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The balloon dilatation catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, poplited, tibial, peroneal, subclavian and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

The Tiche is an Over the Wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The device features a low profile balloon and tip. The working length of the catheter range from 40cm-135cm. A hydrophilic coating is applied from the distal shaft. The balloon dilatation catheter features a dual lumen shaft ending in a Y-hub manifold. The balloon has two radiopaque markers for positioning the balloon relative to the stenoses. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter at specific pressure. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text describes the 510(k) summary for the Tiche PTA Balloon Dilatation Catheter. It outlines the device's technical specifications, intended use, and the performance testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain acceptance criteria for an AI/ML device, nor does it describe a study involving AI assistance for human readers, a standalone AI algorithm performance study, or a multi-reader multi-case (MRMC) comparative effectiveness study.

The document pertains to a traditional medical device (a balloon dilatation catheter) and the performance testing described is related to the physical and functional characteristics of this hardware device, not to the performance of an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance for an AI/ML device. The document discusses acceptance criteria for bench testing of the catheter (e.g., dimensional verification, balloon rated burst pressure, biocompatibility), and states that "The test results met all acceptance criteria." However, these are not relevant to AI/ML performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document details the following for the Tiche PTA Balloon Dilatation Catheter:

• Acceptance Criteria and Reported Device Performance: The document states that "The test results met all acceptance criteria." These criteria relate to various bench tests including:

  • Dimensional verification
  • Simulated Use
  • Balloon Rated Burst Pressure
  • Balloon Fatigue & Compliance
  • Balloon Inflation and Deflation Time
  • Catheter Bond Strength
  • Tip Pull Strength
  • Flexibility and Kinking
  • Torque Strength
  • Radiopacity
  • Coating Friction & Integrity
  • Particulate Evaluation
  • Catheter Body Bust Pressure
  • Balloon Rated Burst Pressure (in stent)
  • Balloon Fatigue (in stent)
  • Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity, Genotoxicity)
  • Sterilization Packaging and Shelf Life

  The performance reported for all these tests is that they "met all acceptance criteria."

The request specifically asks for information related to an AI/ML device, which is not what the provided document describes.

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