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The Solitaire™ FR 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 Solitaire™ FR 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 device is intended for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The device is a nitinol self-expanding, fully retrievable, stent-based design that allows for clot retrieval when deployed in occluded target vessels after acute ischemic stroke. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers for visualization on the proximal and distal ends. The device is supplied sterile and is intended for single-use only by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

Here's a summary of the acceptance criteria and study findings for the Solitaire™ FR Revascularization Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the non-inferiority study design comparing the Solitaire FR device to the predicate Merci Retriever.

Note: The document specifies non-inferiority for the primary effectiveness endpoint. For safety and secondary outcomes, the "acceptance criteria" are implied by the comparative study demonstrating comparable or superior performance to the predicate device.

Bench Testing - In Vitro Clot Retrieval

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

• Sample Size (Clinical Trial - ITT randomized population):
  • Solitaire FR arm: 58 subjects
  • Merci arm: 55 subjects
  • Total ITT randomized population: 113 subjects (The total ITT population including roll-in subjects was 144, but comparative analyses were based solely on the randomized population).
• Data Provenance: The study was a "multi-center, IDE, randomized, prospectively controlled Study" (SWIFT trial). The specific countries of origin are not mentioned, but "multi-center" implies data from multiple clinical sites.

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

The document states: "Post study device use angiographic data was used to assess the primary endpoint by the Core Lab (blinded to treatment assignment)."

• Number of experts: Not specified (refers to a "Core Lab").
• Qualifications of experts: Not specified, but a "Core Lab" typically implies a team of qualified medical professionals specializing in interpreting such data (e.g., neuroradiologists).

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method for disagreements among experts, if multiple experts were involved in the Core Lab. It only mentions that the Core Lab was "blinded to treatment assignment" for primary endpoint assessment.

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

• No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This study compares two medical devices (Solitaire FR vs. Merci Retriever) for stroke treatment, not the performance of human readers with or without AI.

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

• No, this device is a physical medical device (thrombus retriever), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable. The device's performance is measured directly in clinical use.

7. The Type of Ground Truth Used

• Clinical Outcomes/Composite Endpoint: The primary effectiveness endpoint was "successful recanalization measured by TIMI flow without symptomatic hemorrhage." This is a composite clinical outcome determined by post-procedure angiography (TIMI flow) and clinical assessment for symptomatic hemorrhage.
• Expert Angiographic Review: Post-study device use angiographic data was assessed by a Core Lab (blinded to treatment assignment) to determine the TIMI flow.
• Clinical Assessment: Neurological outcomes (mRS, Barthel Index, NIHSS), mortality, and adverse events were assessed by clinical personnel during follow-up visits.

8. The Sample Size for the Training Set

• This device is a physical medical device and its performance was evaluated through preclinical and clinical studies, not through AI model training. Therefore, there is no "training set" in the context of an AI algorithm. The "roll-in" Solitaire FR subjects (31 subjects) in the clinical trial were not randomized and likely served to familiarize sites with the device and procedures, but not as an AI training set.

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

• As explained in point 8, there is no AI training set for this physical medical device.

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