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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 Reperfusion Catheter JET 7 (modified) is a component to the currently available Penumbra System. The Reperfusion Catheter JET 7 (modified) delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The devices are provided sterile, nonpyrogenic, and intended for single use only.

The provided document is a 510(k) Premarket Notification for the Penumbra System® (Reperfusion Catheter JETTM 7). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria for an AI/device performance.

Therefore, the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria in a clinical or comparative effectiveness setting (especially for AI where human-in-the-loop performance is assessed) cannot be fully provided based on the given text.

The document does include acceptance criteria for biocompatibility testing and bench-top testing and reports whether the device passed these criteria. However, these are engineering and materials performance criteria, not clinical performance criteria with a test set of patient data, ground truth established by experts, or MRMC studies typically seen for AI-based diagnostic devices.

Here's what can be extracted and what cannot:

Information that CAN be extracted and presented:

• Table of acceptance criteria and reported device performance (for non-clinical tests): This is available for biocompatibility and bench-top testing.
• Sample size for non-clinical testing: This is generally implied by "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)" for biocompatibility and for bench tests by "These evaluations confirm that the units used in this Design Verification testing meet all product specifications." but specific numbers are not given for each test.
• Data provenance for non-clinical testing: Performed internally by Penumbra, Inc. labs or contracted labs following GLP.
• Ground truth type for non-clinical testing: Based on established industry standards and regulatory guidelines (e.g., EN ISO 10993-1, specific assay results, physical measurements).

Information that CANNOT be extracted from the provided text:

• Sample sized used for the test set (clinical data): No specific clinical test set data is provided. The document states "No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes."
• Data provenance (e.g., country of origin of the data, retrospective or prospective) for clinical data: Not applicable, as no new clinical study was conducted.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new clinical study was conducted involving expert ground truth for patient data. Physician evaluation was done for bench testing, but details on the number and qualifications of physicians are not given, nor is it a blind adjudication process.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device, but a physical medical device (catheter).
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical data: Not applicable.
• The sample size for the training set (for AI): Not applicable.
• How the ground truth for the training set was established (for AI): Not applicable.

Acceptance Criteria and Device Performance (Non-Clinical Data from provided text):

The device is a medical catheter, and the performance criteria discussed are related to its physical properties, material safety, and mechanical function, not an AI's diagnostic performance.

1. Table of acceptance criteria and the reported device performance (for Biocompatibility and Bench-Top Testing):

Biocompatibility Test Results

Design Verification - Bench Top Testing

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

• Biocompatibility: "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)." Specific sample sizes for each test are not detailed but are implied by GLP standards. Data provenance is implied to be laboratory testing within the US (due to FDA submission) or by a GLP-compliant lab.
• Bench-Top Testing: No specific sample sizes mentioned for each attribute, but the results indicate performance of "the units used in this Design Verification testing." Data provenance is laboratory testing.
• Clinical/AI study: No clinical study was conducted.

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

• Biocompatibility/Bench-Top Testing: For "Physician Evaluation" in bench testing, "Multiple Physician performance evaluation" was conducted. The specific number or qualifications are not provided beyond "Physician." This is not establishing "ground truth" in the sense of clinical disease states.
• Clinical/AI study: Not applicable.

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

• Not applicable as no clinical test set for diagnosis/AI performance was used.

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. This is not an AI-assisted diagnostic device.

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

• Not applicable. This is a physical medical device.

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

• Biocompatibility: Ground truth is based on established, quantitative laboratory standards and biological responses as defined by ISO and USP guidelines.
• Bench-Top Testing: Ground truth is based on engineering specifications, physical measurements, and functional performance in simulated environments.
• Clinical/AI study: Not applicable.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI device.

In summary, the provided document details the non-clinical (biocompatibility and bench) testing and acceptance criteria for a physical medical device (catheter) to demonstrate substantial equivalence, rather than a clinical study for an AI-based diagnostic device.

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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 3D Revascularization Device is an additional component to the currently available Penumbra System. The Penumbra System's fundamental mechanism of action is aspiration. Aspiration draws clot into the Penumbra Reperfusion Catheter to remove the clot. The 3D Revascularization Device is designed to assist the Reperfusion Catheter with thrombus removal if needed. The device is provided sterile, non-pyrogenic, and intended for single use only.

The provided text describes the 510(k) summary for the Penumbra 3D Revascularization Device, including a clinical study to assess its safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria for this medical device is demonstrated through a non-inferiority clinical study. The primary effectiveness endpoint was reaching a modified Thrombolysis In Cerebral Infarction (mTICI) score of 2-3.

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

For the clinical study (Penumbra 3D Trial):

• Test Set (Primary Effectiveness Cohort):
  • All Patients: N=150
  • 3D / Penumbra System arm: N=74
  • Penumbra System alone arm: N=76
• Data Provenance: The study was a prospective, randomized, concurrent controlled, multi-center study. The text does not explicitly state the country of origin but typically such trials for FDA approval involve sites within the US or internationally recognized centers.

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

• Ground Truth for Effectiveness (mTICI score): Angiographic results were adjudicated by an independent Core Laboratory. The number and specific qualifications of the experts within this laboratory are not detailed in the provided text.
• Ground Truth for Safety (SAEs): Serious adverse events (SAEs) were adjudicated by a Clinical Events Committee. The number and specific qualifications of the experts within this committee are not detailed.

4. Adjudication Method for the Test Set

• Effectiveness (mTICI score): "Angiographic results were adjudicated by an independent Core Laboratory." The specific method (e.g., 2+1, 3+1) is not explicitly stated, but the use of a "Core Laboratory" implies a standardized and expert review process.
• Safety (SAEs): "The primary safety endpoint was adjudicated by a Clinical Events Committee." Similar to effectiveness, the specific method is not detailed, but external committee adjudication suggests a robust review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a "multi-reader multi-case (MRMC) comparative effectiveness study" involving human readers improving with AI vs without AI assistance was not conducted or described. This study directly compared two device interventions (3D/Penumbra System vs. Penumbra System alone) and evaluated their impact on patient outcomes. The device itself is not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• This question is not applicable as the device is a medical instrument (revascularization device) used directly in a procedure, not an algorithm, and by its nature requires human intervention to be operated. It does not have a standalone "algorithm-only" performance as an AI system would.

7. Type of Ground Truth Used

• Effectiveness: The primary effectiveness ground truth was the modified Thrombolysis In Cerebral Infarction (mTICI) score, which is an angiographic assessment of reperfusion, indicating the level of blood flow restoration in the occluded vessel. This was determined by an independent Core Laboratory.
• Safety: The ground truth for safety involved the reporting and adjudication of Serious Adverse Events (SAEs) by a Clinical Events Committee.
• Secondary Endpoints: Functional outcome at 90 days was assessed using the modified Rankin Scale (mRS) score, which is a measure of neurological disability or dependence in daily activities.

8. Sample Size for the Training Set

• The document describes a clinical trial (Penumbra 3D Trial) that enrolled patients for a comparative effectiveness study. This is an evaluation study, not a study that involves a "training set" in the context of machine learning. Therefore, a training set sample size is not applicable here. The device was likely developed and refined through engineering studies, bench testing, and animal studies (pre-clinical data) before the human clinical trial.

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

• As a "training set" in the machine learning sense is not applicable to an evaluation of this physical medical device, this question is not relevant. The device's design and functionality were established through the non-clinical data (biocompatibility, bench-top testing, animal studies) and then validated in the clinical trial.

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