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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 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 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 (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

The Solitaire™ Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Revascularization 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 distal nitinol portion of the Solitaire™ Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends and also features radiopaque markers along the circumference of the working length of the devices are supplied sterile and are intended for single-use only.

The prompt asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text.

Based on the provided information, the submission is for a labeling modification to reduce the recommended minimum vessel diameter for the Solitaire™ Revascularization Device, 4 mm device models. The core device design and Indications for Use remain unchanged from the predicate devices. Therefore, the performance criteria and studies focus on demonstrating that this labeling modification does not introduce new safety or effectiveness concerns.

Here's the breakdown of the information as requested:

1. Table of acceptance criteria and the reported device performance:

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

• Test Set Sample Size: The exact sample size for the retrospective analysis of the STRATIS registry data is not explicitly stated in the provided text. It mentions "a retrospective subgroup analysis."
• Data Provenance: The data is from the STRATIS registry, described as a retrospective analysis. The country of origin is not specified, but STRATIS (Stroke TreAtment with a Solitaire stent-retriever and Intravenous t-PA) is an international registry, so the data likely encompasses multiple countries.

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

This information is not provided in the text. The STRATIS registry would have had various clinical endpoints and adjudication processes, but the details of experts establishing ground truth for the specific retrospective subgroup analysis are not described.

4. Adjudication method for the test set:

This information is not provided in the text.

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 performed. The device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance was done as this is a medical device (thrombectomy device), not an imaging or diagnostic algorithm.

7. The type of ground truth used:

For the clinical performance, the ground truth would be based on patient outcomes data collected as part of the STRATIS registry (e.g., successful reperfusion rates, clinical disability scores, adverse event rates), as adjudicated in the original registry study design. For the bench tests, the ground truth is based on engineering measurements against predefined specifications.

8. The sample size for the training set:

• Training Set Sample Size: The concept of a "training set" in the context of device approval (especially for a physical medical device and a labeling modification) is not applicable in the same way it would be for an AI/ML algorithm. The device design and previous iterations would have been "trained" through extensive R&D and prior clinical trials for predicate devices, but there isn't a "training set" in the computational sense.
• The "retrospective analysis of subject vessel size was performed using the STRATIS registry data" to support the labeling modification, implying that this existing clinical data was used for validation rather than for "training" a new device or algorithm.

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

As above, the concept of a "training set" with ground truth establishment in the AI/ML sense is not applicable for this device submission. The existing clinical data from the STRATIS registry, which includes patient outcomes, would serve as the "ground truth" for evaluating the clinical performance of the device in smaller vessels. The establishment of this ground truth would have been defined by the STRATIS registry protocol, including clinical assessments and imaging.

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The Solitaire™ Platinum 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 subject 6-40-10 Solitaire™ Platinum Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Platinum 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™ Platinum Revascularization Device facilitates clot retrieval. The Solitaire™ Platinum Revascularization Device has Platinum Iridium radiopaque markers on the working cell length, proximal and distal ends. The subject Solitaire™ Platinum Revascularization Device is a portfolio expansion to the predicate Solitaire™ Platinum Revascularization Device (K153071).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Solitaire™ Platinum Revascularization Device (6x40 mm)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes both biocompatibility testing and non-clinical bench testing. There is also clinical data leveraged from a registry.

Biocompatibility Acceptance Criteria & Performance:

Non-Clinical Bench Testing Acceptance Criteria & Performance:

Clinical Performance (Leveraged from STRATIS Registry 4x40 Subgroup):

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

• Non-Clinical Animal Testing: The study used an "in-vivo Yorkshire cross swine model." The number of animals is not explicitly stated, but it evaluated 4 out of 8 proposed target sites (Right Vertebral, Left Vertebral, Right Internal Thoracic, Left Internal Thoracic, Right Costocervical, Left Costocervical, Renal, Ascending Pharyngeal).
  • Provenance: Prospective, animal model.
• Confirmatory Clinical Data (Leveraged from STRATIS Registry):
  • Sample Size: A total of 984 patients were enrolled in the STRATIS Registry. From this, the analysis for the 4x40 Solitaire devices (predicate and reference) included 296 patients who were treated only with these devices.
  • Provenance: Prospective, multi-center, observational registry conducted in the United States (55 sites).

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

• Animal Testing: The document does not specify the number of experts or their qualifications for evaluating the animal testing results (e.g., Luminal Thrombus, Endothelial Cell Coverage, etc.).
• Clinical Data (STRATIS Registry):
  • Clinical Events Committee: An independent Clinical Events Committee was used for adverse event adjudication. The number of experts or their specific qualifications (e.g., type of physician, years of experience) are not detailed.
  • Core Lab: An independent Core Lab was used for procedural image assessment. The number of experts or their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Clinical Data (STRATIS Registry): The document states that an "independent Clinical Events Committee for adverse event adjudication and an independent Core Lab for procedural image assessment" were used. This indicates an independent adjudication process, but the specific method (e.g., 2+1, 3+1 consensus) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done as described for AI assistance. The clinical data leveraged was from an observational registry evaluating clinical outcomes of the device in humans. This study was not comparing human readers with and without AI assistance; rather, it was assessing the device's performance in a real-world clinical setting.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This document describes a medical device (revascularization device), not an algorithm or AI software. Therefore, there is no "standalone" algorithm-only performance to report. The performance discussed for the clinical data is the device's performance in situ within a human patient, with clinicians performing the procedure.

