(37 days)
For use as a sensing device to measure and display the temperature of the treatment area during procedures with the NS-130 laser.
The Thermal Sensing Handpiece Accessory is a temperature detector which will provide the laser operator with a readout of the temperature of the treatment area
The provided text does not contain detailed information about specific acceptance criteria or an analytical study proving the device meets those criteria. The "Performance Data" section explicitly states "None."
Instead, the document is a 510(k) Premarket Notification summary that:
- Identifies the device, its intended use, and a legally marketed predicate device.
- Concludes that the CoolTouch Thermal Sensing Handpiece Accessory is "substantially equivalent" to the predicate device based on an evaluation of risks and hazards and "various testing of the modifications." However, it does not elaborate on what this "various testing" entailed or present specific data.
- Includes the FDA's letter confirming the substantial equivalence determination, allowing the device to be marketed.
Therefore, for your request, I must report that the requested information is largely unavailable in the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No specific performance data is reported as "Performance Data: None." The conclusion states "various testing of the modifications" was done, leading to the substantial equivalence finding, but no numerical or descriptive performance metrics are provided. |
2. Sample size used for the test set and the data provenance:
- Sample Size (test set): Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific test set or ground truth establishment by experts is described for a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set or adjudication process is described for a performance study.
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:
- No MRMC study was mentioned. The device is a "thermal sensing handpiece accessory," not an AI-driven diagnostic system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an accessory that provides information to a human operator, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific performance study requiring ground truth is detailed.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a regulatory filing for substantial equivalence, focusing on the device's description and comparison to a predicate, rather than a detailed report of a performance study with specific acceptance criteria and results.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.