(144 days)
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The pRESET LITE 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.
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The pRESET LITE Thrombectomy 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 thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.
The pRESET® LITE 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.
The provided document is a 510(k) summary for the phenox pRESET LITE Thrombectomy Device. It details the device's indications for use, comparison to a predicate device, and performance data to support substantial equivalence.
Based on the nature of this document (a 510(k) summary for a thrombectomy device), it does not describe a study involving an AI/Machine Learning device that requires a test set, ground truth experts, or MRMC studies. The performance data presented are for bench testing and biocompatibility, which are typical for physical medical devices, not AI software.
Therefore, many of the requested criteria such as "Sample sized used for the test set", "Number of experts used to establish the ground truth", "Adjudication method", "MRMC comparative effectiveness study", "Standalone performance", "Type of ground truth used", "Sample size for the training set", and "How the ground truth for the training set was established" are not applicable to this document's content.
The document explicitly states:
- "No animal testing was required to support substantial equivalence."
- "No clinical testing was required to support substantial equivalence."
This confirms that the assessment relies on non-clinical (bench) performance data and a comparison to a predicate device, rather than data from human or animal studies with clinical endpoints or AI performance metrics.
However, I can extract the acceptance criteria and reported device performance from the "Non-Clinical Performance Data - Bench" section.
Acceptance Criteria and Reported Device Performance (as extrapolated from Bench Testing)
The document primarily relies on engineering and material science-based acceptance criteria for a physical medical device. The "Conclusions" column in Table 5 serves as the reported device performance, indicating a "Pass" for each test, implying the acceptance criteria were met.
- Table of Acceptance Criteria and the Reported Device Performance:
| Test Name | Acceptance Criteria (Inferred from Description) | Reported Device Performance |
|---|---|---|
| Simulated Use | It shall be possible to safely and reliably prepare, deploy and retract the device in a nominal and worst-case 3D model as described in the instructions for use without damage to the device. | Pass |
| Simulated Clot Retrieval | It shall be possible to retrieve synthetic clots from a 3D neurovascular model as described in the instructions for use. | Pass |
| Kink Resistance | It shall be possible to deploy the device to the intended location without kinking of the device. | Pass |
| Dimensional Verification | Expanded outer diameter (OD), Retriever device length, Working length of retrieval device, Effective length of retrieval device, Diameter of heat shrink, Uncovered length, Marker position, System length shall meet specified dimensions. | Pass |
| Radial Force | The relative Chronic Outward Force (RCOF) in the labeled vessel diameters must meet acceptance criteria. | Pass |
| Austenitic Finish (Af) Transition Temperature | The Af transition temperature shall be appropriate for clinical use. | Pass |
| Radiopacity | Proximal and distal ends of the retrieval device must be radiopaque. | Pass |
| System Surface Finish | The external surface of the effective length of the device shall appear free from extraneous matter, process and surface defects. | Pass |
| Device Deployment | It shall be possible to safely and reliably deploy the device as described in the instructions for use without damage to the device. | Pass |
| Retraction into the Microcatheter | It shall be possible to advance a representative microcatheter over the deployed device, at the site of deployment, until it is fully contained within the inner lumen of the microcatheter without damage to the device. | Pass |
| Delivery and Re-sheathing Forces | The maximum delivery and re-sheathing forces measured during simulated use clinical conditions must meet acceptance criteria. | Pass |
| Re-Sheathing | It shall be possible to re-sheath the device, as described in the instructions for use, after it has been prepared, deployed and retracted as described in the instructions for use. | Pass |
| System Tensile Strength | The minimum tensile strength of the thrombectomy system is evaluated to the acceptance criteria. | Pass |
| Torque Strength | The system must not break after 3 full rotations of the insertion wire. | Pass |
| Ancillary Device Compatibility | The device shall be compatible with ancillary devices as listed in the Directions for Use (DFU). | Pass |
- Sample sized used for the test set and the data provenance: Not applicable. This document describes physical bench testing for a mechanical device, not a data-driven AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical medical device's bench testing is typically established by engineering specifications and objective measurements, not expert consensus readouts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is for a mechanical thrombectomy device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance data presented, the "ground truth" (or acceptance criteria) is based on engineering specifications, standardized test methods (e.g., ASTM, ISO), and performance expectations for a physical medical device in simulated environments.
- The sample size for the training set: Not applicable. This is a physical device, not an AI model.
- How the ground truth for the training set was established: 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.