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510(k) Data Aggregation
(63 days)
ND: YAG ACCESSORY FOR PHOTODERM SYSTEM
The PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.
The Nd: YAG laser accessory is a pulsed medical laser operating at a wavelength of 1064 nanometers. The device is operated by the PhotoDerm® system and emits high energy pulses of 1- 10 ms duration and up to 150 j/cm2. The Nd: YAG laser accessory is a hand held device that replaces the standard optical treatment head used in the PhotoDerm® machines.
The provided document is a 510(k) Premarket Notification for the PhotoDerm® Nd:YAG Accessory. It primarily focuses on demonstrating substantial equivalence to existing devices and does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against such criteria. The "Performance Standards" section only states conformity with federal regulations for medical laser systems (21 CFR 1040.10 and 1040.11), which are general safety and performance standards for laser products, not specific clinical acceptance criteria for the intended use.
Therefore, most of the requested information cannot be extracted from this document, as it is not a clinical study report.
Here's an attempt to answer based on the available information, with many points being "Not Applicable" or "Not Provided":
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific performance metrics for clinical efficacy/safety. The document states compliance with general federal regulations for medical laser systems (21 CFR 1040.10 and 1040.11). | Not explicitly stated in terms of specific performance metrics for clinical efficacy/safety. The device is described as emitting high energy pulses of 1-10 ms duration and up to 150 J/cm². Comparison is made to predicate devices in terms of technical specifications, operating performance features, general physical configuration, and intended uses. The energy delivered is stated to be "in the range of energy values delivered by the predicate devices." |
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 for test set: Not provided.
- Data provenance: Not provided. This document does not describe a clinical study.
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. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process 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. This is a laser device, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a laser device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth for device performance in a clinical context is described in this document. The "ground truth" for substantial equivalence is based on comparison to predicate devices' technical specifications and intended use.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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