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The RIST Radial Access 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 Catheter is a flexible, single lumen catheter compatible with 0.038inch quidewires. It is designed to deliver interventional devices into the peripheral, coronary, and neuro vasculature, facilitate introduction of diagnostic agents in the neuro vasculature, and is intended to provide access to the target site via transradial access. The RIST Radial Access Catheter consists of a radiopaque catheter shaft reinforced with stainless steel and has a luer connector at its proximal end for the attachment of accessories and the infusion of fluids. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes, namely Simmons 2 (SIM2) and Berenstein (BER), The catheter has a nominal outer diameter of 0.070 inches and a nominal inner diameter of 0.040 inches. It is available in two working lengths: 120 cm. The RIST Radial Access Catheter is compatible with the RIST Cath Radial Access Long Sheath (K191551) and off-the-shelf accessories. The RIST Radial Access Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The provided text discusses the RIST Radial Access Catheter (K201682) and its substantial equivalence to predicate devices, primarily focusing on performance testing. However, it does not contain information related to an AI/ML device. The document is a 510(k) summary for a physical medical device (catheter) and the performance data presented pertains to physical properties, mechanical tests, and biocompatibility, not AI model performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set data) are specific to the evaluation of AI/ML models, which are not applicable to the RIST Radial Access Catheter described here.

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

The RIST Radial Access Catheter is a flexible, single lumen catheter compatible with 0.035 inch and 0.038-inch guidewires. It is designed to deliver interventional devices into the peripheral, coronary, and neuro vasculature and is intended to provide access to the target site via transradial access. The RIST Radial Access Catheter consists of a radiopaque catheter shaft reinforced with stainless steel and has a luer connector at its proximal end for the attachment of accessories and the infusion of fluids. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes, namely Simmons 2 (SIM2) and Berenstein (BER). The catheter has a nominal outer diameter of 0.070 inches and a nominal inner diameter of 0.040 inches. It is available in two working lengths: 120 cm and 130 cm. The RIST Radial Access Catheter is compatible with the RIST Cath Radial Access Long Sheath (K191551) and off-theshelf accessories. The RIST Radial Access Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The provided text is a 510(k) Summary for the RIST Radial Access Catheter. This document details the engineering and performance tests conducted to demonstrate the device's substantial equivalence to a predicate device, rather than the evaluation of an AI/ML medical device.

Therefore, many of the typical acceptance criteria and study design elements requested in the prompt, such as:

• A table of acceptance criteria and reported device performance related to AI/ML metrics (e.g., sensitivity, specificity, AUC)
• Sample size for the test set and data provenance (e.g., country, retrospective/prospective) related to clinical data for AI/ML performance
• Number of experts and their qualifications for establishing ground truth for AI/ML
• Adjudication method for the test set for AI/ML
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study for human readers with and without AI
• Standalone (algorithm-only) performance
• Type of ground truth used (expert consensus, pathology, outcome data) for AI/ML
• Sample size for the training set and how ground truth was established for training

cannot be extracted from this document. The document describes a traditional medical device (catheter) and its physical and functional performance testing, not an AI or machine learning algorithm.

The document focuses on establishing substantial equivalence based on:

1. Indications for Use: Identical to the predicate device.
2. Technological Characteristics: Comparison of materials, dimensions, and operational principles.
3. Performance Data: A series of design verification and validation tests, and biocompatibility tests directly on the catheter itself.

However, I can provide the acceptance criteria and reported performance for the physical device based on the available information:

Acceptance Criteria and Device Performance (for a physical catheter; not an AI/ML device)

Study Details (for a physical catheter, not AI/ML):

1. Sample sizes used for the test set and the data provenance: The document generally states "All units" or "Samples" without specifying the exact number of units tested for each criterion. The data provenance is internal RIST Neurovascular testing, leveraging some data from previously cleared devices (K152202, K161262, K152876). The studies are evidently prospective, laboratory/benchtop tests, not clinical studies on human subjects, hence "country of origin of the data" in a clinical sense is not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For the In vitro Simulated Use Study - Bench and Radiopacity tests, "physicians" were used. For the In vitro Simulated Use Study - Usability, "evaluators representative of the intended user population" were used. No specific number or qualifications (e.g., years of experience, specialty) of these experts are provided in the summary.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and not mentioned, as these are primarily objective engineering performance tests rather than subjective human assessments requiring adjudication. For the tests involving physicians/evaluators, specific adjudication methods are not detailed.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done, as this is a physical medical device (catheter), not an AI/ML system being evaluated for diagnostic accuracy improvement.
5. If a standalone performance was done: Yes, the described performance tests (e.g., tensile strength, torque strength, dimensional verification, kink resistance, burst, leak tests, biocompatibility, sterilization) were performed directly on the RIST Radial Access Catheter in a standalone manner to demonstrate its inherent properties and safety.
6. The type of ground truth used: For most engineering tests, the ground truth is established by the specified ISO/ASTM standards and internal acceptance criteria (e.g., a specific pressure for burst test, a specific force for tensile strength). For the simulated use and radiopacity tests, the 'ground truth' is the observable, functional performance and perception by the evaluating physicians/users, often compared to the predicate device. Biocompatibility used standard biological test methods.
7. The sample size for the training set: Not applicable. This is a physical device submission, not an AI/ML algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable, as there is no training set for a physical device.

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