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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 family, including the Trevo ProVue and Trevo XP ProVue 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. 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 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 Guide Wire Extension to Retriever facilitates removal or exchange of a catheter while maintaining Retriever position in anatomy. After exchange has been completed, the extension can be detached.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a bulleted or numbered list with specific thresholds. Instead, the study aims to demonstrate superior clinical outcomes for the treatment arm compared to the control arm across several endpoints. The success thresholds are defined within the study design.

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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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The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter and as a conduit for retrieval devices.

The Modified HD Guide Catheters are single lumen, braided, variable stiffness shaft catheters designed for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular system. The catheters include a radiopaque marker on the distal and for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

Here's an analysis of the acceptance criteria and study details for the Modified HD Guide Catheter, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document categorizes testing into "Testing and Non-Clinical Performance Data" (bench testing) and "Clinical Performance Data" (review of existing clinical studies and post-market data).

• Non-Clinical Performance Data (Bench Testing):

  • The document states "All samples met acceptance criteria." but does not specify the exact number of samples used for each bench test (e.g., Tip Patency during Aspiration, Lumen Compatibility, etc.). It only implies that multiple samples (denoted by "All samples") were tested for each criterion.
  • Data Provenance: The bench testing utilized a "neurovascular model cast from actual human neurovascular arteries." This is a controlled experimental setup, not data from live patients.
  • Specifically for the expanded indications, "Finished sterilized devices were used for the simulated use testing."

• Clinical Performance Data:

  • TREVO 2 Study: 99 patients where the DAC (Modified HD Guide Catheter) was used.
    • Provenance: Retrospective analysis of an IDE trial ("TREVO 2 study... designed to support FDA clearance of the Trevo Retriever in the U.S."). Enrolled at 26 sites in the United States and one site in Spain.
  • TREVO Study: 30 patients where aspiration through DAC was applied (a subset of 34 patients where DAC was used).
    • Provenance: Retrospective analysis of a post-marketing prospective, multi-center, single-arm study performed at seven sites in Europe.
  • Post-Market Surveillance: A review of product complaints and Medical Device Reports (MDRs) from 2008 to July 31, 2013. The exact number of complaints reviewed is not given, but it is stated that 10 MDRs were filed.
    • Provenance: Real-world post-market data.
  • Literature Review: 15 published articles pertaining to DAC use.
    • Provenance: Published scientific literature.

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

• Non-Clinical (Bench) Testing: The document does not specify the number or qualifications of experts involved in observing and confirming the "Pass" results for the bench tests. It likely involved internal engineering or research staff.
• Clinical Performance Data (TREVO and TREVO 2 Studies):
  • The original TREVO 2 and TREVO studies would have had clinical investigators and potentially core labs or adjudication committees, but their specific roles in establishing "ground truth" for catheter performance (as opposed to primary study endpoints for the Retriever device) are not detailed here.
  • The 510(k) summary states that "None of the procedure related or CEC adjudicated events were related to DAC," implying that a Clinical Events Committee (CEC) was used in the TREVO study to adjudicate events. Their specific qualifications are not provided in this 510(k) summary.

4. Adjudication Method for the Test Set

• Non-Clinical (Bench) Testing: No specific adjudication method is mentioned. Results were simply reported as "Pass" based on visual verification or adherence to specified methods.
• Clinical Performance Data: The TREVO study mentioned events being "CEC adjudicated," indicating a Clinical Events Committee (CEC) was involved in reviewing adverse events. The specific method within the CEC (e.g., 2+1, 3+1) is not detailed. The TREVO 2 study also implies similar clinical oversight.

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 MRMC comparative effectiveness study mentioned, nor is there any AI assistance component to this device. This is a physical medical device (catheter), not an AI-powered diagnostic tool. Therefore, this section is not applicable.

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

Not applicable, as this device is a physical catheter and does not involve an algorithm.

7. The Type of Ground Truth Used

• Non-Clinical (Bench) Testing:
  • For most bench tests, the "ground truth" was based on pre-defined acceptance criteria and direct observation of the device's physical performance characteristics (e.g., patency, resistance, integrity, absence of fracture/leakage) in a simulated environment (neurovascular model).
• Clinical Performance Data (TREVO 2 and TREVO Studies):
  • The "ground truth" in these studies relates to the clinical outcomes of the overall thrombectomy procedure, specifically revascularization rates and the absence of device-specific adverse events. While the primary ground truth would be patient outcomes as assessed by clinicians (e.g., angiography for revascularization, neurological exams for NIHSS), the review here focuses on whether the DAC was implicated in any negative outcomes.

