(286 days)
The Mehl QD Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair.
The Mehl QD Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair.
The provided text describes a laser system for hair removal and its substantial equivalence to other devices, but it does not contain the detailed information required to fill out the requested table and answer the specific questions about acceptance criteria, study design, and ground truth establishment.
Here's a breakdown of what is and is not present:
Information Present in the Text:
- Device Name: MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL
- Intended Use: Removal of unwanted body and facial hair.
- Classification: Class II (Performance Standards) device, Product Code 79GEX, regulated under 21 CFR 878.4810.
- Substantial Equivalence:
- Clinical Studies Mentioned: Three clinical studies were conducted to measure the ability of the ruby laser to remove hair.
- One Study Result: "38.4% of the sites receiving only one treatment showed a 100% reduction in hair density after an average of 72 days."
- Safety Information: "No safety issues were identified. No scarring or purpuric reactions were observed, though skin discoloration (hyper- and hypopigmentation) was noted, but was seen to resolve within a few months."
Information NOT Present in the Text (and therefore cannot be provided for the requested table and questions):
- Specific Acceptance Criteria: The text mentions one performance metric (38.4% reduction), but it doesn't state this as a pre-defined "acceptance criterion" that the device must meet for regulatory approval. There's no explicit list of criteria.
- Test Set Sample Size for all studies: Only one specific result from one study has a number associated with it (implicitly, the number of "sites" that achieved 100% reduction, but not the total number of sites or patients in that study). The total number for all three studies is not given.
- Data Provenance (country, retrospective/prospective): Not mentioned.
- Number of Experts for Ground Truth: Not mentioned, and ground truth for hair removal is typically clinical observation.
- Qualifications of Experts: Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Study: This is a human-in-the-loop study often used for AI devices. A laser system for hair removal is not an AI device, so an MRMC study would not be applicable or expected.
- Effect size of human readers with/without AI assistance: Not applicable for this device.
- Standalone (algorithm-only) performance: Not applicable as it's a physical device, not an algorithm.
- Type of Ground Truth: Implied to be clinical observation of hair density, but not explicitly stated or detailed.
- Training Set Sample Size: The concept of a "training set" is relevant for AI/ML devices. This is a laser device, so there isn't a training set in that sense. The clinical studies represent validation, not training.
- How Ground Truth for Training Set was Established: Not applicable.
Conclusion:
Based on the provided text, it's impossible to complete the requested table and answer many of the specific questions because the document is a 510(k) summary focusing on substantial equivalence and a high-level overview of clinical findings, not a detailed clinical study report or a description of an AI/ML device validation.
If this were an AI device, the lack of this information would be a significant gap. For a laser device, the requirements for specifying "ground truth" and "training sets" are generally different. However, even for a medical device, clear acceptance criteria and detailed clinical study methodology are usually essential for comprehensive evaluation.
§ 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.