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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® 27 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 aid in 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 describes the pre-clinical bench testing conducted for the Phenom® 27 Catheter, a medical device. The purpose of the study was to demonstrate that a modified version of the catheter (with an increased effective length) is substantially equivalent to the previously cleared predicate device.

Here's an analysis of the acceptance criteria and study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for each test. Instead, it describes each test, its purpose, and concludes with a qualitative "Results" section, often stating that the results are "within the expected range" or "equivalent" to the predicate device, or that all samples "passed."

Here's an adapted table based on the provided information, interpreting the "Test Method Summary" as implicitly defining the acceptance criteria (i.e., meeting the standard, providing a reference, or demonstrating functional equivalence) and "Results" as the device's performance against these criteria.

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

• Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., "n=X catheters were tested"). It uses phrases like "All test samples," "All samples," or implies multiple units were tested (e.g., "Flow rate data was collected for the modified (160cm) device and the predicate device (150cm)").
• Data Provenance: The study described is a pre-clinical bench testing study. This means the data was generated in a laboratory setting, not from human or animal subjects. The provenance is internal Cathera, Inc. testing, not from any specific country of origin in terms of patient data. It is prospective in the sense that the testing was conducted on the modified device to demonstrate its performance.

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

• This information is not applicable as the study is a pre-clinical bench test of a physical device, not an AI/imaging diagnostic study that requires expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable as the study is a pre-clinical bench test of a physical device, not an AI/imaging diagnostic study that requires human adjudication. The "results" are objective measurements or observations against predefined standards or comparison with a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance for diagnostic tasks, which is not the subject of this document.

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 document describes the bench testing of a physical medical device (catheter), not an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this pre-clinical bench testing is based on engineering specifications, international and national standards (e.g., ISO 10555-1, BS EN 13868:2002, BS EN 1707:1997), and comparison to the established performance of the legally marketed predicate device. For example, for flow rate, the "expected range" and "equivalence" to the predicate served as the reference. For dimensional verification, the "specified attributes" were the ground truth. For accessibility/tractability, reaching the M1 region of the neurovascular model was the ground truth for success.

8. The Sample Size for the Training Set

• This information is not applicable as this document describes the testing of a physical medical device, not an AI system that requires a "training set."

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

• This information is not applicable for the same reason as point 8.

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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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