(355 days)
The Light Age EpiCare™ Alexandrite Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing after a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin.
It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
The Light Age EpiCare™ Alexandrite Laser has an Alexandrite crystal rod as a lasing medium. Pulsed energy is emitted at 755 nanometers in the near infrared portion of the spectrum. Energy from the laser is delivered to the target area via optical fiber with handpiece, which produces a circular beam on the skin. The EpiCare™ Alexandrite Laser is equipped with safety interlocks to protect patients and operators.
This 510(k) summary does not contain the detailed study results that would allow for a complete description of acceptance criteria and device performance in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing a standalone clinical study report with specific acceptance criteria and detailed performance metrics.
However, based on the provided text, I can infer some information relevant to the request.
Here's an attempt to answer your questions based only on the provided text, with significant limitations due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in the form of percentages, p-values, or confidence intervals. The basis for safety and effectiveness is stated as "essentially the same wavelength, the same operation principle, essentially the same fluence levels, and the same spot size" as predicate devices. The indication for "permanent hair reduction" typically implies a specific percentage of hair reduction over a defined period, but this is not quantified in the provided text.
| Performance Metric (Implied) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Hair Reduction Efficacy | Stable long-term or permanent hair reduction, similar to predicate devices. | Stated to achieve "stable long-term, or permanent hair reduction." |
| Treatment of Vascular Lesions | Efficacy similar to predicate devices. | Indicated for the "treatment of vascular lesions." |
| Treatment of Benign Pigmented Lesions | Efficacy similar to predicate devices. | Indicated for the "treatment of benign pigmented lesions." |
| Treatment of Wrinkles | Efficacy similar to predicate devices. | Indicated for the "treatment of wrinkles." |
| Safety Profile | No new questions of safety or efficacy compared to predicate devices. | "The Light Age EpiCare™ Alexandrite Laser... presents no new questions of safety or efficacy, and is substantially equivalent to the predicate devices." Equipped with "safety interlocks to protect patients and operators." |
| Skin Types | Effective and safe for all skin types (Fitzpatrick I-VI) including tanned skin. | Indicated for "all skin types (Fitzpatrick I-VI) including tanned skin." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention any specific sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective study design). This 510(k) summary relies on demonstrating substantial equivalence to pre-existing predicate devices, not on a new clinical trial with a defined test set.
3. 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)
Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study involving adjudication of a test set.
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
Not applicable. This device is a laser for medical treatments, not an AI diagnostic or assistance system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (laser), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Given the nature of a 510(k) for a laser device, the "ground truth" for its effectiveness would generally be based on clinical outcomes (e.g., observed hair reduction, visual improvement of lesions/wrinkles) from studies (either specifically for this device or, more likely in a 510(k), for the predicate devices) and expert clinical judgment. However, the document does not detail how "ground truth" was established for any specific study for this device. It primarily relies on the established safety and effectiveness of its predicate devices.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device that requires a training set.
§ 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.