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1. The Solitaire™ X 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™ X 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™ X 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 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 subject 3 mm Solitaire™ X Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The subject 3 mm Solitaire™ X 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 subject 3 mm Solitaire™ X Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The subject 3 mm Solitaire™ X Revascularization Device 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 Solitaire X Revascularization Device is designed to restore blood flow by removing thrombus in patients experiencing ischemic stroke. The device, specifically the 3mm variant, underwent several tests to demonstrate its performance and safety, leading to its substantial equivalence determination.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions a retrospective analysis of vessel sizes using the STRATIS registry data as a "clinical" study to support substantial equivalence. While it explicitly states this, it does not provide the sample size of this retrospective analysis.

• Data Provenance: The STRATIS registry data was "previously submitted in K193576," suggesting it's existing, likely multi-center, clinical trial or registry data. The country of origin is not specified but is likely international, given the nature of major stroke registries. It is retrospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the retrospective analysis of vessel sizes. Given it's a "retrospective analysis of vessel sizes," the ground truth would likely be based on imaging reports and clinical assessments already documented in the STRATIS registry by the original clinicians and radiologists involved in the patient care and data collection.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method for the retrospective analysis. As it relies on existing registry data, the "ground truth" would implicitly be the clinical diagnoses and measurements recorded at the time of the original study or patient care within the STRATIS registry.

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:

The document does not describe an MRMC comparative effectiveness study involving human readers with or without AI assistance. The described "clinical" study is a retrospective analysis of vessel sizes, not an evaluation of AI assistance for human readers.

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

The document does not describe a standalone performance study of an algorithm. The Solitaire™ X Revascularization Device is a physical mechanical thrombectomy device, not an AI or software algorithm. The "clinical" study mentioned is a retrospective analysis of vessel sizes, likely performed to understand the distribution of vessel sizes relevant to the device's application, rather than to evaluate an algorithm's performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the retrospective analysis, the ground truth would inherently be

• Imaging measurements and clinical diagnoses documented within the STRATIS registry data. This would include measurements of vessel sizes and characterization of occlusions based on imaging (e.g., CTA, MRA) and patient outcomes. It's a form of outcomes data and expert-reported imaging findings from the original clinical context.

8. The Sample Size for the Training Set:

The document does not mention a training set for an algorithm. The Solitaire™ X Revascularization Device is a physical medical device, not a machine learning model that requires training data.

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

As there is no mention of a training set for an algorithm, this question is not applicable.

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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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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 (< 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 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™ 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.

The Solitaire™ 4 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 4 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™ 4 Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The Solitaire™ 4 Revascularization Device also features radiopaque markers along the circumference of the working length of the device. The devices are supplied sterile and are intended for single-use only.

The provided text is a 510(k) Summary for the Solitaire™ 4 Revascularization Device, which is a medical device for treating acute ischemic stroke. It describes the device, its indications for use, comparison to a predicate device, and performance data.

However, the questions posed in your request (Acceptance Criteria, Study Details, Sample Size, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Details) are typically associated with the evaluation of AI/ML-driven medical devices that require demonstration of algorithmic performance against a defined ground truth.

The Solitaire™ 4 Revascularization Device is a physical mechanical thrombectomy device. The performance data provided in this document focuses on bench testing (non-clinical) to ensure the device's physical properties, such as length, force, particulate generation, durability, and tensile strength, meet specifications. It explicitly states:

• "No clinical or animal testing was performed on the subject device because there is no change in the indications for use or the fundamental scientific technology of the device."
• "Bench testing confirmed that the modifications to Solitaire™ 4 met product specifications and do not raise new questions on the safety and effectiveness of the device."

Therefore, most of the information requested, which pertains to AI/ML device validation, is not applicable to this traditional medical device submission.

Here's a breakdown of what can be extracted from the document based on your questions, and what cannot:

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

The document provides a summary of non-clinical bench tests. It states that "Acceptance criteria met" for each test, but it does not specify the numerical acceptance criteria themselves or the reported performance values. It only confirms that the device passed.

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

The document doesn't provide specific sample sizes (e.g., number of devices tested) for the bench tests. It also does not discuss data provenance in terms of country of origin or retrospective/prospective, as this is laboratory bench data, not clinical patient data.

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

Not applicable. Ground truth as typically understood for AI/ML models (e.g., medical image annotations) is not relevant for the bench testing of a physical device. The "ground truth" here is engineering specifications and physical measurements.

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

Not applicable. This is not a process that requires multi-reader adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No, an MRMC study was explicitly not done. The document states: "No clinical or animal testing was performed on the subject device because there is no change in the indications for use or the fundamental scientific technology of the device."

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the bench tests is the engineering specifications and performance standards set for the device's physical properties. For example, a "System Tensile" test has a pre-defined acceptance criterion for the amount of force the device must withstand.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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1. The Solitaire™ 2 and Solitaire ™ Platinum Revascularization Devices is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute 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™ 2 and Solitaire TM Platinum Revascularization Devices 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 and Solitaire™ Platinum Revascularization Devices 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 subject device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends and, for some SKUs, at several locations along the body of the stent. The devices are supplied sterile and are intended for single-use only.

