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ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (ScleroSafe) is intended for the delivery of Asclera®, an FDA-approved sclerosant (Asclera®), in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.

The subject device, the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (or ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe) is intended for the delivery of FDA-approved sclerosant Asclera® in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.

The ScleroSafe device includes a 5 Fr dual lumen catheter ("DLC"), mountable on a 0.018 inch straight-tipped guidewire in an over-the-wire configuration. The DLC is connected to a hub that splits the catheter into two separate tubes. One of the tubes ends with a blue luer lock for the aspiration extension and the other with a transparent luer lock for the injection. Following needle insertion into the guidewire is removed and a Dual Procedure Syringe ("DPS") is connected to the DLC hub via dedicated luers. The larger syringe (10 ml) is connected to blue luer lock connector (Aspiration Extension) of the smaller syringe (5 ml) is connected to a transparent luer lock connector of the catheter (Injection Extension) so fluids are simultaneously injected through one lumen and aspirated through another lumen. ScleroSafe is provided in two sizes: 150mm and 350mm.

The provided text describes a medical device, the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm, and its premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons, rather than providing specific acceptance criteria and a detailed study report for a novel AI/ML device.

Therefore, many of the requested elements for AI/ML device evaluation (like MRMC studies, expert adjudication for ground truth of an AI model, training set size, etc.) are not present in this document as it pertains to a different type of medical device (a physical catheter/syringe system).

However, I can extract information related to the device's performance based on the clinical study part mentioned, even though it's not strictly "acceptance criteria" in the AI/ML sense, but rather a performance outcome from a human-in-the-loop clinical use evaluation.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent.

Device: ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe)

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative "acceptance criteria" in a table format for the clinical performance. Instead, it describes subjective outcomes for safety and efficacy in a clinical study.

2. Sample size used for the test set and the data provenance:

• Sample Size: 20 patients
• Data Provenance:
  • Country of Origin: Germany
  • Retrospective or Prospective: Retrospective (The company retrospectively evaluated the subject device in 20 ScleroSafe procedures that were performed in 20 patients in Germany between January and June 2019).

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 in the text. The clinical study describes outcomes (vein obliteration, recurrence, adverse events) which would have been assessed by treating physicians and follow-up clinicians, but the specific number and qualifications of independent experts establishing a "ground truth" for a test set are not mentioned, as this is not an AI/ML study involving image interpretation.

4. Adjudication method for the test set:

• This information is not provided. As it's a clinical follow-up rather than multi-reader image interpretation, formal adjudication methods like 2+1 or 3+1 are typically not described in this context for human clinical assessment.

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 performed. This device is not an AI/ML diagnostic or assistive tool, but a physical medical device.

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

• No. This is not an AI/ML algorithm. The performance described is of the physical device used by clinicians.

7. The type of ground truth used:

• The "ground truth" in this context refers to the clinical outcomes and assessments by healthcare professionals.
  • Obliteration/Recurrence: Assessed by "duplex check at follow up session." This implies sonographic assessment.
  • Safety: Clinical observation and assessment of adverse events by treating staff.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model that requires a training set. The clinical study described served as a performance evaluation.

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

• Not applicable. (See point 8).

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