(214 days)
The Spectrum Epilaser® has several indications for use based on the selective absorption of natural chromophores, particularly melanin and tattoos. The Ruby laser wavelength of 694.3 nanometers and the pulse duration of the normal mode system are well absorbed by these pigments. Indications for use include the treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black).
The Epilaser® is a normal mode ruby laser operating at 694.3 nanometers with fluence levels from 10-40 J/cm², a pulse duration from 200 usec to 3 msec and a spot size of 5-12 mm. The delivery system includes an articulating arm and cooled contact handpiece.
This 510(k) summary for the K955612 Spectrum Epilaser® Normal Mode Ruby Laser does not contain the detailed information required to answer the requested questions about acceptance criteria and a study proving device performance.
The document is a regulatory summary for device clearance, not a clinical study report. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific performance metrics from a dedicated study with defined acceptance criteria.
Here's why each point cannot be addressed with the provided information:
- A table of acceptance criteria and the reported device performance: This information is not present. The document states "The Epilaser® was demonstrated to be substantially equivalent to the predicate devices on the basis of similar mechanisms of action and indications for use." This is a general statement about regulatory clearance, not a quantitative performance report.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test set or study data is described. The document vaguely mentions "Data from in vitro, in vivo and clinical results found in the open literature were also provided," but this refers to supporting information for substantial equivalence, not a dedicated performance study for this specific device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No ground truth establishment is described because no specific test set or clinical study is detailed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is mentioned as no specific test set or study is detailed.
- 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 device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: As this is a medical device (laser), not an algorithm or AI system, the concept of "standalone performance" in that context does not apply. Performance would typically involve treatment outcomes.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No specific ground truth is described. The indications for use are "treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black)," implying clinical efficacy would be based on visual assessment of lesion reduction/removal, but no study details are given.
- The sample size for the training set: There is no training set mentioned, as this is a physical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable, as there is no training set.
In summary, the provided document is a 510(k) summary for a laser device focused on demonstrating substantial equivalence for regulatory clearance. It does not contain the information requested about specific acceptance criteria and detailed performance studies with sample sizes, expert ground truth, or AI-related metrics.
§ 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.