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The iCare ST500 tonometer is a device intended to be used for the intraocular pressure of the human eye.

The iCare ST500 tonometer is intended to be used by healthcare professionals.

The iCare ST500 tonometer is based on a patented, induction-based rebound method, which allows intraocular pressure (IOP) to be measured by a healthcare professional accurately, rapidly and without an anesthetic. The iCare ST500 tonometer measures a patient's IOP while he or she is in an upright (sitting) position. It is attached to a slit lamp with the ST500 Adapter, making it easy to use during a standard eye exam. This tonometer is designed only for use with a slit lamp not as a handheld device. The tonometer is compatible with most of the common slit lamp models on the market.

The tonometer system consists of the iCare ST500 tonometer (together with ST500 Remote and ST500 Adapter, ST500 SmartCradle and a medical power supply used with ST500 SmartCradle), and a compatible printer and slit lamp.

With the iCare rebound measurement method, a miniature, lightweight, single-use probe is launched in a direction perpendicular to the surface of the center of the cornea of the eye. The probe is composed of a medical grade plastic tip and a metal shaft. The metal shaft is magnetized prior to the measurement. During the measurement, the probe can be considered to act like a moving magnet that induces an electric signal in the surrounding coil allowing for a highly accurate measurement of the probe's motion. After launching. the probe briefly contacts the cornea and bounces back. The tonometer records multiple parameters covering the motion of the probe, including deceleration, and rebound time. Using a proprietary algorithm, the device can calculate the eye's IOP.

The displayed IOP reading is derived from the results from a sequence of six individual probe rebounds. The displayed IOP measurement is also stored in the tonometer's memory for later retrieval.

The iCare ST500 tonometer has a rechargeable battery and can be charged in the ST500 SmartCradle powered by a medical power supply. The tonometer can be operated by using the buttons on the tonometer or by using the wireless battery-operated ST500 Remote control.

Here's a breakdown of the acceptance criteria and study details for the iCare ST500 (TA04) tonometer, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Test Set Sample Size: 156 eligible eyes from 165 enrolled subjects. In cases where both eyes were eligible, the eye with the higher GAT reference pressure was used for analysis.
• Data Provenance: Not explicitly stated from which country the data originated. It mentions "subjects having an appointment to the investigational site and from subjects recruited using a study announcement," implying a prospective study conducted at one or more clinical sites, likely in Finland where the applicant is based.

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

• The document implies that Goldmann Applanation Tonometer (GAT) measurements were used as the reference standard (ground truth) in the clinical study. It does not specify the number of expert ophthalmologists or optometrists who performed the GAT measurements, nor their detailed qualifications (e.g., years of experience). Healthcare professionals would typically perform GAT measurements.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method for the test set. Given that GAT is considered a clinical gold standard, it's possible that a single GAT measurement was taken as truth, or if multiple readings were taken, the average was used without formal adjudication by additional experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done concerning AI assistance. This device is a tonometer with an AI-like algorithm for IOP calculation, but the focus of the clinical study was on its standalone accuracy against an established reference (GAT), not on human reader improvement with or without AI assistance. The "AI" here refers to the proprietary algorithm used to calculate IOP from probe motion, not a diagnostic AI system assisting human interpretation.

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

• Yes, a standalone performance study was done for the iCare ST500 tonometer. The clinical study compares the device's measurements directly to GAT, indicating its standalone performance without human interpretation or adjustment of the device's numerical output. The "algorithm only" aspect is embedded within the device's functionality to calculate IOP.

7. The Type of Ground Truth Used

• Clinical Ground Truth: Goldmann Applanation Tonometer (GAT) measurements. GAT is widely considered the clinical gold standard for intraocular pressure measurement.

8. The Sample Size for the Training Set

• The document does not provide information about a separate training set or its sample size. The device uses a "proprietary algorithm" to calculate IOP, but details on how this algorithm was developed, trained, or validated (if machine learning was used) are not disclosed in this summary. The provided clinical and bench testing data refer to the validation of the finalized device.

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

• As the document does not mention a specific training set, it does not provide details on how ground truth for such a set would have been established. If the proprietary algorithm involved machine learning, its training data and ground truth establishment would be a separate, undisclosed process. The current document focuses on the regulatory validation of the final product.

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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 HOME2 tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

The iCare HOME2 tonometer (model TA023) 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 the patients themselves. 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 HOME2 tonometer is a further developed version of iCare HOME tonometer. It features enhancements such as possibility to measure IOP in any angle between 0° and 90° (horizontal to supine patient position) and possibility for wireless measurement result transfer to mobile device or to PC. External design and user interface have been modified for better usability and ergonomics. The measurement data can be uploaded to iCare CLINIC for further analysis using either iCare EXPORT (desktop application) or iCare PATIENT2 (mobile application). iCare PATIENT2 is a mobile app intended for transferring eye pressure measurement data from the iCare tonometer to the iCare CLINIC cloud service or an external system. The app displays the eye pressure measurement results and helps in glaucoma management. It is indicated for use by healthcare professionals and patients. Measurement results can be transferred to iCare CLINIC with either through a Bluetooth connection or by connecting the USB C type connector to the device and mobile phone, depending on the user's mobile phone operating system.

