(208 days)
The TX-10 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.
The TX-10 is a tonometer designed using a non-contact measurement system. A ir puff gently measures the intraocular pressure with the help of an autoalignment system. Features quick and easy measurement that does not require any special skills.
The provided text describes the Canon TX-10 Tonometer and its comparison to the Canon T-2 Tonometer and proposed ISO Specifications.
Here's the information extracted and organized according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (ISO Specifications) | TX-10 Performance |
|---|---|---|
| Regression Slope | 0.95 to 1.05 | 0.996 |
| Regression Y-intercept | -1.0 to +1.0 mmHg | 0.462 mmHg |
| Standard Deviation of Difference (Sd) | 2.5 mmHg | 1.56 mmHg |
| Coefficient of Correlation | Unspecified | 0.926 |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only presents summarized performance 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.
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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not an AI-assisted device. The document describes a tonometer, which is a medical device for measuring intraocular pressure. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device and no such study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself, the TX-10 Tonometer, is a standalone device that performs measurements without human intervention in the measurement process (it has an "auto-alignment system" and "non-contact measurement system"). The performance data presented is for the device's accuracy in measuring intraocular pressure.
7. The type of ground truth used
The document implicitly uses a "reference standard" or "gold standard" for intraocular pressure measurement against which the TX-10 and T-2 tonometers were compared, as indicated by the regression analysis (slope, y-intercept) and standard deviation of difference. However, the specific method for establishing this ground truth (e.g., applanation tonometry performed by experts, a different type of tonometer, etc.) is not explicitly stated.
8. The sample size for the training set
This information is not applicable as the product described is a physical medical device (tonometer) and not an AI/algorithm-based system requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 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.