(311 days)
The indications for use for the SILKPRO-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the SILKPRO-S20S-755A include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes) The indications for use for the SILKPRO-S20S-810B include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
The working principle of SILKPRO Titanium Diode Laser System is selective photothermal effect. It uses its unique long pulse width laser to penetrate the epidermis to the hair follicle. The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The treatment head adopts a uniquely designed sapphire dynamic cooling device. SILKPRO Titanium Diode Laser System is a sophisticated high-tech laser equipment. The machine includes water cooling system. Water flows through the pipes in the handpiece to dissipate heat for the light source and the TEC water cooling block , which is used to cool the skin tissue during treatment.
The provided text is a 510(k) premarket notification for a medical device, specifically a laser system for hair removal. It aims to demonstrate that the new device, SILKPRO Titanium Diode Laser System, is substantially equivalent to a legally marketed predicate device, the Soprano Titanium.
However, the provided document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of an AI/ML-driven medical device. The document is a traditional 510(k) summary, which focuses on demonstrating substantial equivalence based on technological characteristics, intended use, and safety/performance verification through non-clinical testing (e.g., electrical safety, software validation, biocompatibility).
The text does not mention:
- Any AI/ML components or algorithms in the device.
- Performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML validation.
- Test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies.
Therefore, I cannot populate the requested table or sections related to AI/ML device validation. The information in the prompt is specific to an AI/ML system's evaluation, which is not described in the provided FDA document.
To directly answer your request based on the provided text, the document does not present the type of information needed to fill out the table and study description you've requested because the device (SILKPRO Titanium Diode Laser System) is a traditional laser device, not an AI/ML device.
The document primarily focuses on demonstrating substantial equivalence by comparing the technical specifications and intended use of the proposed device to a predicate device. The "acceptance criteria" are implied by meeting the standards and demonstrating similar safety and performance characteristics to the predicate, as verified through non-clinical tests.
If this were an AI/ML device, the requested information would be crucial. Since it is not, the concept of "acceptance criteria" and "study proving it meets acceptance criteria" for an AI/ML system, as you've defined, is not applicable here.
§ 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.