(87 days)
The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for the treatment of pseudofolliculitis barbae in Skin Types I-VI.
The SLP™ 1000 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 - 1000 ms, and a selectable pulse energy of .5-100 J. The complete system consists of a power unit, chiller, a footswitch, and a handpiece connected to the laser unit with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch is depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the user interface panel on top of the power unit, which provides an interface to the system computer.
The provided text does NOT describe acceptance criteria or a study that proves the device meets specific criteria.
Instead, the document is a 510(k) Summary of Safety and Effectiveness submission to the FDA for the Palomar SLP™ 1000 Diode Array Laser System. Its primary purpose is to demonstrate substantial equivalence to existing legally marketed predicate devices, not to prove performance against specific acceptance criteria for a new clinical indication.
Here's a breakdown of why the requested information cannot be extracted from this document:
- No Acceptance Criteria or Performance Data: The document explicitly states: "The differences in the specifications of the SLPTM Performance Data: 1000 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy." This means the submission is not presenting new performance data or acceptance criteria that would typically be associated with a clinical study to demonstrate efficacy. It's relying on the presumed safety and effectiveness of the predicate devices.
- Focus on Substantial Equivalence: The conclusion clearly states, "Based on the foregoing, the SLP™ 1000 Diode Conclusion: Laser System is substantially equivalent to the legally-marketed claimed predicate device for permanent hair reduction." The FDA's letter also confirms this substantial equivalence determination. This is the core of a 510(k) submission.
- Lack of Study Details: Because the submission relies on substantial equivalence and does not report new performance data, it naturally won't contain information about:
- Sample sizes (test or training sets)
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- MRMC studies or effect sizes
- Standalone algorithm performance
- Types of ground truth
- How ground truth was established
In summary, the provided text does not contain the information requested about acceptance criteria and a study to prove the device meets them because the submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against specific criteria through a new study.
§ 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.