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510(k) Data Aggregation
(27 days)
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:
| Information Requested | Details from the Document |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not provided in this document. The document focuses on demonstrating substantial equivalence based on technical changes and compliance with general safety standards, not on new clinical performance metrics. The measurement range of the device is stated as 5-50 mmHg, but this is a characteristic, not a performance criterion against a ground truth. |
| 2. Sample size for the test set and data provenance | Not applicable/Not provided. No new clinical test set data is presented for this 510(k) submission, as it explicitly states, "No clinical studies were performed to test this device modification." The evaluation relies on the safety and effectiveness of the previously cleared predicate device and the assessment that the changes do not introduce new risks. |
| 3. Number of experts used to establish ground truth & qualifications | Not applicable/Not provided. As no new clinical studies were performed for this specific modification, there's no mention of experts establishing ground truth for a test set in this document. |
| 4. Adjudication method for the test set | Not applicable/Not provided. No new clinical studies were performed for this specific modification. |
| 5. MRMC comparative effectiveness study and effect size | Not applicable/Not provided. The document does not describe any MRMC studies or human-in-the-loop performance evaluations specifically for this device modification. The device is a tonometer, which directly measures IOP, and thus, comparative effectiveness with human readers (in the sense of image interpretation for AI) isn't directly relevant in the same way it would be for an AI-powered diagnostic imaging device. Its accuracy would typically be compared to a gold standard IOP measurement method. |
| 6. Standalone (algorithm only without human-in-the-loop) performance | Not explicitly detailed as a new study. While the tonometer itself operates standalone to measure IOP, the document does not present new standalone performance data (e.g., accuracy against a gold standard) for this modified device. The assertion of substantial equivalence implies that its standalone performance is considered equivalent to the predicate device, for which such data would have been provided in its original 510(k). |
| 7. Type of ground truth used | Not applicable/Not provided in this document for new studies. For IOP measurement devices, the ground truth for performance studies would typically be established by a well-calibrated reference tonometer (e.g., Goldmann Applanation Tonometer) or other validated methods, but this is referring to the original predicate device's clearance. |
| 8. Sample size for the training set | Not applicable. This device is hardware-based for IOP measurement and the modifications pertain to software for data management/connectivity and minor hardware appearance changes. There is no indication of a machine learning-based component that would require a "training set" in the traditional sense of AI algorithm development for classification or prediction from data within the scope of this 510(k) submission. Therefore, a training set is not pertinent to the changes described. |
| 9. How the ground truth for the training set was established | Not applicable. As there is no training set for a machine learning algorithm described in this 510(k) modification, this question is not relevant to the provided text. The device performs a direct physical measurement. The software changes concern data handling and connectivity, not interpretive AI. |
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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(112 days)
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.
| Aspect Tested | Acceptance Criteria (Implicitly Stated) | Reported Device Performance |
|---|---|---|
| Bench Performance - Accuracy (vs. Manometer) | Differences between Icare HOME tonometer and manometer values at each pressure should be less than +/- 3 mmHg. | Differences were less than +/- 3 mmHg across the range. |
| Bench Performance - Precision (Standard Deviation) | Standard deviations and coefficients of variation should be consistently low. | Standard deviations and coefficients of variation for each Icare Home tonometer were consistently low (0-8%) across the measurement range, specifically <0.52 mmHg and <5.5% CV for 10-30 mmHg. |
| Bench Performance - Accuracy (10, 20, 30 mmHg) | Within-level measurement differences maximal 1 mmHg, at least 50% of measurements same (IQR=0). Within-unit mean, overall mean, and average of means close to actual pressure. | Within-level measurement differences were at most 1 mmHg; at least 50% of within-level measurements were the same (IQR = 0); means were close to actual pressure. |
| Bench Performance - Accuracy (40, 50 mmHg) | Within-level measurement differences within 3 mmHg; at least 50% of measurements within 1-2 mmHg. | Within-level measurement differences within 3 mmHg; at least 50% within 1 mmHg (40 mmHg) and 2 mmHg (50 mmHg). |
| Bench Performance - Bias/Imprecision at Extremes | Expected to be within acceptable limits for intended use. | Slightly more bias and imprecision at extremes (2 mmHg at 5 mmHg, 2-3 mmHg at 40 and 50 mmHg). CV of 8.1% at 5 mmHg vs 0.0-5.5% for 10-50 mmHg. Still deemed "suitable for home-use." |
| Bench Performance - Operator/Instrument Variability | Little variation due to operator or between instruments. | Very little difference attributed to either inter-operator or inter-instrument variability. |
| Clinical Performance - Agreement with GAT (Overall) | Limits of agreement meeting ANSI Z80.10-2009 performance goals (less than 5% outside ± 5 mmHg, less than 1% outside ± 7.5 mmHg). | Mean difference (HOME - GAT) = -0.53 mmHg; SD = 2.43 mmHg. 3.2% outside ± 5 mmHg, 0.3% outside ± 7.5 mmHg. All ANSI performance goals met. |
| Clinical Performance - Agreement with GAT (by IOP Group) | Less than 5% outside ± 5 mmHg and less than 1% outside ± 7.5 mmHg for each group (≤16 mmHg, >16 to <23 mmHg, ≥23 mmHg). | 2.8%, 4.2%, 1.5% outside ± 5 mmHg; 0.7%, 0.0%, 0.0% outside ± 7.5 mmHg respectively. All ANSI performance goals met. |
| Clinical Performance - Repeatability (Overall) | Repeatability to be comparable or acceptable for a home-use device. | Overall Repeatability CV% = 9.76%. |
| Clinical Performance - Safety (Adverse Events) | No adverse events reported. | No adverse events (including corneal abrasions) were reported in the clinical study. |
| Clinical Performance - Safety (Corneal Staining) | Minimal increase in staining, no clinically significant increase (typically ≥ 2 grades). | 5% experienced increased staining after certification, 11.3% after all HOME measurements. Only 1.3% experienced a clinically significant increase (≥2 grades). No subject experienced ≥3 grades increase. |
| Clinical Performance - Safety (Discomfort - VAS) | Minimal change in discomfort. | Median change from baseline was zero, max increase 23 units on 100-point VAS scale. |
| Human Factors - Safety Critical Observations | No safety critical observations, use errors, or close calls associated with critical severity outcomes. | All 17 participants successfully completed all scenarios without committing any use errors, close calls, or operational difficulties associated with critical severity outcomes. |
| Human Factors - Moderator Assistance | No assistance required for critical tasks. | No participants required moderator assistance for critical tasks. |
| Human Factors - Practicality of Use (Home Use Period) | Patients able to acquire measurements as intended (3-6 times/day). | 1.8% of subject-days logged <3 measurements; most subjects used 3 times/day; 10.3% logged 6 measurements. |
| Human Factors - Attempts per Measurement | Similar to simulated conditions. | Mean attempts per successful measurement (1.5) similar to simulated testing (1.4). Proportion of 1-attempt measurements (75.9%) same as simulated testing. |
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.
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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)
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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.
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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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