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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.

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 Pump MAX.

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

The Penumbra System ACE 68 Reperfusion Catheter is a component to the currently available Penumbra System. The ACE 68 Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. ACE 68 is provided sterile, non-pyrogenic, and intended for single use only.

The document describes the Penumbra System ACE 68 Reperfusion Catheter and its substantial equivalence to a predicate device. Below is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for individual tests conducted as part of design verification or shelf-life testing. It merely states that "The physical and mechanical properties of the ACE 68 Reperfusion Catheter were assessed using standard test methods and pre-determined acceptance criteria." and "all tests passed successfully."

The data provenance is from bench-top testing conducted by the manufacturer, Penumbra, Inc. This is prospective data generated specifically for the device submission. The country of origin of the data is not specified beyond being generated by Penumbra, Inc. in Alameda, California, USA.

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

No information is provided regarding the number of experts or their qualifications for establishing ground truth for the test set. The tests described are primarily physical and mechanical properties and simulated use, not diagnostic interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective physical and mechanical tests rather than subjective evaluations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for this device. The study focused on the physical and mechanical performance of the device and its substantial equivalence to a predicate, not on a human-in-the-loop performance with AI.

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

No, this device is a medical catheter system, not an AI algorithm. Therefore, an algorithm-only standalone performance study is not applicable.

7. The Type of Ground Truth Used

The ground truth used for these tests are engineering specifications, physical measurements, and observable outcomes (e.g., no kinking, fluoroscopic visibility, no leaks, effective clot removal in a simulated environment, no corrosion, specific pressure resistance values). For "Simulated Use," the ground truth is whether the device performed as expected in the anatomical model (e.g., did not collapse, removed clots).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for a physical medical 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 (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

The Penumbra System ACE 68 Reperfusion Catheter is a component to the currently available Penumbra System. The ACE 68 Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. ACE 68 is provided sterile, non-pyrogenic, and intended for single use only.

The Penumbra System ACE 68 Reperfusion Catheter received 510(k) clearance (K161064) based on substantial equivalence to the previously cleared Penumbra System ACE 68 Reperfusion Catheter (K152541). The study conducted in support of this clearance was a Design Verification (Bench-Top Testing), alongside Shelf Life Testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact sample size (number of devices) used for each individual bench-top test. It generally states that "The physical and mechanical properties of the ACE 68 Reperfusion Catheter were assessed using standard test methods and pre-determined acceptance criteria." and "The subject ACE 68 Reperfusion Catheters met all established requirements" for shelf life.
• Data Provenance: This was a non-clinical bench-top testing and shelf-life testing. The data is therefore from laboratory simulations and controlled environments, not human subjects. The country of origin for the data is not explicitly stated, but the sponsor is Penumbra, Inc. located in Alameda, CA, USA. This is retrospective in the sense that the device changes were made, and then these verification tests were performed.

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

• This type of bench-top engineering testing does not typically involve human experts establishing "ground truth" in the same way clinical studies do. The "truth" is established by adherence to predefined engineering specifications and standard test methods.
• For the "Simulated Use" test, while it involves an "anatomical model which simulated the tortuosity of the neurovasculature," the assessment of "effectiveness of the devices to remove clots and that the Reperfusion Catheter does not collapse under vacuum" would be based on objective observation and measurement against predefined criteria rather than subjective expert consensus on clinical outcomes. The document does not mention the involvement or qualifications of experts for defining the ground truth for this non-clinical testing.

4. Adjudication method for the test set

• Not applicable as this was bench-top testing against predefined specifications, not a clinical study requiring adjudication of outcomes by multiple readers or judges.

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 was not performed. This document describes the non-clinical (bench-top) testing for a physical medical device (catheter), not an AI algorithm.

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

• No, this device is a physical medical instrument (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The type of ground truth used

• The "ground truth" for this non-clinical testing consisted of pre-determined, objective engineering specifications and acceptance criteria. For example, a specific burst pressure (45 psi for 30 sec minimum), specific particulate counts (≤ 6000 for ≥ 10 um), or visual confirmation (no kinking, fluoroscopically visible markerband).

8. The sample size for the training set

• Not applicable. This is not an AI or machine learning study, so there is no "training set."

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

• Not applicable. This is not an AI or machine learning study.

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