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The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters, with 150 mm and 210 mm balloon lengths, are intended to dilate stenoses in the femoral, popliteal, and infra-popliteal arteries.

The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is an over-thewire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, coaxial dual lumen shaft, and a distal dilatation balloon. Hydrophilic coating covers the distal 240 mm of the catheter and radiopaque markers indicate the proximal and distal dilating surface of the balloon and facilitate placement across the stenosis. The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is compatible with 4 F introducer catheters and 0.014" diameter guidewires. The catheter is provided with useable catheter lengths of 120 cm and 150 cm.

The provided text describes a 510(k) premarket notification for a medical device, the AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than a standalone study with specific acceptance criteria and detailed performance data often found in AI/Reader studies.

Therefore, many of the requested categories (2, 3, 4, 5, 7, 8, 9) are not applicable or cannot be extracted from this type of regulatory submission. The information provided primarily pertains to the general performance data and conclusion.

Here's the breakdown 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

Not applicable. This is a 510(k) submission based on bench testing and comparison to predicate devices, not a clinical study on a test set of data.

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

Not applicable. No expert ground truth establishment for a test set is mentioned.

4. Adjudication method for the test set

Not applicable. No test set adjudication is mentioned.

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 device is a physical medical device (balloon catheter), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device. The device (catheter) performance was evaluated via bench testing.

7. The type of ground truth used

For bench testing, the "ground truth" would be established engineering specifications, performance standards, and the performance characteristics of the predicate devices. The study compares the new device's physical and mechanical properties against these established benchmarks.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design, materials, and fundamental technology are stated to be "same or similar" to previously cleared devices.

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

Not applicable. There is no "ground truth for a training set" as it's not an AI/machine learning device.

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The AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The AMPHIRION DEEP catheter has a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated (balloon included). The AMPHIRION DEEP catheter is available in different balloon sizes (balloon diameters of 1.5 and 2.0 mm and balloon lengths of 20, 40, 80 and 120 mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.014" and the usable catheter length is 120cm.

The provided document is a 510(k) summary for the AMPHIRION™ DEEP 0.014" OTW PTA BALLOON CATHETER, a medical device. This type of document is for a medical device that does not use AI/ML technology, and therefore, many of the requested categories are not applicable. The document describes the device, its intended use, and how its safety and effectiveness were demonstrated through in-vitro testing and comparison to predicate devices, rather than a study with acceptance criteria and device performance as typically understood for AI/ML devices.

Here's an attempt to answer the questions based on the provided text, noting where information is not applicable or unavailable:

1. Table of acceptance criteria and the reported device performance

Since this is a physical medical device (a catheter) and not an AI/ML device, the "acceptance criteria" and "reported device performance" are based on a series of in-vitro physical tests designed to ensure the device meets engineering specifications and safety standards, rather than diagnostic accuracy metrics.

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

For physical medical devices, "test set" typically refers to the number of individual devices or components subjected to specific physical bench tests. The document does not specify the exact sample sizes (e.g., number of catheters tested for burst pressure), nor does it describe data provenance in terms of country of origin or retrospective/prospective, as these concepts are not applicable to the in-vitro mechanical and material tests described.

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

Not applicable. Ground truth for physical device testing is established by engineering specifications, material standards, and validated testing methodologies, not by expert consensus on clinical data.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical data interpretation or labeling decisions, typically involving multiple human readers to establish a consensus ground truth. This is not relevant for the in-vitro physical testing of a catheter.

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 a physical medical device, not an AI/ML diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant.

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

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

7. The type of ground truth used

For this device, the "ground truth" for demonstrating safety and effectiveness was based on:

• Engineering Specifications: Performance metrics (e.g., burst pressure, dimensions) were compared against predefined engineering and design specifications.
• Material Standards: Biocompatibility testing followed established material science standards.
• Predicate Device Equivalence: Performance was deemed "substantially equivalent" to legally marketed predicate devices through comparison of physical characteristics and mechanical testing data.

8. The sample size for the training set

Not applicable. This is a physical medical device, and the concept of a "training set" is not relevant.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary regarding AI/ML relevance:

The provided document describes a traditional 510(k) submission for a physical medical device (PTA balloon catheter). It focuses on demonstrating substantial equivalence to predicate devices through physical characteristics (design, materials, dimensions) and in-vitro performance testing (e.g., burst pressure, biocompatibility). None of the information suggests the involvement of AI/ML technology, hence many of the questions regarding AI/ML study design and performance metrics are not applicable.

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