(155 days)
The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for I no rulomar buper and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin. subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph suboutined about and glands, and glands, and specifically for the following indications.
Dermatology and Plastic Surgery for: Hair Removal in Skin Types I-VI Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis
The SLP™ 2000 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 corresponding fluence delivered through a 10 mm handpiece tip. The laser pulses are generated at a maximum pulse repetition frequency of 5 Hz by diodes located in the laser unit. The complete system consists of a laser 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 laser unit, which provides an interface to the system computer.
The provided text describes the Palomar SLP™ 2000 Diode Array Laser System and its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria or details of a study that proves the device meets those acceptance criteria in the format requested.
The crucial sentence regarding performance is: "The differences in the specifications of the SLP™ 2000 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy." This statement indicates that the device's performance is deemed equivalent to the predicate, but it does not provide quantitative acceptance criteria or a study with specific measurements against those criteria.
Therefore, many of the requested fields cannot be filled. I will fill in what information is available and indicate where information is not present.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in terms of quantitative measures) | Differences in specifications of SLP™ 2000 and predicate device do not result in different performance or raise new questions of safety or efficacy. |
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: Not specified.
- Data Provenance: Not specified. The document relies on substantial equivalence to a legally marketed predicate device (LightSheer Diode Array Laser, K973324) rather than presenting new performance data from a specific study of the SLP™ 2000 against explicit acceptance criteria.
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)
- Not applicable as no specific test set or ground truth establishment process is described for the SLP™ 2000.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no specific test set is described.
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 MRMC comparative effectiveness study was done. This device is a laser 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 as this is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable as no specific ground truth for performance evaluation of the SLP™ 2000 against quantitative acceptance criteria is described. The basis for approval is substantial equivalence to a predicate device.
8. The sample size for the training set
- Not applicable as this is a laser system, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable as this is a laser system, not a machine learning model.
§ 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.