(121 days)
- The pRESET® Thrombectomy 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 thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.
- The pRESET® Thrombectomy Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experience stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.
The pRESET® Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and the middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.
Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance (pRESET) (Intent-to-Treat Population) | Predicate Device (Solitaire) (Intent-to-Treat Population) | Difference (pRESET minus Solitaire) | 1-Sided 95% Confidence Interval (Lower, Upper Bound) | Met/Not Met (Based on Thresholds) |
|---|---|---|---|---|---|
| Primary Effectiveness: 90 Day mRS ≤ 2 (Proportion of subjects with global disability mRS ≤ 2 at 90 days after index procedure) | 95 (54.91%) | 96 (57.49%) | -2.57% | -11.42%, 6.28% | Met (Lower bound -11.42% > -12.5%) |
| Primary Safety: 24 Hour sICH (Proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage within 24 hours) | 0 (0.00%) | 2 (1.20%) | -1.20% | -2.58%, 0.19% | Met (Upper bound 0.19% -12.1%) |
Note: The "Met/Not Met" column is inferred based on the stated "a priori threshold" for each criterion. The document explicitly states that the pRESET device was "demonstrated to be non-inferior" for these outcomes.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Intent-to-Treat (ITT) Population: 340 subjects (173 pRESET, 167 Solitaire)
- Per Protocol (PP) Population: 266 subjects (138 pRESET, 128 Solitaire)
- As Treated (AT) Population: 322 subjects (166 pRESET, 156 Solitaire)
- Data Provenance: Prospective, multicenter, randomized controlled clinical trial conducted across 24 sites in the US (n=19) and Germany (n=5).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for parameters like eTICI scores or mRS assessments. However, it's a clinical trial, implying that such assessments would be made by qualified medical professionals (e.g., neurologists, interventional neuroradiologists) at each of the 24 participating sites. The ground truth for neurological and functional evaluations, and imaging interpretations (e.g., ASPECTS, core infarct volume, eTICI), would have been established by these clinical trial personnel.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (like 2+1, 3+1) for the test set. In a multicenter clinical trial investigating medical devices, independent core labs or central adjudication committees are often used for key endpoints, especially for imaging and neurological outcomes, to ensure consistency and reduce bias. However, this level of detail is not provided in the summary.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical trial comparing two thrombectomy devices (pRESET vs. Solitaire), not comparing human readers with and without AI assistance. The "readers" in this context would be the clinicians performing the procedures and assessing outcomes, not interpreting images for AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is a study of a physical medical device (thrombectomy device), not an algorithm or AI system. Therefore, no standalone algorithm performance study was relevant or performed.
7. The Type of Ground Truth Used
The ground truth used in the clinical trial includes:
- Clinical Outcomes Data: Modified Rankin Scale (mRS) at 90 days (patient disability), symptomatic intracerebral hemorrhage (sICH) within 24 hours.
- Angiographic Data: eTICI (Expanded Thrombolysis in Cerebral Infarction) scores indicating blood flow restoration.
- Imaging Data: ASPECTS score (visual assessment of ischemic changes on CT), core infarct volume (from MRI-DWI or CTP).
These are established by clinical assessments and imaging interpretations by medical professionals.
8. The Sample Size for the Training Set
The document describes a clinical trial (PROST) evaluating the pRESET Thrombectomy Device against the Solitaire Revascularization Device. This is a comparative effectiveness study, not a machine learning study. Therefore, there is no "training set" in the context of an algorithm or AI. The term "training set" is not applicable here.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI/algorithm, this question is not applicable. The data collected was for a clinical trial to demonstrate safety and effectiveness, and the outcomes were assessed using standard clinical and imaging measures.
§ 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.