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The Solitaire™ 2 Revascularization Device is intended 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Solitaire™ 2 device is designed to restore blood flow in subjects experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptom onset. It is indicated for subjects who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers on the proximal and distal ends.
The following modifications have been made to the device in support of this application:
• The attachment zone has been redesigned for greater tensile strength.
• The marker band has been redesigned to aid the crimping process.
• The pushwire now contains a fluorosafe marker.
• The Solitaire™ 2 Device uses one piece of PTFE tubing.

This K123378 submission for the Solitaire™ 2 Revascularization Device is a medical device submission for a thrombus retriever, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Solitaire™ FR Revascularization Device) based on modifications to the device design and subsequent non-clinical bench testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-clinical bench testing submission for a medical device modification, the "acceptance criteria" are implied by successful completion of the specified tests, demonstrating that the device modifications do not adversely affect its performance compared to the predicate. No specific numerical thresholds (e.g., sensitivity, specificity) for performance are provided as would be expected for an AI/ML diagnostic or prognostic tool.

2. Sample size used for the test set and the data provenance:

• Test set sample size: Not applicable. These were non-clinical bench tests on the device itself, not clinical data sets. The "sample" would refer to the number of devices or components tested for each parameter. This information is not detailed in the summary provided.
• Data provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting by the manufacturer (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth in this context typically refers to clinical diagnosis or outcome. For bench testing, the "ground truth" is defined by the engineering specifications and established test methods for device performance parameters.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This is not a clinical study involving reader adjudication.

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 is not an AI/ML device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For this device, the "ground truth" for non-clinical testing is defined by the engineering specifications and performance standards for medical devices of this type, which are assessed through a series of defined bench tests. There is no biological or clinical "ground truth" in the AI/ML sense in this submission.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI/ML device.

In summary, the K123378 submission demonstrates substantial equivalence for the Solitaire™ 2 Revascularization Device primarily through extensive non-clinical bench testing, focusing on the mechanical and physical performance characteristics of the modified device components. It does not involve any AI/ML components or clinical data analyses as would be relevant for the questions posed.

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The Solitaire™ FR Revascularization Device is intended 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Solitaire™ FR Revascularization Device is intended 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The device is intended for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The device is a nitinol self-expanding, fully retrievable, stent-based design that allows for clot retrieval when deployed in occluded target vessels after acute ischemic stroke. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers for visualization on the proximal and distal ends. The device is supplied sterile and is intended for single-use only by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

Here's a summary of the acceptance criteria and study findings for the Solitaire™ FR Revascularization Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the non-inferiority study design comparing the Solitaire FR device to the predicate Merci Retriever.

Note: The document specifies non-inferiority for the primary effectiveness endpoint. For safety and secondary outcomes, the "acceptance criteria" are implied by the comparative study demonstrating comparable or superior performance to the predicate device.

Bench Testing - In Vitro Clot Retrieval

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Trial - ITT randomized population):
  • Solitaire FR arm: 58 subjects
  • Merci arm: 55 subjects
  • Total ITT randomized population: 113 subjects (The total ITT population including roll-in subjects was 144, but comparative analyses were based solely on the randomized population).
• Data Provenance: The study was a "multi-center, IDE, randomized, prospectively controlled Study" (SWIFT trial). The specific countries of origin are not mentioned, but "multi-center" implies data from multiple clinical sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document states: "Post study device use angiographic data was used to assess the primary endpoint by the Core Lab (blinded to treatment assignment)."

• Number of experts: Not specified (refers to a "Core Lab").
• Qualifications of experts: Not specified, but a "Core Lab" typically implies a team of qualified medical professionals specializing in interpreting such data (e.g., neuroradiologists).

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method for disagreements among experts, if multiple experts were involved in the Core Lab. It only mentions that the Core Lab was "blinded to treatment assignment" for primary endpoint assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This study compares two medical devices (Solitaire FR vs. Merci Retriever) for stroke treatment, not the performance of human readers with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, this device is a physical medical device (thrombus retriever), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable. The device's performance is measured directly in clinical use.

7. The Type of Ground Truth Used

• Clinical Outcomes/Composite Endpoint: The primary effectiveness endpoint was "successful recanalization measured by TIMI flow without symptomatic hemorrhage." This is a composite clinical outcome determined by post-procedure angiography (TIMI flow) and clinical assessment for symptomatic hemorrhage.
• Expert Angiographic Review: Post-study device use angiographic data was assessed by a Core Lab (blinded to treatment assignment) to determine the TIMI flow.
• Clinical Assessment: Neurological outcomes (mRS, Barthel Index, NIHSS), mortality, and adverse events were assessed by clinical personnel during follow-up visits.

8. The Sample Size for the Training Set

• This device is a physical medical device and its performance was evaluated through preclinical and clinical studies, not through AI model training. Therefore, there is no "training set" in the context of an AI algorithm. The "roll-in" Solitaire FR subjects (31 subjects) in the clinical trial were not randomized and likely served to familiarize sites with the device and procedures, but not as an AI training set.

9. How the Ground Truth for the Training Set Was Established

• As explained in point 8, there is no AI training set for this physical medical device.

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The ev3 Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer a selective technique of temporary vascular occlusion, which is useful in selectively stopping blood flow in a vessel. The ev3 Occlusion Balloon Catheters may also be used in balloonassisted embolization of intracranial aneurysms.

The ev3 Occlusion Balloon Catheters are single lumen, open-ended balloon catheters designed for advancement into the vasculature over a 0.010" guidewire. Balloon inflation is accomplished by advancement of the guidewire through the open distal end of the balloon, redirecting inflation media to the balloon through side holes in the catheter wall.

The Occlusion Balloon Catheters are available in diameters ranging from 3 to 7 mm and lengths ranging from 7 to 30 mm.

The devices are packaged in a sterile pouch and are intended for single use only.

The provided text is for a medical device (Occlusion Balloon Catheters) and states explicitly that no nonclinical, clinical, or animal data were included in this submission. Therefore, no acceptance criteria or study data demonstrating device performance are available in the provided document.

The submission is for a 510(k) for an Occlusion Balloon Catheter, which relies on demonstrating substantial equivalence to previously cleared predicate devices, rather than new clinical or performance data for the device itself.

Given this, I cannot provide the requested information about acceptance criteria and study details for this specific submission as it is not present in the provided text.

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