(162 days)
These devices are intended for use with any pulsed Holmium: YAG 2.1 micrometer laser (with compatible connector) for incision, excision, resection, ablation, vaporization, coagulation and hemostasis.
The Resposable Holmium Bare Fibers are reusable fiberoptic energy delivery devices. These devices consist of an optical fiber which may or may not be contained in a catheter tube, cannula, needle, handpiece or handle. The fibers range from 50 to 1000 microns core diameter and will be offered with various distal tip configurations.
The provided documents are a 510(k) summary and FDA clearance letter for a medical device called "Resposable Holmium Bare Fibers". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through extensive clinical trials. Therefore, much of the requested information about acceptance criteria and clinical studies is explicitly stated as "Not Applicable" or "No nonclinical/clinical tests were submitted."
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided documents, there are no specific acceptance criteria or reported performance metrics from a formal study described. The 510(k) summary states, "No nonclinical test data were submitted in this Premarket Notification." and "No clinical tests were submitted in this Premarket Notification." The basis for clearance is substantial equivalence to an existing predicate device (Trimedyne Disposable Holmium Bare Fibers) due to minor material and configuration changes allowing for sterilization/reuse.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (No specific acceptance criteria or performance metrics from a formal study are provided in the document.) | Not applicable (No performance data from a formal study are provided in the document.) |
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: Not applicable. No test set was used for a study described in the provided documents.
- Data Provenance: Not applicable. No study data provenance is mentioned as no tests were submitted.
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 by experts is mentioned as no test set or study was submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as no test set or study was submitted.
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. No MRMC comparative effectiveness study was done. This device is a laser fiber, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a laser fiber, not an algorithm. Therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth was established as no clinical or nonclinical tests were submitted for this 510(k). The assessment was based on substantial equivalence.
8. The sample size for the training set
- Not applicable. No training set was used as no machine learning or AI component is part of this device or its evaluation in this submission.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for a training set was established for the reasons mentioned above.
§ 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.