(243 days)
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The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ische 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.
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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.
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The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ische to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (
The Solitaire™ Revascularization Device 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 Solitaire™ Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The Solitaire™ Platinum Revascularization Device also features radiopaque markers along the circumference of the working length of the devices are supplied sterile and intended for single-use only.
The provided document describes the 510(k) premarket notification for the Solitaire™ Revascularization Device, seeking expanded indications for use. The acceptance criteria and the study used to demonstrate the device meets these criteria are detailed below.
It's important to note that this document is for a medical device, not an AI algorithm. Therefore, many of the requested fields related to AI-specific performance metrics (e.g., human readers improvement with AI, standalone algorithm performance, AI data provenance, training set size, etc.) are not applicable here. The study focuses on the clinical effectiveness and safety of the physical device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a medical device approval and not an AI algorithm, formal "acceptance criteria" in the sense of specific performance metrics with numerical thresholds are not explicitly stated as they would be for an AI submission. Instead, the study aims to demonstrate clinical safety and effectiveness for the expanded indications, primarily measured by patient outcomes. The key performance indicators are derived from the study endpoints.
| Outcome Measure | Acceptance Criteria (Not explicitly stated as numerical targets, but implied favorable outcome) | Reported Device Performance (Solitaire Group vs. Control) |
|---|---|---|
| Primary Efficacy Endpoint: Modified Rankin Scale (mRS) at 90 days | The device should demonstrate a favorable shift in the distribution of mRS scores, indicating reduced post-stroke neurological disability, compared to standard medical therapy. Implicitly, this means a statistically significant improvement in functional outcomes. | Favorable shift in mRS scores (p-value=0.014). |
| Median mRS: Solitaire = 3.0 (IQR 2.0, 4.0) vs. Control = 4.0 (IQR 3.0, 6.0). | ||
| For mRS 0-2 (functional independence): Solitaire = 31.2% (10/32) vs. Control = 15.3% (13/85). | ||
| For mRS 6 (death): Solitaire = 12.5% (4/32) vs. Control = 27.1% (23/85). | ||
| Primary Safety Endpoint: All-cause mortality at 90 days | Mortality rate with the device should be acceptable and ideally lower than or comparable to the control group, demonstrating an acceptable safety profile. | All-cause mortality: Solitaire = 10.5% (4/38) vs. Control = 25.6% (23/90). (Lower mortality in Solitaire group) |
| Primary Safety Endpoint: Symptomatic Intracranial Hemorrhage (sICH) within 36 hours | The occurrence of sICH should be low and acceptable, indicating a safe procedure. | Symptomatic ICH: Solitaire = 2.6% (1/38) vs. Control = 4.4% (4/90). (Low rate in both groups, slightly lower in Solitaire) |
| Technical Efficacy: (mTICI score) | The device should achieve successful reperfusion (mTICI 2b/3) in a significant proportion of treated patients. | mTICI ≥ 2b post-procedure (central reading): Solitaire = 65.6% (21/32). (mTICI was not assessed for the control group immediately post-procedure as they did not undergo endovascular therapy). |
| Imaging Outcomes: Reperfusion rate (Tmax > 6 seconds) | The device should demonstrate a high rate of successful reperfusion (>90% reduction in region of perfusion delay) compared to control. | Reperfusion rate (%): Solitaire = 92.6 ± 20.2 (24) [Median 100.0] vs. Control = 48.7 ± 46.0 (63) [Median 53.8]. |
| Successful reperfusion (>90%): Solitaire = 83.3% (20/24) vs. Control = 17.5% (11/63). | ||
| Imaging Outcomes: Complete recanalization at 24h | The device should achieve a high rate of complete recanalization of the primary arterial occlusive lesion. | Complete recanalization at 24h: Solitaire = 82.8% (24/29) vs. Control = 19.2% (14/73). |
| Imaging Outcomes: Infarct volume (ml) at 24h | The device should ideally result in smaller infarct volumes and less infarct growth compared to control. | Infarct volume (ml) at 24h per core lab: Solitaire = 64.5 ± 67.2 (38) [Median 35.0] vs. Control = 74.3 ± 80.7 (89) [Median 41.0]. (Slightly smaller median volume in Solitaire group, but mean is similar). |
