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The Opti-Plast® XL 5.5 F PTA Catheter is recommended for use in the Percutaneous Transluminal Angioplasty of the Iliac and Femoral vessels. This catheter is not for use in coronary arteries. The device is indicated for single use only and indicated not to be resterilized nor reused.

The Vas-Cath Opti-Plast® XL 5.5 F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accomodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheters were designed to be used in conjuction with a 0.035 inch diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labelled diameter and length at a 5 atmosphere operating pressure.

Here's an analysis of the provided text regarding the Opti-Plast® XL 5.5F PTA Catheter, addressing the requested information:

Analysis of Acceptance Criteria and Study for Opti-Plast® XL 5.5F PTA Catheter

Based on the provided 510(k) summary, the device is a medical catheter and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to its physical and functional performance, demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the characteristics of the predicate device (Opti-Plast® PTA Catheter K933483) and industry standards for such devices. The "reported device performance" refers to the results of the bench testing.

Note: For the dimensional characteristics (e.g., balloon diameter, operating pressure), the Opti-Plast® XL is different from the specific 10mm predicate balloon but is being compared for its safety and effectiveness, likely falling within acceptable variations for its intended use or being equivalent to the Medi-tech® XXL™ Balloon Dilatation Catheter (K952063) for its indications. The key assertion is that the overall performance based on the bench tests is substantially equivalent.

2. Sample Size for the Test Set and Data Provenance

The provided text only explicitly mentions "Bench testing." This implies the "test set" consisted of physical samples of the Opti-Plast® XL 5.5F PTA Catheter undergoing various laboratory tests.

• Sample Size: The document does not specify the exact number of catheters tested for each characteristic.
• Data Provenance: The data provenance is laboratory-based bench testing of the manufactured device. It is not related to patient data or human subjects.

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

This question is not applicable to this type of device submission. For a medical device like a catheter, "ground truth" is established through engineering specifications, material standards, and performance metrics defined by regulatory bodies and industry best practices. There are no human experts determining a "ground truth" in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

This question is not applicable as the "test set" involves physical device testing against predefined engineering and performance standards, not human interpretation or consensus. No adjudication method is described or implied.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of outputs (e.g., medical images, AI algorithms). The Opti-Plast® XL 5.5F PTA Catheter is an interventional device; its performance is assessed through bench testing, not human reading of cases.

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

No, a standalone (algorithm-only) performance study was not done. This question is relevant for AI or software as a medical device (SaMD). The Opti-Plast® XL 5.5F PTA Catheter is a physical medical device.

7. The Type of Ground Truth Used

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

• Engineering specifications and design parameters: The device is designed to meet specific dimensions, material properties, and functional characteristics.
• Industry standards: Performance characteristics (e.g., burst pressure, fatigue) are likely evaluated against recognized ASTM or ISO standards for angioplasty catheters.
• Predicate device performance: The performance of the Opti-Plast® XL 5.5F PTA Catheter in bench tests is compared against the established performance of the legally marketed predicate device (Opti-Plast® PTA Catheter K933483) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of a physical medical device submission like this. Training sets are used for machine learning algorithms.

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

This question is not applicable as no training set exists for this type of device.

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