(78 days)
In addition to previously cleared indications for use, the CoolTouch Model LC215/CoolLipo Nd:YAG Surgical Laser is indicated for laser-assisted lipolysis.
The CoolTouch LC215/CoolLipo Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with microcannula setup.
The provided text is a 510(k) summary for the CoolTouch LC215/CoolLipo Nd:YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a study proving its performance against specific criteria.
Therefore, many of the requested details, such as specific acceptance criteria, reported performance against those criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment, are not available in this document.
Here's what can be extracted and what is explicitly stated as not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | Not Available |
| (The document states "Clinical Performance Data: None" and "Nonclinical Performance Data: None") |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable, as no clinical or non-clinical performance data is reported. The document states "Clinical Performance Data: None" and "Nonclinical Perfomance Data: None".
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no clinical or non-clinical performance data is reported.
4. Adjudication method for the test set
- Not applicable, as no clinical or non-clinical performance data is reported.
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 comparative effectiveness study was done. This device is a laser surgical system, not an AI-assisted diagnostic or imaging device. The document explicitly states "Clinical Performance Data: None".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone performance study of an algorithm was done. This document pertains to a physical medical device (laser system), not an algorithm. The document explicitly states "Clinical Performance Data: None".
7. The type of ground truth used
- Not applicable, as no clinical or non-clinical performance data is reported.
8. The sample size for the training set
- Not applicable, as no clinical or non-clinical performance data is reported.
9. How the ground truth for the training set was established
- Not applicable, as no clinical or non-clinical performance data is reported.
Summary from the provided document:
The 510(k) summary indicates that the CoolTouch LC215/CoolLipo Nd:YAG Laser System is deemed "substantially equivalent" to predicate devices based on its principle of operation, wavelength, and essentially the same pulse energy rate. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None," meaning no new studies were conducted to prove its performance against specific acceptance criteria for this 510(k) submission. The FDA clearance is based on the device's technical specifications aligning with previously cleared devices.
§ 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.