(179 days)
Diomed 810 nm Surgical Lasers and EVLT Procedure Kit are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Diomed 810 nm Surgical Lasers and EVLT Procedure Kit is a semiconductor diode lasers operating at 810 ± 20 microns and associated disposables.
The provided text describes a 510(k) summary for the Diomed 810 nm Surgical Lasers and EVLT Procedure Kit, which establishes substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria, specific study results, or the methodology used to generate performance data in the way a traditional study report would.
Here's an analysis of the information available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific quantitative performance metrics. It generally states:
"Clinical tests performed by Diomed have demonstrated the substantially equivalent performance of the Diomed 810 nm Surgical Lasers and EVLT Procedure Kit with the predicate device used for substantially equivalent indications."
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical tests performed by Diomed," but it does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The nature of the device (a surgical laser) suggests that "ground truth" would likely be related to clinical outcomes, rather than image interpretation requiring multiple expert readers.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the likely nature of the "clinical tests" (evaluating surgical outcomes), a formal adjudication method for a test set in the context of expert consensus may not be applicable in the same way as for diagnostic imaging.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided and is unlikely to be relevant for this type of device. MRMC studies are typically used for diagnostic devices where human readers interpret medical images. This device is a surgical laser, and its performance would be assessed through surgical outcomes.
6. Standalone Performance Study
The document states "Clinical tests performed by Diomed have demonstrated the substantially equivalent performance," implying a study was done on the device's performance. However, it does not explicitly state if this was a "standalone" study in the sense of an algorithm-only performance without human intervention, as the device is a surgical tool requiring human operation. The performance described would inherently involve human users.
7. Type of Ground Truth Used
The document implies that "clinical tests" were performed. For a surgical laser used for endovascular coagulation of veins, "ground truth" would most likely be established through clinical outcomes data, such as:
- Successful occlusion of the saphenous vein.
- Absence of reflux post-procedure.
- Adverse events (e.g., pain, bruising, nerve injury).
- Follow-up ultrasound findings.
The document does not explicitly state the type of ground truth, but clinical outcomes are the most logical.
8. Sample Size for the Training Set
This information is not provided. The concept of a "training set" is typically associated with machine learning algorithms. While clinical experience and data might inform the design and use of a medical device, the document does not suggest a formal machine learning training set was used for this laser device.
9. How Ground Truth for the Training Set Was Established
This information is not provided, as a formal "training set" in the context of machine learning is not mentioned or implied for this device.
In summary:
The 510(k) summary provided is for a surgical laser, and it focuses on establishing substantial equivalence to a legally marketed predicate device based on "clinical tests." It lacks the detailed quantitative performance metrics, study methodologies, and expert involvement descriptions that would be typical for an AI/ML-driven diagnostic device. The primary takeaway is that the device's performance was deemed "substantially equivalent" to the predicate, but the specifics of how that equivalence was determined (e.g., sample sizes, precise outcomes measured) are not included in this summary.
§ 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.