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The ISAAC™ Neurovascular Navigation Catheter is indicated for use in facilitating advancement of catheters through the neuro and peripheral vasculature and introduction of diagnostic agents. The ISAAC™ Neurovascular Navigation Catheter is not intended for use in the coronary vasculature.

The ISAAC™ Neurovascular Navigation Catheter) is a braid-reinforced variable stiffness catheter with a pre-shaped distal segment. The distal end of the catheter is coated with a hydrophilic coating around the curve of the pre-shaped section of the Simmons (SIM) configuration. It is a single lumen catheter with a radiopaque distal coiled section and a Luer hub on the proximal end. The ISAAC Catheter is sterile, non-pyrogenic and intended for single use only.

The FDA 510(k) summary for the MicroVention, Inc. ISAAC Neurovascular Navigation Catheter (K222115) indicates that a range of performance testing was conducted to demonstrate the device's substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Benchtop and Biocompatibility Testing: The specific sample sizes for each individual benchtop and biocompatibility test are not explicitly detailed in this summary. However, these tests are generally conducted on a statistically significant number of device units or material samples to ensure representativeness and reproducibility.
• Animal Study: The animal study was conducted using a "porcine model." The exact number of animals involved is not specified, but it's referred to as an "acute animal testing" in a "porcine model."
• Data Provenance:
  • Benchtop Testing: Likely laboratory-generated data from MicroVention, Inc., performed under controlled conditions.
  • Biocompatibility Testing: Performed on material extracts or the device itself, likely by specialized laboratories following ISO standards.
  • Animal Study: Conducted in accordance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58), indicating a prospective study specifically designed to assess the device. The provenance is internal to the controlled study environment.

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

• Benchtop and Biocompatibility Testing: The summary does not specify the use of "experts" to establish a ground truth in the traditional sense (e.g., for image interpretation). Instead, these tests rely on objective, measurable criteria defined by established international standards (e.g., ISO, ASTM). The "ground truth" would be the direct measurement or observation of the device's physical, mechanical, and biological properties against predefined limits or comparison with a predicate.
• Animal Study: The evaluation of the animal study results regarding complications and performance comparability would involve veterinarians and potentially pathologists who are experts in animal physiology and disease interpretation. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set Without Explanation:

• Benchtop and Biocompatibility Testing: An "adjudication method" in the sense of resolving discrepancies between multiple expert interpretations is generally not applicable to the objective measurements performed in these tests. Results are typically pass/fail based on predetermined specifications or direct comparison to controls/predicates.
• Animal Study: While not explicitly stated, observations in animal studies, especially pathological findings, often involve review by multiple experts (e.g., veterinary pathologists). If discrepancies occur, an adjudication process involving consensus or a tie-breaking expert would likely be in place, though this is not detailed in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not Applicable. The ISAAC Neurovascular Navigation Catheter is a physical medical device (catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

• Not Applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• Benchtop Testing: Objective physical and mechanical measurements, adherence to industry standards, and comparison to predicate device characteristics.
• Biocompatibility Testing: Results obtained from standardized biological assays (e.g., cell cultures, animal models for irritation/sensitization) providing objective data on biological reactions, evaluated against established acceptance criteria (e.g., "non-cytotoxic," "non-irritant").
• Animal Study: Direct observation of device performance (tracking, support) and histological/pathological assessment for complications (e.g., dissection, thrombus, tissue injury) in a living porcine model, compared against the control article.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical medical device, and the concept of a "training set" for an AI algorithm is not relevant here. The device design and manufacturing process would involve extensive engineering development and iterative testing (developmental testing) which is distinct from an AI training set.

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

• Not Applicable. As there is no "training set" in the context of an AI algorithm for this device, a method for establishing its ground truth is not relevant. The device development relies on engineering principles, material science, and performance testing against established standards and predicate device characteristics.

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The Benchmark Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Benchmark Intracranial Access System is designed to aid the physician in accessing the target vasculature during interventional procedures. The Benchmark Intracranial Access System is composed of a Delivery Catheter used for introduction of interventional devices and a corresponding Select Catheter. Use of the Benchmark Intracranial Access System facilitates navigation to the target vascular location and delivery of interventional devices. The Benchmark Intracranial Access System devices are compatible with off-the-shelf accessories. Various lengths and distal shapes of both the Benchmark Delivery Catheter and 5F Select Catheter are provided for physician convenience.

The provided text is a 510(k) Summary for the Penumbra Benchmark Intracranial Access System. This type of document is for a medical device seeking regulatory clearance based on substantial equivalence to a predicate device, rather than a new AI/ML-enabled device that requires an efficacy study with rigorous acceptance criteria and clinical validation as typically seen in AI/ML product submissions.

Therefore, the requested information elements related to AI/ML device performance, ground truth, expert review, training/test sets, and MRMC studies are not applicable to this document.

