(29 days)
The SmoothSkin Pure Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch 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 SSC1 device 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 shaft. The absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "SmoothSkin Pure Switch (SSC1)," an Intense Pulsed Light (IPL) hair removal device.
Crucially, this document specifies that the device's substantial equivalence is based on its similarity to legally marketed predicate devices, not on a clinical study demonstrating its performance against specific acceptance criteria for a new AI/algorithm-driven diagnostic/prognostic device.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm. The clearance is based on the device's technical specifications and intended use being similar to existing cleared devices, and compliance with general safety and performance standards (electrical safety, EMC, biocompatibility), rather than a specific demonstration of diagnostic/prognostic accuracy or the improvement of human reader performance.
The document does not contain:
- A table of acceptance criteria and reported device performance for an algorithm.
- Sample sizes for a test set for an algorithm.
- Information on experts for ground truth establishment.
- Adjudication methods for a test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth for an algorithm.
- Training set sample size or ground truth establishment for a training set.
The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section primarily lists compliance with various electrical safety, electromagnetic compatibility, and biocompatibility standards. It does not describe a clinical study in the sense of demonstrating a new diagnostic or prognostic capability's accuracy or impact on human performance.
In summary, the provided text does not contain the information requested for AI/algorithm performance studies and acceptance criteria, as the device's clearance is based on predicate device equivalence and compliance with general device safety standards.
§ 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.