(85 days)
Alexandrite 755nm laser source:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is 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, on all skin types (Fitzpatrick I - VI) including tanned skin. Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG 1064nm laser source:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (sun spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for benign pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
The DEKA MOTUS A Y is a medical device equipped with two laser sources: 755nm and 1064mm. The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. Handpiece activation is either by footswitch or fingerswitch.
The provided text is a 510(k) premarket notification letter from the FDA regarding the DEKA MOTUS AY device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-driven medical device.
The document details the device's substantial equivalence to predicate devices based on technical specifications and indications for use, but it explicitly states under "Clinical Performance Data: None" and focuses on "Non-Clinical Performance Data" which are limited to conformance with electrical and laser safety standards.
Therefore, I cannot extract the information required to answer your questions as they relate to AI/ML device performance and validation.
Here's why the provided text isn't relevant to your request for AI/ML device validation specifics:
- Device Type: The DEKA MOTUS AY is a laser surgical instrument, not an AI/ML diagnostic or therapeutic device. Its performance is evaluated based on physical characteristics and safety standards, not on algorithms interpreting data or making predictions.
- "Acceptance Criteria" in this context: For this device, acceptance criteria would be technical specifications (e.g., wavelength, fluence, pulse duration within a certain range), safety standards compliance, and equivalence to legally marketed predicates. These are listed in tables comparing the device to its predicates.
- "Study that proves the device meets the acceptance criteria": For this device, the "proof" comes from non-clinical testing for compliance with electrical and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and the fact that its specifications are substantially equivalent to already cleared devices. There's no AI algorithm to validate.
If you provide a document related to an AI/ML medical device submission, I would be able to answer your questions.
§ 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.