the eye and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP.

A single measurement sequence includes six measurements. After the six measurements are completed, the tonometer calculates the final IOP and the result is provided on the display.

Here's a breakdown of the acceptance criteria and study information for the Icare ic100 tonometer based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific numerical targets. Instead, it focuses on demonstrating that the Icare ic100 performs comparably to its predicate device, the Icare TA01i. The core of the performance demonstration is that the operational principle, measurement algorithm, and rebound technology are identical.

Therefore, the "acceptance criteria" are implied to be substantially equivalent performance to the predicate device, particularly with regard to IOP measurement accuracy.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on a specific "test set" and its sample size for evaluating the Icare ic100's primary measurement performance (IOP accuracy). The submission primarily relies on the equivalency of the measurement method, algorithm, and rebound technology to the predicate device.

It states that "Verification tests, where applicable, have been carried out in accordance with ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers to confirm that the performance and safety aspects of the modified tonometer are comparable with the Icare TA01i." However, specific sample sizes (e.g., number of subjects, number of measurements) for these verification tests are not provided in this document.

Therefore, we cannot determine the sample size or data provenance (country, retrospective/prospective) from the provided text for a specific performance test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. Since the submission focuses on substantial equivalence to a predicate device with an identical measurement algorithm, it's possible that direct clinical studies establishing a new ground truth were not deemed necessary or details were not included in this summary. The ground truth for the predicate's calibration was stated to be "Goldmann reference tonometer data."

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs Without AI Assistance

This device (Icare ic100 tonometer) is a standalone medical device for measuring intraocular pressure. It is not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or data alongside AI. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed.

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

The entire device operates as a standalone algorithm without continuous human-in-the-loop intervention during the measurement process itself. The "algorithm only" performance is the device's performance. The document states:

• "The Icare ic100 (TA011) uses the same operating principle found in the predicate device and in all rebound type tonometers."
• "The IOP measurement algorithm is unchanged from the FDA cleared Icare tonometer model TA01i (K063873). Parameters from the signals produced by the probe momentarily contacting the eye (rebound parameters) are used to calculate an IOP-index. An embedded calibration table which was derived using Goldmann reference tonometer data is used to calculate an IOP value (in mmHg) based on the IOP-index."

This indicates that the standalone algorithm's performance is fundamental to the device's function, which is considered substantially equivalent to the predicate.

7. The Type of Ground Truth Used

For the calibration table embedded in the algorithm (which is identical to the predicate), the ground truth used was Goldmann reference tonometer data. This is explicitly stated: "An embedded calibration table which was derived using Goldmann reference tonometer data is used to calculate an IOP value (in mmHg) based on the IOP-index."

8. The Sample Size for the Training Set

The document states that the "IOP measurement algorithm is unchanged from the FDA cleared Icare tonometer model TA01i (K063873)" and that its calibration table was "derived using Goldmann reference tonometer data." However, the sample size for this derivation (training set for the calibration table) is not provided in this document.

9. How the Ground Truth for the Training Set was Established

The ground truth for the training set (from which the calibration table was derived for the predicate device's algorithm) was established using Goldmann reference tonometer data. The Goldmann applanation tonometer is considered the clinical gold standard for IOP measurement. This implies that measurements from the rebound tonometer were compared against concurrently measured Goldmann values to create the calibration.

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