(90 days)
1550nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
1927nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring the coagulation of soft tissue.
The Fiber laser Treatment systems (HS-232) is the desktop type, and (HS-233) is the mobile 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 an Erbium(1550nm) and Thulium(1927nm) fiber laser, producing a pulsed beam upon activation by a footswitch. The system is equipped with a 650nm aiming beam with less than 2mW, the beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.
The 1550nm laser and 1927nm laser works independently and cannot work together, the output laser source can be selected according to different indication for use
The provided text is a 510(k) clearance letter and an accompanying 510(k) summary for the Fiber Laser Treatment Systems (HS-232, HS-233). This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving the device meets acceptance criteria is not present in this document. The FDA 510(k) process for this type of device (laser surgical instrument) typically relies heavily on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing (electrical safety, EMC, performance against standards) and functional comparisons, rather than requiring extensive clinical trials with specific performance endpoints.
Here's a breakdown of what can and cannot be answered from the provided text:
What can be extracted:
- Device Name: Fiber Laser Treatment Systems (HS-232, HS-233)
- Intended Use/Indications for Use:
- 1550nm: Intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
- 1927nm: Intended for use in dermatological procedures requiring the coagulation of soft tissue.
- Non-Clinical Testing Performed: Electrical safety and electromagnetic compatibility based on several IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
- Clinical Testing: Not applicable, as stated in the document.
What cannot be extracted (as per your request, because the document doesn't contain a specific study demonstrating performance against acceptance criteria beyond general safety and equivalence):
- A table of acceptance criteria and the reported device performance: No specific performance acceptance criteria (e.g., minimum percentage of fractional skin resurfacing achieved, specific coagulation depth) or reported performance results (e.g., test scores, sensitivity, specificity, accuracy) are provided. The "performance testing" mentioned refers to verifying design specifications and compliance with standards, not performance against clinical or perceptual criteria.
- Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned as clinical testing was not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test with expert-established ground truth was reported.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a laser surgical instrument, not an AI-powered diagnostic device with human reader interaction.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical laser system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established for "performance" beyond compliance with engineering standards.
- The sample size for the training set: Not applicable as this is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA document focuses on demonstrating that the Fiber Laser Treatment Systems are substantially equivalent to previously cleared predicate devices based on technological similarity, indications for use comparison, and compliance with general electrical safety and laser standards. It does not detail a study proving the device meets specific clinical performance acceptance criteria.
§ 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.