Search Results

1. The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
2. The Solitaire™ Revascularization Device is indicated 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment.

The Solitaire™ 4 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 4 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™ 4 Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The Solitaire™ 4 Revascularization Device also features radiopaque markers along the circumference of the working length of the device. The devices are supplied sterile and are intended for single-use only.

The provided text is a 510(k) Summary for the Solitaire™ 4 Revascularization Device, which is a medical device for treating acute ischemic stroke. It describes the device, its indications for use, comparison to a predicate device, and performance data.

However, the questions posed in your request (Acceptance Criteria, Study Details, Sample Size, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Details) are typically associated with the evaluation of AI/ML-driven medical devices that require demonstration of algorithmic performance against a defined ground truth.

The Solitaire™ 4 Revascularization Device is a physical mechanical thrombectomy device. The performance data provided in this document focuses on bench testing (non-clinical) to ensure the device's physical properties, such as length, force, particulate generation, durability, and tensile strength, meet specifications. It explicitly states:

• "No clinical or animal testing was performed on the subject device because there is no change in the indications for use or the fundamental scientific technology of the device."
• "Bench testing confirmed that the modifications to Solitaire™ 4 met product specifications and do not raise new questions on the safety and effectiveness of the device."

Therefore, most of the information requested, which pertains to AI/ML device validation, is not applicable to this traditional medical device submission.

Here's a breakdown of what can be extracted from the document based on your questions, and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document provides a summary of non-clinical bench tests. It states that "Acceptance criteria met" for each test, but it does not specify the numerical acceptance criteria themselves or the reported performance values. It only confirms that the device passed.

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

The document doesn't provide specific sample sizes (e.g., number of devices tested) for the bench tests. It also does not discuss data provenance in terms of country of origin or retrospective/prospective, as this is laboratory bench data, not clinical patient data.

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

Not applicable. Ground truth as typically understood for AI/ML models (e.g., medical image annotations) is not relevant for the bench testing of a physical device. The "ground truth" here is engineering specifications and physical measurements.

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

Not applicable. This is not a process that requires multi-reader adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No, an MRMC study was explicitly not done. The document states: "No clinical or animal testing was performed on the subject device because there is no change in the indications for use or the fundamental scientific technology of the 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, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the bench tests is the engineering specifications and performance standards set for the device's physical properties. For example, a "System Tensile" test has a pre-defined acceptance criterion for the amount of force the device must withstand.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Ask a specific question about this device