The iCare HOME2 tonometer is intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document for iCare HOME2 (K211355) does not explicitly list "acceptance criteria" in a bulleted or numbered format with specific thresholds. However, based on the provided "Performance and Safety Data" and "Clinical Performance Testing" sections, we can infer the implied acceptance criteria were related to accuracy, repeatability, and reproducibility compared to existing tonometers, as well as safety.

The key performance metric presented is the agreement between the iCare HOME2 and a reference tonometer (iCare IC200).

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

• Sample Size: 47 patients.
• Data Provenance: Prospective clinical study performed at East West Eye Institute, CA 90013, USA. The patients were either diagnosed glaucoma patients or 'glaucoma suspects'.

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

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. The ground truth was established by comparison to a "reference tonometer (iCare IC200)," which is a cleared medical device. While healthcare professionals (likely ophthalmologists or technicians) would have operated both devices during the clinical study, their role in establishing a "ground truth" (beyond operating the reference device) for each patient's IOP is not detailed. The iCare IC200 itself is considered a "reference" for comparison.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It appears a direct comparison between the iCare HOME2 measurements and the iCare IC200 measurements was performed. A "random eye was selected as the study eye for each patient."

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

The study described is not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers with and without AI assistance.** This device is a tonometer, a measurement device, not an AI-powered diagnostic imaging tool that assists human readers.** Therefore, this question is not applicable to the submitted document.

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

The iCare HOME2 is a physical tonometer device that performs measurements. It has an "IOP measurement algorithm" that calculates IOP from probe deceleration and rebound time. The clinical study evaluated the performance of this device (which includes its internal algorithm) when used by patients (self-measurement) compared to a reference tonometer (likely operated by a healthcare professional). Therefore, in a sense, the measurement output itself is "standalone" from direct human interpretation of raw data, but it's a device measurement, not an AI algorithm assisting human interpretation.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparison to a legally marketed reference medical device: the iCare IC200 tonometer (cleared in K190316). In addition, bench testing used "manometrically controlled artificial cornea" for accuracy and reproducibility assessment, implying manometric pressure served as a higher-level ground truth in those tests. For the clinical study, the IC200 served as the comparative standard.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI. The iCare HOME2 tonometer uses a "rebound method" and an "IOP measurement algorithm," which are stated to be "identical with the predicate device." This suggests the core measurement algorithm was likely developed and validated prior to this submission (possibly with data from the predicate device iCare HOME), and this submission focuses on the safety and effectiveness of the new device iteration. No specific training set for a machine learning model is mentioned.

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

As no specific training set for an AI/machine learning model is mentioned for iCare HOME2, information on how its ground truth was established is not available in the provided document. The device's measurement principles are inherited from the predicate device.

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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 that measures the intraocular pressure (IOP) without the need for topical anaesthesia. It is for prescription use only and to be used under the supervision of a healthcare professional. The device is intended to be used by patients at home.

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 sequence includes six measurements. The probe moves to the cornea and back during every measurement. The tonometer stores information on every complete measurement sequence of six measurements. The stored information includes the calculated final IOP, time and date of the measurement, identification of the eye (right or left) and the quality level of the measurement (i.e. the standard deviation of the six individual measurements).

The measurement data can be uploaded to Icare CLINIC for further analysis using either Icare EXPORT (desktop application) or Icare PATIENT (mobile application). Icare CLINIC is a browser-based software designed for managing patient information and the IOP measurement data.

The provided text does not contain detailed information about specific acceptance criteria related to a performance study for the Icare HOME tonometer, nor does it describe a study that explicitly proves the device meets such criteria in terms of clinical accuracy or diagnostic performance. Instead, this document is a 510(k) summary for a premarket notification, focusing on demonstrating substantial equivalence to a predicate device.

The document highlights:

• Changes: The modifications are primarily related to software (Icare LINK replaced with Icare CLINIC, Icare EXPORT, and Icare PATIENT) and connectivity (added Android support). There are also minor changes to user interface sounds and product appearance.
• Performance and Safety Data: The document states that the device has been tested according to relevant FDA recognized consensus standards for electrical safety, ophthalmic instruments, usability, software lifecycle processes, and photobiological safety.
• No Clinical Studies: Crucially, it explicitly states: "No clinical studies were performed to test this device modification." This means there is no new clinical data presented here to establish performance metrics (like accuracy, sensitivity, specificity, etc.) against a ground truth in a clinical setting for this specific modification. The substantial equivalence is based on the argument that the technological changes do not raise new issues of safety or effectiveness, and therefore, the performance is assumed to be equivalent to the predicate device.

Given this, I cannot extract the detailed information requested in the prompt (acceptance criteria, reported device performance, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, how training set ground truth was established) as this information is not present in the provided document for this specific 510(k) submission. The document focuses on demonstrating that the modified device is substantially equivalent to the predicate device without requiring new clinical performance data.

However, based on the general context of medical device regulatory submissions and the information provided, here's what can be inferred or stated regarding the lack of such information:

In summary, this 510(k) document is a "Special 510(k)" for a device modification, and the strategy is to demonstrate substantial equivalence to a predicate device without new clinical performance data, relying on the argument that the changes do not affect the fundamental safety and effectiveness of the IOP measurement.

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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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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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