(335 days)
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:
| Acceptance Criteria (Bench Performance) | Reported Device Performance (Bench) | Acceptance Criteria (Clinical Performance - from ANSI Z80.10:2014) | Reported Device Performance (Clinical - compared to GAT) |
|---|---|---|---|
| Accuracy: ± 1.2 mmHg (IOP ≤ 20 mmHg) | Met criterion | Max allowed % outside ±5 mmHg: 5% (overall) | 1.3% (overall) |
| Accuracy: ± 2.2 mmHg (IOP > 20 mmHg) | Met criterion | Max allowed % outside ±5 mmHg: 5% (IOP ≤ 16 mmHg) | 0.0% |
| Coefficient of variation CV 99.7%) | R-squared > 99.7% | Max allowed % outside ±5 mmHg: 5% (IOP ≥ 23 mmHg) | 0.0% |
| Mean difference from true manometric pressure: 99.5%) | Mean difference: 0.10 mmHg, SD: 0.98 mmHg, R-squared > 99.5% |
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.
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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.
- Sample Size:
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.
§ 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.