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The 400um Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The 400um Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for the treatment of incompetent (i.e. refluxing) perforator veins (IPVs).

The 400μm Perforator and Accessory Vein Ablation Kit is used to treat patients with varicose veins. Varicose veins are large, twisted, visibly bulging veins usually located in the legs. Varicose Veins occur when either the blood flow is too slow or valves are not functioning correctly resulting in "pile-up" of blood within the lower extremity veins. AngioDynamics proposes that this include the Incompetent Perforator Veins (IPVs). The 400um Perforator and Accessory Vein Ablation Kit is provided in a procedure kit which includes a 400μm Fiber along with the following accessory components:

• 21G Entry Needle
• . 4F Introducer Sheath/Dilator
• 0.018" Guidewire ●
  The 400μm Perforator and Accessory Vein Ablation Kit is presented sterile and contains all of the accessories needed to perform the EVLT procedure, with the exception of generic disposable items routinely found in a well-equipped minor treatment room such as drapes, swabs, bandages etc.

The provided text is a 510(k) summary for the AngioDynamics 400um Perforator and Accessory Vein Ablation Kit. It details the device, its intended use, and substantial equivalence to predicate devices, including a clinical study conducted to evaluate its performance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The primary acceptance criterion is acute primary ablation success for Incompetent Perforator Veins (IPVs).

2. Sample Size and Data Provenance

• Sample Size for Test Set: 125 Incompetent Perforator Veins (IPVs) were treated (ITT Population). The number of patients in the ITT set was 74 (sum of patients from all sites listed in the table under "Site").
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was "multi-center" and the sponsor is AngioDynamics, Inc. based in Marlborough, Massachusetts, USA. Given it's an FDA submission, it's highly likely to be US-based or an international study adhering to US regulatory standards.
  • Retrospective or Prospective: Prospective. The study is described as a "single-arm, prospective, multi-center, non-blinded clinical trial."

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts used to establish the ground truth for the test set, nor their qualifications. The study focused on clinical outcomes post-procedure rather than interpretation of diagnostic images by experts. The "ground truth" for acute primary ablation success seems to be determined by clinical assessment at the 10-day visit.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. Given that the primary endpoint is "acute primary ablation success" based on clinical assessment, it's likely that this was determined by the treating clinician or study investigator at each site, rather than a separate panel of adjudicators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This study evaluated the performance of the device itself for a therapeutic procedure (ablation), not a diagnostic algorithm that assists human readers. Therefore, there's no discussion of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This study is not evaluating an AI algorithm or diagnostic tool. It's evaluating the performance of a medical device (a laser ablation kit) used in a therapeutic procedure. The "performance data" refers to the clinical outcome of the procedure when using the device, not an algorithm's performance.

7. Type of Ground Truth Used

The type of ground truth used is clinical outcome data (acute primary ablation success at the 10-day visit). This is a direct measure of the effectiveness of the therapeutic intervention.

8. Sample Size for the Training Set

Not applicable. This study is a clinical trial evaluating a physical medical device (laser ablation kit) for a therapeutic procedure. It does not involve machine learning or AI, and therefore there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided text.

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