(41 days)
EVLT kits and Diomed D15plus and D30plus Diode Lasers are indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein
Not Found
The provided document is a 510(k) substantial equivalence letter from the FDA for a medical device: "EVLT Kit and D15Plus and D30Plus Diode Lasers."
This type of document primarily confirms that a new device is "substantially equivalent" to an already legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.
Crucially, a 510(k) does not typically contain detailed acceptance criteria, device performance tables, sample sizes for studies, ground truth establishment, or information about AI/MRMC studies as would be expected for a novel device or a clinical trial submission. The focus is on demonstrating equivalence to an existing device.
Therefore, most of the information requested in the prompt cannot be extracted from the provided text.
Here's a breakdown of what can be inferred or what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not provide specific acceptance criteria or detailed performance data for the EVLT Kit and Diode Lasers. Substantial equivalence relies on demonstrating that the new device is as safe and effective as a predicate device, but specific performance metrics against pre-defined acceptance criteria are not typically part of this public summary.
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: This information would be found in detailed study reports, which are not included in this FDA 510(k) letter.
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: This information pertains to the underlying data and ground truth establishment for a clinical trial or performance study, which is not detailed in this 510(k) letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: As above, this level of detail regarding study methodology is not present.
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: The device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a laser surgical instrument, not an algorithm. Standalone algorithm performance studies are not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available: Without detailed study reports, the type of ground truth used for any underlying data supporting the predicate comparison cannot be determined from this document. However, for a surgical device for varicose veins, ground truth would likely involve clinical outcomes, imaging confirmation of treatment success (e.g., ultrasound demonstrating vein closure), and expert clinical assessment.
8. The sample size for the training set
- Not Available: This information would be part of detailed study reports, which are not provided here. Also, for a device like this, the concept of a "training set" as understood in machine learning/AI is not applicable. The device's safety and effectiveness are established through engineering design, bench testing, and potentially clinical studies, rather than a machine learning training paradigm.
9. How the ground truth for the training set was established
- Not Applicable / Not Available: As mentioned, the concept of a "training set" doesn't directly apply here in the AI/ML sense. For traditional medical devices, the "ground truth" for design validation and clinical evidence would be established through a combination of engineering principles, established medical knowledge, clinical observations, and potentially clinical trial results compared to standard-of-care. The specific methods are not detailed in this 510(k) letter.
In summary, the provided document is a regulatory clearance letter, not a detailed technical or clinical study report. It focuses on the legal determination of substantial equivalence, not the granular details of performance studies.
§ 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.