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The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke 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.

The subject 6-40-10 Solitaire™ Platinum Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Platinum Revascularization Device is designed for use in the neurovasculature such as the Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ Platinum Revascularization Device facilitates clot retrieval. The Solitaire™ Platinum Revascularization Device has Platinum Iridium radiopaque markers on the working cell length, proximal and distal ends. The subject Solitaire™ Platinum Revascularization Device is a portfolio expansion to the predicate Solitaire™ Platinum Revascularization Device (K153071).

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

Device: Solitaire™ Platinum Revascularization Device (6x40 mm)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes both biocompatibility testing and non-clinical bench testing. There is also clinical data leveraged from a registry.

Biocompatibility Acceptance Criteria & Performance:

Non-Clinical Bench Testing Acceptance Criteria & Performance:

Clinical Performance (Leveraged from STRATIS Registry 4x40 Subgroup):

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

• Non-Clinical Animal Testing: The study used an "in-vivo Yorkshire cross swine model." The number of animals is not explicitly stated, but it evaluated 4 out of 8 proposed target sites (Right Vertebral, Left Vertebral, Right Internal Thoracic, Left Internal Thoracic, Right Costocervical, Left Costocervical, Renal, Ascending Pharyngeal).
  • Provenance: Prospective, animal model.
• Confirmatory Clinical Data (Leveraged from STRATIS Registry):
  • Sample Size: A total of 984 patients were enrolled in the STRATIS Registry. From this, the analysis for the 4x40 Solitaire devices (predicate and reference) included 296 patients who were treated only with these devices.
  • Provenance: Prospective, multi-center, observational registry conducted in the United States (55 sites).

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

• Animal Testing: The document does not specify the number of experts or their qualifications for evaluating the animal testing results (e.g., Luminal Thrombus, Endothelial Cell Coverage, etc.).
• Clinical Data (STRATIS Registry):
  • Clinical Events Committee: An independent Clinical Events Committee was used for adverse event adjudication. The number of experts or their specific qualifications (e.g., type of physician, years of experience) are not detailed.
  • Core Lab: An independent Core Lab was used for procedural image assessment. The number of experts or their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Clinical Data (STRATIS Registry): The document states that an "independent Clinical Events Committee for adverse event adjudication and an independent Core Lab for procedural image assessment" were used. This indicates an independent adjudication process, but the specific method (e.g., 2+1, 3+1 consensus) is not detailed.

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

• No, an MRMC comparative effectiveness study was not done as described for AI assistance. The clinical data leveraged was from an observational registry evaluating clinical outcomes of the device in humans. This study was not comparing human readers with and without AI assistance; rather, it was assessing the device's performance in a real-world clinical setting.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This document describes a medical device (revascularization device), not an algorithm or AI software. Therefore, there is no "standalone" algorithm-only performance to report. The performance discussed for the clinical data is the device's performance in situ within a human patient, with clinicians performing the procedure.

7. The Type of Ground Truth Used

• Biocompatibility: In vitro and in vivo laboratory test results (e.g., cell viability, immune responses, clotting times, mutagenicity).
• Bench Testing: Engineering measurements and evaluations against design specifications.
• Animal Testing: Histopathological and physiological observations in an animal model (e.g., luminal thrombus, endothelial cell coverage, inflammation).
• Clinical Data (STRATIS Registry):
  • Adverse Events: Adjudicated by an independent Clinical Events Committee, likely based on medical records, clinical observations, and definitions of adverse events.
  • Procedural Image Assessment: Adjudicated by an independent Core Lab, likely measuring revascularization success (TICI scores) from imaging data.
  • Functional Independence (mRS 0-2): Patient outcomes measured by modified Rankin Scale (mRS) at 90 days.

8. The Sample Size for the Training Set

• Not applicable. For this type of medical device (physical revascularization device), there is no "training set" in the context of an AI/ML algorithm. The "training set" concept is relevant for data-driven models that learn from data.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided document.

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