(118 days)
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.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance (Icare ic100) |
|---|---|---|
| Measurement Method | Identical to predicate device | Identical to predicate device (IOP measurement algorithm unchanged, rebound technology identical) |
| IOP Measurement Algorithm | Identical to predicate device | Identical to predicate device (K063873) |
| Rebound Technology | Identical to predicate device | Identical to predicate device |
| Range of Measurement | Same as predicate (7-50 mmHg) | Same as predicate (7-50 mmHg) |
| Accuracy / Equivalence to Predicate | Performance comparable to Icare TA01i, validated according to ANSI Z80.10-2014 & IEC standards. | Verification tests carried out in accordance with ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers confirmed that performance and safety aspects are comparable. |
| Electrical Safety | Compliance with IEC 60601-1 | In compliance with IEC 60601-1 |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | In compliance with IEC 60601-1-2 |
| Software Life Cycle Processes | Compliance with IEC 62304 | Verified against the requirements of IEC 62304 |
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.
§ 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.