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1. The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are indicated for use to restore blood flow in the neurovasculature by removing thrombus for the ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.

2. The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are 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 thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.

The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.

This document is a 510(k) Summary for a medical device (pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device) and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable or not provided in this document because the submission relies on non-clinical performance data (bench testing) to demonstrate substantial equivalence, not clinical effectiveness or performance with human-in-the-loop.

Here's a breakdown of the available information based on your request, highlighting what is provided and what is absent:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

The document primarily discusses acceptance criteria in the context of bench testing. The general acceptance criterion for all non-clinical performance tests is that the device "met acceptance criteria" and "demonstrated compliance to all the design attributes and that the device performs as intended." Specific quantitative acceptance criteria for each test are not explicitly detailed beyond general descriptions.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable or Not Provided for a Substantial Equivalence (510k) Submission based solely on Non-Clinical Data:

This 510(k) submission states "No clinical testing was required to support substantial equivalence." Therefore, the following points regarding clinical studies, human readers, and ground truth for clinical data are not applicable in this context.

2. Sample sizes used for the test set and the data provenance: Not applicable given "No clinical testing was required." The "test set" here refers to non-clinical bench test samples (e.g., number of devices tested for kink resistance or clot retrieval). The document does not specify the exact number of devices tested for each bench test, but implies sufficient testing to support "Pass" conclusions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth typically refers to clinical diagnosis or outcome, which was not established in this non-clinical submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 a medical device for mechanical thrombectomy, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" or standard for comparison is defined by engineering specifications, validated test methods (e.g., ASTM standards), and comparability to the predicate device's performance. For instance, in Simulated Clot Retrieval, the ground truth is successful retrieval of synthetic clots under defined conditions.

8. The sample size for the training set: Not applicable. This refers to training data for AI/ML models, which is not relevant for this mechanical device submission.

9. How the ground truth for the training set was established: Not applicable.

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1. The pRESET LITE Thrombectomy 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 thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.

2. The pRESET LITE Thrombectomy 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 thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.

The pRESET® LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and the middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.

The provided document is a 510(k) summary for the phenox pRESET LITE Thrombectomy Device. It details the device's indications for use, comparison to a predicate device, and performance data to support substantial equivalence.

Based on the nature of this document (a 510(k) summary for a thrombectomy device), it does not describe a study involving an AI/Machine Learning device that requires a test set, ground truth experts, or MRMC studies. The performance data presented are for bench testing and biocompatibility, which are typical for physical medical devices, not AI software.

Therefore, many of the requested criteria such as "Sample sized used for the test set", "Number of experts used to establish the ground truth", "Adjudication method", "MRMC comparative effectiveness study", "Standalone performance", "Type of ground truth used", "Sample size for the training set", and "How the ground truth for the training set was established" are not applicable to this document's content.

The document explicitly states:

• "No animal testing was required to support substantial equivalence."
• "No clinical testing was required to support substantial equivalence."

This confirms that the assessment relies on non-clinical (bench) performance data and a comparison to a predicate device, rather than data from human or animal studies with clinical endpoints or AI performance metrics.

However, I can extract the acceptance criteria and reported device performance from the "Non-Clinical Performance Data - Bench" section.

Acceptance Criteria and Reported Device Performance (as extrapolated from Bench Testing)

The document primarily relies on engineering and material science-based acceptance criteria for a physical medical device. The "Conclusions" column in Table 5 serves as the reported device performance, indicating a "Pass" for each test, implying the acceptance criteria were met.

1. Table of Acceptance Criteria and the Reported Device Performance:

2. Sample sized used for the test set and the data provenance: Not applicable. This document describes physical bench testing for a mechanical device, not a data-driven AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical medical device's bench testing is typically established by engineering specifications and objective measurements, not expert consensus readouts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 for 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: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance data presented, the "ground truth" (or acceptance criteria) is based on engineering specifications, standardized test methods (e.g., ASTM, ISO), and performance expectations for a physical medical device in simulated environments.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

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1. The Trevo Retriever 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 start within 6 hours of symptom onset.

2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus 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.

3. The Trevo Retriever 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 (0-50cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

The acceptance criteria for the Trevo NXT ProVue Retriever are not explicitly stated in numerical thresholds within the provided text. However, the document asserts that the device is substantially equivalent to its predicate device (K210502) and that the performance is "similar" to established safety and performance profiles. The primary change supported by this submission is a labeling modification concerning the minimum vessel diameter for certain models.

