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510(k) Data Aggregation
(88 days)
The EMBOTRAP™ III Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus 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 EMBOTRAP™ III Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EMBOTRAP™ III Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.
This is an analysis of a 510(k) submission for the EMBOTRAP™ III Revascularization Device. The provided document does not describe acceptance criteria and a study proving device performance in the context of an AI/ML medical device. Instead, it details the substantial equivalence of a physical medical device (a thrombus retriever) to predicate devices through various non-clinical tests.
Therefore, I cannot extract the information requested as it pertains to AI/ML device acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training set).
The document focuses on:
- Biocompatibility Testing: Demonstrating the device is non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, non-hemolytic, has acceptable complement activation, and is thromboresistant.
- Sterilization and Shelf Life: Validating the EO sterilization process and a 3-year shelf life.
- In Vitro (Bench) Testing: Evaluating physical characteristics like dimensions, radial force, cage recovery, durability, tensile strength, marker push-out force, flexibility, kink resistance, coating integrity, torque durability, corrosion resistance, tip flexibility, re-sheathing force, deliverability force, radiopacity, clot retrieval performance, and physician usability.
- In Vivo (Animal) Studies: Assessing usability, effectiveness, and safety in a swine model, comparing it to predicate devices.
- Clinical Studies: Stating that no clinical study was performed because there was no change to the indications for use or fundamental scientific technology (this is typical for a 510(k) focused on substantial equivalence to existing devices).
Given the nature of the device (a thrombus retriever), the acceptance criteria and performance data are entirely focused on physical and biological characteristics, not AI/ML performance metrics.
In summary, the provided text does not contain any information relevant to the acceptance criteria or study design for an AI/ML medical device.
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(267 days)
The NeVa™ PV Thrombectomy Device is indicated for:
- The non-surgical removal of emboli and thrombi from peripheral blood vessels.
- Temporary use in peripheral vessel occlusion.
- Use with aspiration and with the injection or infusion of contrast media and other fluids.
The NeVa™ PV Thrombectomy Device is a sterile, single-use thrombectomy device designed to for use in the peripheral vasculature to restore blood flow via non-surgical removal of emboli and thrombi from peripheral vessels in the vasculature. The NeVa™ PV device consists of a self-expanding nitinol basket attached to a core pusher wire that can be delivered through a micro catheter, deployed across a clot, and then removed with the clot to enable revascularization of the occluded vessel. To aid in fluoroscopic visualization, radiopaque markers are positioned at the distal end, proximal end, and along the nitinol basket of the NeVa™ PV device. A flexible atraumatic soft tip attached to the distal end of the nitinol basket is radiopaque for enhanced fluoroscopic visualization.
The NeVaTM PV device is provided sterile and is intended for single patient use. The device is not intended to be re-sterilized or re-used. No accessories are provided with the NeVaTM PV device. The device is intended to be used in conjunction with the appropriately sized microcatheter as indicated in the proposed Instructions for Use.
The provided text describes the regulatory clearance of a medical device, the NeVa™ PV Thrombectomy Device, based on its substantial equivalence to a predicate device. It details the device's characteristics, indications for use, and a summary of nonclinical testing performed to demonstrate its performance. However, the document does not contain information about acceptance criteria for a study, nor does it detail a study that proves the device meets specific acceptance criteria in the context of an algorithm or AI performance.
The document is for a medical device clearance (510(k)) that relies on substantial equivalence to a predicate device (ReVive™ PV Thrombectomy Device), not on meeting specific quantitative performance metrics as one might see for an AI/algorithm-based medical device.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of AI/algorithm evaluation. The document focuses on the physical and functional performance of a mechanical thrombectomy device.
To directly address your request given the provided text, I must state that the information is not present in the provided regulatory submission.
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(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.
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