| Infarct growth (ml) at 24h per core lab: Solitaire = 48.6 ± 61.4 (38) [Median 19.9] vs. Control = 57.6 ± 70.6 (89) [Median 32.8]. (Smaller median growth in Solitaire group). | ||
| Additional Safety: Procedural Complications | Low rates of arterial dissection, access site complications requiring surgical repair/transfusion, embolization to previously unaffected territory, and vessel perforation, indicating procedure safety. | Arterial dissection: 0.0% (0/38). |
| Access site complication requiring surgical repair or transfusion: 0.0% (0/38). | ||
| Embolization to previously unaffected territory: 0.0% (0/38). | ||
| Vessel perforation: 2.6% (1/38). |
2. Sample size used for the test set and the data provenance
- Test Set (Analysis Cohort - mITT):
- Solitaire group: 32 subjects (from an initial 38 out of 182 total in DEFUSE 3 where Solitaire was the first device used)
- Control group: 85 subjects (from an initial 90 out of 182 total in DEFUSE 3)
- Total mITT: 117 subjects
- Data provenance: The original DEFUSE 3 study was a multicenter, randomized, open-label trial (prospective). The document doesn't specify countries, but DEFUSE 3 was a US-based trial involving multiple sites across the United States. The analysis performed for this submission was a sub-analysis (post-hoc) of previously collected prospective clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts involved in establishing "ground truth" for the test set. However, it mentions several elements that would have required expert interpretation:
- Blinded outcome assessment: The primary outcome (mRS at day 90) was evaluated by blinded assessors, implying qualified personnel.
- Central reading of imaging: mTICI scores and other imaging outcomes were assessed by a "central reader" and "core lab," which implies expert radiologists/neurologists, though specific numbers or qualifications are not provided in this document.
- RAPID software: Used for imaging analysis (ischemic core volume, mismatch ratio, mismatch volume), suggesting a standardized, software-assisted approach to image interpretation for eligibility and outcomes.
4. Adjudication method for the test set
The document does not explicitly describe an adjudication method like 2+1 or 3+1 for the test set. Instead, it states:
- "Blinded outcome assessment" for the modified Rankin Scale (mRS) at day 90.
- "Central reading" for mTICI and other imaging parameters by a "core lab."
These practices typically involve a single expert or a panel of experts making determinations in a blinded fashion, but specific adjudication rules are 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
- Not applicable. This submission is for a physical medical device (revascularization device), not an Artificial Intelligence (AI) algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for a physical medical device, not an AI algorithm. Therefore, a standalone performance assessment of an algorithm was not performed. The "Solitaire" device itself is the intervention being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" or reference standard for evaluating the device's effectiveness and safety was based on:
- Clinical outcomes data: Primarily the Modified Rankin Scale (mRS) scores at 90 days, which are well-established clinical measures of functional independence after stroke.
- Mortality rates: All-cause mortality at 90 days.
- Safety event rates: Occurrence of symptomatic intracranial hemorrhage (sICH) and other adverse events.
- Imaging-based outcomes: Reperfusion rates (TICI scores), complete recanalization, infarct volume, and infarct growth, assessed by central readers/core labs, serving as objective measures of the device's action.
8. The sample size for the training set
- Not applicable. This submission is for a physical medical device, not an AI algorithm. There is no "training set" in the context of machine learning. The clinical data from the DEFUSE 3 study served as the primary evidence for the device's clinical performance.
9. How the ground truth for the training set was established
- Not applicable. As noted above, there is no "training set" for an AI algorithm in this context. The "ground truth" for the clinical study (DEFUSE 3) involves established clinical endpoints (mRS, mortality, sICH) and imaging assessments by expert clinicians and core labs, as described in point 7.
§ 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.