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The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinumiridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.

The provided text describes a 510(k) submission for the React™ 71 Catheter, focusing on demonstrating substantial equivalence to a predicate device after a change in device length. The information primarily covers non-clinical bench testing.

Here's an analysis of the provided information against your requested categories:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated. The text mentions "non-clinical bench testing was conducted," but does not provide details on the number of devices tested for each criterion.
• Data Provenance: Not specified. "Non-clinical bench testing" typically implies laboratory-based tests. The country of origin of the data is not mentioned. The data is prospective in the sense that new tests were conducted for this submission, but it's not clinical human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the study described is non-clinical bench testing, not a study involving human or animal data requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the study described is non-clinical bench testing against predefined performance criteria, not a study involving subjective interpretations requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This submission is for a percutaneous catheter, not an AI-powered diagnostic device.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (catheter), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench tests, the "ground truth" is defined by the acceptance criteria established in the test methods, based on FDA Guidance 1757 and FDA Recognized Consensus Standards 5-125 & 5-129. These are objective engineering and performance standards, not clinical ground truths like pathology or expert consensus.

8. The sample size for the training set

This section is not applicable. This is a 510(k) submission for a physical medical device, not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the reasons stated in point 8.

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The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinum-iridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.

The provided document describes the React™ 71 Catheter. Based on the content, here's a breakdown of the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests, their methods, and states that the React™ 71 Catheter "met the acceptance criteria" or similar statements for each. Specific quantitative acceptance criteria are generally not provided in this summary, but the results confirm compliance.

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

The document does not specify exact sample sizes for each test. For the biocompatibility study on thrombogenicity, it mentions a "Canine Model" with "four (4) hours (±30 minutes) without systemic anticoagulation," and comparing a "control article" to the "test article." This implies a very small comparative animal study, rather than a large test set for AI evaluation.

The provenance of data (e.g., country of origin, retrospective/prospective) is not provided as the tests are primarily bench and animal studies (biocompatibility) conducted in controlled laboratory settings for device performance and safety.

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

Not applicable. This is a medical device submission based on product performance and biocompatibility testing, not an AI/software submission requiring expert ground truth for classification or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/software submission involving human interpretation or adjudication for ground truth, this information is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This is a medical device submission for a catheter, not an AI system that would typically undergo MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's physical and biological performance in bench and animal tests.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on established scientific and engineering standards and methods. For example:

• Biocompatibility: In vitro and in vivo testing (e.g., cell cultures, guinea pigs, mice, canine model) following ISO 10993 standards.
• Performance Data – Bench: Standardized laboratory tests (e.g., ISO, ASTM, USP) for physical, mechanical, and material properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no concept of a "training set" as understood in AI/machine learning. The device design and manufacturing processes are refined through engineering development, not machine learning training.

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

Not applicable, as there is no training set for an AI model. For the device itself, the "ground truth" for its design and performance requirements is established through regulatory standards, predicate device characteristics, and engineering specifications.

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