(62 days)
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 Solitaire™ Platinum device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed 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 distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers on the working cell length, proximal and distal ends. The Solitaire™ Platinum device is a modification to the currently cleared Solitaire™ 2 Revascularization Device to increase the working length radiopacity.
The provided text is a 510(k) summary for the Solitaire™ Platinum Revascularization Device. It describes the device, its indications for use, and how it was deemed substantially equivalent to predicate devices. However, this document does not contain information about an AI/ML-based device, nor does it detail acceptance criteria and a study proving an AI/ML device meets those criteria.
The information requested in your prompt (acceptance criteria table, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is specific to the development and validation of AI/ML medical devices. The Solitaire™ Platinum Revascularization Device is a physical medical device (a thrombectomy device), and its evaluation primarily involved bench testing, animal usability testing, and comparison to predicate physical devices.
Therefore, I cannot fulfill your request to create:
- A table of acceptance criteria and reported device performance for an AI/ML device, as this document does not describe AI/ML device performance. The listed "performance data" refers to mechanical properties and visibility of a physical device.
- Sample sizes used for the test set and data provenance related to an AI/ML model, because no AI/ML model is discussed.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect size for human readers with/without AI assistance.
- Standalone (algorithm only) performance data.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
- Sample size for the training set for an AI/ML model.
- How ground truth for the training set was established for an AI/ML model.
The document explicitly states: "No animal testing for safety and efficacy or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device." and "No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model number." This further confirms the absence of typical AI/ML validation studies such as those involving human readers or large datasets for model training and testing.
In summary, the provided text does not contain the information necessary to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria, as it pertains to a physical medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).