(262 days)
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:
| Acceptance Criteria (Bench-top Performance) | Reported Device Performance |
|---|---|
| Particulate Testing | Met established requirements |
| Coating Integrity Testing | Met established requirements |
| Simulated Use Testing | Met established requirements |
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.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).