(169 days)
Incision, excision, ablation, vaporization and hemostasis of soft tissue
Derma™ 20 is a pulsed medical laser system incorporating an Er:YAG laser, operating at a wavelength of 2.94 microns. The device emits pulses of up to 1.7 joules on tissue. The pulse width is 350 μsec, the pulse rate is 5-12 pulses per second. The system is composed of the following units: • Laser optical rail assembly • Articulated arm • Power supply and pulse forming network (PFN) • Cooling system • Control electronics system • Power distribution box
This document is a 510(k) summary for the Derma™ 20 Laser System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than new performance claims and clinical studies for acceptance criteria.
Therefore, for aspects related to acceptance criteria, study design, and performance metrics typical of AI/software as a medical device (SaMD) clearances, the provided text contains no relevant information. This device is a laser system, not an AI or imaging diagnostic device, and thus the requested information (like sensitivity, specificity, MRMC studies, ground truth establishment, training/test set details) is not applicable to this 510(k) submission.
Here's a breakdown of why each numbered point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: Not applicable. This document is a summary for a hardware device (laser system) claiming substantial equivalence. There are no performance metrics like sensitivity, specificity, or AUC mentioned that would have acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented. The device's "performance" is primarily defined by its physical specifications (wavelength, pulse energy, pulse width, pulse rate) which are compared to predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described as there is no diagnostic or interpretive software component.
- Adjudication method for the test set: Not applicable. No test set requiring expert adjudication is described.
- 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 is a hardware laser system, not an AI or diagnostic tool that would involve human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device; there is no algorithm or standalone performance study.
- The type of ground truth used: Not applicable. No ground truth is established for such a device. Its function is to perform surgical procedures, not to make diagnostic assessments.
- The sample size for the training set: Not applicable. As there's no AI component, there's no training set.
- How the ground truth for the training set was established: Not applicable. No training set or associated ground truth.
In summary, the provided 510(k) summary for the Derma™ 20 Laser System does not contain any of the requested information because it is a hardware device demonstrating substantial equivalence, not a software/AI device making performance claims that require clinical study data, ground truth, or reader studies. The "Clinical Performance Data" and "Nonclinical Performance Data" sections explicitly state "None," indicating that the submission relies on the established safety and effectiveness of the predicate devices.
§ 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.