(52 days)
The Vari-Lase® Bright Tip fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
The Vari-Lase Bright Tip Fiber is a 600um core laser fiber that is 3.5 meters in length. The distal tip of the fiber is encased in ceramic which provides ultrasound visibility during clinical use.
The provided text describes a 510(k) premarket notification for a medical device called the "Vari-Lase® Bright Tip™ Fiber." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of a diagnostic or AI-based system.
Therefore, many of the requested categories for a study proving acceptance criteria, especially those related to AI model performance, expert ground truth, and comparative effectiveness studies, are not applicable to this submission.
Here's an analysis based on the information available:
Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria with corresponding numerical performance metrics as might be found for a new diagnostic algorithm. Instead, the acceptance criteria are implicitly met by successful completion of various bench tests that confirm the device's functional and safety attributes.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Ultrasound visibility | Confirmed suitability for intended use (e.g., "visibility under ultrasound") |
| Energy transmission | Confirmed suitability for intended use |
| Tip integrity (tensile strength) | Confirmed suitability for intended use |
| Tip integrity (burn-back) | Confirmed suitability for intended use |
| Ability to achieve intended use | Confirmed suitability for intended use |
| Substantial Equivalence to Predicate Device | Achieved; stated as "substantially equivalent" |
Inapplicability for AI-Specific Questions:
The device in question, the Vari-Lase® Bright Tip™ Fiber, is an optical fiber used in laser surgical procedures. It is a physical medical device, not an AI or diagnostic software. Therefore, the following points are not applicable to this 510(k) submission:
- Sample size used for the test set and the data provenance: Not applicable. The testing involved bench tests on physical devices, not a dataset of patient cases.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established through engineering specifications and objective measurements, not expert consensus on medical images or patient data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic or interpretation device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance would be engineering specifications and physical test results (e.g., measurements of light transmission, force required to break the tip, visual confirmation of ultrasound visibility).
- The sample size for the training set: Not applicable. There is no training set for an AI model.
- How the ground truth for the training set was established: Not applicable.
Summary of Testing and Conclusion (from the document):
- Study Type: Bench testing.
- Purpose: To confirm the suitability of the modified laser fiber for its intended use, specifically "visibility under ultrasound, energy transmission, and integrity of the tip following simulated clinical use (tensile strength of the ceramic tip and burn-back)."
- Conclusion: The tests "confirmed the suitability of the device for its intended use." The device was also found "substantially equivalent to the currently marketed Vari-Lase Fiber, based on comparisons of the device classification, indications for use, technological characteristics, and sterilization methods."
§ 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.