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The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position catheters, stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.

The Ostial Pro Stent Positioning System is a medical grade, disposable guidewire system. The Ostial Pro Stent Positioning System will be used by interventional cardiologists and interventional radiologists to ensure precise stent implantation in aorta-ostial procedures. The product will be used in coronary and renal stenting procedures. The product is provided sterile and intended for single use. This finished product will be compatible with 6, 7 and 8 French catheters.

The provided text describes a 510(k) premarket notification for the "Ostial Pro Stent Positioning System," a medical device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials.

Therefore, many of the typical acceptance criteria and study design elements for AI/machine learning devices (like sample sizes for test/training sets, expert ground truth methods, multi-reader multi-case studies, or standalone performance) are not applicable and not present in this document.

The application asserts substantial equivalence through design verification testing, biocompatibility testing, and preclinical animal testing. These tests are designed to show that the device performs as intended and is as safe and effective as existing, legally marketed devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in the traditional sense of performance metrics (like accuracy, sensitivity, specificity) for an AI or diagnostic device. Instead, it states that the device's safety was evaluated through various tests, and these collective results demonstrated substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable/not specified. The testing involved design verification, biocompatibility, and preclinical animal testing, not a "test set" of patient data for algorithm performance.
• Data Provenance: Not applicable. No patient data (e.g., country of origin, retrospective/prospective) is described since this is not an AI/diagnostic device performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth establishment for a test set is not described as this is not an AI/diagnostic device performance study. The evaluation focused on engineering and biological safety characteristics.

4. Adjudication method for the test set:

• Not applicable. No test set requiring expert adjudication is described.

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:

• No. This is not an AI-powered diagnostic or assistive device. It is a guidewire system.

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

• No. This is not an AI algorithm.

7. The type of ground truth used:

• The concept of "ground truth" as typically applied to machine learning or diagnostic imaging evaluation is not directly relevant here. The "truth" in this context is adherence to engineering specifications, biological compatibility, and observable performance in preclinical models, which is established through standard laboratory and animal testing protocols rather than expert consensus on patient data.

8. The sample size for the training set:

• Not applicable. This is not an AI device that involves a training set.

9. How the ground truth for the training set was established:

• Not applicable. No training set is involved.

Summary of the Study per the Document:

The study described is a series of design verification tests, biocompatibility tests, and preclinical animal tests. These studies aim to demonstrate that the physical device (Ostial Pro Stent Positioning System) is safe, performs its intended function (to introduce and position catheters/stents and facilitate alignment), and is substantially equivalent to existing predicate guidewires. The specific details of these tests (e.g., number of animals, specific stress levels in design tests) are not provided in this summary but would be part of the full 510(k) submission. The "substantially equivalent" determination is the key finding that allows the device to be marketed.

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