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The Benchmark Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Benchmark Intracranial Access System is designed to aid the physician in accessing the target vasculature during interventional procedures. The Benchmark Intracranial Access System is composed of a Delivery Catheter used for introduction of interventional devices and a corresponding Select Catheter. Use of the Benchmark Intracranial Access System facilitates navigation to the target vascular location and delivery of interventional devices. The Benchmark Intracranial Access System devices are compatible with off-the-shelf accessories. Various lengths and distal shapes of both the Benchmark Delivery Catheter and 5F Select Catheter are provided for physician convenience.

The provided text is a 510(k) Summary for the Penumbra Benchmark Intracranial Access System. This type of document is for a medical device seeking regulatory clearance based on substantial equivalence to a predicate device, rather than a new AI/ML-enabled device that requires an efficacy study with rigorous acceptance criteria and clinical validation as typically seen in AI/ML product submissions.

Therefore, the requested information elements related to AI/ML device performance, ground truth, expert review, training/test sets, and MRMC studies are not applicable to this document.

However, I can extract the information pertinent to the device's non-AI/ML performance and regulatory submission.

Acceptance Criteria and Study for the Benchmark Intracranial Access System:

This submission is for a medical device (catheter system), not an AI/ML-enabled device. The "acceptance criteria" here refer to performance tests demonstrating the device's functional and material integrity.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified in the document. The general statement "The following bench-top performance tests were performed on the subject device" implies that a sufficient number of devices were tested to draw conclusions, but the exact count is not given.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The "data" here comes from bench-top laboratory tests conducted by the manufacturer, Penumbra, Inc.

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

• Not applicable. This device is not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from clinical images or data. Performance was assessed via bench-top testing.

4. Adjudication method for the test set:

• Not applicable. Performance was assessed via bench-top testing against pre-defined engineering and material specifications, not through human adjudication of clinical outcomes or interpretations.

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 is not an AI/ML device, and no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• For this device, the "ground truth" or reference standard for performance is based on engineering specifications, material standards, and functional requirements for a percutaneous catheter system, as measured through controlled bench-top tests. It is not derived from expert consensus, pathology, or outcomes data in the clinical sense relevant to AI/ML.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria consists of bench-top performance tests. As stated in section 1.7.1:

• "The following bench-top performance tests were performed on the subject device and all have met the acceptance criteria: Particulate Testing and Coating Integrity Testing. Simulated Use Testing."

Additionally, a biocompatibility assessment was conducted, concluding that "no additional biocompatibility testing is required" because the device uses identical materials, similar processing, and identical sterilization methods as previously tested and cleared Penumbra products (referenced to ISO 10993-1 categories for limited exposure, externally communicating devices with circulating blood contact).

No animal or clinical studies were conducted as "bench testing was determined sufficient for verification and validation purposes." (Section 1.7.3)

The overall conclusion is that the device is "substantially equivalent to the predicate device" based on these bench-top tests, confirming operating principle, design concept, fundamental technology, and device performance.

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The Benchmark™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Benchmark™ Intracranial Access System is designed to aid the physician in accessing the target vasculature during interventional procedures. Benchmark Intracranial Access System is composed of a Delivery Catheter (guide catheter) used to support other diagnostic or therapeutic devices and a corresponding Select Catheter (microcatheter). Use of the Benchmark Intracranial Access System facilitates navigation to the target vascular location and delivery of the necessary diagnostic and/or therapeutic agents. The Benchmark Intracranial Access System devices are compatible with off-the-shelf accessories. Various lengths and distal shapes of both the Benchmark Delivery Catheter and 5F Select Catheter are provided for physician convenience.

The provided document K142321 is a 510(k) Pre-market Notification for the Penumbra, Inc. Benchmark™ Intracranial Access System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving novel clinical effectiveness through a comparative effectiveness study. As such, the information requested regarding acceptance criteria and studies would primarily relate to non-clinical performance and biocompatibility.

Here's a breakdown of the requested information based on the provided text:

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

Please refer to the tables below, which are directly extracted and compiled from Section 7.10.1 Biocompatibility Testing and 7.10.2 Bench-top Testing of the document.

Biocompatibility Testing

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:
  • For Biocompatibility studies, sample sizes vary by test as detailed in the Biocompatibility table above (e.g., cell culture for cytotoxicity, animal models for sensitization, irritation, systemic toxicity, pyrogen, and some hemocompatibility tests).
  • For Bench-top testing, sample sizes are N=10 or N=30 for most tests, as specified in the Bench-top table above.
  • No human clinical test set is described or required for this 510(k) submission.
• Data Provenance: The document does not specify the country of origin for the data. All studies are described as "non-clinical" or "bench-top testing." Biocompatibility studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. These are prospective non-clinical laboratory studies.

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)

Not applicable. This 510(k) submission is for a medical device (catheter system) and relies on non-clinical (biocompatibility and bench-top engineering/performance) testing, not on interpretation of medical images or clinical outcomes that would require expert human review for ground truth establishment.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human reviewers assess data (e.g., medical images) to establish a consensus ground truth. The presented studies are non-clinical engineering and biological tests with objective acceptance criteria.

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. A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and would not be relevant for this type of medical device (intracranial access system). This submission is for hardware, not an AI or imaging diagnostic device.

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

No. This is not an algorithm or AI device; it's a physical medical device. Performance is evaluated through standard engineering and biological tests.

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

The "ground truth" for the non-clinical studies is defined by objective, pre-determined acceptance criteria based on established engineering standards and biological safety guidelines (e.g., ISO 10993). Examples include specific thresholds for cell lysis grade, weight loss, temperature rise, particle counts, tensile strength, and pressure resistance.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The studies described are validation tests for device performance and safety.

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

Not applicable, as there is no training set for this type of device submission.

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