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The 014 Hydrophilic Coated PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The 014 Hydrophilic Coated PTA Balloon Dilatation Catheter is an over the-wire (OTW) co-axial percutaneous transluminal angioplasty (PTA) catheter system designed for use with a 0.014" guidewire. The shaft of the PTA balloon catheter contains a distal balloon and a manifold on the proximal. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer catheter shaft acts as the passage for the inflation medium for balloon expansion. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a bifurcated manifold and strain relief that allows for the use of the 0.014" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The 014 Hydrophilic Coated PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtO) and is intended for single use only.

The document provided is a 510(k) summary for a medical device (014 Hydrophilic Coated PTA Balloon Dilatation Catheter) and does not contain information related to an AI/ML-driven device. Therefore, some of the requested information (like number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable.

The document describes the device's acceptance criteria in terms of various performance bench tests, biocompatibility, and sterilization, and confirms that the device meets these criteria through non-clinical testing.

Here's a summary of the available information:

1. Table of Acceptance Criteria and 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 primarily refers to "non-clinical testing" and "bench testing." It does not specify the exact sample sizes for each test performed. The tests are laboratory-based (bench, biocompatibility, sterilization), so "data provenance" in terms of clinical patient data or geographic origin is not applicable here. These are likely conducted in a controlled lab environment by the manufacturer (Creagh Medical, Ltd., dba Surmodics, Inc. in Ireland, with sterilization site in Ireland).

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)

This is not applicable as the device is not an AI/ML diagnostic or image analysis device that requires expert ground truth for interpretation. Ground truth for these types of engineering and biocompatibility tests typically comes from established scientific methods, standards (e.g., ISO), and regulatory guidelines, rather than expert consensus on medical images.

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

Not applicable, as there is no human interpretation or diagnostic ground truth to adjudicate for this type of device testing.

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-assisted device. The document explicitly states: "No clinical data is being submitted for the 014 Hydrophilic Coated PTA Balloon Dilatation Catheter."

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for the performance tests relies on pre-defined specifications, engineering tolerances, established scientific standards (e.g., ASTM for hemolysis), and regulatory standards (e.g., ISO for biocompatibility and sterilization). For instance, for bench tests like "Rated Burst Pressure," the ground truth is the specified burst pressure it must withstand. For "Biocompatibility," the ground truth is that the device must pass the criteria outlined in ISO 10993-1. For "Sterilization," the ground truth is compliance with ISO 11135:2014.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable. This device does not involve machine learning or a training set.

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The Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.

The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic in lower limb arteries. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion.

The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen.

The dilatation catheter has a hydrophobic silicone coating on the outer surface of the proximal shaft and a hydrophilic polymeric based coating on the outer surface of the distal shaft, coated over 150 mm length (valid for 1.5 and 2 mm balloon diameter and 20 to 100 mm balloon length) or coated over 75 mm length (valid for 2 mm balloon diameter and 140 to 220 mm balloon length, and 2.5 to 4 mm balloon diameter and 20 to 220 mm balloon lenqth). The balloon has a hydrophilic patchwork coating.

The dilatation catheter is compatible with quide wire and introducer sheath sizes according to the recommendations on the label.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It generally refers to "all sizes," "all tested samples," or implies replicate testing (e.g., "90% of the balloons will survive the 20 inflation cycles"). The data provenance for these non-clinical tests is internal to the manufacturer (BIOTRONIK) and is retrospective, as the tests were conducted to secure prior market clearance.

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

Not applicable. This device is a physical medical device (catheter), and the "ground truth" for its performance and safety is established through engineering and biological testing against predefined specifications and regulatory standards, not through expert consensus on diagnostic interpretations.

4. Adjudication method

Not applicable, as this is a physical medical device. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., medical imaging AI).

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 MRMC comparative effectiveness study was done. This is a medical device clearance for a physical non-diagnostic product, not an AI-assisted diagnostic tool. No clinical data was submitted, and the determination of substantial equivalence did not rely on clinical data.

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

Not applicable. This is a physical medical device. There is no algorithm or AI component mentioned.

7. The type of ground truth used

The "ground truth" for the non-clinical tests detailed in the document is based on pre-defined engineering specifications, international standards (ISO-10993), and FDA guidance documents (e.g., Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters). For biocompatibility, it relies on established biological endpoints and observable reactions in in-vitro and in-vivo models.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

Not applicable. See point 8.

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