7. The Type of Ground Truth Used

• Biocompatibility: In vitro and in vivo laboratory test results (e.g., cell viability, immune responses, clotting times, mutagenicity).
• Bench Testing: Engineering measurements and evaluations against design specifications.
• Animal Testing: Histopathological and physiological observations in an animal model (e.g., luminal thrombus, endothelial cell coverage, inflammation).
• Clinical Data (STRATIS Registry):
  • Adverse Events: Adjudicated by an independent Clinical Events Committee, likely based on medical records, clinical observations, and definitions of adverse events.
  • Procedural Image Assessment: Adjudicated by an independent Core Lab, likely measuring revascularization success (TICI scores) from imaging data.
  • Functional Independence (mRS 0-2): Patient outcomes measured by modified Rankin Scale (mRS) at 90 days.

8. The Sample Size for the Training Set

• Not applicable. For this type of medical device (physical revascularization device), there is no "training set" in the context of an AI/ML algorithm. The "training set" concept is relevant for data-driven models that learn from data.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided document.

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The Solitaire™ Platinum 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 subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed 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 provided text describes the Solitaire™ Platinum Revascularization Device and its performance data to establish substantial equivalence with a predicate device. The information primarily focuses on bench testing and biocompatibility rather than clinical studies involving human or animal subjects for the new devices (4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The table below combines information from multiple sections of the document to present the acceptance criteria and the conclusion for each test. The "Reported Device Performance" column reflects the conclusion stated in the document, which consistently indicates that the device met the acceptance criteria and is substantially equivalent to the predicate.

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

• Sample Size for Test Set: The document does not explicitly state numerical sample sizes for most of the bench tests (e.g., how many devices were tested for delivery force). For "Multiple Re-sheathing Durability," it implies that devices were tested for "up to four (4) times" deployment and re-sheathing, but not the number of physical devices sampled. For "Proximal Marker to Distal Marker" and "Radial Force," it states "100% in-process" measurement, which implies all manufactured units were tested. For biocompatibility tests, details on sample sizes are not provided within this summary sheet.
• Data Provenance: The data is from "bench testing" and "biocompatibility" studies, primarily conducted in a laboratory setting. There is no information regarding the country of origin of the data. The data is prospective as it was generated specifically for the submission.

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)

This is not applicable. The tests described are primarily physical/mechanical bench tests and in-vitro/in-vivo (animal for biocompatibility) biocompatibility tests. "Ground truth" in the context of expert consensus (like for medical image interpretation) is not relevant for these types of engineering and biological safety evaluations. The acceptance criteria are based on established standards (ISO) and internal specifications.

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

This is not applicable. The tests are directly measured against predefined numerical or qualitative acceptance criteria. There is no expert adjudication process for the results of these bench or biocompatibility tests mentioned.

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

An MRMC comparative effectiveness study was not done. This document pertains to the regulatory submission for a physical medical device (revascularization device) and focuses on engineering performance and biocompatibility, not on AI-assisted diagnostic or interpretative tasks typically assessed by MRMC studies.

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

A standalone performance study of an algorithm was not done. This device is a physical medical device, not a software algorithm.

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

The "ground truth" for the bench tests are the established engineering specifications and physical properties of the device, as measured by standard laboratory methods. For biocompatibility, the ground truth is based on biological safety standards (e.g., ISO 10993 series) which define acceptable biological responses. There is no "expert consensus," "pathology," or "outcomes data" specifically mentioned as ground truth for these specific validation tests of the new devices, as the focus is on physical and material properties, and the new devices are considered substantially equivalent to a predicate.

8. The sample size for the training set

This is not applicable. The document describes the performance testing of a physical medical device (Solitaire™ Platinum Revascularization Device), not a machine learning or AI algorithm that requires a "training set."

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

This is not applicable, as there is no training set for this type of device submission.

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The Solitaire™ Platinum 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™ Platinum device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed 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 distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers on the working cell length, proximal and distal ends. The Solitaire™ Platinum device is a modification to the currently cleared Solitaire™ 2 Revascularization Device to increase the working length radiopacity.

The provided text is a 510(k) summary for the Solitaire™ Platinum Revascularization Device. It describes the device, its indications for use, and how it was deemed substantially equivalent to predicate devices. However, this document does not contain information about an AI/ML-based device, nor does it detail acceptance criteria and a study proving an AI/ML device meets those criteria.

The information requested in your prompt (acceptance criteria table, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is specific to the development and validation of AI/ML medical devices. The Solitaire™ Platinum Revascularization Device is a physical medical device (a thrombectomy device), and its evaluation primarily involved bench testing, animal usability testing, and comparison to predicate physical devices.

Therefore, I cannot fulfill your request to create:

1. A table of acceptance criteria and reported device performance for an AI/ML device, as this document does not describe AI/ML device performance. The listed "performance data" refers to mechanical properties and visibility of a physical device.
2. Sample sizes used for the test set and data provenance related to an AI/ML model, because no AI/ML model is discussed.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results or effect size for human readers with/without AI assistance.
6. Standalone (algorithm only) performance data.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
8. Sample size for the training set for an AI/ML model.
9. How ground truth for the training set was established for an AI/ML model.

The document explicitly states: "No animal testing for safety and efficacy or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device." and "No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model number." This further confirms the absence of typical AI/ML validation studies such as those involving human readers or large datasets for model training and testing.

In summary, the provided text does not contain the information necessary to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria, as it pertains to a physical medical device.

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