(108 days)
The AngioDynamics, VenaCure 1470 Laser is indicated for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.
The AngioDynamics VenaCure 1470 Laser is a Class IV Diode Laser with a wavelength of 1470nm. The 1470 Laser is intended for use in delivering up to 12 Watts of energy and is intended to be used with AngioDynamics Fiber Optic Delivery System Procedure Kits for use in endovascular coagulation of the Great Saphenous Vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
The provided text describes a 510(k) summary for the AngioDynamics VenaCure 1470 Laser, focusing on demonstrating substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in the provided document.
However, based on the information available, here's what can be extracted:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a direct comparison table of predicate vs. new device performance for clinical outcomes. Instead, it relies on demonstrating equivalent performance through a series of engineering and safety tests.
| Acceptance Criterion (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence | "The results of the qualification/validation demonstrates equivalent performance to the predicate devices..." |
| EMC Compliance | Underwent "EMC Testing" |
| Software Verification | Underwent "Software Verification / Validation" |
| Product Longevity | Underwent "Product Life Time & Life Cycle Testing" |
| Electrical Safety | Underwent "Electrical Safety Testing" |
| Laser Safety | Underwent "Laser Safety Testing" |
| Environmental Robustness | Underwent "Environmental Testing" |
| Optical Output Performance | Underwent "Optical Output Performance" testing (intended for 12 Watts of energy, 1470nm wavelength) |
| Output Power Stability | Underwent "Output Power Stability" testing |
| System Performance | Underwent "System Performance" testing |
| Shock and Vibration | Underwent "Product Shock and Vibration Transit Testing" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily focuses on testing the device itself (e.g., engineering, safety, software) rather than a clinical test set of patients or images. Therefore, clinical sample sizes and data provenance are not applicable or provided. The "tests" mentioned are primarily laboratory-based and engineering evaluations.
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. The provided document does not describe a clinical study with a "test set" requiring expert ground truth establishment for clinical outcomes. The "ground truth" for the engineering and safety tests would be defined by the specifications and standards the device is designed to meet, not by human experts in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical "test set" and thus no adjudication method described.
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. This document describes a laser device for medical procedures, 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 is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the engineering and safety tests mentioned, the "ground truth" is based on established engineering principles, regulatory standards (e.g., electrical safety standards, laser safety standards), and the design specifications of the device. There is no clinical "ground truth" (like pathology or outcomes data) specifically discussed in the context of this 510(k) summary, as it relies on substantial equivalence to previously approved devices with established clinical safety and effectiveness.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not a device with a "training set."
§ 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.