(83 days)
The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne. It is intended for over-the-counter use.
The Tria Sapphire is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
The provided document is a 510(k) summary for the Tria Sapphire device, a blue light therapy system intended for the treatment of mild to moderate inflammatory acne. It focuses on demonstrating substantial equivalence to a predicate device (Tria Beauty, Inc., ATS-1 OTC, K090312).
However, the document does not contain the detailed information required to answer your specific questions about:
- Acceptance criteria and reported device performance (in terms of clinical efficacy metrics like sensitivity, specificity, accuracy, or reduction in acne lesions)
- Sample sizes for a test set for clinical performance
- Number/qualifications of experts for ground truth establishment
- Adjudication methods
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used for clinical efficacy
- Sample size for training set (of an AI/ML algorithm)
- Ground truth establishment for the training set
The document primarily discusses:
- Non-Clinical Performance: Testing for electrical safety, electromagnetic compatibility, biocompatibility, and software verification/validation. These are about device function and safety, not clinical efficacy performance against a specific metric.
- Clinical Performance (Usability Study): It mentions a "60-subject, all-comers OTC usability study."
- Purpose: To demonstrate that subjects could self-select correctly, use the device properly, and comprehend labeling.
- Outcome: "No safety issues were identified. Usability results were consistent with the predicate ATS-1 OTC device and are appropriate for over-the-counter clearance."
This "clinical" study is a usability study, not a clinical efficacy study designed to prove a certain level of performance (e.g., a specific percentage reduction in acne lesions or accuracy in diagnosis). The 510(k) pathway for this device relied on demonstrating substantial equivalence to a predicate device, and the usability study was likely used to show that despite being a new device, it could be safely and effectively used by the target OTC population, similar to the predicate.
Therefore, based solely on the provided text, I cannot complete the table or answer the specific questions related to AI/ML device performance, clinical efficacy metrics, or ground truth establishment for such metrics.
The device outlined in this 510(k) is a light therapy system, and the "performance data" discussed is primarily related to safety, engineering specifications, and usability, rather than the kind of clinical performance data one would expect for an AI/ML-driven diagnostic device (e.g., sensitivity, specificity, AUC, etc., against a gold standard).
If this was an AI/ML device, the detailed information you're asking for would be crucial and would typically be found in a separate clinical study report or a more extensive performance section of the 510(k) submission, which is not present in this summary.
§ 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.