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The iCare IC200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

The iCare IC200 tonometer (model TA031) is a hand-held, battery-operated device which measures intraocular pressure (IOP) without the need for topical anaesthesia by rebound tonometry. The tonometer is to be used by a healthcare professional. The tonometer uses the rebound method. A small and light, sterile, single-use probe makes brief contact with the eye. The device measures the deceleration of the probe and the rebound time and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP. The measurement method, the IOP measurement algorithm and rebound technology (including disposable probe) are identical with the predicate device. iCare IC200 tonometer can obtain IOP measurements in all angles between horizontal and supine directions. External design has not been modified. The user interface menu has been updated to contain a Quick Measure mode. The new Quick Measure feature is used to measure patient's IOP with fewer rebound measurements and faster measurement cycle. Quick Measure takes two or three rebound measurements; two if both results are within 2 mmHg and third if the difference between the first two measurements is greater than 2 mmHg.

The provided document, a 510(k) Premarket Notification review for the iCare IC200 tonometer, outlines the acceptance criteria and the study performed to demonstrate substantial equivalence to a predicate device. This submission focuses on a new feature of the device, the "Quick Measure" mode, rather than the entire device itself, as the underlying technology remains the same as the predicate.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criterion for the Quick Measure mode's performance is its ability to meet the performance goals of the ANSI Z80.10:2014 standard for ophthalmic tonometers, specifically regarding agreement with reference tonometers (GAT and Perkins) within ±5 mmHg. This is presented across different Intraocular Pressure (IOP) subgroups.

Table 1: Acceptance Criteria and Reported Device Performance for iCare IC200 Quick Measure Mode

Note: The document only provides the reported performance in terms of percentage of eyes outside ±5 mmHg. It does not explicitly state a numerical acceptance criterion (e.g., "must be less than X%"). However, meeting "performance goals per GAT reference tonometer (see Table 3)" indicates that these achieved percentages were deemed acceptable.

Study Details

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

• Sample Size (Eyes):
  • GAT Group (Low IOP): 44 eyes
  • GAT Group (Medium IOP): 65 eyes
  • GAT Group (High IOP): 40 eyes
  • Total (from table 3): 149 eyes
• Data Provenance: The Quick Measure performance data was obtained from a retrospective clinical data analysis. The country of origin is not specified in the document.

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

• The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical data analysis. The ground truth appears to be established by comparison to recognized reference tonometers (GAT and Perkins).

4. Adjudication Method for the Test Set:

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The study retrospectively compared the Quick Measure function to existing clinical data, which presumably had established reference measurements.

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:

• No, an MRMC comparative effectiveness study was not done. This submission is for a tonometer, a device that directly measures a physiological parameter (IOP), not an AI-assisted diagnostic imaging tool that requires human interpretation. The "Quick Measure" is a new mode of the device affecting its measurement sequence, not an AI assisting human readers.

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

• Yes, in effect. The "Quick Measure" mode, like the existing default mode, is an algorithm within the tonometer that calculates IOP. The performance data presented in Table 3 directly assesses the accuracy of this algorithm (the Quick Measure mode) against established reference tonometers. The document also states:
  • "Accuracy of the iCare IC200 quick measure mode was assessed in a bench test using a manometrically controlled artificial cornea."
  • "Repeatability and accuracy testing completed with iCare IC200 quick measure mode demonstrated high agreement with manometric pressure and reference tonometer used in default measurement mode (iCare IC200)."
  • "Reproducibility test completed with iCare IC200 quick measure mode demonstrated high agreement with manometric pressure regardless of the device, operator, or the measurement angle."
    These statements indicate testing of the algorithm's performance independent of human variability beyond simply operating the device.

7. The Type of Ground Truth Used:

• The ground truth used for the clinical data analysis was comparison to recognized reference tonometers: the Goldmann Applanation Tonometer (GAT) for sitting measurements and the Perkins tonometer for supine measurements. It also mentions comparison to manometric pressure in bench testing for accuracy and reproducibility.

8. The Sample Size for the Training Set:

• The document does not provide information on a specific training set size. The "Quick Measure" feature is described as a software modification to an existing device, and the method, algorithm, and technology are stated to be "identical with the predicate device." It's possible that the "training" was implicit in the existing device's development or that the "retrospective clinical data analysis" served as the primary validation, rather than a separate, large-scale training phase distinct from the existing device's development.

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

• As the document does not specify a distinct training set for the Quick Measure mode, it also does not detail how ground truth for such a set was established. The ground truth for the validation (test set) was established via GAT and Perkins reference tonometers and manometric pressure. The fundamental measurement mechanism and algorithm are inherited from the predicate device, which would have undergone its own rigorous validation (likely with similar ground truth methods) during its initial clearance (K190316).

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