However, I can extract the information pertinent to the device's non-AI/ML performance and regulatory submission.

Acceptance Criteria and Study for the Benchmark Intracranial Access System:

This submission is for a medical device (catheter system), not an AI/ML-enabled device. The "acceptance criteria" here refer to performance tests demonstrating the device's functional and material integrity.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified in the document. The general statement "The following bench-top performance tests were performed on the subject device" implies that a sufficient number of devices were tested to draw conclusions, but the exact count is not given.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The "data" here comes from bench-top laboratory tests conducted by the manufacturer, Penumbra, Inc.

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

• Not applicable. This device is not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from clinical images or data. Performance was assessed via bench-top testing.

4. Adjudication method for the test set:

• Not applicable. Performance was assessed via bench-top testing against pre-defined engineering and material specifications, not through human adjudication of clinical outcomes or interpretations.

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 is not an AI/ML device, and no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• For this device, the "ground truth" or reference standard for performance is based on engineering specifications, material standards, and functional requirements for a percutaneous catheter system, as measured through controlled bench-top tests. It is not derived from expert consensus, pathology, or outcomes data in the clinical sense relevant to AI/ML.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria consists of bench-top performance tests. As stated in section 1.7.1:

• "The following bench-top performance tests were performed on the subject device and all have met the acceptance criteria: Particulate Testing and Coating Integrity Testing. Simulated Use Testing."

Additionally, a biocompatibility assessment was conducted, concluding that "no additional biocompatibility testing is required" because the device uses identical materials, similar processing, and identical sterilization methods as previously tested and cleared Penumbra products (referenced to ISO 10993-1 categories for limited exposure, externally communicating devices with circulating blood contact).

No animal or clinical studies were conducted as "bench testing was determined sufficient for verification and validation purposes." (Section 1.7.3)

The overall conclusion is that the device is "substantially equivalent to the predicate device" based on these bench-top tests, confirming operating principle, design concept, fundamental technology, and device performance.

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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 JET 7 with MAX Delivery Device, known as Penumbra JET 7MAX, is an additional configuration being added to the currently available Penumbra System. The MAX Delivery Device is an optional accessory for use with the Penumbra JET 7 Reperfusion Catheter and is removed prior to aspiration. The Reperfusion Catheter Penumbra JET 7 delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, nonpyrogenic, and intended for single use only.

The provided text describes the 510(k) submission for the Penumbra System® JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX). The submission primarily relies on non-clinical data (biocompatibility and bench-top testing) and reference to previous animal testing of a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document clearly outlines acceptance criteria and results for Biocompatibility Testing and Design Verification (Bench-Top Testing).

Biocompatibility Testing (for MAX Delivery Device only, as Reperfusion Catheter was previously tested):

Design Verification - Bench-Top Testing:

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

• Test set sample size: Not explicitly stated for each test, but implied to be sufficient for the "Pass" results, particularly for biocompatibility (e.g., "no single animal," "2 or more animals" in acceptance criteria implies a small animal sample). For bench testing, it refers to "the units used in this Design Verification testing." No human subjects were involved in the testing for this specific submission.
• Data Provenance: The data is non-clinical (biocompatibility and bench testing), conducted by the manufacturer, Penumbra, Inc. The biocompatibility studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP). The animal testing for the predicate device (Penumbra JET 7) was performed using a "porcine model" (K173761). The document does not specify the country of origin for the data other than the manufacturer being based in Alameda, California, USA. The studies are prospective in the sense of being planned tests to demonstrate compliance.

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

Not applicable. This submission relies on objective physical and chemical testing (biocompatibility, bench testing) and animal study results rather than expert interpretation of patient data to establish ground truth for the device's performance. The ground truth for these tests is based on pre-defined scientific and engineering specifications and established biological responses.

4. Adjudication method for the test set

Not applicable. As the testing involves objective measurement of physical and biological properties against set specifications, expert adjudication (like in clinical trial image reading) is not required.

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 mechanical medical device (catheter system), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance for human readers are not relevant.

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

Not applicable. This is not an AI/algorithm-based device. Its performance is evaluated through physical, mechanical, and biological testing.

7. The type of ground truth used

The ground truth for this submission is based on:

• Pre-defined quantitative specifications: For bench-top testing (e.g., minimum bond strength, maximum friction force, particulate counts, dimensional measurements).
• Biological response criteria: For biocompatibility testing, based on ISO standards (e.g., cytotoxicity grade, irritation difference, systemic toxicity signs, pyrogenicity temperature rise, hemolytic index, statistical similarity to predicate for clotting times and complement activation).
• Physiological/anatomical models: For simulated use in bench testing and animal models for previous evaluations of the predicate device.

8. The sample size for the training set

Not applicable. This is a medical device approval based on non-clinical performance data and substantial equivalence to a predicate, not an AI/ML model trained on a dataset.

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

Not applicable, as there is no training set for an AI/ML model in this submission.

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