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The Cordis AVIATOR PLUS PTA Balloon Dilatation catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac. femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is a catheter with a distal balloon and utilizes a rapid exchange design and accepts a 0.014" guide wire. The catheter tip is tapered to facilitate crossing of tight lesions. The proximal hub is used as a balloon inflation port. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement.

The provided text describes a Special 510(k) submission for a device modification, the Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter. This type of submission relies on the concept of "substantial equivalence" to a predicate device, rather than explicit acceptance criteria with numerical performance targets from a clinical study.

Therefore, many of the requested data points (like sample size for test sets, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission because clinical performance studies with specific acceptance criteria are generally not required for device modifications that can demonstrate substantial equivalence through non-clinical design verification and validation testing.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense. The 510(k) summary states: "The safety and effectiveness of the subject Cordis AVIATOR PLUS PTA Balloon Catheter has been demonstrated via data collected from non-clinical design verification and design validation tests and analyses."

This indicates that the device met internal design specifications and engineering performance criteria (e.g., burst pressure, durability, trackability, crossing profile, guidewire compatibility) through bench testing and potentially animal studies, which are not detailed in this public summary. These non-clinical tests would have their own acceptance criteria, but they are not the type of clinical performance criteria usually associated with AI/diagnostic devices.

The "reported device performance" is essentially that it passed these non-clinical tests and is "substantially equivalent" to its predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical "test set" in the context of human data or diagnostic imaging was used for this 510(k) submission. The evaluation was based on non-clinical design verification and validation tests.

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

Not applicable. Ground truth in the context of clinical endpoints or diagnostic accuracy is not relevant for this non-clinical submission. Engineering and quality control experts would have assessed the device against its specifications.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for a balloon dilatation catheter's 510(k) submission, especially one based on device modification and non-clinical data. This type of study would be for AI-powered diagnostic devices comparing human performance with and without AI assistance.

6. If a Standalone Performance Study Was Done

Not applicable. Standalone (algorithm-only) performance is relevant for AI algorithms. This is a physical medical device (balloon catheter), and its performance is evaluated through non-clinical engineering tests.

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" was established by engineering design specifications and performance standards. The device performs as intended according to its design and manufacturing criteria, which are sufficient to demonstrate substantial equivalence to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI for this physical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

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The Cordis AMIIA PTA Balloon Dilatation catheter is intended for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.

The Cordis AMIIA PTA Balloon Dilatation Catheter is a catheter with a distal DURALYN™ inflatable balloon. The catheter utilizes a Rapid Exchange design, consisting of a single inflation lumen and a distal guide wire lumen. The guide wire lumen begins at the distal tip and terminates at the guide wire exit port. The guide wire exit port (hole) is approximately 25 cm from the distal tip. The maximum guide wire diameter that may be used is printed on the package label. The catheter tip is tapered to facilitate crossing of tight lesions. The proximal hub is used as a balloon inflation port. The balloon is inflated by injecting diluted contrast medium through this hub. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement. The nominal balloon diameter and length are printed on the identification band near the hub. The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance table incorporated with the product, for diameters of the balloon at given pressures. The design of this catheter does not incorporate a lumen for distal dye injection. The balloon catheter with a usable shaft length of 142 cm has two proximal shaft markers (90 cm and 100 cm from the distal tip). Both indicate the relative position of the catheter tip to the distal end of the guiding catheter. An additional marker is located at the distal port exit notch and aids in locating the guide wire exit.

The provided text describes the Cordis AMIIA PTA Balloon Dilatation Catheter and its substantial equivalence to predicate devices, focusing on its intended use and safety. It does not contain information about specific acceptance criteria, device performance metrics, or a formal study with a test set, ground truth, or statistical analysis (like MRMC studies) as requested in the prompt. The document explicitly states that "No biocompatibility test was required, as the original device has not changed and there was no change in the vascular application of the device" and that safety and effectiveness were demonstrated via "non-clinical design verification tests and analyses." This suggests that the approval was based on engineering and design verification rather than a clinical performance study with human subjects.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is an attempt to answer the questions based only on the provided information, noting where information is absent:

1. A table of acceptance criteria and the reported device performance
   The document does not explicitly list quantitative acceptance criteria or reported device performance metrics from a formal study. It broadly states that safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   Not applicable (N/A). The document indicates that safety and effectiveness were demonstrated via "non-clinical design verification tests and analyses" rather than a clinical test set. No sample size for a test set or data provenance is mentioned.

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)
   Not applicable (N/A). There is no mention of experts or ground truth establishment for a test set. The approval is based on substantial equivalence and non-clinical design verification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable (N/A). No test set requiring 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 (N/A). The device is a physical medical catheter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable (N/A). The device is a physical medical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Not applicable (N/A). The document refers to "non-clinical design verification tests and analyses" for safety and effectiveness, implying engineering and performance specifications rather than clinical ground truth like pathology or outcomes data. The basis for approval is substantial equivalence to predicate devices.

8. The sample size for the training set
   Not applicable (N/A). No training set is mentioned as this is a physical medical device.

9. How the ground truth for the training set was established
   Not applicable (N/A). No training set or associated ground truth establishment is mentioned.

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