Here's an attempt to structure the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or numerical performance metrics for the Trevo NXT ProVue Retriever. Instead, it relies on demonstrating substantial equivalence to a predicate, particularly in the context of a labeling change for compatibility. The "performance" assessment is qualitative, focusing on "similar performance and safety profile".

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

• Test Set Description: A "retrospective analysis of device performance per vessel size" was conducted.
• Sample Size: Not explicitly stated. The analysis was performed "using The ASSIST Registry data." The number of cases or patients included in this retrospective subgroup analysis is not provided.
• Data Provenance: Retrospective. The country of origin of "The ASSIST Registry" data is not specified in the provided text.

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

• The document does not mention the use of experts to establish ground truth for "The ASSIST Registry data" specifically for this retrospective analysis. The data from "The ASSIST Registry" would presumably have its own established ground truth generated during data collection, but this is not detailed here. The submission focuses on analyzing existing data.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The study involved a retrospective analysis of registry data, not a new dataset requiring expert adjudication for ground truth.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study was a retrospective analysis of an existing registry.

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

• Not applicable. The device is a mechanical thrombectomy device, not an algorithm or AI. The "performance" refers to the clinical effectiveness of the physical device.

7. The Type of Ground Truth Used

• For the retrospective analysis of "The ASSIST Registry data," the ground truth would be the clinical outcomes data and procedural data recorded within that registry. For example, successful recanalization (restoring blood flow), reduction in disability, and safety events (as mentioned in "similar performance and safety profile").

8. The Sample Size for the Training Set

• Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. (See #8)

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1. The pRESET® Thrombectomy 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 thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.
2. The pRESET® Thrombectomy Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experience stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.

The pRESET® Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and the middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "Met/Not Met" column is inferred based on the stated "a priori threshold" for each criterion. The document explicitly states that the pRESET device was "demonstrated to be non-inferior" for these outcomes.

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

• Sample Size for Test Set:
  • Intent-to-Treat (ITT) Population: 340 subjects (173 pRESET, 167 Solitaire)
  • Per Protocol (PP) Population: 266 subjects (138 pRESET, 128 Solitaire)
  • As Treated (AT) Population: 322 subjects (166 pRESET, 156 Solitaire)
• Data Provenance: Prospective, multicenter, randomized controlled clinical trial conducted across 24 sites in the US (n=19) and Germany (n=5).

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for parameters like eTICI scores or mRS assessments. However, it's a clinical trial, implying that such assessments would be made by qualified medical professionals (e.g., neurologists, interventional neuroradiologists) at each of the 24 participating sites. The ground truth for neurological and functional evaluations, and imaging interpretations (e.g., ASPECTS, core infarct volume, eTICI), would have been established by these clinical trial personnel.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1, 3+1) for the test set. In a multicenter clinical trial investigating medical devices, independent core labs or central adjudication committees are often used for key endpoints, especially for imaging and neurological outcomes, to ensure consistency and reduce bias. However, this level of detail is not provided in the summary.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical trial comparing two thrombectomy devices (pRESET vs. Solitaire), not comparing human readers with and without AI assistance. The "readers" in this context would be the clinicians performing the procedures and assessing outcomes, not interpreting images for AI.

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

No, this is a study of a physical medical device (thrombectomy device), not an algorithm or AI system. Therefore, no standalone algorithm performance study was relevant or performed.

7. The Type of Ground Truth Used

The ground truth used in the clinical trial includes:

• Clinical Outcomes Data: Modified Rankin Scale (mRS) at 90 days (patient disability), symptomatic intracerebral hemorrhage (sICH) within 24 hours.
• Angiographic Data: eTICI (Expanded Thrombolysis in Cerebral Infarction) scores indicating blood flow restoration.
• Imaging Data: ASPECTS score (visual assessment of ischemic changes on CT), core infarct volume (from MRI-DWI or CTP).

These are established by clinical assessments and imaging interpretations by medical professionals.

8. The Sample Size for the Training Set

The document describes a clinical trial (PROST) evaluating the pRESET Thrombectomy Device against the Solitaire Revascularization Device. This is a comparative effectiveness study, not a machine learning study. Therefore, there is no "training set" in the context of an algorithm or AI. The term "training set" is not applicable here.

