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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 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 has a hydrophilic coating 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. An insertion tool is provided to introduce the Retriever into a Microcatheter. The Insertion Tool is a sheath in which the Retriever comes preloaded. Once half the retriever's length is inserted into the microcatheter, the insertion tool is removed. Retrievers have a modified proximal end that permits attachment of the Abbott Vascular DOC Guide Wire Extension (REF 22260). Joining the Guide Wire Extension to the Retriever facilitates removal or exchange of a catheter while maintaining the Retriever position in anatomy. After the exchange has been completed, the extension can be detached.

The provided text is a 510(k) Summary for the Stryker Neurovascular Trevo XP ProVue Retriever. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria for an AI device. The information requested in your prompt (e.g., acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, MRMC studies) is typically found in regulatory submissions for AI/ML-based medical devices, which assess algorithm performance.

The provided document does not contain the specific type of information needed to fully answer your request regarding acceptance criteria and performance data for an AI-powered device.

However, I can extract the information that is present concerning the Trevo Retriever, which is a mechanical thrombectomy device, and interpret it in the context of device performance, even if it's not an AI device.

Let's break down what is available and what is not:

What is Available (relevant to a physical medical device, not AI/ML):

• Device Type: Neurovascular Mechanical Thrombectomy Device (a physical medical device, not an AI/ML algorithm).
• Purpose: To restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke.
• Performance Data - Non-Clinical:
  • Test: Simulated Use
  • Test Method Summary: "Simulated Use testing utilized a neurovascular model with a re-circulating water bath at 37℃ to simulate the human arterial circulation and to assess the device's ability to retrieve the clot and achieve recanalization."
  • Conclusion/Performance: "Simulated Use met acceptance criteria."
• Performance Data - Clinical:
  • Data Source: Analysis of Real World Data (RWD) from the Trevo Retriever Registry.
  • Purpose: To assess safety or effectiveness on the combination use of Trevo Retriever and intermediate catheter aspiration approach.
  • Additional Support: Comprehensive review of relevant clinical literature.

What is NOT available (and would be expected for an AI/ML device as per your prompt):

• A table of acceptance criteria and reported device performance for an AI/ML algorithm. The document only states that "Simulated Use met acceptance criteria" without specifying the precise quantitative criteria or results.
• Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective). The "Simulated Use" refers to a bench test, not a patient test set, and the "Trevo Retriever Registry" is mentioned for clinical data, but no specifics about its use as a "test set" for performance evaluation against acceptance criteria are given.
• Number of experts used to establish ground truth for the test set and their qualifications. This is relevant for AI/ML evaluation.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size. This is specific to AI clinical utility.
• If a standalone (algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

Summary in relation to your prompt, given the provided document:

Since the provided text describes a physical medical device (a thrombectomy device) and not an AI/ML algorithm, most of the requested points related to AI/ML software validation (like training set, ground truth experts, MRMC studies) are not applicable and thus not present in the document.

The "acceptance criteria" mentioned in the non-clinical performance section only states that the "Simulated Use met acceptance criteria," but it does not specify what those criteria were (e.g., success rate, time to recanalization, etc.) nor does it provide the exact performance metrics achieved.

Therefore, I cannot construct the table or provide the detailed answers to most of your questions based on the provided text, as it does not pertain to an AI/ML device.

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The Trevo Retrievers are 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.

The Trevo ProVue and XP ProVue Retrievers consist of a flexible, tapered core wire with a shaped self-expanding section at the distal end for clot capture and removal. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. The Trevo Retrievers have a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retrievers. The Trevo Retrievers are delivered to the site of occlusion in the neurovasculature through a microcatheter. The torque device may be used to lock the core wire of the Trevo Retriever to the microcatheter during the procedure, allowing the Trevo Retriever and microcatheter to be retracted as a system through the guide catheter and removed from the body with captured clot.

The acceptance criteria for the Trevo ProVue and XP ProVue Retrievers, a neurovascular mechanical thrombectomy device, are derived from the clinical study, bench testing, animal studies, and various regulatory requirements. The study supporting these criteria is primarily the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) trial, with additional non-clinical and animal studies.

Here's a breakdown of the acceptance criteria and reported device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" for each performance metric with specific thresholds (e.g., "must achieve X%"). Instead, the assessment is based on demonstrating safety and effectiveness as compared to medical management alone, or meeting benchmarks set by non-clinical testing. Where specific targets are not given, the trial's statistically significant improvement or demonstration of comparable safety/effectiveness serves as the "meeting" of the criteria.

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

The primary clinical study supporting the device's expanded indication for the Trevo Retrievers was the MR CLEAN trial.

• Test Set Sample Size:

  • TREVO FDA Cohort: 120 patients (from the IAT arm, met specific criteria) (N=120 for primary safety; N=96 for primary effectiveness after exclusions).
  • Medical Management (MM) Control Group: 249 patients (after exclusions for IV t-PA timing).
  • Total Patients in MR CLEAN (originally randomized): 500 patients (233 IAT, 267 control).

