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Pirouette 035 PTA Catheter is intended for balloon of the iliac, femoral, popliteal, infra-popliteal and renal arteries.

The Pirouette 035 Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating. The manifold connector and shaft design consists of a quidewire lumen allowing the catheter to track over a quidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .035 inch (0.89 mm) wire guides. The Pirouette 035 PTA Catheter Family includes multiple balloon sizes ranging from 3 to 12 mm in diameter and 20 to 200mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the quidewire hub of the manifold. The effective lengths of the catheter are 75cm and 130cm.

The provided text is a 510(k) summary for the Pirouette 035 Percutaneous Transluminal Angioplasty (PTA) Catheter. It describes the device, its intended use, and compares it to a predicate device (Pirouette 018). The core of the performance data section relies on non-clinical bench testing and leveraging data from the predicate device for biocompatibility, sterilization, shelf life, and packaging. No clinical studies were performed for the purpose of obtaining safety and effectiveness data for the Pirouette 035.

Therefore, I cannot provide information on acceptance criteria and study details related to AI or human expert performance, as the device is a physical medical catheter, not an AI-powered diagnostic or assistive tool. The concept of "acceptance criteria" in this context refers to engineering specifications and performance benchmarks for the physical device.

However, I can extract the relevant information from the document regarding the non-clinical testing and general acceptance criteria for this type of medical device.

Here's a breakdown based on the provided document, addressing the closest equivalent concepts:

Acceptance Criteria and Device Performance (Non-Clinical)

The document describes various non-clinical tests performed on the Pirouette 035 catheter. The acceptance criteria for these tests are generally stated as the device "met the pre-determined acceptance criteria," implying that the device demonstrated performance within specified engineering tolerances for each test. The document does not provide specific numerical thresholds or target values for these criteria, but rather lists the types of tests conducted.

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

Since specific numerical acceptance criteria are not provided in the document, the table will reflect the types of tests performed and the general statement of performance.

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

• Sample Size for Test Set: The document does not specify the sample sizes for any of the non-clinical tests (e.g., how many catheters were burst tested). It only lists the types of tests.
• Data Provenance: The bench testing (non-clinical tests) was performed by ArraVasc Limited (the manufacturer). The company is based in Ireland (2 Ballybrit Business Park, Galway, Ireland). The data is prospective in the sense that the tests were conducted specifically for the submission of the Pirouette 035.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable to this type of device and study. "Ground truth" established by human experts, especially for image interpretation or diagnosis, is a concept relevant to AI/ML or diagnostic devices. For a physical catheter, the "ground truth" and performance evaluation are based on objective engineering measurements and laboratory tests against predefined physical and chemical specifications, not subjective expert assessment. The experts involved would be engineers and lab technicians.

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

• This question is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth from multiple human readers in AI/imaging studies. For bench testing of a physical device, results are objective measurements against specifications, not subjective reads requiring adjudication.

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. This type of study (MRMC, AI assistance) is not applicable as the device is a physical catheter, not an AI or diagnostic tool. The document explicitly states: "No clinical studies were performed for the purpose of obtaining safety and effectiveness data."

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

• No. This question is not applicable as the device is a physical catheter, not an algorithm. Bench testing evaluates the physical device's performance standalone.

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

• The "ground truth" for the non-clinical tests is the objective engineering specifications and industry standards (e.g., ISO 10555-1, ISO 10555-4, ISO 10993-1). The device's performance is measured directly against these benchmarks.

8. The sample size for the training set:

• This question is not applicable. "Training set" refers to data used to train an AI model. For a physical device, there is no AI training set.

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

• This question is not applicable for the same reason as #8.

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