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1. 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.

2. 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.

3. 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.

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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1. The Solitaire™ 2 Revascularization 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 intravenous tissue plasogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
2. 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.

The Solitaire™ 2 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 2 Revascularization Device is designed for use 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™ 2 Revascularization Device facilitates clot retrieval and has Iridium radiopaque markers on the proximal and distal ends. The devices are supplied sterile and are intended for single-use only.

The provided text describes the acceptance criteria and the study that proves the Solitaire™ 2 Revascularization Device meets those criteria. Here's a structured breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents two main categories of performance data: biocompatibility and bench testing. Clinical data is used for comparative effectiveness rather than direct acceptance criteria for the device itself in this specific section.

Biocompatibility Testing:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Clinical Study (SWIFT PRIME):
  • Total Randomized Subjects: 196 (98 in each group: IV t-PA alone vs. IV t-PA + Solitaire)
  • Analysis Cohort (after exclusions): 161 subjects (84 in the IV t-PA + Solitaire™ group and 77 with IV t-PA only). Further refined to 144 subjects for primary and secondary efficacy endpoints after additional exclusions.
  • Data Provenance: Global, multicenter. The study was a prospective, randomized, open, blinded endpoint (PROBE) clinical study (IDE G120142).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not explicitly state the exact number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical study's endpoints. However, it does mention:

• Blinded evaluation of modified Rankin Scale (mRS) for neurological disability outcomes. This implies that the mRS scores, which serve as a critical component of the ground truth for effectiveness, were assessed by experts who were blinded to the treatment arm.
• Clinical Events Committee adjudication for adverse events. This indicates a panel of experts reviewed and categorized adverse events.
• Core Laboratory assessed data for symptomatic ICH, infarct volume, and reperfusion ratio. This suggests specialized facilities with expert staff were responsible for these assessments.

While the specific count and detailed qualifications are not provided, the involvement of blinded evaluators, a Clinical Events Committee, and a Core Laboratory indicates that ground truth was established through expert assessment according to established protocols.

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

The document mentions "Clinical Events Committee adjudication" for adverse events. While it doesn't specify a 2+1 or 3+1 method, "adjudication" implies a process where a committee of experts reviews and resolves discrepancies in event classification or assessment. It suggests a structured review by multiple parties, but the exact number of reviewers per case or tie-breaking mechanism is 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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any mention of AI assistance. This study compared a medical device (Solitaire™ 2 Revascularization Device) with or without IV t-PA, not an AI system.

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

No, a standalone algorithm performance study was not done, as this document is about a mechanical thrombectomy device, not an algorithm or AI.

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

The ground truth for the clinical study was established using a combination of:

• Clinical Outcomes Data: Primarily, the 90-day global disability assessed via the blinded evaluation of Modified Rankin Scale (mRS). This is a widely accepted functional outcome scale often based on trained interviewer assessment.
• Imaging-based Assessments: Volume of cerebral infarction, reperfusion ratio, and arterial revascularization (TICI 2b or 3) assessed by a Core Laboratory. This implies expert interpretation of medical images.
• Adjudicated Adverse Events: Reviewed and categorized by a Clinical Events Committee.

8. The sample size for the training set

The document does not describe the development or training of an algorithm or AI. Therefore, there is no training set sample size mentioned. The clinical study (SWIFT PRIME) is a comparative effectiveness study for a medical device in patients.

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

As there is no training set for an algorithm or AI described in the document, this question is not applicable.

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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 (IVt-PA) or fail IVt-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.

This purpose of this application is to add one (1) new model number (SFR2-4-40) to the Solitaire™ 2 Revascularization Device family. The additional model will be identical to the currently cleared Solitaire™ 2 4x20 (SFR2-4-20) model, with the exception of a longer retriever length.

The provided document is a 510(k) summary for the Solitaire™ 2 Revascularization Device, specifically for the addition of a new 4x40mm model (SFR2-4-40). The application aims to demonstrate substantial equivalence to previously cleared Solitaire™ devices. As such, it relies on bench and animal testing rather than a new clinical study. The concept of "acceptance criteria" and "device performance" in the context of this document refers to the results of these non-clinical tests meeting specific thresholds, often in comparison to the predicate device.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

For this device, "acceptance criteria" are implied by the conclusions that "All devices met acceptance criteria" and that performance was "same as the predicate device" or that findings were "comparable." Specific numerical acceptance criteria are not explicitly detailed in this summary, but the successful conclusions for each test imply they were met.

2. Sample sizes used for the test set and the data provenance

• Bench Testing: The document does not specify the exact sample sizes for each bench test (e.g., number of devices tested for delivery force). It generally states "Samples were measured" or "Samples were evaluated."
• Animal Study Test Set:
  • Sample Size: 12 swine. (6 for acute study, 6 for chronic 30-day study).
  • Provenance: Not explicitly stated (e.g., country of origin for the animals), but it's an animal study conducted by the manufacturer/sponsor (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular) to support the device. It is a prospective study in the sense it was designed and executed for this submission.

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

• Bench Testing: Not applicable. Bench tests rely on direct measurement and established engineering principles, not expert interpretation of data as ground truth for a test set in the same way clinical data would.
• Animal Study: "Usability for the acute and chronic study were assessed by an interventionalist." The number of interventionalists is not specified, nor are their specific qualifications provided beyond the title "interventionalist."

4. Adjudication method for the test set

• Bench Testing: Not applicable. These are objective measurements against internal specifications or predicate device performance.
• Animal Study: No explicit adjudication method (e.g., 2+1, 3+1 consensus) is described for the animal study. The "interventionalist" assessed usability, and histological findings were compared.

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 MRMC study was done. This submission is for a medical device (thrombus retriever) that directly treats a condition, not an AI/imaging diagnostic tool that assists human readers.

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

• Not applicable. This device is a physical medical device (thrombus retriever), not an algorithm or AI system. Its performance is evaluated through its mechanical capabilities and biological interaction, not as a standalone algorithm.

7. The type of ground truth used

• Bench Testing: The "ground truth" for bench tests is the objective, physical measurement of device characteristics against pre-defined engineering specifications or direct comparison to the predicate device's measured performance.
• Animal Study: The "ground truth" was established through:
  • Angiographic images: Visual assessment of vessel status.
  • Histopathological evaluation: Microscopic examination of tissue for damage, hemorrhage, and thrombi.
  • Interventionalist assessment: Subjective (but expert-driven) assessment of usability attributes (delivery, positioning, deployment, etc.).

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device's evaluation, as it is not an AI/machine learning device. The 510(k) process for this type of device relies on demonstrating equivalence through non-clinical (bench and animal) testing to a predicate device, not through training a model on data.

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

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant to this device submission.

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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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