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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 is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two 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.

This document is a 510(k) premarket notification for a medical device called the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter. It's a submission to the FDA to demonstrate that the modified device is "substantially equivalent" to an already marketed device, meaning it's equally safe and effective.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Study Details:

The provided document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving these criteria were met using those metrics. Instead, the document focuses on demonstrating "substantial equivalence" to a predicate device through performance testing (bench testing) and similarity in intended use, materials, and technological characteristics.

Therefore, a table of acceptance criteria and reported device performance, and most of the detailed questions about studies, cannot be directly answered from the provided text as they relate to clinical effectiveness studies with human subjects or AI algorithm performance.

However, based on the available information, we can infer the acceptance criteria for a 510(k) submission of this type:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document focuses on demonstrating substantial equivalence, not on providing efficacy and safety data from clinical trials in the way an AI algorithm or a novel drug might. The "acceptance criteria" here are primarily satisfied by demonstrating that the device is fundamentally the same as a previously approved device.

The following questions relate to performance studies, often associated with AI/ML devices or clinical trials. Since this document is a 510(k) for a physical medical device (a balloon catheter) demonstrating substantial equivalence, these specific types of studies are not described or relevant in this context.

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing, not a clinical test set with patient data.
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 clinical data is not relevant to this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical test set from patient data. The "ground truth" for the bench testing would be engineering specifications and predicate device performance.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling from data.
9. How the ground truth for the training set was established: Not applicable.

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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 is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two 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.

The provided text describes a Premarket Notification (510(k)) Summary for the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria in the traditional sense.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this context. The "study" mentioned is primarily bench testing to support substantial equivalence for newly added balloon sizes, not a clinical trial evaluating diagnostic or treatment efficacy against specific performance metrics.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not relevant:

Acceptance Criteria and Device Performance for AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter

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

In the context of a 510(k) for a device like a PTA balloon catheter, "acceptance criteria" are not typically expressed as performance metrics like sensitivity/specificity for a diagnostic device or success rates for a novel therapeutic device against predefined thresholds. Instead, the acceptance criteria revolve around demonstrating substantial equivalence to a predicate device, meaning it has the same intended use, similar technological characteristics, and performs as safely and effectively.

For this specific submission, the "performance" referenced primarily pertains to bench testing to support the substantial equivalence claim for the newly added balloon sizes. The document explicitly states: "Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the AMPHIRIONTM DEEP 0.014" OTW PTA Balloon Catheter meets the requirements that are considered acceptable for the intended use."

The document does not provide specific numerical acceptance criteria (e.g., burst pressure tolerance, deflation time) or reported performance values from these bench tests. It simply states that the tests were performed and support the claim.

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

The document refers to "Performance testing (bench)."

• Sample Size for Test Set: Not specified. Bench tests often involve a certain number of units per size/configuration to ensure statistical validity, but the exact count is not disclosed in this summary.
• Data Provenance: The tests are "bench" tests, meaning in-vitro laboratory testing, not human or animal studies. Therefore, concepts like country of origin for patient data are not applicable.

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

Not applicable. For bench testing of a device like a balloon catheter, "ground truth" is typically defined by engineering specifications, material properties, and physical measurements, not by expert clinical consensus. The evaluation is against engineering standards and requirements, not expert interpretations of clinical data.

4. Adjudication method for the test set

Not applicable. As described above, the "test set" involves bench testing against engineering specifications, not clinical cases requiring expert 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

Not applicable. This device is a medical instrument (PTA balloon catheter), not a diagnostic imaging system or an AI-powered tool. Therefore, MRMC studies involving human readers or AI assistance are entirely irrelevant.

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.

7. The type of ground truth used

For the bench testing, the "ground truth" would be the engineering specifications and validated testing methodologies against which the device's physical properties and performance characteristics (e.g., burst pressure, inflation/deflation times, guidewire compatibility, shaft flexibility) are measured. These are objective measurements compared to predefined limits and the predicate device's performance.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI or machine learning model that requires a "training set."

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

Not applicable. See point 8.

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