(130 days)
The MicroSpot Handpiece is intended for Dermatological procedures and Skin resurfacing procedures.
The MicroSpot Handpiece is a handpiece with microbeam output to be used with the previously cleared MCL 31 Dermablate (K150140). The MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. The MCL 31 can be operated with a handpiece of larger spotsize or with a microbeam handpiece. The system incorporates a suction unit for the safe removal of laser plume.
This document is a 510(k) Pre-Market Notification for the Asclepion Laser Technologies GmbH MicroSpot Handpiece. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a clinical study for novel performance claims. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth cannot be extracted from this document.
However, based on the provided text, here is what can be inferred and what information is not available:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal clinical acceptance criteria or report on device performance against such criteria. The "performance" described relates to technical characteristics and safety testing for substantial equivalence.
| Item | Acceptance Criteria (Not explicitly stated for clinical performance) | Reported Device Performance / Assessment |
|---|---|---|
| Clinical Performance | (N/A – not a novel device requiring specific clinical performance acceptance criteria) | Demonstrated substantial equivalence to predicate devices for intended use (Dermatological and Skin resurfacing procedures). |
| Technical Performance | Meets all design specifications; Conforms to specified ISO and IEC standards. | Laboratory testing validated and verified design specifications were met. Evaluated single microspot size, laser pulse duration, energy release, and energy in a duration test. |
| Safety | Safe for its intended use. | Nonclinical (standards compliance, lab testing) and animal performance data (histological study on pig skin) supported safety. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Animal Performance Data (Histological Study):
- Sample Size: 9 pigs.
- Data Provenance: Not explicitly stated, but the company is based in Germany. The study appears to be prospective (controlled experimental application of the device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified in the document. The histological samples were collected and presumably analyzed by experts, but their number and qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. 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 document describes a laser handpiece, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Animal Performance Data (Histological Study): Histological analysis of biopsied pig skin samples. This serves as a form of ground truth for assessing tissue response, ablation depth/width, and thermal damage.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. 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.