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The MIDWAY Delivery Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The MIDWAY Delivery Catheters are single lumen percutaneous catheters designed to provide a conduit for introduction of interventional devices to the peripheral, coronary, and neuro vasculature. The MIDWAY Delivery Catheter is a single lumen, coil-reinforced, variable stiffness catheter with a radiopaque marker band on the distal end and a Luer hub on the proximal end. The MIDWAY Delivery Catheter is compatible with sheaths and guide catheters appropriately sized for the outer diameter of the MIDWAY Delivery Catheter. The MIDWAY Delivery Catheter has a hydrophilic coating on the distal segment of the catheter shaft.

The document provided is a 510(k) summary for a medical device (MIDWAY Delivery Catheter) seeking substantial equivalence to existing predicate devices. It does not contain information about a study proving the device meets acceptance criteria for a clinical or AI performance study. Instead, it outlines bench performance testing and other non-clinical data to demonstrate substantial equivalence to legally marketed predicate devices.

Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to the information provided.

However, I can extract the acceptance criteria and confirmed performance for the bench performance tests that were conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The following information is not present in the provided document:

• 2. Sample size used for the test set and the data provenance: The document refers to "bench performance testing" which are laboratory-based tests of physical properties and functionality, not a clinical "test set" of patient data. The sample sizes for these bench tests are not specified, nor is data provenance (country of origin, retrospective/prospective).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this was bench testing, not a study requiring expert-established ground truth on clinical data.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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. The device is a physical delivery catheter, not an AI-powered diagnostic tool.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the "ground truth" would be established engineering specifications and industry standards for mechanical performance, material integrity, and functionality.
• 8. The sample size for the training set: Not applicable, as this is bench testing for a physical device, not an AI/ML model that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Overall Study Information:

The study described is a series of bench performance tests and confirmation of existing data from reference devices (MIDWAY 43 Delivery Catheter and MIDWAY 62 Delivery Catheter were compared to Reperfusion Catheter RED 43 (K222808) and Reperfusion Catheter RED 62 (K203440), respectively). The primary purpose was to demonstrate substantial equivalence to predicate devices for a new indication (introduction of interventional devices into peripheral, coronary, and neuro vasculature).

Key Findings:

• All listed bench performance tests (Simulated Use, Compatibility, Particulate, Coating Integrity, Surface Integrity, Tensile Strength, Burst Pressure) met their respective acceptance criteria.
• The subject devices share the same design, materials, and manufacturing as their reference devices.
• Other performance data for the reference devices (Biocompatibility, Shelf Life, Sterilization, Packaging) were also used to support the subject device.
• No animal or clinical studies were deemed necessary for the 510(k) submission.
• The conclusion is that the MIDWAY Delivery Catheters are substantially equivalent to the predicate devices, perform as intended, and do not raise new questions of safety or effectiveness.

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