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The Phenom™ Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy.

This document is a 510(k) premarket notification for the Phenom™ Catheters. As such, it's a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving device meeting specific clinical acceptance criteria in the way a clinical trial would.

Therefore, many of the requested points related to a specific clinical study (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or directly derivable from this type of regulatory document.

However, I can extract information regarding the bench testing performed to establish substantial equivalence, which serves as the "study" in this context to prove the device meets certain performance characteristics relative to predicate devices.

Here's the breakdown based on the provided text, addressing the applicable points and explaining why some are not applicable:

Description of Acceptance Criteria and Substantiating Study

The Phenom™ Catheters are submitted as substantially equivalent to predicate devices, meaning their performance characteristics must be comparable to those existing devices and demonstrate no new safety or effectiveness concerns. The "acceptance criteria" are implicitly defined by the safety and performance standards established by the predicate devices and general regulatory requirements for this class of device. The "study" proving the device meets these criteria is a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various bench tests conducted to support the substantial equivalence. The "acceptance criteria" for these tests would typically be defined internally by the manufacturer to ensure the new device performs comparably to or within acceptable limits derived from the predicate devices. Since specific numerical acceptance criteria (e.g., "burst pressure > X bar") are not explicitly stated in this summary, the table will list the performance tests performed, implying that the acceptance was meeting the internal specifications aligned with the predicate 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 for Test Set: This refers to the number of devices or components tested for each bench test. This information is not provided in this summary. Bench testing typically involves a statistically significant number of samples for each test, but the exact numbers are not detailed here.
• Data Provenance: The bench tests are laboratory-based, performed by the manufacturer (Cathera, Inc., Mountain View, CA). This is not human data, so "country of origin" or "retrospective/prospective" does not directly apply in the usual clinical sense. The worst case representation was chosen considering neurovascular anatomy.

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

• Not applicable. Bench testing for substantial equivalence does not involve establishing ground truth from human expert interpretation in the way clinical studies with AI algorithms do. Performance is measured against engineering specifications and comparisons to predicate device data.

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

• Not applicable. See point 3.

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. This device is a catheter, not an AI diagnostic algorithm. Therefore, MRMC studies involving human readers and AI assistance are not relevant to its regulatory approval in this context.

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

• Not applicable. This device is a catheter, not an AI algorithm.

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

• The "ground truth" for the bench tests are engineering specifications, material standards, and performance characteristics derived from predicate devices. For example, "burst pressure" has a defined threshold, and "biocompatibility" is assessed against ISO standards. The evaluation included performance in "more complex and higher risk neurovascular anatomy," implying simulated environments or models representing this.

8. The sample size for the training set

• Not applicable. As this is a physical medical device (catheter) undergoing bench testing for substantial equivalence, there is no "training set" in the context of machine learning or AI.

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

• Not applicable. See point 8.

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