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The PTA-Plus PTA Balloon Catheter is indicated for use within synthetic arteriovenous dialysis fistulae to remove embolic material (thrombus/debris) and dilate stenosis for treatment of obstructive lesions.

The proposed PTA-Plus PTA Balloon Catheter is designed for de-clotting and treating stenosis in synthetic dialysis grafts. It is an .035" guide-wire compatible, PTA balloon catheter with a proprietary valve system which allows injection of contrast and an embolectomy coil for mechanical removal of thrombus.

Here's a breakdown of the acceptance criteria and study information for the Hotspur Technologies, Inc. PTA-Plus PTA Balloon Catheter, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document states that the PTA-Plus PTA Balloon Catheter met "all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance documents, test protocols, and/or customer inputs." However, it does not provide a specific table or list of quantitative acceptance criteria values alongside the device's reported performance for each criterion. Instead, it broadly lists the types of tests performed and concludes that the device successfully met the established specifications.

Therefore, the table below reflects the categories of tests conducted and the general performance outcome as stated in the submission. Specific numerical values for acceptance criteria or performance are not detailed in the provided text.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size for the in-vitro or in-vivo tests. For the in-vivo testing, it mentions "ovine specimens" and "test and control comparator groups" but no specific number of animals.
• Data Provenance:
  • In-vitro testing: Performed internally ("in-vitro").
  • In-vivo testing: Conducted using an animal model (ovine specimens). The study was performed "in accordance with 21 CFR Part 58 'Good Laboratory Practices for Nonclinical Laboratory Studies'," which suggests a controlled, prospective study design. There's no mention of the country of origin, but given the submission to the FDA, it's likely U.S.-based or conducted under U.S. regulatory standards.

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

This information is not provided in the document. The device's performance was evaluated through physical, chemical, and animal testing rather than human interpretation or expert-established ground truth in the context of diagnostic performance.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation involved physical/chemical bench testing and animal studies, not human adjudication of results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a medical instrument (balloon catheter), not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a medical instrument, not an algorithm. The "standalone" performance here would refer to its physical and functional attributes, which were tested in-vitro and in-vivo.

7. The type of ground truth used

• Biocompatibility: Established by adherence to ISO and ASTM standards and specific assay results (e.g., non-toxic, non-sensitizing, non-pyrogenic).
• In-vitro Performance: Established by engineering specifications, comparative performance to predicate devices (which themselves met established safety and efficacy profiles), and adherence to predefined test protocols (e.g., balloon burst pressure, inflation/deflation times).
• In-vivo Performance: Established by surgical implantation outcomes, observation of animal specimens, and post-survival vessel and organ histology, comparing responses to test and control devices. The ground truth here is the physiological response and histological findings in the ovine model.

8. The sample size for the training set

This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models, which is not applicable to this physical medical device. The "training" for this device would refer to its design and manufacturing processes, which are not detailed in terms of a data set.

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

This information is not applicable for the same reasons as point 8.

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