(266 days)
The Dermablate Effect Er:YAG laser with handpiece of larger spot sizes is intended for use for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery, oral surgery and ophthalmology (skin around the eyes).
The Dermablate Effect Er:YAG laser with fractional handpiece is intended for dermatological and skin resurfacing procedures.
The Dermablate Effect can be equipped optionally with the following modules: Asclepion Pulsed Light (APL) and Acoustic Wave (AW).
The Asclepion Pulsed Light is intended for permanent hair reduction, treatment of vascular and pigmented lesions and inflammatory acne.
The Acoustic Wave is intended for the activation of connective tissue.
The Dermablate Effect is a pulsed Er:YAG laser emitting a wavelength of 2940 nm, that can optionally be equipped with a pulsed light module (APL) and an acoustic wave module (AW).
Unfortunately, I cannot directly help you with your request. The provided text is a 510(k) summary for a medical device (Dermablate Effect). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Key issues preventing me from fulfilling your request are:
- Absence of Acceptance Criteria and Performance Data: The 510(k) summary explicitly states "Nonclinical Performance Data: None" and for "Clinical Performance Data," it only mentions a "Fractional Er:YAG histological report of Prof. D. Cassuto" without providing any specific criteria, metrics, or measured performance values. This means there's no information about acceptance criteria or how the device's performance was quantitatively evaluated against them.
- Lack of Detailed Study Information: The brief mention of a "histological report" is not a detailed study description. It doesn't contain the essential information you're asking for, such as sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics.
- Focus on Substantial Equivalence, Not De Novo Performance: The 510(k) process is about demonstrating substantial equivalence to pre-existing devices, not necessarily proving novel performance against a predefined set of acceptance criteria in a detailed clinical trial like a PMA (Pre-Market Approval) submission might require.
To get the information you are looking for regarding acceptance criteria and detailed study data, you would typically need to consult a more comprehensive clinical trial report or a PMA submission for a novel device, rather than a 510(k) summary.
Therefore, I cannot generate the table or answer the specific questions because the necessary data is not present in the provided text.
§ 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.