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The Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The Vein360 Endovenous RFA Catheter is a reprocessed single-use device (SUD) consisting of a molded handle with actuation switch, an integrated instrument cable, and a flexible catheter shaft with a radiofrequency (RF) heating element at the distal end. The catheter and integrated connection cable are provided sterile and meant for single patient use. The catheter's function is to provide thermal energy to the desired treatment site via RF heating of the heating element and to relay temperature back to the RF generator.

The Vein360 Endovenous RFA Catheter is subjected to reprocessing operations following the initial clinical use of the OEM predicate. These operations include cleaning, inspection, packaging and sterilization. After reprocessing, the Vein360 reprocessed Endovenous RFA Catheter retains substantially equivalent performance to that of the OEM predicate. The Vein360 reprocessed Endovenous RFA Catheter is reprocessed one (1) time.

Here's a breakdown of the acceptance criteria and study information for the Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly list quantitative "acceptance criteria" for the performance of the reprocessed device in a pass/fail-type table. Instead, it states that the device demonstrated "substantially equivalent performance" to the OEM predicate devices. The performance evaluation was focused on ensuring that reprocessing did not adversely affect form, fit, or function, and that the reprocessed device performed equivalently to the original.

However, based on the performance data section, we can infer the areas of evaluation and the general outcome:

2. Sample Size Used for the Test Set and Data Provenance

The documents do not specify a "test set" in the context of a clinical trial or a dataset for an AI model. This device is a reprocessed medical device, and its evaluation focused on non-clinical performance testing.

• Sample Size for Non-Clinical Tests:

  • Cleaning validation: Included "enumeration of clinical soil levels" to establish a worst-case basis for artificial test soil development. The validation involved using both clinical and artificial test soils, but specific sample sizes (e.g., number of catheters tested) are not provided.
  • Ex vivo tissue study: Performed in "three (3) tissue types" (muscle, liver, and kidney). The number of catheters or repetitions within this study is not specified.
  • For other tests (e.g., electrical, physical, mechanical), the number of units tested is not individually listed. The statement "extensive scope of performance tests executed to fully demonstrate substantial equivalence" suggests multiple units were likely tested for each parameter.

• Data Provenance: The studies were non-clinical, involving laboratory testing and ex vivo tissue studies. The ex vivo study was performed by an "independent laboratory." There is no mention of country of origin for any data or whether it was retrospective or prospective in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This evaluation did not involve a "test set" in the context of human expert review for ground truth, as it's a reprocessed device undergoing performance testing against its original, new counterpart.

4. Adjudication Method for the Test Set

Not applicable. There was no expert "adjudication" in the clinical sense for this type of performance evaluation.

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 is not an AI-powered diagnostic device, and therefore, no MRMC study or AI-assisted human reader improvement assessment was conducted.

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

Not applicable. This is a physical, reprocessed medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the reprocessed device's performance was established by comparing its performance directly to the OEM predicate devices. This comparison was based on:

• Physical specifications and dimensions.
• Electrical characteristics.
• Mechanical properties.
• Biocompatibility and sterilization standards.
• Results from validated cleaning processes.
• Direct comparison of ablative performance in ex vivo tissue models.

Essentially, the OEM predicate device's established performance served as the benchmark for "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable. There is no training set for this device.

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