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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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The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic200 tonometer measures the IOP by utilizing the rebound method, where a small (1.8 mm diameter), light (26.5 mg) probe makes brief contact with the eve. The Icare ic200 probes are sterile (gamma sterilized), single-use accessories of the device. All other accessories of the Icare ic200 are non-sterile and do not have direct patient contact.

Icare ic200 allows IOP measurement of patients in all positions between sitting position (direction of probe movement 0°) and supine position (direction of probe movement 90°).

Identical to the predicate device, the Icare ic200 (TA031) tonometer records the speed of the probe upon initiation of a measurement sequence. When the moving probe contacts the cornea, the probe decelerates at a rate which depends on the intraocular pressure. 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.

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. JOP measurement result can be transferred to printer or to a PC via Bluetooth® connection.

The measurement method, the IOP measurement algorithm and rebound technology (including sterile, single-use probe) of Icare ic200 are identical to the predicate device Icare ic100 (TA011, K153694).

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Icare ic200 Tonometer

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that the Icare ic200 met the predetermined acceptance criteria for accuracy and bias over the measurement range, ensuring substantial equivalence to the previously cleared Icare ic100 tonometer. While the exact numerical acceptance criteria for bench testing (beyond matching the predicate) are not fully detailed for all parameters, the reported performance indicates that they were met. For clinical performance, the ANSI Z80.10:2014 standard's criteria were used, and the device conformed to them.

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

• Clinical Test Set:

  • Sample Size: 152 eyes
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "clinical study" and "performed as intended," implying prospective data collection for this submission.

• Bench Test Set:

  • Sample Size:
    • Accuracy and bias: Not explicitly stated, but performed with a "simulated IOP model."
    • Repeatability: 10 measurements were performed (with 3 different angles for the tonometer).
    • Reproducibility: Two operators performed three measurements with three different ic200 units in each measurement setup, resulting in 162 measurements per operator.
  • Data Provenance: Laboratory bench testing.

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

• Clinical Study: The ground truth was established by comparator devices:

  • Goldmann Applanation Tonometer (GAT) for sitting position.
  • Tonopen Avia and Perkins for supine position.
  • No information is provided on the number or qualifications of the operators for these reference devices in the clinical study.

• Bench Testing:

  • The ground truth was established by a "manometrically controlled test cornea" (i.e., a physical reference standard).
  • No human experts were involved in establishing the ground truth directly for this bench test.

4. Adjudication Method for the Test Set:

• Clinical Study: Not explicitly mentioned, but the comparison was against established reference devices (GAT, Tonopen Avia, Perkins) for IOP measurement. There's no indication of a separate expert adjudication process for the clinical data itself beyond direct measurement comparisons.
• Bench Testing: No adjudication method mentioned; the comparison was against a known manometric pressure.

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:

• No, an MRMC comparative effectiveness study was not done.
• This device is a tonometer, a measurement device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images with or without AI assistance. The study focused on the device's accuracy and performance compared to established tonometry methods.

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

• Yes, a standalone performance assessment was conducted for the device's measurement algorithm. The device itself performs the IOP measurement and provides a numerical result without human interpretation of raw data. The bench testing (comparing to manometric pressure) and the clinical study (comparing to reference tonometers) are effectively standalone assessments of the device's measurement capabilities. The software calculates the IOP from probe speed during impact.

7. The Type of Ground Truth Used:

• For Bench Testing: Manometric pressure from a controlled test cornea.
• For Clinical Testing: Intraocular pressure measurements from legally marketed predicate and reference devices: Goldmann Applanation Tonometer (GAT), Tonopen Avia, and Perkins tonometer.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. The document describes a 510(k) submission for a rebound tonometer, which uses a physical measurement (rebound method) and an "IOP measurement algorithm" that is stated to be identical to its predicate device. This typically implies a deterministic algorithm or one trained on historical data, but the document does not detail a specific "training set" in the context of machine learning. The focus is on verifying and validating the device's performance, not on a new algorithm's training.

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

• Not Applicable / Not Provided. As mentioned above, the concept of a "training set" and its ground truth is not detailed in this submission because it's for a traditional medical device's performance verification, not necessarily a machine learning model requiring a distinct training phase in the context of this document. The "IOP measurement algorithm" and rebound technology are identical to the predicate, suggesting it was established previously.

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