(178 days)
The laser system MeDioStar H (with and without skin cooling system) is intended to remove unwanted body hair and vascular lesions.
The laser system MeDioStar H is restricted to sale to or use by licensed professionals in the United States.
The laser system MeDioStar H operates as a pulsed diode laser which emits a beam of coherent light at 808 nanometers.
The provided text does not contain specific acceptance criteria or a study proving the device meets those criteria. Instead, it is a 510(k) summary for the AESCULAP-MEDITEC GMBH Laser System MeDioStar H, asserting substantial equivalence to predicate devices rather than presenting performance data.
Here's a breakdown of why the requested information cannot be fully provided based on the input:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document. For 510(k) submissions, acceptance criteria often relate to demonstrating substantial equivalence in terms of technological characteristics and intended use compared to legally marketed predicate devices, rather than specific performance metrics against pre-defined thresholds.
- Reported Device Performance: The document explicitly states: "Performance data: None. The specifications and intended uses of the laser system MeDioStar H are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- No test set or performance data is mentioned, therefore no sample size or data provenance is available.
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 applicable as no test set or ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no test set is described.
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:
- No such study was mentioned. The device is a laser system, not an AI-powered diagnostic tool, so an MRMC study involving human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device (laser system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable as no performance data or ground truth establishment process is described. The basis for clearance is substantial equivalence to predicate devices.
8. The sample size for the training set:
- Not applicable as no training set or algorithm development is mentioned.
9. How the ground truth for the training set was established:
- Not applicable as no training set is described.
Summary based on the provided text:
The 510(k) submission for the AESCULAP-MEDITEC GMBH Laser System MeDioStar H relies on substantial equivalence to predicate devices rather than presenting novel performance data against specific acceptance criteria. The document explicitly states that "performance data were not required" because the device specifications and intended uses are "the same or very similar" to those of legally marketed lasers (Conerent / Palomar - LightSheer (K982940), LASERSCOPE - Lyra (K990903), and Candela - CANDELA GENTLELASE II DERMATOLOGICAL LASER (K984601)).
Therefore, the "acceptance criteria" in this context are primarily met by demonstrating that the device is as safe and effective as its predicate devices, based on their established performance and the fundamental principles of laser technology for hair removal and vascular lesions. No specific clinical study results or detailed performance metrics are provided in this summary.
§ 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.