(41 days)
The SOPRANO™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The SOPRANO™ System is indicated for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The modified MSq SOPRANO™ Hair Removal Diode Laser System is comprised of the following components:
- Console Unit that includes the main CPU Board, Power Supply Units, . Control Panel, Service Panel, Cooling System, Keyswitch, Emergency Stop, and Isolating Transformer;
- Handpiece (with Connector) that includes Optical Head, Tissue Cooling . system (the cold plate) and Handpiece Trigger;
- Footswitch. .
The provided document is a 510(k) summary for the MSq SOPRANO™ Hair Removal Diode Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria in the manner typically seen for novel medical diagnostics or AI software.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the specifics of a study proving the device meets those criteria, such as sample sizes, expert qualifications, adjudication methods, or MRMC studies.
Instead of specific acceptance criteria met by the device itself, the document focuses on demonstrating substantial equivalence to a predicate device.
Here's what can be extracted based on the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable. The document does not describe specific performance metrics or acceptance criteria for the SOPRANO™ system in terms of clinical outcomes (e.g., success rates, hair reduction percentages) and how they were met by a study.
- The "acceptance criteria" in this context is "substantial equivalence" to the predicate device, MSq MYTHOS™ Hair Removal Diode Laser System (K030805), based on shared indications for use, device operation, and overall technical and functional capabilities. The document asserts that the SOPRANO™ system meets this criterion.
2. Sample Size for the Test Set and Data Provenance:
- Not provided. The document does not describe a clinical "test set" with a specific sample size. The substantial equivalence argument relies on comparing technical specifications and overall capabilities to the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not provided. This type of information is not relevant to a substantial equivalence argument for a laser hair removal system based on technical modifications.
4. Adjudication Method:
- Not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is not mentioned or implied, as the device is not an AI diagnostic software requiring human reader evaluation.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. The SOPRANO™ device is a laser system, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable. This concept does not apply to the 510(k) summary for this device. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
8. The Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary: The provided 510(k) summary for the SOPRANO™ Hair Removal Diode Laser System demonstrates substantial equivalence to a predicate device by asserting shared indications for use, device operation, and technical/functional capabilities. It does not contain the detailed clinical study information (acceptance criteria, sample sizes, expert involvement, "ground truth" establishment, etc.) that would be expected for a novel device or AI-based diagnostic tool.
§ 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.