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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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The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purposes of improving myocardial perfusion. The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. The Sapphire® II PRO balloon dilatation catheter is also indicated for: percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

The Sapphire II PRO balloon dilatation catheter is a rapid exchange balloon catheter with a working length of 140cm design for both coronary and peripheral indications. This catheter was previously cleared for coronary use (K173680, K163114) and this submission is intended to support the peripheral use of this balloon catheter. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.0-4.0mm and lengths from 5-30mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for the Ø1.0-1.5mm configurations). The catheter is compatible with 4F or larger guiding sheaths or 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a guiding sheath or guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sapphire II PRO Balloon Dilatation Catheter, focusing on the peripheral use indication:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table format alongside performance data. Instead, it states that the device "met all acceptance criteria" and "were similar to the reference devices" for the performed tests.

The performance tests conducted include:

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

The document does not provide specific sample sizes for any of the tests. It refers to testing being "leveraged from the reference device (K173680, K163114)" for many criteria, and "additional testing was performed" for others.

There is no information on the country of origin of the data, and the studies are retrospective in the sense that existing data from previous clearances (K173680, K163114) were used, supplemented by new (implicitly prospective) tests for the peripheral use indication.

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

This document describes a medical device clearance for a balloon catheter, not an AI/software device. Therefore, the concept of "experts" establishing ground truth in the context of clinical imagery or diagnostic data is not applicable here. The ground truth for device performance is established through engineering and performance testing against predetermined specifications.

4. Adjudication Method for the Test Set

Not applicable for this type of medical device performance testing. Adjudication methods like "2+1" or "3+1" are relevant for expert review of clinical cases, often in AI development contexts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, an MRMC comparative effectiveness study was not done. This is a physical medical device, not an AI system being evaluated for diagnostic or interpretive tasks by human readers.

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 system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications and established performance standards for balloon dilatation catheters. These standards are likely derived from industry best practices, regulatory guidance, and clinical requirements for the safe and effective operation of such devices. For example, balloon burst pressure needs to meet a certain PSI, and shaft flexibility needs to fall within a defined range.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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