(53 days)
The DioScan Scanning Handpiece Accessory is indicated for incision, excision, vaporization, ablation, cutting, hemostasis, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.
The DioScan Scanning Handpiece is intended to allow the rapid treatment of a large area of skin by scanning a laser spot over a treatment area. The area treated allows the majority of the operator's time to be spent in treatment, with a small proportion of time spent in moving the scanner between areas. To minimize patient discomfort and reduce spent in moving the counter ous, the handpiece employs a cooled sapphire window in thermal contact with the skin during treatment.
The provided text is a 510(k) summary for the DioScan Scanning Handpiece Accessory. It explicitly states that no performance data or studies were required because the device's specifications and indications for use are "the same or very similar" to legally marketed predicate devices.
Therefore, the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from this document, as such a study was not performed for this submission.
Here's a breakdown based on the information provided:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: None explicitly stated as performance data was not required. The implicit acceptance criterion for this 510(k) submission was "substantial equivalence" to predicate devices.
- Reported Device Performance: Not applicable, as performance data was not required or reported.
2. Sample size used for the test set and the data provenance:
- Not applicable, as no performance tests were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no performance tests were conducted.
4. Adjudication method for the test set:
- Not applicable, as no performance tests were conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No, an MRMC comparative effectiveness study was not done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done. This device is a physical handpiece accessory, not an algorithm.
7. The type of ground truth used:
- Not applicable, as no performance tests were conducted.
8. The sample size for the training set:
- Not applicable, as no training set was used for this type of device submission.
9. How the ground truth for the training set was established:
- Not applicable, as no training set was used.
§ 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.