• Data Provenance:

  • Country of Origin: The Netherlands (MR CLEAN was conducted in every endovascular hospital center in the Netherlands).
  • Retrospective or Prospective: Prospective, randomized, open-label, controlled, multicenter trial.

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

The document mentions expert review for several endpoints:

• Recanalization and Occlusion Assessment (Table 4 & 5):
  • Number of Experts: "Consensus review by up to three readers" for occlusion assessment (Table 4). "Consensus review by at least three readers" for TICI score recanalization (Table 5).
  • Qualifications: The document does not explicitly state the specific qualifications (e.g., years of experience, subspecialty) of these readers/experts. However, given the nature of the study (neurovascular stroke treatment), it is highly probable they were experienced neurologists, neuroradiologists, or stroke specialists involved in the study's clinical centers.

4. Adjudication Method for the Test Set

• Adjudication Method: "Consensus review by up to three readers" or "at least three readers" was used for evaluating arterial occlusion and recanalization (TICI scores). This implies a method where multiple experts independently (or collectively) assess the imaging and arrive at a joint decision. The specific process (e.g., if there were disagreements, how they were resolved beyond just "consensus") is not detailed beyond "consensus review."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement

• No, a typical MRMC comparative effectiveness study, as often seen for diagnostic AI, was not performed in this context.
  • The MR CLEAN trial directly compared patient outcomes with and without the device (with medical management), rather than evaluating how human readers' diagnostic accuracy or treatment decisions improved with AI assistance.
  • The Trevo Retrievers are a mechanical device for thrombectomy, not a diagnostic AI algorithm intended to assist human readers in interpreting images. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" does not directly apply to this device's clinical evaluation.

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

• Yes, in essence, the "device" (Trevo Retrievers) was evaluated in a standalone manner as a treatment in the context of the clinical trial.
  • The MR CLEAN trial evaluated the performance of the neurovascular mechanical thrombectomy device (Trevo Retrievers) in conjunction with best medical management against best medical management alone. This is effectively a "standalone" evaluation of the device's therapeutic effect, rather than an "algorithm only" evaluation, as it's a physical medical device.
  • The device's performance is measured by its direct impact on patient outcomes when used by clinicians, not as an interpretive AI tool.

7. The Type of Ground Truth Used

• Clinical Outcomes/Expert Assessment (Blinded):
  • Primary Effectiveness (mRS): The 90-day mRS assessment was performed by an assessor who was blinded to the subject's treatment allocation. This is a high-quality method for establishing ground truth for functional independence.
  • Imaging-based Endpoints (Occlusion/Recanalization): Assessed by a consensus review by up to three/at least three readers (presumably domain experts) after 24 hours using CTA or MRA and the AOL/TICI scales.
  • Safety Endpoints: Based on collected adverse events, neurological assessments (NIHSS), and mortality data, which are objective clinical measures or physician-reported events.
  • Animal Studies: Safety ground truth established by intra-procedural angiography and histopathology assessments performed by experts.

8. The Sample Size for the Training Set

• Not Applicable in the traditional sense for an AI/algorithm: The information provided describes the regulatory approval of a physical medical device (mechanical thrombectomy retriever), not an AI algorithm. Therefore, there is no "training set" for an AI model.
• The clinical data from the MR CLEAN trial serves as the pivotal clinical evidence supporting the device's effectiveness and safety, analogous to a validation set for an AI, but it's not a "training set" for an algorithm.

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

• Not Applicable: As explained above, this is a physical medical device, not an AI algorithm, so there is no "training set" or ground truth establishment process for an AI model. The "ground truth" for the device's performance is established through rigorous clinical trials and non-clinical testing as described in the previous sections.

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The Trevo XP ProVue Retriever (4x30mm) 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.

The Trevo XP ProVue Retriever (4x30mm) consists of a flexible, tapered core wire with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device is provided with the Retriever to facilitate manipulation. The torque device is used to lock the core wire to the microcatheter during the procedure. Locking of the torque device to the wire allows the microcatheter and Retriever to be retracted as a system during clot retrieval. An insertion tool is provided to introduce the Retriever into a microcatheter. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.

The provided text describes a 510(k) premarket notification for the Trevo XP ProVue Retriever (4x30mm). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new clinical outcome. Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not explicitly present in the provided text as they are typically associated with de novo approvals or significant device modifications requiring new clinical evidence.

However, I can extract information related to the acceptance criteria for bench and animal testing, and the study methodologies employed to demonstrate substantial equivalence.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test were "meets acceptance criteria." The device performance is generally stated as having met these unspecified criteria. The document emphasizes substantial equivalence to the predicate device through bench and animal testing.

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

• Bench Testing: The sample sizes for individual bench tests are not explicitly stated in the summary document. The phrasing "All samples meet acceptance criteria" suggests that a sufficient number of devices were tested per manufacturing and quality control standards, but the exact N is not provided.
• Animal Testing: The document mentions that a "larger diameter device (6x30mm) than the subject device (4x30mm)" was used for animal studies as a "worst case." The number of animals used is not specified.
• Data Provenance: The bench and animal studies were conducted by Concentric Medical, Inc. (the submitter). These are prospective studies performed specifically for this 510(k) submission. No country of origin for the data is explicitly mentioned beyond the submitter's location in Mountain View, California, USA.

