(72 days)
The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
The VARI-LASE procedure kit contains one or more of the following: 600 um laser fiber 0.035" or 0.018" guide wire Introducer sheath or catheter 19 Gauge/7cm Percutancous Entry Needle 21 Gauge/7 cm Percutaneous Entry Needle Fiber lock
Due to the nature of the submitted document, which is a 510(k) summary for a medical device (Vari-Lase Endovenous Laser Procedure Kit), the information provided focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for the device's performance.
Therefore, many of the requested categories (e.g., sample sizes, expert qualifications, MRMC studies, specific performance metrics against acceptance criteria) are not present in this type of regulatory submission. The 510(k) process primarily relies on non-clinical testing and comparison to legally marketed predicate devices.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated as acceptance criteria, but implied as a necessary characteristic for a medical device. | "Testing has been conducted to verify the biocompatibility..." |
| Performance of Components | Not explicitly stated as acceptance criteria. | "...and performance of the components." |
| Substantial Equivalence | The device should be substantially equivalent to predicate devices in terms of indications for use, components, and technological characteristics. | "The VARI-LASE Procedure Kit is substantially equivalent to the identified predicate devices based on a comparison of the indications for use and the components supplied and the technological characteristics of the supplied components." |
| Intended Use | The device should be effective for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein, and for treatment of incompetence and reflux of superficial veins in the lower extremity. | The device is indicated for these uses, implying it meets the necessary performance for these indications, as demonstrated by equivalence to predicates. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "testing" but does not provide details on sample sizes for any experimental test sets.
- Data Provenance: Not specified. Given the nature of a 510(k) for a laser kit, the testing mentioned (biocompatibility, component performance) would likely be laboratory-based/bench testing rather than clinical study data from patients, especially if relying on substantial equivalence to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the submission focuses on non-clinical testing and substantial equivalence, not on clinical performance studies that would typically involve expert-adjudicated ground truth.
4. Adjudication method for the test set
- This information is not provided. Clinical adjudication methods are generally not part of a 510(k) submission for this type of device, which relies on demonstrating equivalence to predicates through non-clinical means.
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
- No, an MRMC comparative effectiveness study was not done and is not mentioned or required for this type of device (a laser procedure kit with no explicit AI component). The device is a surgical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable as the device is a physical surgical instrument kit, not an algorithm or AI software, and does not operate in a standalone algorithmic capacity.
7. The type of ground truth used
- For the non-clinical testing (biocompatibility, component performance), the "ground truth" would likely be established through scientific testing standards, material specifications, and validated laboratory methods. For the overall device, the "ground truth" for its clinical utility is implicitly established by the legally marketed predicate devices to which it claims substantial equivalence. No pathology or outcomes data is explicitly mentioned as being used for ground truth in this 510(k) summary.
8. The sample size for the training set
- Not applicable/Not provided. This device is a physical medical instrument, not a machine learning model, so there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set for an AI/ML model, this information is not relevant.
§ 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.