(114 days)
The Fiber Laser Treatment System is in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
The Fiber laser Treatment system (HS-230) is the desktop type. It consist of mainframe(touch-screen data input system, power supply control system and cooling system), fiber treatment handpiece (laser output system ) and footswitch. The Fiber Laser Treatment System is a Erbium fiber laser, producing a pulsed beam of near-infrared light (1550nm) upon activation by a footswitch. The beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.
The provided text describes a 510(k) premarket notification for a medical device called "Fiber Laser Treatment System" (K221770). This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for a novel AI device.
Based on the provided information, I can extract the following:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical testing for safety and performance against recognized electrical and laser safety standards. Acceptance is implied by compliance with these standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety: IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Complies |
| Electromagnetic Compatibility: IEC 60601-1-2:2014 (Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests) | Complies |
| Laser Safety: IEC 60825-1:2014 (Safety of Laser products-Part 1:Equipment classification and requirements) | Complies |
| Particular Requirements for Surgical Lasers: IEC 60601-2-22:2007 (Medical electrical equipment-Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) | Complies |
| Biocompatibility: ISO 10993-1 (Material Biocompatibility) | Complies |
2. Sample size used for the test set and the data provenance:
- The document explicitly states that non-clinical testing was performed. This typically involves laboratory testing of the device itself and its components, not studies on a "test set" of patient data in the way AI/software devices are evaluated.
- Therefore, there is no patient sample size mentioned, nor is there information on data provenance (country of origin, retrospective/prospective) because such data was not applicable to this type of regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this is a physical medical device (fiber laser) and not an AI/software device requiring interpretation of medical images or data, there was no "ground truth" to be established by experts in this context. The "ground truth" for compliance testing is against the specified engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Since there was no test set involving expert review for diagnostic accuracy or similar, no adjudication method was used.
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, an MRMC study was not done. This device is a laser treatment system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical laser device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the non-clinical testing was compliance with recognized international standards for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993-1).
8. The sample size for the training set:
- Not applicable. The device is a physical laser system, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned or implied, this question does not apply.
In summary: The provided document is for a traditional medical device (laser system) and focuses on demonstrating substantial equivalence through comparison of technical specifications and compliance with non-clinical performance and safety standards, rather than clinical studies involving patient data or AI performance evaluation. Therefore, many of the questions related to AI device evaluation are 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.