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

• Bench Testing: No external experts are mentioned for establishing ground truth for the bench tests. These tests are industrial performance evaluations against internal specifications.
• Animal Testing: The animal studies were conducted in compliance with GLP regulation (21 CFR Part 58), which implies qualified personnel (e.g., veterinarians, pathologists, study directors) were involved in the conduct and evaluation, but their specific number or qualifications are not detailed.
• Clinical Data: No clinical study was performed for this 510(k) submission (stated in the document as "No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject device."). Therefore, no experts were used to establish ground truth from a clinical test set.

4. Adjudication Method for the Test Set

Not applicable, as no human-read test set or clinical study requiring adjudication is described. The evaluations were based on quantifiable bench tests and animal observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject device."

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

This refers to a medical device in the context of hardware, specifically a "thrombus retriever" catheter. The concept of "standalone algorithm performance" is not applicable here as it is not an AI/software device.

7. The Type of Ground Truth Used

• Bench Testing: Ground truth for bench tests is based on engineering specifications and physical measurements, which are inherently objective and quantitative (e.g., tensile strength, radial force, dimensions).
• Animal Testing: Ground truth in animal studies would typically involve pathological examination and observations for adverse events (e.g., "evidence of arterial transmural dissection or perforation"). This is based on direct biological and histological assessment.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument (thrombus retriever), not a machine learning algorithm requiring a training set.

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

Not applicable. This device is a physical medical instrument (thrombus retriever), not a machine learning algorithm.

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The Trevo XP ProVue Retriever (6x25 mm) 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.

The Trevo XP ProVue Retriever (6x25mm) consists of a flexible, tapered core with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.

The provided text describes the Trevo XP ProVue Retriever (6x25 mm) and summarizes the testing conducted to support its substantial equivalence to a predicate device (Trevo XP ProVue Retriever (4x20mm)). However, it does not contain specific acceptance criteria for each test or detailed performance metrics in the format of a table comparing criteria to reported performance. Instead, it generally states that tests "meet acceptance criteria" or provides qualitative conclusions.

Therefore, for aspects requiring quantitative acceptance criteria and reported device performance (like a comparative table), a direct answer cannot be fully generated as that level of detail is not explicitly present. Similarly, information regarding sample size for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance with specific metrics, or training set details are not provided in the given document.

Based on the available information, here's what can be inferred and stated:

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

The document lists various tests and provides a "Conclusions" column for each, generally stating that the device "meets acceptance criteria." It does not provide the numerical acceptance criteria themselves or quantitative reported device performance in most cases.

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

• Sample Size for Test Set: Not explicitly stated for most tests.
  • For Animal Studies: 12 test articles (devices) were deployed (4 per animal) across 6 treatment runs in both internal maxillary arteries (IMAs) of animals, resulting in the assessment of 6 arteries (2 per animal) for both acute and chronic studies.
• Data Provenance:
  • Simulated Use: Conducted using a silicone neurovascular model cast from actual human neurovascular arteries.
  • Animal Studies: Conducted in swine, in compliance with GLP regulation (21 CFR Part 58). This is prospective animal data.

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 document. The tests primarily involve engineering performance metrics, simulated use outcomes, and animal study observations (angiography, histopathology) conducted by unspecified personnel. There is no mention of external human experts establishing ground truth for the test set in the context of diagnostic interpretation or similar tasks.

4. Adjudication method for the test set

This information is not provided in the document. The tests described are primarily physical/mechanical performance tests, simulated use, and animal studies. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based diagnostic studies involving human interpretation.

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 mention of an MRMC comparative effectiveness study, AI assistance, or human reader performance improvement in this document. The device is a mechanical thrombectomy retriever, not an AI-powered diagnostic or assistive tool.

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

This question is not applicable as the device is a medical instrument (thrombectomy retriever) and not an algorithm or AI system. Its performance is inherent to the device itself (mechanical, physical, and biocompatibility characteristics), not an algorithm that operates standalone. The animal and simulated use studies demonstrate its "standalone" performance as a device.

7. The type of ground truth used

• For physical/mechanical tests (e.g., tensile strength, radial force, deliverability, particulate evaluation): The "ground truth" is defined by established engineering specifications and physical measurements, and compliance with these objective criteria.
• For Radiopacity: Visual assessment under fluoroscopy.
• For Coating Integrity: Visual assessment, comparison of test articles, and consideration of other correlated tests (lubricity, durability, particulate generation).
• For Simulated Use: The ability to retrieve simulated thrombus in a physical model, guided by procedural instructions derived from the Instructions for Use.
• For Animal Studies: Histopathology and angiography results are used to assess vessel response, dissection, perforation, thrombosis, stenosis, etc., against predefined safety criteria.

8. The sample size for the training set

This information is not provided and is not applicable to the type of device (a medical instrument). Training sets are typically associated with machine learning or AI models, which this device is not.

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

This information is not provided and is not applicable for the same reasons as #8.

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