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The Rist™ 071 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 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 the distal end 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 catheter has a nominal outer diameter of 0.084 inches and a nominal inner diameter of 0.071 inches. It is available in three working lengths: 95 cm, 100 cm, and 105 cm. 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.

The Rist™ 071 Radial Access Guide Catheter is a medical device intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The acceptance criteria and supporting studies are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The device underwent extensive testing, and the results consistently indicated that "All units met the acceptance criteria" or similar statements. Specific numerical acceptance criteria were not explicitly provided in the document for most tests, but the qualitative statement of meeting criteria is present.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test in the "Test Set." However, it repeatedly mentions "All units" or "All units met" indicating that a sufficient number of samples were tested to achieve statistical significance or to demonstrate compliance.

The data provenance is not specified in terms of country of origin. The studies are described as "Design verification and validation" (in-house testing) and based on applicable ISO/ASTM/USP standards, suggesting a laboratory-based, prospective testing approach. No mention of retrospective or prospective clinical data for the test set is present, as this is a pre-market submission focused on device performance rather than clinical outcomes.

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

For the "In vitro Simulated Use Study," it states that "A simulated interventional procedure was performed by physicians." The exact number of physicians or their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

For the "Radiopacity" test (from the predicate device), "Physicians were shown fluoroscopic images." Again, the specific number and qualifications of these physicians are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the tests. The results indicate a direct pass/fail or "met acceptance criteria" outcome, implying consensus on the directly measurable or observable results rather than a subjective assessment requiring adjudication. For physician-evaluated tests, the document indicates a general 'acceptance criteria met' without detailing disagreement resolution.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The studies focused on device performance characteristics rather than comparing human reader performance with or without AI assistance. The device itself is a physical catheter, not an AI-powered diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No standalone algorithm performance study was done. This is consistent with the nature of the device as a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

The ground truth for most performance tests was established by adherence to recognized international standards (ISO, ASTM, USP) and predefined internal specifications for various physical, chemical, and biological properties. This includes:

• Physical Measurements: Dimensional accuracy (ID, OD, length), tensile strength metrics, burst pressure values, torque limits, kink resistance thresholds.
• Chemical/Biological Properties: Biocompatibility assays (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility), chemical compatibility.
• Functional Performance: Leak testing, coating integrity, particulate count, simulated use performance, radiopacity (as confirmed by physicians).
• Sterility and Packaging Integrity: Demonstrated through sterilization validation and packaging tests.

8. Sample Size for the Training Set

No training set is applicable or mentioned. This device is a physical medical device, not a machine learning model that requires a training set.

9. 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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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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