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The Penumbra System / Penumbra System MAX are in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal caroiid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

The purpose of this 510(k) pre-market notification is to implement the following modifications to the Instructions for Use for clarity.
. Added Summary of PIVITOL Trial Clinical Data
. Moved a precaution statement to the Warnings section
Added statement that the use of a Separator may not be needed for . Reperfusion Catheters with an I.D. of 0.054in or larger.

The provided 510(k) summary (K133317) for the Penumbra System / Penumbra System MAX primarily focuses on modifications to the Instructions for Use (IFU) and demonstrates substantial equivalence to predicate devices, rather than presenting a comprehensive study proving the device meets explicit acceptance criteria in a clinical or imaging performance context typically seen for AI/ML devices.

However, based on the non-clinical data provided, we can infer the implied acceptance criteria and the study that addresses these criteria for the modifications being sought. The "device" in this context refers to the Penumbra System / Penumbra System MAX with the clarified IFU.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device 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: Not explicitly stated as a number of devices or trials beyond "All Sizes" for catheter tip pressure and "(054, 5MAX & 5MAX ACE)" for aspiration flow rate and clot removal. This suggests testing was performed on representative models of these specific catheter sizes.
• Data Provenance: The tests were non-clinical, using "a glass model" for clot removal. The data provenance is laboratory-based, performed by the manufacturer, Penumbra, Inc., located in Alameda, CA, USA. This is a retrospective analysis of device function, not clinical data from patients.

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 was non-clinical engineering testing. The "ground truth" was established by direct physical measurements of pressure and flow rates, and direct observation of clot removal in a simulated environment. No human expert interpretation was required for establishing these performance metrics.

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

Not applicable, as this was non-clinical engineering testing, not a clinical study involving human interpretation or subjective assessment.

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 submission is for a physical medical device (thrombus removal catheter) and its updated instructions for use, not an AI/ML-driven diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is not an algorithm-based device.

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

The ground truth for these non-clinical tests was based on physical measurements and direct observation against predetermined engineering specifications and functional outcomes (e.g., complete clot removal, pressure equality, higher flow rate).

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. There is no training set for this device.

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The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

The Penumbra System MAX components are additional components of the currently available Penumbra System. The Penumbra System MAX components provide a larger lumen to assist in the efficient removal of thrombus from the brain. The devices are provided sterile, non-pyrogenic, and intended for single use only.

The Penumbra System® MAX components are additional components of the currently available Penumbra System. The summary of non-clinical data details the testing that substantiates the safe and effective performance of the Neuron MAX System and its substantial equivalence to predicate devices. This includes Biocompatibility testing, Design Verification (Bench-Top Testing), and an Animal study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria for each test were "Pass," meaning the device met the established requirements for each attribute.

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

• Bench-top Testing: Sample sizes for individual tests ranged from 3 to 30 units (e.g., N=30 for Pouch Seal Strength, N=10 for Particulate Testing, N=3 for Flow Rate). The data provenance is internal laboratory testing ("All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements."). This is considered retrospective data from a manufacturing/design verification process.
• Biocompatibility Testing: The document does not specify exact sample sizes for each biocompatibility test but states that "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices," which implies standard laboratory animal testing where applicable (e.g., Rabbit Pyrogen Study, Acute Intracutaneous Reactivity, Acute Systemic Toxicity, Sensitization). This data is from controlled laboratory experiments.
• Animal Study: The document mentions "An animal study was conducted to evaluate the safe use of the Penumbra System MAX in a swine model." The exact sample size for the animal study is not explicitly provided in the summary, but it refers to "experimental conditions" and "test vessel segments," suggesting a controlled study within a lab setting. This is prospective animal data.

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

Not applicable. The studies described are non-clinical (bench-top, biocompatibility, animal studies) and do not involve human diagnostic or treatment decision-making where expert consensus would establish ground truth for a test set. The "ground truth" here is determined by objective physical, mechanical, biological, or physiological measurements against predefined engineering and biological safety standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are non-clinical studies. The results are objective measurements/observations (e.g., "Pass," "No evidence of toxicity," "No vessel injury") rather than interpretations requiring adjudication among human experts.

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 document describes the safety and effectiveness testing of a physical medical device (catheter system) for mechanical thrombus removal, not an AI or imaging-based diagnostic device that would involve human readers.

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

Not applicable. This document describes a physical medical device.

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

The ground truth for these non-clinical studies was established by:

• Predefined engineering specifications and performance parameters for mechanical and physical properties.
• Established international and national standards for biocompatibility (e.g., ISO 10993, USP, ASTM, 21 CFR Part 58).
• Physiological observations, angiographic evaluations, gross pathology, and histology in the animal model.

8. The Sample Size for the Training Set

Not applicable. This document refers to the testing of a physical medical device. There is no "training set" in the context of machine learning or AI. The design verification and biocompatibility testing involved various "test units" or "samples" for specific tests, as detailed in the table, to ensure the device met its design specifications.

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

Not applicable, for the same reason as #8. Ground truth in this context refers to the defined specifications and standards the device was designed to meet and was tested against.

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