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

The RIST Cath Radial Access Long Sheath (RIST Cath) is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft and has a radiopaque marker band on the distal end to aid in visualization. The catheter has a nominal outer diameter of 0.093 inches and a nominal inner diameter of 0.079 inches. It is available in two working lengths: 95 cm and 100 cm. The RIST Cath is intended to provide access to the target site via transradial access and once in place, provides a reinforcing conduit for other intravascular devices. The RIST Cath Radial Access Long Sheath has a PTFE-lined lumen to facilitate movement of other devices passing through its lumen. Accessories included with the device are a radial access dilator and a hemostasis valve. The RIST Cath is supplied sterile, non-pyrogenic, and intended for single use only.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All pre-determined acceptance criteria were met" for all listed tests. However, it does not explicitly state the numerical acceptance criteria for each test. It primarily reports that the device "met the acceptance criteria" for each specific test.

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

The document does not explicitly state the sample size used for the test set (number of devices tested for each performance criterion). However, for test methods like "Tensile Strength" and "PTFE Delamination," it mentions "All units met..." which suggests that a certain number of units were tested. The overall context is a premarket notification (510(k)) for a medical device seeking substantial equivalence, meaning the data is likely derived from retrospective testing performed by the manufacturer. The data provenance (country of origin) is not specified.

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

For the "In vitro Simulated Use Study - Bench," it states that "A simulated interventional procedure was performed by physicians." For the "In vitro Simulated Use Study - Usability," "Evaluators representative of the intended user population evaluated the RIST Cath Radial Access Long Sheath..."

• Number of experts: Not explicitly stated (e.g., "3 physicians").
• Qualifications of experts: "Physicians" for the bench study and "Evaluators representative of the intended user population" for the usability study. Specific specialties or years of experience are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "Results" column consistently states that "All units met the acceptance criteria" or similar, implying a direct assessment against predefined criteria rather than a consensus among multiple adjudicators for subjective outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study typically assesses the impact of an AI system on human reader performance, which is not relevant for this medical device (a catheter sheath).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical device (a catheter sheath), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant. The performance studies are focused on the physical characteristics and functionality of the device itself.

7. Type of Ground Truth Used

The ground truth for the various performance tests is established by:

• Engineering specifications and standards: Many tests reference ISO standards (e.g., ISO 10555-1, ISO 80369-7, ISO 11135:2014) or ASTM standards (e.g., ASTM F-88/F88M-15).
• Established testing protocols and acceptance criteria: For each test, there were pre-determined acceptance criteria based on the device's design and intended function.
• Visual inspection and measurements: For dimensional checks, visual inspections, etc.
• Biological testing standards: For biocompatibility tests, standards like EN ISO 10993-1 were followed.
• Clinical simulation by physicians: For the in-vitro simulated use study, the performance parameters assessed by physicians against expected clinical performance would serve as the ground truth.

There is no mention of pathology, outcomes data, or expert consensus in the sense of comparing device performance against a gold standard interpretation of a clinical condition (which would be common for diagnostic AI).

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve a "training set" in the context of machine learning or AI algorithms.

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

Not applicable, as there is no training set for this type of device.

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