(130 days)
The PicoStar laser system is indicated for the following at the specified wavelength:
532 nm:
Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-III.
1064 nm:
Removal of tattoos for all skin types (Fitzpatrick I-V) to treat the following tattoo colors: black, brown, green, blue and purple.
Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
Only with microspot handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Only with microspot handpiece. indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
PicoStar is a solid state laser capable of delivering energy at wavelengths of 1064 nm, or 532 nm at short durations of max 400 picoseconds (ps) and repetition rates up to 10 Hz. The device system is composed of a system console, an articulated arm, and attached delivery handpieces (full spot or microspot). The laser output at each wavelength is delivered to the skin through an articulated arm delivery system terminated by a handpiece. The PicoStar is controlled via a touch screen display housed in the front of the device. The control panel enables the user to select the desired energy density level and repetition rate. Emission is triggered by means of a footswitch.
The provided text is a 510(k) summary for the PicoStar laser system. It outlines the device's indications for use, technological characteristics, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria and a study proving a device meets those criteria for an AI/machine learning medical device.
The document states:
- "Clinical Performance Data: None" on page 6.
- "Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". PicoStar passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards." on page 5. This refers to software engineering practices, not a performance study of an AI algorithm based on clinical data.
The PicoStar device is a laser surgical instrument, and its clearance is based on substantial equivalence to a predicate laser device, supported by non-clinical performance data (electrical safety, EMC, software lifecycle processes, risk management) and biocompatibility, not by a clinical study on AI performance metrics.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets those criteria from this document. The document pertains to the regulatory clearance of a laser device, not an AI/ML-driven diagnostic or therapeutic device that would require such performance studies.
§ 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.