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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 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 is a component to the currently available Penumbra System. The Reperfusion Catheter JET 7 component provides a larger lumen to assist in the efficient removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.

The Penumbra System Reperfusion Catheter JET 7 is a medical device for revascularization in acute ischemic stroke. It was compared to a predicate device, the Penumbra System ACE 68 Reperfusion Catheter, to demonstrate substantial equivalence through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device underwent various non-clinical tests (biocompatibility, bench-top, and animal studies) to confirm its safety and performance. The tables below summarize the acceptance criteria and results for key tests mentioned in the provided text.

Biocompatibility Testing

Bench-top Testing

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

• Biocompatibility: The specific number of samples for each biocompatibility test (e.g., number of extracts, animals) is not explicitly stated in the summary, but it implies standard practices for these types of tests conducted under GLP. The data provenance is from previously performed studies (leveraged from the predicate device ACE 68, K161640 cleared on July 12, 2016). These studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP). The location of these previous studies is not specified but is assumed to be within a regulated, GLP-compliant environment.
• Bench-Top Testing: The text does not specify exact sample sizes for each bench-top test, but it states that "the units used in this Design Verification testing meet all product specifications," suggesting multiple samples were tested for each attribute.
• Animal Study: The study used porcine subjects. "One side of each swine was treated with the Reperfusion Catheter JET 7 and the contralateral side was treated with predicate device." The exact number of swine is not stated, but the Dog Thrombogenicity test (part of biocompatibility) mentions "2 out of 2 test site and 2 out of 2 control sites," suggesting a small number of animals for that specific test.

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

• Biocompatibility: Not directly applicable in the sense of expert consensus for ground truth on performance. Biocompatibility results are based on objective laboratory measurements against established standards (EN ISO 10993-1:2009/AC:2010). The animal study involved a "Sponsor Pathologist" to assess vascular response by gross necropsy and histopathology. No specific number or additional qualifications beyond "Sponsor Pathologist" are provided.
• Bench-Top Testing: A "Physician Evaluation" was performed for deliverability and clot removal. The number of physicians and their specific qualifications are not detailed beyond "Multiple Physician."

4. Adjudication Method for the Test Set

• Biocompatibility: For tests like Systemic Toxicity, the results were assessed based on objective criteria (e.g., weight loss, mortality, abnormal behavior). For the Dog Thrombogenicity study, assessment of thrombosis was made by the Sponsor Pathologist. No formal adjudication (e.g., 2+1, 3+1) is mentioned as it's typically not explicitly used for these types of non-clinical tests unless there are subjective interpretations needing consensus, which isn't detailed here.
• Bench-Top Testing (Physician Evaluation): The method of physician evaluation for deliverability and clot removal is not described as having an adjudication process beyond "multiple physician performance evaluation."

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

No MRMC comparative effectiveness study was done. The submission states, "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes." The comparison was primarily against the predicate device based on non-clinical data and leveraging clinical outcomes from existing literature on similar devices.

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

This device (Penumbra System Reperfusion Catheter JET 7) is a physical medical device, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The device's performance is inherently "standalone" in vitro and in vivo animal testing, with human involvement primarily in operating the device and evaluating the results.

7. The Type of Ground Truth Used

• Biocompatibility: Ground truth was established by adherence to recognized international standards (EN ISO 10993-1:2009/AC:2010) and objective measurements defined within these standards. For the animal study, pathology (gross necropsy and histopathology by a Sponsor Pathologist) served as the ground truth for vascular response.
• Bench-Top Testing: Ground truth was established by engineering specifications, physical measurements, and qualitative assessments (e.g., "no kinking," "no leaks," "fluoroscopically visible") based on predefined acceptance criteria. For the "Physician Evaluation," the ground truth was expert opinion/observation on deliverability and clot removal compared to a baseline (predicate device).

8. The Sample Size for the Training Set

This product is a physical medical device and not an AI/machine learning algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's design and manufacturing processes are developed based on engineering principles and prior knowledge from predicate devices.

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

As explained in point 8, the concept of a "training set" does not apply to this physical medical device.

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