(59 days)
- The Solitaire™ 2 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 plasogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
- 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™ 2 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 2 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™ 2 Revascularization Device facilitates clot retrieval and has Iridium radiopaque markers on the proximal and distal ends. The devices are supplied sterile and are intended for single-use only.
The provided text describes the acceptance criteria and the study that proves the Solitaire™ 2 Revascularization Device meets those criteria. Here's a structured breakdown of the requested information:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents two main categories of performance data: biocompatibility and bench testing. Clinical data is used for comparative effectiveness rather than direct acceptance criteria for the device itself in this specific section.
Biocompatibility Testing:
| Test Category | Test Description | Method | Acceptance Criteria | Conclusion |
|---|---|---|---|---|
| Cytotoxicity | L929 MTT Cytotoxicity | ISO 10993-5 | Viability is ≥70%. | Acceptance criteria met |
| Sensitization | Guinea Pig Maximization Sensitization | ISO 10993-10 | Test article does not elicit a sensitization response. | Acceptance criteria met |
| Irritation | Intracutaneous Irritation Test | ISO 10993-10 | Differences in the mean test and control scores of the extract dermal observations are . | Device was evaluated for particulate generation under simulated use in a representative tortuous anatomical model per USP (Same as method, implying conforming to USP limits). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Clinical Study (SWIFT PRIME):
- Total Randomized Subjects: 196 (98 in each group: IV t-PA alone vs. IV t-PA + Solitaire)
- Analysis Cohort (after exclusions): 161 subjects (84 in the IV t-PA + Solitaire™ group and 77 with IV t-PA only). Further refined to 144 subjects for primary and secondary efficacy endpoints after additional exclusions.
- Data Provenance: Global, multicenter. The study was a prospective, randomized, open, blinded endpoint (PROBE) clinical study (IDE G120142).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not explicitly state the exact number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical study's endpoints. However, it does mention:
- Blinded evaluation of modified Rankin Scale (mRS) for neurological disability outcomes. This implies that the mRS scores, which serve as a critical component of the ground truth for effectiveness, were assessed by experts who were blinded to the treatment arm.
- Clinical Events Committee adjudication for adverse events. This indicates a panel of experts reviewed and categorized adverse events.
- Core Laboratory assessed data for symptomatic ICH, infarct volume, and reperfusion ratio. This suggests specialized facilities with expert staff were responsible for these assessments.
While the specific count and detailed qualifications are not provided, the involvement of blinded evaluators, a Clinical Events Committee, and a Core Laboratory indicates that ground truth was established through expert assessment according to established protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document mentions "Clinical Events Committee adjudication" for adverse events. While it doesn't specify a 2+1 or 3+1 method, "adjudication" implies a process where a committee of experts reviews and resolves discrepancies in event classification or assessment. It suggests a structured review by multiple parties, but the exact number of reviewers per case or tie-breaking mechanism is not detailed.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any mention of AI assistance. This study compared a medical device (Solitaire™ 2 Revascularization Device) with or without IV t-PA, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done, as this document is about a mechanical thrombectomy device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study was established using a combination of:
- Clinical Outcomes Data: Primarily, the 90-day global disability assessed via the blinded evaluation of Modified Rankin Scale (mRS). This is a widely accepted functional outcome scale often based on trained interviewer assessment.
- Imaging-based Assessments: Volume of cerebral infarction, reperfusion ratio, and arterial revascularization (TICI 2b or 3) assessed by a Core Laboratory. This implies expert interpretation of medical images.
- Adjudicated Adverse Events: Reviewed and categorized by a Clinical Events Committee.
8. The sample size for the training set
The document does not describe the development or training of an algorithm or AI. Therefore, there is no training set sample size mentioned. The clinical study (SWIFT PRIME) is a comparative effectiveness study for a medical device in patients.
9. How the ground truth for the training set was established
As there is no training set for an algorithm or AI described in the document, this question is not applicable.
§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.