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510(k) Data Aggregation
(50 days)
The CATS-L® Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.
The CATS-L Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. The CATS-L prism is made of PMMA, the corneal contact diameter is 6.28 mm, and the total length of the prism is 29.28 mm.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Area of Applanation | ANSI Z80.10-2018 A1.1 | Diameter of $3.06 \pm 0.02$ mm | Met acceptance criteria |
| Surface of Pressure Body – surface imperfections | ANSI Z80.10-2018 A1.2 | Free from surface imperfections that could damage the eye | Met acceptance criteria |
| Surface of Pressure Body – Diameter | ANSI Z80.10-2018 A1.2 | Diameter minimum of 6.0 mm | Met acceptance criteria |
| Surface of Pressure Body – Flatness | ANSI Z80.10-2018 A1.6 | Flat with a tolerance of 10 or fewer fringes over the 4-mm central diameter | Met acceptance criteria |
2. Sample size used for the test set and the data provenance:
- Sample Size: Five samples of the CATS-L tonometer prisms were evaluated.
- Data Provenance: The document does not specify the country of origin. The study is described as "design verification bench testing," implying a prospective, controlled laboratory setting rather than retrospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described is bench testing against specified engineering standards, not a clinical study involving human experts establishing ground truth from patient data.
4. Adjudication method for the test set:
This information is not applicable as the testing was bench testing against engineering standards, not a clinical study requiring expert adjudication of results.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a tonometer prism, which is a physical accessory for measuring intraocular pressure, not an AI or imaging diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone performance study of an algorithm was not done. This device is a physical medical device accessory, not a software algorithm. The "performance data" refers to bench testing of the physical properties against engineering standards.
7. The type of ground truth used:
The ground truth used was based on engineering standards specified in ANSI Z80.10-2018. Specifically, sections A1.1, A1.2, and A1.6 for various physical and optical properties of the tonometer prism.
8. The sample size for the training set:
This information is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.
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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.
-
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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(15 days)
The Diaton Tonometer is intended to measure intraocular pressure (IOP). The device is intended for use as an aid in the diagnosis of glaucoma and for monitoring IOP.
Tonometer diaton. This new IOP measuring method through the eyelid in the sclera area, unique to our device, eliminates completely any effect on the mucous eye membrane.
Here's an analysis of the provided text regarding the Diaton Tonometer, focusing on acceptance criteria and the study that proves the device meets those criteria:
Diaton Tonometer Acceptance Criteria and Performance Study
The provided document describes the predicate device comparison and technological characteristics but does not explicitly define quantitative acceptance criteria for the Diaton Tonometer's performance in a standalone study. Instead, the "Conclusion" section states that the "results of the comparison medical tests of Tonometer diaton and Goldmann tonometer demonstrated their high coincidence degree in the whole range with the compared devices." This suggests that the acceptance criteria were based on demonstrating substantial equivalence to the predicate device (Goldmann Manual Tonometer) in terms of IOP measurement accuracy.
Given the information, we can infer the reported device performance and the implicit acceptance criteria based on its equivalence to the Goldmann Tonometer.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter/Criteria | Acceptance Criteria (Inferred from Substantial Equivalence to Goldmann Tonometer) | Reported Device Performance |
|---|---|---|
| IOP Measurement Accuracy | High coincidence with Goldmann Manual Tonometer across its measurement range. | "The results of the comparison medical tests of Tonometer diaton and Goldmann tonometer demonstrated their high coincidence degree in the whole range with the compared devices. We achieved the same results from all devices." (This implies a level of accuracy comparable to the Goldmann Tonometer, which is the gold standard). |
| Measurement Range | Comparable to or suitable for clinical needs (5-60 mmHg specified). | 5-60 mm Hg |
| Time of Single Measurement | Efficient for clinical use. | 3 seconds (not more) |
| Painless diagnostics | Yes | Achieved without anesthetics and antiseptics |
| Elimination of infection risk | Yes | Achieved |
| Independence from cornea's crookedness | Yes | Achieved |
| Evaluation of IOP in patients after corneal operations | Yes | Achieved |
| IOP measurement in children | Yes | Achieved |
| Monitoring of Glaucoma treatment | Yes | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size of patients or eyes used in the "comparison medical tests." It vaguely refers to "medical tests."
Data Provenance: The company is based in Ryazan, Russia (Ryazan State Instrument-Making Enterprise), so it's highly probable the study data originated from Russia. The document does not specify if the study was retrospective or prospective, but clinical comparison tests are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document refers to "comparison medical tests" where the Diaton Tonometer was compared to the Goldmann Tonometer. The Goldmann Tonometer is considered the clinical gold standard for IOP measurement. While it doesn't explicitly state "experts" establishing ground truth, the comparison implies that the Goldmann measurements served as the reference standard, which would typically be performed by trained ophthalmologists or technicians.
Qualifications of Experts: Not specified. However, for a Goldmann Tonometer, the measurements are performed by trained personnel, likely ophthalmologists, optometrists, or ophthalmic technicians.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set. It simply states that the results of the Diaton Tonometer were compared to those of the Goldmann Tonometer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not mentioned. The study described is a comparison study between the Diaton Tonometer and a predicate device (Goldmann Tonometer) for direct measurement. It does not evaluate how human readers improve with or without AI assistance, as the Diaton Tonometer itself is a measurement device, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the study described is essentially a standalone performance assessment of the Diaton Tonometer. It measures the device's ability to determine IOP independently and then compares those measurements to a predicate device. The device provides an objective reading on an LCD screen without requiring human interpretation other than reading the displayed value.
7. The Type of Ground Truth Used
The ground truth used was the measurement obtained from the Goldmann Manual Tonometer. The Goldmann Tonometer is widely considered the clinical gold standard for intraocular pressure measurement. Therefore, the ground truth is based on a clinical gold standard measurement.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" or "training data." As this is a medical device for direct measurement rather than an AI/machine learning algorithm requiring training, the concept of a training set is not applicable in the context described. The focus is on the performance of the device itself (hardware and its embedded algorithm, if any) against a known standard.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no mention of a "training set" in the context of this device. Therefore, how its ground truth was established is not applicable. The device's measurement mechanism and calibration would have been established during its development and manufacturing, but this is distinct from establishing ground truth for a dataset used to train an AI model.
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