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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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The NES Reprocessed RF Stylet (RFS) is intended for use in vessel and tissue coagulation including:

• Treatment of incompetent (i.e. refluxing) perforator and tributaiy veins.

The NES Reprocessed RF Stylet (RFS) is a reprocessed VNUS RFS (510(k) # K052003). The device is a high frequency electrosurgical system designed for blood vessel and tissue coagulation in general surgical procedures. This device's energy source comes from a compatible and separately cleared Radiofrequency (RF) Generator. The device has been validated to be reprocessed a maximum of one time. The NES Reprocessed RF Stylet (RFS) is provided sterile (EtO) and is a single use, disposable device. The device is used in a healthcare facility. The device's function is to deliver RF energy to the desired treatment site and relay temperature and other information to the RF Generator. The device consists of one model. The device itself consists of the stylet shaft, handle and cable. A sharp is included with the device for patient insertion. The tip of the stylet serves to deliver the RF energy to the desired treatment site while the cable plugs into the RF generator (for power and relay temperature/other feedback). The tip, inner and outer lumen are the only patient-contacting parts. The patient-contacting material is as follows: AISI 304 SST and polyimide. All patient-contacting material has proven to be biocompatible. The non patient-contacting material is as follows: poly methyl methacrylate and polypropylene. The device is compatible with the separately cleared Radiofrequency (RF) Generator. The NES Reprocessed RF Stylet (RFS) is considered an external communicating device with circulating blood contact for a duration of less than 24 hours.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the NES Reprocessed RF Stylet (RFS), rather than an AI/ML powered device. As such, the information typically requested for AI/ML device studies (such as sample size for test/training sets, ground truth establishment with expert consensus, adjudication methods, or MRMC studies) is not applicable or provided in the document.

The acceptance criteria and the study proving the device meets these criteria are focused on demonstrating that the reprocessed device is substantially equivalent to its predicate device and maintains its safety and effectiveness.

Here's a breakdown of the provided information, framed within the context of a reprocessed medical device:

1. A table of acceptance criteria and the reported device performance

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 does not specify exact sample sizes (e.g., number of devices reprocessed and tested) for each of the performance tests. The testing appears to be conducted on reprocessed devices themselves, rather than clinical patient data. The provenance of the data is implicit in that it comes from testing conducted by Northeast Scientific, Inc. as part of their 510(k) submission. No specific country of origin for the data or whether it was retrospective or prospective is mentioned, but given it's a device reprocessing validation, it would be laboratory-based testing.

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)

For the "Design Validation" section, it is stated that the evaluation was done by "a user and expert of the device." The specific number (one or more) is not definitively stated, nor are their exact qualifications beyond "user and expert." This is not a ground truth establishment in the AI/ML sense, but rather a usability and design review.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

No adjudication method is relevant or described, as this is laboratory testing of a reprocessed medical device's physical and functional properties, not an interpretative task requiring consensus among experts.

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

This is not an AI/ML powered device, so no MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not an AI/ML powered device, so no standalone algorithm performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is its physical and functional performance, as measured against established engineering and biocompatibility standards for medical devices, as well as comparison to the original (predicate) device's specifications. For example, for biocompatibility, the "ground truth" is that the device does not cause adverse biological reactions, confirmed by passing specific biological tests. For functional performance, the "ground truth" is that the device successfully performs its intended function without errors.

8. The sample size for the training set

This is not an AI/ML powered device; therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/ML powered device and therefore there is no training set or associated ground truth establishment in that context.

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