(84 days)
The Sharplan Ruby Laser System, with its fiber delivery system, is intended for use in dermatology for the removal of unwanted body hair.
The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed laser energy of a 694.3 nm wavelength in the free running mode through an optical fiber beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.
This document is a 510(k) summary for the Sharplan Modified Ruby Laser System, seeking clearance from the FDA. It states that the device is substantially equivalent to a predicate device and is intended for dermatology for the removal of unwanted dark body hair. No new indications for use were sought. Therefore, it explicitly states that no clinical data was presented.
Given this information, it is not possible to provide the details requested in your prompt as they relate to clinical studies, performance criteria, ground truth, and expert evaluation, because such studies were not conducted or submitted for this particular 510(k) clearance.
Specifically, the following information is not available from the provided text:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data from a specific study are mentioned, as no clinical data was presented.
- Sample size used for the test set and the data provenance: No test set was used for a clinical study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment occurred in the absence of clinical data.
- Adjudication method for the test set: Not applicable as there was no test set or clinical study.
- 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: Not applicable. This device is a laser system, not an AI diagnostic or assistance tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable as there was no training set for a clinical study or algorithm.
- How the ground truth for the training set was established: Not applicable.
The basis for this 510(k) clearance was "substantial equivalence" to a predicate device (SLS Chromos 694 QD Ruby Laser System, K962109), implying that its safety and effectiveness are inferred from the predicate device's established use and technology. The document explicitly states: "No new indications were sought in this premarket notification. Therefore, no clinical data was presented."
§ 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.