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510(k) Data Aggregation
(123 days)
Solitaire 2 and Solitaire Platinum Revascularization Device
- The Solitaire™ 2 and Solitaire ™ Platinum Revascularization Devices is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute 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.
- The Solitaire™ 2 and Solitaire TM Platinum Revascularization Devices 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™ 2 and Solitaire™ Platinum Revascularization Devices is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion 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 subject device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends and, for some SKUs, at several locations along the body of the stent. The devices are supplied sterile and are intended for single-use only.
The provided text describes a 510(k) summary for the Medtronic Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices, focusing on a labeling change to include an alternative aspiration source. The study described is a non-clinical bench test. Therefore, many of the typical acceptance criteria and study details for an AI/device performance study (like MRMC, expert ground truth, sample sizes for training/test sets with provenance, etc.) are not applicable in this context.
However, based on the provided text, I can extract the following information relevant to device acceptance criteria and testing:
Device: Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices
Purpose of Submission: Labeling change to include an alternative aspiration source (Riptide™ Aspiration System) in addition to the 60 cc syringe.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (Simulated Clot Retrieval Testing) | Test |
|---|---|---|
| Clot retrieval performance with alternative aspiration source should be equivalent to the cleared device with a 60 cc syringe. | Clot retrieval performance of the subject device was equivalent to the predicate performance. | Simulated clot retrieval testing (Purpose: Compare the clot retrieval performance of the subject device when used with the alternative aspiration source to the cleared device use with a 60 cc syringe.) |
Note on "Acceptance Criteria": The document does not explicitly state numerical acceptance criteria in the typical sense for a clinical or AI performance study. Instead, the "acceptance criterion" for this submission is implicitly demonstrated through equivalence testing in a non-clinical setting: the new configuration (device with alternative aspiration source) must not perform worse than the existing cleared configuration (device with syringe aspiration) in terms of its primary function (clot retrieval).
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify the exact number of test samples (e.g., clots, simulated vessels) used for the simulated clot retrieval testing. It only mentions "The sizes used in the simulated clot retrieval testing were identical to the primary predicate device and representative of the additional predicate devices."
- Data Provenance: Non-clinical bench testing. No country of origin is specified, as it's a bench test, not clinical data. The study is prospective in the sense that the bench tests were conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study described is a non-clinical bench test involving physical properties (clot retrieval performance, vacuum pressure), not human interpretation of medical images or data requiring expert review for ground truth.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as point 3.
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:
This information is not applicable. The submission is for a physical medical device (revascularization device) and a change in its aspiration source, not an AI-powered diagnostic or assistive tool. Therefore, no human readers or MRMC studies were conducted as part of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as it is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For Simulated Clot Retrieval Testing: The ground truth is established by the physical outcome of the bench test (i.e., whether the device successfully retrieved the simulated clot, and its performance compared to the predicate device).
- For Vacuum pressure testing: The ground truth is objective measurements of vacuum pressure.
8. The sample size for the training set:
This information is not applicable as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for a physical medical device as described in this context.
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