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

As there is no training set for an AI/algorithm, this question is not applicable. The data collected was for a clinical trial to demonstrate safety and effectiveness, and the outcomes were assessed using standard clinical and imaging measures.

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1. The Trevo Retriever 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 start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus 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.
3. The Trevo Retriever 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 (0-50cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

Here's a breakdown of the acceptance criteria and study information for the Trevo NXT ProVue Retriever, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on establishing substantial equivalence to a predicate device, specifically regarding a change in labeling for compatibility with smaller aspiration catheters. It doesn't explicitly state quantitative acceptance criteria for primary clinical endpoints of the device itself in the context of a de novo submission. Instead, it demonstrates through comparative data that the modified use case (with smaller catheters) maintains equivalent performance to the established use case.

Study Information

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

   • Test Set A (Simulated Use & Particulate Characterization): Sample sizes are not explicitly stated, but these were bench tests performed by Stryker Neurovascular.
   • Test Set B (Animal Study): Sample size for the animal study is not specified.
   • Test Set C (Real-World Data - RWD):
     • An administrative claims database (details regarding country/scope not specified).
     • Post-market registries: "The Trevo Retriever Registry" and "The ASSIST Registry" (details regarding country/scope not specified).
     • Retrospective data, as it's an "analysis of Real-World Data (RWD) from an administrative claims database, post-market registries...as well as a review of relevant literature."

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

   • The document does not specify the number or qualifications of experts for establishing ground truth for any of the clinical/RWD test sets. The RWD analysis likely used existing clinical outcomes as "ground truth." For bench and animal studies, "ground truth" would be determined by the study design and measurements.

3. Adjudication Method for the Test Set:

   • The document does not describe any adjudication method for the RWD or registry data.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study involving human readers or AI assistance in that direct context was described. The RWD analysis was focused on the device's performance with different aspiration catheter sizes, not on human-AI interaction.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. The device is a physical neurovascular mechanical thrombectomy device, not an algorithm. The "performance data" refers to the device's efficacy and safety in its intended use.

6. Type of Ground Truth Used:

   • Bench Testing: Internal performance criteria and measurements.
   • Animal Study: Evaluation of vascular trauma, recanalization, and distal emboli based on experimental observations.
   • Real-World Data (RWD):
     • Patient outcomes data from an administrative claims database.
     • Revascularization rates (eTICI>2c) and 90-day Modified Rankin Scale (MRS) from post-market registries and relevant literature. This would be considered outcomes data.

7. Sample Size for the Training Set:

   • Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The document refers to testing data to support a change in labeling for compatibility.

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

   • Not applicable, as there is no "training set" for this physical device.

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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 (

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 Trevo Retriever 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 start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus 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.
3. The Trevo Retriever 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)-MI segments with smaller core infarcts (0-50 cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

This document describes the Stryker Neurovascular Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever, neurovascular mechanical thrombectomy devices reviewed under K203219. The submission confirms substantial equivalence to previous devices (K190779 and K200117) made by the same manufacturer. The core argument for substantial equivalence relies on the fact that the indications for use, materials, manufacturing processes, design, technology, biocompatibility, packaging, and sterilization methods remain the same, with the only change being a modification to the core wire dimension.

Here's an analysis of the provided information concerning acceptance criteria and the study proving adherence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance values for each test. Instead, it provides a summary of various bench tests and their "Conclusions," stating that "Device integrity met acceptance criteria," "Deliverability force met acceptance criteria," etc. The specific quantitative acceptance values are not detailed.

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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 (

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 Trevo Retriever 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 start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus 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.
3. The Trevo Retriever 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 (0-50 cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

This document is an FDA 510(k) Summary for the Stryker Neurovascular Trevo NXT ProVue Retriever, seeking to demonstrate its substantial equivalence to a previously cleared predicate device (K192207). It explicitly states that there are no changes to the device's intended use or indications for use. The core of the submission revolves around the fact that the only change made to the device is a re-naming convention for stent size, referring to "cell coverage length" instead of the previous naming convention. Therefore, the performance data presented is minimal and specifically targets this labeling change.

Because the device itself, its materials, manufacturing, and intended use are unchanged from a predicate device, and the only change is in how a dimension is described for labeling purposes, the study design for proving acceptance is significantly different from what would be expected for a novel device or a device with new functionalities.

