(23 days)
The SmoothSkin Pure Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The SmoothSkin Pure Adapt is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use.
The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp.
Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair sharty is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
The provided document is a 510(k) Summary for the SmoothSkin Pure Adapt (SSG3) hair removal device. It details the device's intended use and compares it to a predicate device. However, it does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the way you are asking about (e.g., performance metrics like sensitivity/specificity, human reader studies, or ground truth establishment).
The non-clinical and/or clinical tests summary section (page 5) lists compliance with various standards related to electromagnetic compatibility, usability, essential performance, photobiological safety, and biocompatibility. These are general safety and performance standards for medical devices, not specific performance criteria for hair removal efficacy or accuracy that would involve a test set, ground truth, or expert review in the way you described for AI/CAD systems.
Therefore, I cannot provide answers to most of your numbered points based on the information given. The document focuses on showing substantial equivalence to a legally marketed predicate device by demonstrating similar technological characteristics and compliance with recognized safety and performance standards.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- The document primarily demonstrates compliance with various safety and performance standards (e.g., IEC 60601 series, ISO 10993 series), rather than specifying quantitative performance acceptance criteria for hair removal efficacy in terms of metrics like sensitivity or specificity.
- For hair removal efficacy, the acceptance criterion implicitly comes from showing substantial equivalence to the predicate device, which is also indicated for "permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime." The document states "Same indications for use," implying the device is expected to achieve similar results as the predicate. However, no specific performance data (e.g., percentage reduction in hair regrowth) is provided from a study to meet this.
2. Sample size used for the test set and the data provenance:
- Not provided. No specific test set for hair removal efficacy is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a study involving expert-established ground truth for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 an IPL hair removal device, not an AI/CAD system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for the types of studies you are referring to. The device's "ground truth" for its intended use is likely based on the clinical outcomes of the predicate device.
8. The sample size for the training set:
- Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through technological comparisons and compliance with recognized standards, rather than detailing a specific clinical performance study with defined acceptance criteria and test sets for efficacy.
§ 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.