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The Reverse™M Micro Catheter is intended for use in neuro, peripheral, and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

The Reverse™ Micro Catheter is a single lumen catheter designed to be introduced over a steerable guide wire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate vessel navigation. The micro catheter incorporates a PTFE liner to facilitate movement or introduction of devices passed through its lumen. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability. The Reverse™ Micro Catheter incorporates a standard luer fitting to facilitate the attachment of ancillary devices. The catheter and included accessories (steam shaping mandrel and peel away introducer sheath) are provided sterile, nonpyrogenic, and are intended for single use only. To accommodate physician preference and anatomical variations, the Reverse™ Micro Catheter is available in two models, Reverse 021, with a 0.021" inner diameter (ID) and, Reverse 027, with a 0.027" ID.

The document you provided describes a medical device, the Reverse™ Micro Catheter, and its non-clinical performance evaluation for substantial equivalence to a predicate device. It does not describe a study involving an AI model or a specific algorithm. Therefore, I cannot provide information about acceptance criteria, device performance, sample sizes, ground truth, expert involvement, or comparative effectiveness studies in the context of AI.

The document focuses on demonstrating that the modified Reverse™ Micro Catheter is substantially equivalent to a previously cleared device (Reverse™ Medical Microcatheter, K130858) based on non-clinical performance data.

Here's a breakdown of what the document does provide, structured to address the spirit of your request where possible, but re-contextualized for a medical device rather than an AI study:

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

The document states that "All testing passed the acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. The performance results are reported as successful completion of tests without new safety or effectiveness issues.

• Dimensional requirements
• Lubricity/friction
• Particulates
• Coating characterization
• Simulated use device compatibility
• Simulated use navigation and delivery
• Shelf-life verification (1 year accelerated aging) | "All testing passed the acceptance criteria."
  "Comprehensive verification and validation activities were successfully completed; raising no new issues of safety or effectiveness." | Implicitly, meeting specifications and predicate equivalence. |
  | Biological Safety | - MEM Elution Cytotoxicity
• Guinea Pig Maximization Sensitization
• Intracutaneous Reactivity
• Acute System Injection
• Materials Mediated Rabbit Pyrogen
• Hemolysis Direct Contact
• Hemolysis Indirect Extract Method
• Complement Activation
• In vivo Thrombogenicity
• Genotoxicity (Ames Assay, in vitro Mouse Lymphoma, in vivo Mouse Micronucleus)
• USP Physicochemical | "Testing demonstrated that the Reverse™ Micro Catheter finished device, accessories, and packaging materials have no residual risk of biological hazards; and are therefore considered biocompatible for their intended use." | Compliance with ISO 10993-1 and related standards. |
  | Microbial Assessments | - Bioburden
• Endotoxin
• Sterility assurance | "Sterilization has been validated and is controlled... to provide a minimum SAL of 10-6." | Minimum SAL of 10-6; compliance with ISO 11135-1. |
  | Packaging Validation | - Visual Inspection
• Bubble Leak
• Seal Strength | "To evaluate integrity of the packaging configuration." (Implied successful evaluation) | Implicitly, maintaining package integrity after sterilization, environmental conditioning, and simulated shipping. |

2. Sample sized used for the test set and the data provenance

The document does not specify sample sizes for individual bench tests, biological safety tests, or packaging validation. It refers broadly to "comprehensive verification and validation activities." The data provenance is internal testing by the manufacturer, Medtronic Neurovascular, for a new medical device. This is prospective testing of the device being submitted for clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable to this type of device submission. There isn't "ground truth" established by experts in the context of an AI algorithm's performance. Instead, the "truth" is determined by established engineering specifications, biocompatibility standards, and functional performance requirements for a physical medical device.

4. Adjudication method for the test set

Not applicable. There's no human-in-the-loop performance or diagnostic adjudication involved for this physical device's non-clinical testing.

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, as this is not an AI device.

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

Not applicable, as this is not an AI device. The testing described is "standalone" in the sense that it's the device itself being tested, not an algorithm.

7. The type of ground truth used

For this medical device, the "ground truth" for the non-clinical tests would be:

• Engineering Specifications: Conformance to pre-defined dimensional, material, and performance requirements (e.g., inner diameter, lubricity, navigation).
• International Standards: Adherence to established standards for biocompatibility (ISO 10993-1), sterilization (ISO 11135-1), and packaging integrity.
• Predicate Device Performance: Demonstrating that the subject device performs "at least as safe and effective as the predicate device."

8. The sample size for the training set

Not applicable, as this is not an AI device.

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

Not applicable, as this is not an AI device.

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