(77 days)
The Acme Medical Aesthetic Nd: YAG Laser is intended for dermatologic use. The 1064nm wavelength, long pulse duration, and large spot size of the Acme Medical Aesthetic Nd: YAG Laser allows for effective coagulation and hemostasis of vascular lesions. The laser system consists of a laser console and a delivery handpiece. The delivery handpiece is placed in contact with the target via a contact tip that is capable of cooling the epidermis. Clinical use of the device is indicated for clinical practitioners in plastic surgery and dermatology who have been technically trained on the use of the Acme Medical Aesthetic Nd: YAG Laser.
For coagulation and hemostasis of vascular lesions.
The Acme Medical Nd:YAG Aesthetic Laser is a long pulsed, solid-state infrared laser. It is intended to deliver laser energy for use in surgical applications requiring coagulation and hemostasis of vascular lesions. The Aesthetic Nd: YAG Laser produces a beam of infrared light at a wavelength of 1064nm. The system consists of:
- a laser console; .
- internal computer; .
- control and display panel; .
- permanently attached fiber optic delivery system; .
- handswitch with the option of a footswitch; and .
- fiber optic coupled handpiece and tip with cooling capability. .
The provided document is a 510(k) Summary Statement for the Acme Medical Nd:YAG Aesthetic Laser. It indicates that no performance data was submitted in conjunction with this Pre-market Notification submission. The determination of substantial equivalence was based solely on the comparison of technical and functional characteristics between the Acme Medical Aesthetic Nd:YAG Laser and predicate lasers. Therefore, the document explicitly states that performance data was not required.
This means that the document does not contain information about acceptance criteria or a study proving the device meets those criteria.
To specifically address the requested information based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document states, "No performance data was submitted in conjunction with this Premarket Notification submission."
- Sample size used for the test set and the data provenance: No test set was used as no performance data was submitted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set was used and no performance data was submitted.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set was used and no performance data was submitted.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser, not an AI-assisted diagnostic tool, and no performance studies were conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance data was submitted.
- The sample size for the training set: Not applicable, as no performance data or algorithm training was relevant for this type of device submission.
- How the ground truth for the training set was established: Not 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.