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Penumbra Reperfusion Catheters and Separators: As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra 3D Revascularization Device: As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra Aspiration Tubing: As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System 3D Revascularization Device is designed to revascularize patients experiencing acute ischemic stroke as a component of the Penumbra System. The Penumbra System's fundamental mechanism of action is aspiration removes clot by drawing it into the Penumbra Reperfusion Catheter. The 3D Revascularization Device is designed to assist the Reperfusion Catheter with thrombus removal if needed. Intended users for this device are physicians who have received appropriate training in interventional neuro-endovascular techniques and treatment of acute ischemic stroke. The device is provided sterile, non-pyrogenic, and intended for single use only.

The provided text describes the Penumbra System (3D Revascularization Device) and its substantial equivalence to a predicate device (Penumbra 3D Revascularization Device, K162901). The submission relies on non-clinical data for verification and validation, explicitly stating that "No clinical study was conducted."

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

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)

The document does not specify a distinct "test set" sample size in the clinical sense, as no clinical study was conducted for this specific submission. The evaluations were primarily bench-top testing and previously completed animal studies. The document does not specify sample sizes for individual bench tests beyond stating "units used in this Design Verification testing." The provenance of the data for bench testing is not explicitly stated beyond being conducted by Penumbra, Inc.

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)

For the "Physician Evaluation" in bench-top testing, the document mentions "Multiple Physician performance evaluation." However, it does not specify the exact number of physicians or their specific qualifications (e.g., years of experience, specialty).

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

The document does not describe an adjudication method for the physician evaluations; it merely states that the evaluations were part of the testing.

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 MRMC study was performed, as stated: "No clinical study was conducted." The device does not appear to be an AI-assisted diagnostic tool, but rather a mechanical revascularization device.

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

This question is not applicable to the device described. The Penumbra System (3D Revascularization Device) is a physical medical device for revascularization, not a standalone algorithm.

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

For the bench-top testing, the "ground truth" was established by predetermined acceptance criteria and product specifications for physical and mechanical properties. For the simulated use and physician evaluations, the ground truth was based on the effectiveness of the devices to remove clots in anatomical models and physician perception of deliverability and clot removal compared to a baseline.

For the animal study portion, the ground truth for vessel response was derived from existing GLP test results from rabbit vessel response studies on the predicate device.

8. The sample size for the training set

No "training set" in the context of an algorithm or AI is mentioned in the document, as no clinical study was conducted for this submission, and the device is a mechanical one. The previous animal studies used for the predicate device were not described as a "training set" in this context.

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

Not applicable, as no training set (in the AI/algorithm sense) was used or described. The document relies on equivalence to a predicate device and extensive non-clinical bench testing and prior animal studies.

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