(91 days)
The Spectra Hair Removal Laser is intended to effect temporary hair removal.
The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.
Here's an analysis of the provided text regarding the Spectra Hair Removal Laser, focusing on the acceptance criteria and study aspects you requested:
Acceptance Criteria and Study Analysis for Spectra Hair Removal Laser (K032846)
This 510(k) submission explicitly states that no performance data was required or submitted for the Spectra Hair Removal Laser. The basis for clearance was substantial equivalence to legally marketed predicate devices, and the indications for use were a subset of those claimed by the predicates. Therefore, the device did not undergo a specific study to prove it meets acceptance criteria, nor were explicit acceptance criteria defined within this document.
Given this, many of the specific questions about the study design cannot be answered from the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No performance data provided |
Explanation: The 510(k) states: "None. The specifications and indications for use of the Spectra Hair Removal Laser are a subset of those claimed in one or more of the clearances for the above-listed predicate devices. Thus performance data were not required." This means the device's performance was considered acceptable based on its similarity to already cleared devices, not on specific, pre-defined quantitative criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not applicable, no performance study was conducted.
- Data Provenance: Not applicable, no performance study was conducted.
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)
- Number of Experts: Not applicable, no performance study was conducted.
- Qualifications of Experts: Not applicable, no performance study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, no performance study was conducted.
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
- MRMC Study: No. This device is a hair removal laser, not a diagnostic AI system with human-in-the-loop interaction for interpretation tasks.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This device is a laser for hair removal, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable, no performance study was conducted. The "ground truth" for this submission was the established safety and effectiveness of its predicate devices for temporary hair removal.
8. The sample size for the training set
- Training Set Sample Size: Not applicable, no AI/ML algorithm was involved, and no performance study was conducted for this specific device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: 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.