8. The Sample Size for the Training Set

Not applicable. This is a physical device and not an AI/machine learning model that requires a training set. The existing clinical data reviewed served as real-world performance evidence, not a "training set."

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

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

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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.

The Modified Trevo ProVue Retriever 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. A radiopaque coil at the distal end allows fluoroscopic visualization. The shaped section is also radiopaque. 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 document describes the Modified Trevo ProVue Retriever, a device intended to restore blood flow in the neurovasculature for ischemic stroke patients. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Cleared Trevo ProVue Retriever, K122478) based on design, materials, and function, with a specific modification to the platinum wire weave.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

• Sample Size: The document does not specify the exact number of Modified Trevo ProVue Retriever samples tested. It states "All samples passed the acceptance criteria."
• Data Provenance: The testing was conducted as bench testing using a silicone neurovascular model cast from actual human neurovascular arteries. This is a retrospective approach in terms of model derivation, but the testing itself is prospective for the device being evaluated. The 'country of origin' of the data is not explicitly stated, but it's part of a submission to the US FDA by a US-based company (Concentric Medical, Inc. in Mountain View, CA).

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 "ground truth" for this type of bench testing is typically the physical and functional characteristics of the device itself and its interaction with the simulated environment, rather than expert interpretation of images or clinical outcomes. The "success" or "failure" of deliverability, deployment, and reloadability would be directly observed and measured against pre-defined engineering specifications.

4. Adjudication method for the test set:

• An adjudication method is not applicable or mentioned. This was a bench test evaluating physical performance, not a study requiring human interpretation or consensus for outcomes.

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 conducted. This device is a mechanical thrombectomy device, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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 mechanical thrombectomy device, not an algorithm or AI system.

7. The type of ground truth used:

• The ground truth for this bench testing was based on engineering specifications and observable physical performance criteria (e.g., successful navigation, deployment, and retrieval within a simulated anatomical model without device failure). It involved assessing whether the device met its design requirements for deliverability, deployment, and reloadability.

8. The sample size for the training set:

• This question is not applicable. There is no training set mentioned, as this is bench testing of a medical device, not a machine learning model.

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

• This question is not applicable as there is no training set involved.

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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.

The Modified Trevo ProVue Retriever 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 new radiopaque markers on the new truncated 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 Modified Trevo ProVue Retriever is offered in two sizes.

The provided text describes a 510(k) submission for a Modified Trevo ProVue Retriever, a medical device intended to remove thrombus in patients experiencing ischemic stroke. The submission focuses on demonstrating substantial equivalence to a predicate device (Concentric Trevo ProVue Retriever K122478) rather than an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted or inferred from the provided text, with an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

The Modified Concentric Microcatheter is a line extension to the existing Concentric Microcatheter, cleared under K113260. Like the predicate device, the Modified Concentric Microcather is a single-lumen, braided shaft, variable stiffness catheter designed for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures. A luer hub on the proximal end of the shaft enables connection to the rotating hemostasis valve included in the package. The radiopaque shaft and distal marker facilitate fluoroscopic visualization. The catheter shaft is coated with a hydrophilic coating to reduce friction during use. The Modified Concentric Microcatheter differs from its predicate in that it has smaller shaft diameters and a longer effective shaft length. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each microcatheter.

The provided submission describes a medical device, the "Modified Concentric Microcatheter," which is a line extension to an existing product. The submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with acceptance criteria for a new AI/software device. Therefore, many of the requested categories related to AI/software performance evaluation (e.g., effect size with human readers, standalone performance, ground truth establishment for training) are not applicable to this document.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study, tailored to the context of a medical device submission demonstrating substantial equivalence:

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

The submission does not explicitly list quantitative acceptance criteria in a tabular format with corresponding performance metrics for the Modified Concentric Microcatheter. Instead, it describes various tests and states that the device successfully met the evaluation for each. The acceptance criteria generally seem to be "successful evaluation" or "meets its intended use" for each test. The performance is reported qualitatively as "successfully evaluated."

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

The document does not explicitly state the sample sizes (number of devices or tests performed) for each specific test. It simply mentions that tests were "performed" or "evaluated."

