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The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position 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. This product is provided sterile and intended for single use. This finished product will be compatible with 6, 7 and 8 French catheters.

The provided 510(k) summary for the Ostial Pro Stent Positioning System (K122089) states that no performance standards have been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act for this type of device.

Instead, the submission relies on performance testing conducted based on a risk analysis and in accordance with various FDA guidance documents and international standards for medical device sterilization, packaging, and biological evaluation, along with specific guidance for guidewires and stents.

The testing conducted was primarily non-clinical engineering tests to demonstrate the device's safety and performance and its substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text, noting where specific details are not available as this is a medical device and not an AI/software device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide specific sample sizes for each test. The testing described is primarily for the physical and material characteristics of the device, not clinical performance data from a patient population. Therefore, terms like "test set," "data provenance," and "country of origin" as typically used for AI/software evaluations are not applicable here. The "data" refers to the results of engineering and laboratory tests.

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

This section is not applicable as the "ground truth" for this type of device is established through adherence to engineering standards and laboratory testing protocols, not through expert consensus on clinical cases. The "experts" would be the engineers and technicians performing the tests and comparing results against established technical specifications.

4. Adjudication Method for the Test Set

This is not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 typically refer to a process for resolving discrepancies in expert interpretations of clinical data, which is not relevant for the engineering tests performed.

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 evaluating the impact of an AI system on human reader performance, which is not the subject of this 510(k) summary for a physical medical device.

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

Not applicable. This device is a physical stent positioning system, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

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

• Engineering specifications and design requirements: Each physical property (e.g., dimensions, torque strength, radio-opacity) has a defined acceptable range or performance target.
• International standards and FDA guidance documents: These documents define the testing methodologies and acceptable limits for various aspects like sterilization, packaging integrity, and biocompatibility.
• Comparison to predicate device characteristics: Substantial equivalence implies that the new device performs similarly to or better than the legally marketed predicate device across critical parameters.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning system. Therefore, there is no "training set" in the context of data used to train an algorithm. The device design and manufacturing process are validated through engineering principles and quality control.

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

Not applicable, as there is no "training set."

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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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