(60 days)
LAD-08 is indicated for ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.
The Norwood Abbey Model LAD-08 is a portable, handheld, battery powered bern hismater The Norwood Abbey Model LAD-60 is a portuois, handelength of 2.94 um and a beam diameter of I he radiant energy produced by thin itsel mas a m. spot-size of 6 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.
The provided document describes a medical device, the Norwood Abbey Model LAD-08 (Epiture™ Easytouch), a laser surgical instrument. However, the document explicitly states:
"No additional studies have been performed on the LAD-08."
This means the submission does not include any studies or data proving the device meets specific acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred:
1. A table of acceptance criteria and the reported device performance:
Not available. The document does not specify any acceptance criteria or report performance data for the LAD-08.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available. No studies were performed, so there is no test set or related 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 available. No studies were performed, so no ground truth was established for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not available. No studies were performed.
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 device is a laser surgical instrument, not an AI-assisted diagnostic tool for human readers. No MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This refers to algorithm performance, and no algorithms were described or tested for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not available. No studies were performed.
8. The sample size for the training set:
Not applicable. No training set for an algorithm was mentioned or used.
9. How the ground truth for the training set was established:
Not applicable. No training set for an algorithm was mentioned or used.
Summary based on the provided text:
The submission for the LAD-08 relies on a claim of substantial equivalence to predicate devices (LAD-01/06) rather than new clinical study data for its performance. The FDA cleared the device based on this substantial equivalence.
§ 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.