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The Rist™ 079 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Rist™ Radial Access Selective Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.

The Rist™ Radial Access Selective Catheter is a flexible, single lumen catheter, with a radiopaque stainless-steel braid reinforced shaft to provide support. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes: Simmons 2 (SIM2) and Berenstein (BER). The braided, tapered shaft of the catheter is visible under fluoroscopy and has a luer connector in its proximal end for the attachment of accessories and the infusion of fluids. The Rist™ Radial Access Selective Catheter has no hydrophilic coating. The Rist™ Radial Access Selective Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The Rist™ 079 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The catheter has a radiopaque marker band on the distal end to aid in visualization. The distal 25 cm of the Rist™ 079 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The Rist™ 079 Radial Access Guide Catheter has a PTFE-lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 079 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The Rist™ 071 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The embedded stainless-steel flat wire cross coil is in the proximal section of the catheter, which transitions to a nitinol round wire single coil in the distal end. The catheter has a radiopaque platinum/iridium marker band on to aid in visualization. The distal 25 cm of the Rist™ 071 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The Rist™ 071 Radial Access Guide Catheter has a PTFE- lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 071 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

Despite the request for a detailed description of acceptance criteria and study information, the provided text does not contain information related to specific acceptance criteria, device performance metrics, or a study report in the context of AI/ML device evaluation.

The document is an FDA 510(k) Premarket Notification for a medical device (catheters), not an AI/ML diagnostic or prognostic system. Therefore, the questions about sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to the content provided.

The document focuses on demonstrating substantial equivalence of the subject catheters to predicate devices, primarily based on design features, indications for use, and bench testing.

Here's a summary of what is available in the document, which addresses some points but not in the context of AI/ML performance evaluation:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that:

• Acceptance Criteria (Implied): The acceptance criteria are implicitly defined by the standards outlined in ANSI/AAMI HE75:2009/(R) 2018. The document does not provide the specific numerical or qualitative acceptance criteria used within this standard for the "In-vitro Simulated Use Study."
• Reported Device Performance: The reported performance is a high-level statement: "The devices met the acceptance criteria." Specific metrics, ranges, or quantitative results are not provided.

2. Sample size used for the test set and the data provenance:
Not applicable, as this was a bench test and not an AI/ML study involving patient data.

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 medical images by experts is not relevant to this bench testing of physical catheter devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

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:
Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.

7. The type of ground truth used:
For the "In-vitro Simulated Use Study," the "ground truth" would be the successful completion of tasks or performance within acceptable parameters as defined by the ANSI/AAMI HE75:2009/(R) 2018 standard for simulated use. This is a technical performance standard, not a clinical ground truth.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

In summary, the provided text describes regulatory approval for physical medical devices (catheters) based on substantial equivalence and bench testing, not an AI/ML-driven device that would require the in-depth data and performance metrics requested in the prompt.

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