(26 days)
The LaserLite Diode Surgical Laser is intended for treatment of pigmented and vascular lesions including leg veins.
The LaserLite Diode Laser System is a semiconductor diode laser operating at 810 + 20 microns.
Here's an analysis of the provided text regarding acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. |
Explanation: The K981090 submission for the LaserLite Diode Surgical Laser System explicitly states: "Performance Data: None. The specifications and indications for use of the LaserLite Diode Surgical Laser System are the same or very similar to those of the claimed predicate devices. The LaserLite Diode Surgical Laser has the same indications for use for which the claimed predicates have been cleared and has no additional indications for use. Because of this, performance data were not required."
Therefore, this document does not contain any specific performance data or acceptance criteria relating to a study of the device's efficacy or safety beyond its substantial equivalence to predicate devices.
Regarding the Absence of the Requested Study Information:
Based on the provided K981090 510(k) summary, the device did not undergo a study to prove it meets specific acceptance criteria in the way described in your request. The FDA cleared this device based on substantial equivalence to already legally marketed predicate devices, not on new performance data generated for the LaserLite Diode Surgical Laser System itself.
Therefore, the following information cannot be extracted from the provided text:
- 2. Sample sized used for the test set and the data provenance: No test set was used for performance evaluation.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set was used.
- 4. Adjudication method for the test set: Not applicable as no test set was used.
- 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 a laser system, not an AI-assisted diagnostic device, and no such study was conducted or reported.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a laser and not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance data was required or provided.
- 8. The sample size for the training set: Not applicable as no machine learning algorithm was involved.
- 9. How the ground truth for the training set was established: Not applicable as no machine learning algorithm was involved.
Conclusion from the Document:
The LaserLite Diode Surgical Laser System was cleared based on its stated specifications and indications for use being "the same or very similar" to those of legally marketed predicate devices (Coherent LightSheer Diode Laser System, Iriderm DioLite 532 Laser System, and Laserscope Aura Laser System). The "Performance Data" section explicitly states "None" and clarifies that "performance data were not required" due to this substantial equivalence.
§ 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.