(28 days)
The SmoothSkin Pure Unplugged is intended for the removal of unwanted hair. The SmoothSkin Pure Unplugged 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 Unplugged is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is battery powered and charged by mains. The handset with removal battery pack, Handset Dock station, and AC Adapter. AC mains is fed to the AC Adapter and converted to DC to charge the battery pack via the docking station contact pins, the device cannot be used when charging. The battery pack 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 absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
Please provide the input document. The provided text is a generic FDA 510(k) clearance letter and summary, which describes a medical device (SmoothSkin Pure Unplugged) but does not contain any information about the acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-enabled device as suggested by the detailed criteria you've outlined.
The document discusses:
- The device's name and regulation
- Comparison to predicate devices
- Technological characteristics and minor changes (energy source, electrical architecture, software for battery management, aesthetics)
- Compliance with electrical safety, EMC, biocompatibility, and software (IEC 62304) standards.
There is no mention of:
- A test set size, data provenance, or a study to prove performance against specific clinical or AI-related metrics.
- Experts establishing ground truth, adjudication methods, or MRMC studies.
- Standalone algorithm performance or a training set.
- Any performance metrics like sensitivity, specificity, AUC, etc., which would be typical for an AI/ML device's acceptance criteria.
Therefore, I cannot fulfill your request using the provided text. To answer your question, I would need a document that describes:
- Specific performance metrics (e.g., accuracy, sensitivity, specificity, F1-score) as acceptance criteria.
- Details of a study (clinical trial or non-clinical validation) that measures these metrics.
- Information on the datasets used (size, type, source).
- Details about how ground truth was established, including expert involvement and adjudication.
- Information about training data for an AI/ML model, if applicable.
§ 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.