Here's a breakdown of the requested information based on the provided text:

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

(Note: The document explicitly states "There are no changes to the device intended use or indications for use statement. Other than the addition of cell coverage length as a new design input and associated labeling change, there are no changes in the device design, materials, manufacturing, packaging and sterilization methods; therefore, biocompatibility data, bench performance data, sterilization and stability data from the predicate device (K192207) are directly applicable to the subject device." This means the acceptance criteria for most performance aspects are implicitly met by referencing the predicate device's prior approval.)

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: Not explicitly stated for the "Dimensional Verification" test. This type of bench testing typically involves testing a statistically significant number of units; however, the exact number is not provided in this summary.
• Data Provenance: The study is a bench test conducted by the manufacturer, Stryker Neurovascular, based in Fremont, California, USA. The data would be prospective, as it's a verification test for a specific change.

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

• Not Applicable. For this submission, the "ground truth" for the acceptance criteria is a direct engineering/dimensional measurement, not a clinical or interpretive assessment requiring expert consensus. The acceptance is based on whether the measured "cell coverage length" falls within engineering specifications.

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

• Not Applicable. As this is a bench test verifying a dimensional specification, there is no need for expert adjudication. The measurement results are compared against predefined engineering tolerances.

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. An MRMC study was not done. This device is a mechanical thrombectomy device, not an AI/imaging diagnostic device. The submission explicitly states "No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology."

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 a software algorithm.

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

• The ground truth for the "Dimensional Verification" was engineering specifications/tolerances for the newly defined "cell coverage length."

8. The sample size for the training set

• Not Applicable. This is a hardware device, not an AI algorithm requiring a training set.

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

• Not Applicable. This is a hardware device, not an AI algorithm requiring a training set.

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1. The Trevo Retriever 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 start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus 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.
3. The Trevo Retriever 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 artely (ICA) or middle cerebral artely (MCA)-Ml segments with smaller core infarcts (0-50 cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

The provided document is a 510(k) summary for the Trevo NXT ProVue Retriever, a neurovascular mechanical thrombectomy device. It describes the device, its intended use, and a comparison to predicate devices, primarily focusing on non-clinical performance and biocompatibility data to establish substantial equivalence.

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

1. Table of Acceptance Criteria and the Reported Device Performance:

The document provides a table of various performance tests, their methods, and conclusions. The acceptance criteria themselves are explicitly stated for biocompatibility tests, but for performance tests, the conclusion is generally "meets acceptance criteria," implying that specific thresholds were defined internally and met.

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: Not explicitly mentioned for each specific performance test. The design validation states "All Users observed that the Trevo NXT ProVue Retrievers successfully met all the design attribute evaluations...". For biocompatibility, standard ISO tests were performed, which usually involve specific numbers of samples or animals as per the standard.
• Data Provenance: The studies are non-clinical (bench testing and in vitro simulated-use studies) and biocompatibility tests. They are not clinical studies involving human patient data, so concepts like country of origin or retrospective/prospective are not applicable in this context. The simulated-use studies were conducted internally for device verification and validation.

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

• Number of Experts: Not explicitly stated. The design validation study mentions "Users evaluated the device in a simulated use tortuous anatomical model". It doesn't specify if these "Users" are experts in establishing ground truth, nor their number or qualifications as one would typically see in a clinical study where expert consensus might establish ground truth for a diagnostic device. In this context of a mechanical device, performance is evaluated against defined physical and functional criteria rather than expert interpretation.

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

• Not applicable as this is a device performance study focusing on physical and functional attributes, not a study requiring adjudication of clinical outcomes or interpretations.

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 a non-clinical evaluation of a mechanical thrombectomy device, not an AI-assisted diagnostic or decision support system.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• For performance testing, the "ground truth" (or reference standard) is based on defined engineering specifications, industry standards (e.g., ISO, ASTM), and predetermined functional requirements. For example, a successful test means the device's dimension falls within a specified range, or it withstands a certain force, or it shows no damage after simulated use.
• For biocompatibility testing, the ground truth is established by the criteria outlined in recognized international standards (ISO 10993-x), which define acceptable biological responses (e.g., hemolysis ≤ 5%, not a sensitizer).

8. The sample size for the training set:

• Not applicable. This is a non-clinical evaluation of a mechanical thrombectomy device, not a machine learning model that requires a training set.

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

• Not applicable.

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