(45 days)
Dermatological procedures requiring the coagulation of soft tissue.
The Palomar Lux1540 Handpiece delivers light with a wavelength of 1540 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical. In standard use, the handpiece is held in firm contact with the skin. The handpiece tip is water-cooled to offer active skin System parameters and other system cooling. features are controlled from the user interface panel on top of the power unit.
Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Premarket Requirement: Substantial Equivalence to Legally Marketed Predicate Device | The Palomar Lux1540 Handpiece is deemed "substantially equivalent" to the legally-marketed predicate device, the Reliant Fraxel (K031795). |
| Functional Capability: Capable of performing fractional photothermolysis | The performance data showed that the Lux1540 "is capable of performing fractional photothermolysis, i.e., creation of a pattern (lattice) of microscopic islets of damage at superficial skin layers." |
2. Sample size used for the test set and the data provenance:
- The document does not specify the sample size used for any test set.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for any test set or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not mention any adjudication method for a test set.
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:
- An MRMC comparative effectiveness study was not conducted. This device is a laser handpiece, not an AI or imaging diagnostic device that would typically involve human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- A standalone performance study was not done in the context of an algorithm. The "performance data" mentioned refers to the device's physical functionality (fractional photothermolysis) rather than an algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state the type of "ground truth" used. The performance data focused on demonstrating the device's physical capability to create fractional photothermolysis, implying that the verification involved observing the physical effects on tissue, likely through histological examination or similar methods, but this is not detailed.
8. The sample size for the training set:
- The document does not mention any training set, as this is not an AI or algorithmic device.
9. How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned for this device.
§ 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.