(303 days)
The Dornier Medilas D LiteBeam + 1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is intended for the treatment of reflux of saphenous veins associated with varicose veins and varicosities.
The Dornier Medilas D Lite Beam + 1470 Laser is a continuous-wave diode laser emitting laser radiation in the invisible range of 1470 nm. The Medilas D LiteBeam+ 1470 incorporates a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D LiteBeam+ 1470 features several operating modes, including Standard, Fibertom and LPS.
The provided text describes a laser surgical instrument (Dornier Medilas D LiteBeam+ 1470) and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for an AI/algorithm-based medical device.
The document is a 510(k) summary for a physical medical device (a diode laser system), not a software or AI device. Therefore, the questions related to AI/algorithm performance, such as test sets, ground truth, expert adjudication, MRMC studies, and standalone performance, are not applicable to this submission.
Here's a breakdown of what is available and what is not:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the laser's clinical application. The submission focuses on compliance with general safety standards and equivalence to a predicate device.
- Reported Device Performance:
- The device is a continuous-wave diode laser emitting at 1470 nm.
- It complies with Class IV performance standards for light-emitting products (21 C.F.R. §1040.10 and §1040.11).
- It complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).
- The core argument is substantial equivalence to the predicate device (Biolitic 15W Ceralas Diode 1470nm Laser, K073063) based on technological characteristics and overall performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This submission for a physical laser device does not involve a "test set" in the context of an algorithm's performance on a dataset. The "performance data" refers to compliance with safety and electrical standards for the device itself, not an evaluation of its clinical effectiveness through a study with a test set of patients/data.
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. See point 2. There's no ground truth established by experts for a test set in this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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:
- Not applicable. This is a physical laser device, not an AI or imaging diagnostic tool that would involve human readers or MRMC studies.
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 (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device relates to its adherence to manufacturing specifications, safety standards, and functional parameters, which are verified through engineering tests and quality control, not clinical data ground truth.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning or require a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.