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The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

The Flash PTA Balloon Dilatation Catheter is designed for dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semicompliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

This document describes the acceptance criteria and the study conducted for the Flash PTA Balloon Dilatation Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a separate "test set" in the context of clinical data or patient samples. The study described is a series of in-vitro performance bench tests and biocompatibility tests. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) and sample size in terms of clinical cases is not applicable here. The samples for these tests would be physical devices or materials, not patient data.

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

Not applicable. The "ground truth" for the in-vitro and biocompatibility tests would be established through predefined scientific and engineering specifications, and validated laboratory methodologies, rather than human expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance criteria are based on pre-defined specifications and validated laboratory testing, not human-reviewed clinical cases that would require adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes laboratory (in-vitro) and biocompatibility testing, not clinical studies involving human readers or patient cases.

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

Not applicable. This device is a physical medical device (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• Established Scientific and Engineering Specifications: For the in-vitro performance bench testing, the device's performance characteristics (e.g., burst pressure, inflation/deflation time, fatigue) must meet predetermined quantitative and qualitative standards.
• Regulatory Standards and Guidelines: For biocompatibility, the ground truth is defined by compliance with international standards such as ISO-10993 and FDA guidelines (e.g., Blue Book Memorandum May 1, 1995) which specify acceptable biological responses to the device materials.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/algorithm that requires a "training set."

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

Not applicable, as no training set was used.

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The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.

The proposed Flash PTA Balloon Dilatation Catheter is designed for dilation of aorto-ostial lesions of peripheral vessels in the arterial system. The Flash PTA Balloon Dilatation Catheter is a .014" guidewirecompatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon that enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Flash PTA Balloon Dilatation Catheter, structured according to your request:

Acceptance Criteria and Study for Flash PTA Balloon Dilatation Catheter

The provided document describes the Flash PTA Balloon Dilatation Catheter, a device for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The information details the device's characteristics, intended use, and performance data used to establish substantial equivalence to a predicate device (Sterling PTA Balloon Dilation Catheter).

However, it's crucial to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone clinical trial with pre-defined acceptance criteria for a novel device. Therefore, some of the requested information, particularly regarding specific performance metrics with numerical acceptance criteria and a detailed clinical study with human readers, is not explicitly present in this type of submission.

The "acceptance criteria" discussed in the document refer to the successful completion of various biocompatibility tests and in-vitro bench tests to ensure the materials and design meet established specifications and perform comparably to the predicate device. The conclusion states: "The Flash PTA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs." This implies that the device successfully passed these tests, but specific numerical thresholds are not provided in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria for performance metrics (e.g., target accuracy, sensitivity, specificity) for a diagnostic or AI-driven device are not applicable here. Instead, the document lists various tests that were successfully completed. The "reported device performance" is essentially that the device passed these tests and was found to be "substantially equivalent" to the predicate.

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

• Test Set Sample Size:
  • In-vitro Bench Testing: Not specified for each individual test. The document states "The proposed Flash PTA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing," implying multiple units were tested for each characteristic.
  • In-vivo Testing: "a swine model" was used. The specific number of animals is not provided.
• Data Provenance:
  • Biocompatibility & In-vitro Bench Testing: Likely performed in a controlled laboratory setting (manufacturer's or contract lab). No specific country of origin is mentioned.
  • In-vivo Testing: Animal model (swine). No specific country of origin is mentioned.
• Retrospective or Prospective: These tests are inherently prospective as they are specifically conducted to evaluate the device.

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

• This device is not an AI/diagnostic device that requires expert-established ground truth in the same way. The "ground truth" for its performance is derived from objective physical measurements, chemical analyses, and biological responses (e.g., burst pressure, material reactions, animal physiological responses).
• Expert involvement would primarily be in designing and interpreting the technical and biological tests, likely by engineers, material scientists, and toxicologists, rather than clinicians establishing a diagnostic ground truth. The document does not specify the number or qualifications of these technical experts.

4. Adjudication Method for the Test Set

• Not applicable in the context of this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints or diagnostic interpretations, not for bench or animal testing. The "adjudication" here would be the successful completion of the pre-defined test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

• No. This is a balloon dilatation catheter, a physical medical device for interventional procedures, not an AI-assisted diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant and were not conducted.

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

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

7. The Type of Ground Truth Used

• As mentioned in point 3, the "ground truth" for this device's performance is based on:
  • Objective Technical Measurements: Such as precise measurements of catheter shaft diameter, balloon dimensions, inflation/deflation times, pressure endurance (rated burst pressure), and material strengths (bond, tip pull, torque).
  • Standardized Biological Assays: Following ISO 10993 for biocompatibility, detecting specific biological reactions (hemolysis, complement activation, pyrogenicity, sensitization).
  • In-vivo Physiological Responses: Observing the physical effects and downstream/cognitive impacts in a live animal model during and after a simulated angioplasty procedure.
  • The term "ground truth" as typically used for AI/diagnostic devices (e.g., pathology, clinical outcomes) doesn't directly apply here.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device, not an AI or machine learning model that requires a training set. The "training" for this device involved design and engineering development, not data-driven algorithm training.

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

• Not applicable. As explained above, there is no "training set" in the context of an AI/ML model for this device.

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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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