(145 days)
The iCare Tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.
The iCare Tonometer TA01i is a portable, handheld, battery operated tonometer, which measures intraocular pressure (IOP). To measure IOP, a very light (26.5 mg) and a slow moving (0.25-0.30 m/s) probe makes momentary contact with the cornea of the eye. The device measures the speed of the probe during the time probe is in contact with cornea. Resulting IOP is displayed on a liquid crystal display (LCD). The force used for the measurement which is directed onto the eye is extremely small, because of the low weight and slow speed of the probe.
The iCare Tonometer TA01i is a device intended for measuring intraocular pressure (IOP) of the human eye. The provided text, a 510(k) summary, details the device's characteristics and compares it to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like "sensitivity ≥ X%" or "specificity ≥ Y%". Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technological features, and overall performance.
The qualitative acceptance criteria can be inferred as:
- Operating Range, Accuracy, and Repeatability: The device must meet acceptance criteria for these aspects.
- Substantial Equivalence to Predicate Devices: The device's performance, safety, and effectiveness must be comparable to previously cleared devices.
- Biocompatibility: The patient-contacting probe must be biocompatible.
- Electromagnetic Compatibility & Electrical Safety: The device must conform to relevant standards.
Here's a summary of the stated performance relative to these inferred criteria:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Operating Range | Met: Evaluated in bench testing. Range: 7-50 mmHg (display range 1-99 mmHg) |
| Accuracy | Met: Evaluated in bench testing. Performance compared to predicate devices (including Goldmann type) in clinical evaluation. |
| Repeatability | Met: Evaluated in bench testing. |
| Substantial Equivalence in Performance, Safety, and Effectiveness to Predicate Devices (e.g., Goldmann Tonometer, Tono-Pen XL, Pascal DCT, TGUc-01 "PRA") | Achieved: "Based on the results of non-clinical and clinical testing, the performance of iCare Tonometer TA01i is judged to be substantially equivalent to predicate devices." Specific comparisons highlight: - Rebound measurement technique (different from applanation for some predicates, but validated). - No maintenance calibration required. - Lightweight, disposable, single-use, sterilized probe. - Probe briefly touches the eye, low force (8-16 mN). - No anesthesia required. - Can be used in any position (with horizontal orientation). |
| Biocompatibility of Patient-Contacting Probe | Met: "The patient contacting probe is considered biocompatible. The appropriate tests for biocompatibility were performed according to "ISO 10993-1:2003, Biological evaluation of medical devices - Part 1 Evaluation and Testing"." |
| Electromagnetic Compatibility (EMC) and Electrical Safety | Met: "The electromagnetic compatibility and electrical safety of the iCare Tonometer TA01i was tested and found to conform to the requirements of IEC 60601-1 and IEC 60601-1-2." |
2. Sample size used for the test set and the data provenance
The document states: "In clinical evaluation, the performance of iCare Tonometer TA01i was compared to predicate devices, including Goldmann type tonometer." However, it does not specify the sample size (number of patients or measurements) used for this clinical evaluation.
Data provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only mentions "clinical evaluation."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. It mentions comparison "to predicate devices, including Goldmann type tonometer," which implies that the predicate device's measurement served as the reference.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set clinicians or measurements. The comparison is stated as being against predicate devices.
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
This device is a standalone tonometer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed, and there is no information about an effect size for human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation of the device itself was performed. The "bench testing" evaluated the device's operating range, accuracy, and repeatability, which are characteristics of the device's standalone performance. The "clinical evaluation" also assessed the iCare Tonometer TA01i's performance independently, comparing its measurements to those of predicate devices. The device is a measurement tool, not an assistive AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The primary ground truth or reference standard used for the clinical evaluation was measurements from predicate devices, specifically noted to include "Goldmann type tonometer." Goldmann applanation tonometry is widely considered the gold standard for IOP measurement.
8. The sample size for the training set
This device is a physical medical device (tonometer), not a machine learning or AI algorithm that requires a "training set" in the computational sense. Therefore, there is no concept of a training set sample size for this device.
9. How the ground truth for the training set was established
As noted above, this device does not use a "training set" in the context of AI/ML. The device's underlying physics and calibration are based on rebound tonometry principles, rather than learned patterns from a dataset.
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.