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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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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 64 and ACE 68 Reperfusion Catheters are components to the currently available Penumbra System. The Penumbra System ACE AC 64 and ACE 68 Reperfusion Catheters are used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.

The provided text describes the Penumbra System ACE 64 and ACE 68 Reperfusion Catheters, which are medical devices intended for revascularization in patients with acute ischemic stroke. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device.

The document does not contain details about acceptance criteria, reported device performance in terms of clinical outcomes, sample sizes for test or training sets in the context of device performance metrics (like sensitivity/specificity), or the involvement of experts for ground truth establishment for such metrics.

Instead, the "study" described is primarily focused on safety verification through animal testing and a reliance on leveraging non-clinical data from the predicate device due to identical designs.

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

1. Table of acceptance criteria and the reported device performance:

The document describes acceptability in terms of meeting "established requirements" for the device, primarily related to safety in a vascular model. It does not provide quantitative performance metrics typical for diagnostic or AI-driven devices (e.g., sensitivity, specificity, accuracy).

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: Not explicitly stated for any "test set" in terms of patient numbers or specific metrics. The study refers to an "accepted porcine vascular model," implying animal subjects. The number of animals used is not specified.
• Data provenance: Porcine vascular model (animal study).
• Retrospective/Prospective: The animal study described is prospective, as it involved evaluating the device in a controlled setting.

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):

• Number of experts: One expert is explicitly mentioned: "Sponsor Pathologist."
• Qualifications: "Sponsor Pathologist." Further specific qualifications (e.g., years of experience, board certification) are not provided.

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

Not applicable. The evaluation was performed by a single "Sponsor Pathologist." There is no mention of a multi-reader adjudication process.

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 device is a physical medical device (catheter) for mechanical thrombectomy, not an AI or diagnostic software. There is no mention of human readers, AI assistance, or MRMC studies.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The ground truth for the animal study (safety and vascular response) was established by:

• Contrast angiography findings.
• Gross necropsy and histopathology performed by the Sponsor Pathologist.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."

Summary of what the document does provide:

The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K142458). The key elements for this claim are:

• Identical design, materials, manufacturing, packaging, and sterilization methods to the predicate.
• Design validation through GLP Animal Testing to assess safety and performance in a "wedged" position using maximum aspiration. The animal study concluded no significant vessel response on angiography and no significant pathological findings.
• Leveraging non-clinical data (biocompatibility, bench-top, sterilization, stability) from the predicate device because the new devices are identical.

The FDA 510(k) clearance process often relies heavily on demonstrating substantial equivalence to a predicate device, which can involve a combination of non-clinical testing and leveraging existing data, rather than requiring extensive new clinical trials or complex performance metrics for novel AI/diagnostic devices.

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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 Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.

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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Penumbra System ACE 64 and ACE 68 Reperfusion Catheters:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (for test sets, where applicable)

• Biocompatibility Testing:

  • In Vitro Cytotoxicity: Not specified in terms of sample size for the test itself, but implies multiple samples for extract testing.
  • Sensitization: "Test Group" - size not specified.
  • Acute Intracutaneous Reactivity: "mean test article and mean control score" - implies multiple samples, size not specified.
  • Acute Systemic Toxicity: "3 or more test animals" (for weight loss criteria), "2 or more test animals" (for morality/behavior) - implies at least 3 animals for each extract/test (likely mice or rats, as common for this test).
  • Rabbit Pyrogen Study: "No single animal" suggests multiple rabbits, specific number not stated.
  • Hemocompatibility In Vitro Hemolysis: Sample extracts, size not specified.
  • Complement Activation: "test samples" compared to "predicate (Exposure Control & Ref Material) control" and "positive control" at "all three exposure times." Specific number of samples not stated.
  • Dog Thrombogenicity: "2 out of 2 test site and 2 out of 2 control sites" - suggests at least two test animals (dogs) for the in-vivo evaluation.
  • Data Provenance: Retrospective, conducted by the manufacturer, or by external labs following GLP. Country of origin not specified, but following EN ISO 10993 guidelines.

• Bench-top Testing:

  • Sample sizes are not explicitly stated for all individual tests, but most indicate "100% Pass," which suggests the testing was performed on a sample of devices and all met the criteria. For particulate testing, the maximum number suggests a specific measurement from a sample.
  • Data Provenance: Retrospective, conducted by the manufacturer.

• Animal Study:

  • Sample Size: A "swine model" was used. The number of individual animals (swine) is not explicitly stated, but the conclusions "No vessel injury was noted on the final angiograms following the vessel response procedure," "No abnormal gross or histology findings were noted in test vessel segments," and "The use of the Penumbra System ACE devices resulted in no significant vascular response in these experimental conditions," suggest sufficient animal subjects were used to support the claim.
  • Data Provenance: Prospective, animal study (GLP Animal Testing).

3. Number of Experts Used and Qualifications (for ground truth establishment)

• Biocompatibility Testing: Experts in toxicology, microbiology, and animal studies would have been involved in the design and interpretation of these studies. Their specific number and qualifications are not detailed in this summary.
• Bench-top Testing: Engineers and material scientists within the manufacturer's R&D and Quality departments would have developed the specifications and assessed the results.
• Animal Study: Veterinarians, interventionalists (to perform the procedures), pathologists (for gross and histology findings), and researchers expert in animal models for vascular devices.
• Note: This document does not pertain to AI/ML or image data, so the concept of experts establishing ground truth for a test set (e.g., radiologist for image interpretation) as typically understood in AI studies is not directly applicable here. The "ground truth" here is physical/biological measurements and observations.

4. Adjudication Method (for the test set)

• Not applicable in the context of this device's non-clinical testing. Adjudication methods (like 2+1 or 3+1) are typically used for medical image interpretation where there is subjective assessment by multiple human readers (e.g., radiologists) that needs to be reconciled to establish a ground truth. The tests described are objective physical, chemical, or biological measurements.

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

• No, a MRMC comparative effectiveness study was not done. This document describes the pre-market non-clinical testing of a physical medical device (catheter), not an AI/ML algorithm for diagnostic imaging or similar applications where human reader performance is augmented.

6. Standalone (Algorithm Only) Performance Study

• No, this is not an AI/ML device. Therefore, a standalone algorithm performance study was not performed.

7. Type of Ground Truth Used

• Biocompatibility Testing: The ground truth is objective biological and chemical reactions/measurements (e.g., cell lysis grade, inflammation scores, weight changes, temperature changes, hemolytic index, C3a/SC5b-9 concentrations, histopathology for thrombogenicity).
• Bench-top Testing: The ground truth is objective physical and mechanical measurements against technical specifications (e.g., dimensions, force measurements, flow rates, visual integrity, particulate counts).
• Animal Study: The ground truth is direct in-vivo observation and pathological assessment (e.g., angiographic evidence of injury, gross pathology findings, histological examination of vessel segments).

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such devices involves engineering design, material selection, and iterative prototyping based on established engineering principles and prior knowledge.

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

• Not applicable, as there is no "training set" in the AI/ML sense for this device. The development process relies on engineering specifications, material science data, and established test methods, rather than a labeled dataset for algorithm training.

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