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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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Solitaire 2 is a light curing, fluoride releasing radio-opaque polyglass composite. This oonlant is designed for filling of the classes I, II, and V according to Black. It also can be pred for splinting of teeth which are traumatically loose, restoration of primary teeth and reconstruction of stumps. It is available in the shades A1, A2, A3, A3, A3, A4, B2, B3, B4, C3, and Incisal.

Solitaire 2 is a light curing, fluoride releasing radio-opaque polyglass composite. It is available in the shades A1, A2, A3, A3, A3, A4, B2, B3, B4, C3, and Incisal.

The provided text is a letter from the FDA regarding the "Solitaire® 2" dental restoration device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter primarily states that the device has been found substantially equivalent to devices marketed prior to May 28, 1976, allowing it to be marketed.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document is a regulatory approval letter, not a scientific study report or performance evaluation.

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