The provided text describes a 510(k) summary for the Medtronic Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices, focusing on a labeling change to include an alternative aspiration source. The study described is a non-clinical bench test. Therefore, many of the typical acceptance criteria and study details for an AI/device performance study (like MRMC, expert ground truth, sample sizes for training/test sets with provenance, etc.) are not applicable in this context.

However, based on the provided text, I can extract the following information relevant to device acceptance criteria and testing:

Device: Solitaire™ 2 and Solitaire™ Platinum Revascularization Devices

Purpose of Submission: Labeling change to include an alternative aspiration source (Riptide™ Aspiration System) in addition to the 60 cc syringe.

1. Table of Acceptance Criteria and Reported Device Performance:

Note on "Acceptance Criteria": The document does not explicitly state numerical acceptance criteria in the typical sense for a clinical or AI performance study. Instead, the "acceptance criterion" for this submission is implicitly demonstrated through equivalence testing in a non-clinical setting: the new configuration (device with alternative aspiration source) must not perform worse than the existing cleared configuration (device with syringe aspiration) in terms of its primary function (clot retrieval).

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

• Sample Size for Test Set: The document does not specify the exact number of test samples (e.g., clots, simulated vessels) used for the simulated clot retrieval testing. It only mentions "The sizes used in the simulated clot retrieval testing were identical to the primary predicate device and representative of the additional predicate devices."
• Data Provenance: Non-clinical bench testing. No country of origin is specified, as it's a bench test, not clinical data. The study is prospective in the sense that the bench tests were conducted for this submission.

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

This information is not applicable as the study described is a non-clinical bench test involving physical properties (clot retrieval performance, vacuum pressure), not human interpretation of medical images or data requiring expert review for ground truth.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as point 3.

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:

This information is not applicable. The submission is for a physical medical device (revascularization device) and a change in its aspiration source, not an AI-powered diagnostic or assistive tool. Therefore, no human readers or MRMC studies were conducted as part of this submission.

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

This information is not applicable as it is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For Simulated Clot Retrieval Testing: The ground truth is established by the physical outcome of the bench test (i.e., whether the device successfully retrieved the simulated clot, and its performance compared to the predicate device).
• For Vacuum pressure testing: The ground truth is objective measurements of vacuum pressure.

8. The sample size for the training set:

This information is not applicable as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable as there is no training set for a physical medical device as described in this context.

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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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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:

Performance Bench 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™ 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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When used as a cervical intervertebral body fusion device, the Breckenridge implant is intended for spinal fusion procedures to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Breckenridge device is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.

When used as a cervical intervertebral fusion device, the C-Thru™ Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru™ Spacers are intended for use with supplemental fixation and autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate the fusion.

The Solitaire®-C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire®-C Cervical Spacer System is to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The cervical intervertebral body PEEK spacers have a hollowed cut-out central area to accommodate autogenous and/or allogeneic bone graft. Furthermore, the upper and lower surfaces have a series of transverse slots or grooves to improve stability and fixation once the device is inserted. All implants in these systems are made of PEEK-OPTIMA®, tantalum, and titanium alloy (Ti-6AI-4V ELI). The spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Solitaire-C spacer is a stand-alone device that must be implanted with the Solitaire-C titanium screws that are part of the system.

The Solitaire®-C Cervical Spacer System and C-Thru™ Anterior Spinal System implants are offered in sterile packed versions while the Breckenridge® Small Intervertebral Body Fusion is packaged non-sterile, to be sterilized by the end user.

This Traditional 510(k) is being submitted to seek clearance for the addition of allograft (cancellous and/or corticocancellous bone graft) indications to the aforementioned cervical intervertebral body PEEK spacer systems (both stand-alone devices and devices which require supplemental fixation).

The provided text is a 510(k) summary for medical devices (cervical intervertebral body fusion systems) and does not describe acceptance criteria for device performance in the context of an AI/ML algorithm or a study that evaluates such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for expanded indications related to bone graft types.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and MRMC/standalone studies is not present in the document.

The document states:

• "The changes proposed did not require non-clinical testing in order to demonstrate substantial equivalence to the predicate devices."
• "Published retrospective clinical data for cervical interbody fusion devices similar to the subject devices was completed to support this Premarket Notification. The published clinical outcomes demonstrated that the use of allograft (cancellous and/or corticocancellous bone graft) in anterior cervical interbody fusion poses no new risks to patients. No changes were made to the existing devices; therefore, no additional testing was required or performed."

This indicates that no new performance studies (clinical or non-clinical) were conducted for the purpose of this 510(k) submission, as the submission primarily pertains to expanding the indications for use of existing devices to include allograft. Therefore, there are no specific device performance metrics or acceptance criteria presented in the context of a new study on the device's efficacy or safety.

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