(58 days)
The Vari-Lase WireFiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for the treatment of incompetence and reflux of superficial veins in the lower extremity.
The WireFiber is a laser fiber that is compatible with a solid state diode laser console operating at a maximum power of 14 watts and wavelengths of 810 nm and 980 mm. The laser fiber is comprised of a 600 um silica core with a dual clad of silica hard clad and polymer, an outer nylon buffer, a strain relief, and an SMA connector. The distal tip of the laser fiber consists of a platinum/iridium sleeve that terminates with a stainless steel/nitinol wire. The laser fiber lengths are between 2.4 meters and 3.6 meters, as measured from the proximal end of the SMA connector to the distal tip, with a maximum diameter of 0.038". The laser fiber is provided with positioning marks.
The provided text is a 510(k) summary for the Vari-Lase WireFiber, detailing its substantial equivalence to predicate devices. It describes the device, its intended use, and the tests performed to demonstrate its safety and effectiveness. However, the document does not present a formal study with acceptance criteria and a detailed report of device performance in the manner requested. Instead, it lists various tests conducted to show equivalence, rather than a specific study designed to meet pre-defined acceptance criteria for a new clinical efficacy claim. Therefore, much of the requested information cannot be extracted directly from this document.
Here's an attempt to answer based on the available information, with clear indications of what is not available or not applicable.
Acceptance Criteria and Device Performance Study for Vari-Lase WireFiber
This document is a 510(k) summary for the Vari-Lase WireFiber. The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness. As such, the submission focuses on tests demonstrating equivalence rather than a new standalone clinical study to establish explicit acceptance criteria for efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Implied/General) | Reported Device Performance (Implied/General) |
|---|---|---|
| Simulated Use Blood Burn | Performance comparable to predicate device; no adverse events/failures. | Results did not raise new safety or performance questions; confirmed substantial equivalence. |
| Simulated Anatomy | Performance comparable to predicate device; no adverse events/failures. | Results did not raise new safety or performance questions; confirmed substantial equivalence. |
| Ultrasound Visualization | Clear visualization comparable to predicate device. | Results did not raise new safety or performance questions; confirmed substantial equivalence. |
| Corrosion Resistance | Adequate resistance for intended use; comparable to predicate. | Results did not raise new safety or performance questions; confirmed substantial equivalence. |
| Tensile Strength | Maintains structural integrity under expected forces; comparable to predicate. | Results did not raise new safety or performance questions; confirmed substantial equivalence. |
| Compressive Force | Maintains structural integrity under expected forces; comparable to predicate. | Results did not raise new safety or performance questions; confirmed substantial equivalence. |
| Biocompatibility | Compliant with ISO standards for medical devices in contact with tissue. | Results did not raise new safety or performance questions stemming from biomaterial assessments; confirmed substantial equivalence. |
| Intended Use | Same as predicate devices. | Vari-Lase WireFiber has the same indications for use as predicate devices. |
| Technological Characteristics | Similar to predicate devices, or differences do not raise new safety/effectiveness questions. | Modifications (sleeve/wire tip design, adhesive, dimensions, buffer material) were qualified and shown not to raise new safety/performance concerns. |
Note: The acceptance criteria listed are implied from the nature of a 510(k) submission and the statement "results... did not raise any new safety or performance questions and confirm that the Vari-Lase WireFiber is substantially equivalent to the predicate Vari-Lase laser fibers." Explicit, quantitative acceptance criteria are not provided in this summary document.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "tests" were conducted but does not provide the number of devices or units tested for each specific characteristic.
- Data Provenance: Not specified. The document does not indicate the country of origin for the data or whether the test data was retrospective or prospective. Given these are bench and materials tests, the concept of "retrospective or prospective" for human patient data doesn't directly apply here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. For a 510(k) submission based on bench testing of physical properties and biocompatibility, the concept of "ground truth" established by human experts in the context of diagnostic interpretation (like radiologists) is not relevant. The ground truth for these tests would be the measurement standards, engineering specifications, and established scientific methodologies used in materials and device testing.
4. Adjudication Method for the Test Set
- Not Applicable. As the tests described are primarily engineering and materials assessments, adjudication methods typically used for expert disagreement in clinical or diagnostic studies are not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not Applicable. This document pertains to a medical device (laser fiber) for surgical procedures, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed and is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. As this device is a physical medical instrument and not an algorithm, a standalone performance study in the context of AI is not relevant.
7. The Type of Ground Truth Used
- For the engineering and materials tests (e.g., tensile strength, corrosion resistance, biocompatibility), the "ground truth" would be established by:
- Validated Test Methods: Standard test protocols (e.g., ISO standards, ASTM standards) for materials characterization.
- Engineering Specifications: Pre-defined performance parameters and limits.
- Predicate Device Performance: Benchmarking against the known performance of the predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set was used.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through various engineering, performance, and biocompatibility tests. It does not present a clinical study with clearly defined acceptance criteria, sample sizes, or expert-established ground truth in the way a diagnostic AI device submission would. The "performance" is demonstrated by showing that the modified device functions similarly to the predicate devices and that the design changes do not introduce new safety or effectiveness concerns.
§ 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.