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The Bipore Balloon Dilation Catheter is intended to be used for multations for out. The Bipos Daily of the iliac, femoral and renal arteries, and for perculariedus thanslaminar angloplace, or the autologous or synthetic arteriovenous dialysis fistulae.

The Bipore Inc. Balloon Dilation Catheter is an over-the-wire double lumen balloon catheter designed for percutaneous transluminal angioplasty (PTA) in peripheral arteries, including iliac, femoral, and renal arteries. The catheter consists of a 5 French nylon-based shaft with two lumens. One lumen is for inflation and deflation of the balloon. The other lumen accepts a guidewire for manipulation of the catheter to the site stenosis. Guidewires up to 0.035" diameter may be used. There is a bifurcated proximal juncture that provides access to each lumen. A non-compliant dilation balloon of nylon (11) is at the distal end of the catheter. When inflated, the balloon exerts a controlled radial pressure. Located under the proximal and distal ends of the balloon are radiopaque markers, which provide a reference point for locating the balloon within the vessel. A Teflon™ sleeve is placed over the deflated balloon prior to shipping. This sleeve is designed to protect the balloon in storage and is removed prior to use.

The acceptance criteria and the methods used to demonstrate that the Bipore Balloon Dilation Catheter (with nylon balloon) meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document outlines several acceptance criteria and implies the device met these criteria for 510(k) clearance, as denoted by the statement: "The proposed device modification meets Bipore, Inc. original device specification." and the fact that the 510(k) was cleared. However, specific numerical performance results for EACH criterion are not explicitly detailed in the provided text. The document primarily focuses on the acceptance criteria thresholds that the new nylon balloon must meet. Based on the clearance, we can infer that the device did meet these criteria.

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

The document states: "The sample size must be sufficiently large enough to yield data that is 95% confident that 99.9% of the balloons will not fail at or below specification." This is a statistical requirement for the sample size, typically indicating a substantial number of units were tested to achieve this confidence level (e.g., for a 95% confidence and 99.9% reliability, a zero-failure test would require at least 299 units). However, the exact numerical sample size used for each test is not explicitly stated.

• Data Provenance: The nature of the tests (material properties, mechanical performance, accelerated aging) indicates that the data was generated through prospective bench testing and in-vitro studies conducted by the manufacturer, Bipore, Inc., in a controlled laboratory environment. The country of origin for the data is not explicitly stated, but given the company's location (Northvale, NJ, USA), it's highly likely the studies were conducted in the USA.

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

This information is not applicable to this submission. The "ground truth" for the performance characteristics of this medical device (a balloon dilation catheter) is established through objective, quantifiable engineering and materials testing (e.g., measuring burst pressure, diameter, inflation time). It does not involve subjective human interpretation of images or clinical data that would require expert consensus.

4. Adjudication Method for the Test Set

This is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in subjective expert assessments, typically for clinical endpoints or image interpretation. The tests described here are objective, quantitative engineering tests with clear pass/fail criteria.

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. This type of study is relevant for evaluating the performance of AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Bipore Balloon Dilation Catheter is a physical medical device, and its performance is assessed via engineering and material tests, not through human interpretation of cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device modification is based on objective and quantifiable engineering specifications and material properties. This includes measurements of:

• Burst pressure (maximum pressure before rupture)
• Dimensional accuracy (balloon diameter at specific pressures)
• Time-based performance (inflation/deflation time)
• Mechanical strength (tensile strength)
• Fatigue resistance (performance after multiple cycles)
• Stability over time (shelf life after accelerated aging)

These are measured directly from the physical device under controlled conditions.

8. The Sample Size for the Training Set

This question is not applicable. This submission details a modification to a physical medical device. There is no "training set" in the context of machine learning algorithms. The material (Nylon 11) itself is characterized, and the manufacturing process is validated, but there isn't a "training set" of data in the AI sense.

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

This question is not applicable for the reasons outlined in point 8. The "ground truth" for the design and manufacturing process of the catheter's components is established through established engineering principles, material science, and quality control procedures to ensure components meet their intended specifications.

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