For the Design Validation Simulated Use Testing, it states "testing was performed in a porcine model." This indicates the use of an ex vivo or in vivo animal model. Data provenance is implied to be from internal testing by Concentric Medical, Inc. The timing of testing is prospective to 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 section is not applicable as the submission is for a medical device (microcatheter) and not an AI/software device requiring expert interpretation for ground truth. The "ground truth" for this device relates to its physical and functional performance, which is assessed through engineering and simulated-use testing.

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

This is not applicable as the testing described pertains to the physical and mechanical properties of a microcatheter, not to the interpretation of images or data that would necessitate an adjudication method among experts.

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 is not applicable. The device is an intravascular catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant to this submission.

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

This is not applicable as the device is a physical medical instrument and does not involve an algorithm.

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

The "ground truth" for this device's performance is established through:

• Engineering specifications and standards: For physical and mechanical properties (kink resistance, leak resistance, flexibility, tensile strength, torque, coating).
• Dimensional measurements: For shaft diameters and length.
• Fluoroscopic visibility standards: For radiopacity.
• Functional assessment in a simulated environment: In the porcine model to confirm intended use.

There is no "expert consensus" or "pathology" in the diagnostic sense, nor is there "outcomes data" presented in this 510(k) summary, as it's a pre-market submission focused on substantial equivalence.

8. The sample size for the training set

This is not applicable as the device is a physical medical instrument and does not involve AI or machine learning algorithms that require a training set.

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

This is not applicable for the same reason as point 8.

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The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

Like the predicate device, the Modified FlowGate™ Balloon Guide Catheter is a coaxiallumen, braid-reinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Modified FlowGate™ Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.

The provided text is a 510(k) Summary for a medical device (Modified Balloon Guide Catheter) and does not describe a study involving an AI/ML device. Therefore, it does not contain information on acceptance criteria, reported device performance in the context of AI/ML, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or the type of ground truth used for AI/ML validation.

Instead, the document focuses on demonstrating substantial equivalence of a modified medical device to its predicate devices, as required for 510(k) clearance by the FDA. The "acceptance criteria" and "study" mentioned in this document refer to the verification and validation testing performed to ensure the modified device meets its design specifications and performs as safely and effectively as the predicate devices.

Here's an interpretation of the requested information based on the provided text, adapted for a medical device rather than an AI/ML system:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a single table of acceptance criteria and reported full device performance in a summary format. Instead, it lists various tests performed and states that the results were successful or met acceptance criteria. For biocompatibility, specific results and conclusions are provided.

Here's a synthesized table based on the information available:

8. The Sample Size for the Training Set:

• Not applicable. This document describes a physical medical device, not an AI/ML system, so there is no "training set." The development of the device would involve engineering design, prototyping, and iterative testing, but not in the sense of a data-driven "training set" for an algorithm.

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

• Not applicable, as there is no training set for this type of device.

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The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

Like the predicate device, the Modified Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.

This document describes a 510(k) submission for a Modified Balloon Guide Catheter (K122581) which claims substantial equivalence to a predicate device (K112404). This is a medical device submission, not an AI/ML product. Therefore, many of the requested criteria related to AI/ML device evaluation frameworks (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission.

The evaluation of this catheter focuses on its mechanical, functional, and biocompatibility performance to ensure it is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of verification and validation (V&V) tests performed on the Modified Balloon Guide Catheter and its accessories. These tests were conducted by Concentric Medical, Inc. (the submitter). The summary states that "The results of verification and validation conducted on the Modified Balloon Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device."

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

• Sample Size for Test Set: This information is not provided in the given text. For medical device V&V testing, sample sizes are typically determined based on statistical rationale for each specific test (e.g., number of units tested for tensile strength, number of balloons for burst pressure). The general statement "successfully evaluated" implies that sufficient units were tested to meet the predetermined acceptance criteria.
• Data Provenance: The data originates from internal testing conducted by Concentric Medical, Inc., for their 510(k) submission to the FDA. The nature of these tests (e.g., mechanical, functional, biocompatibility) implies they are prospective in relation to the submission, as they were specifically carried out to support the device's clearance. Country of origin of data is implicitly the USA, where the company is based, although the specific test labs are not detailed.

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

This question is not applicable as there is no "ground truth" in the context of expert review for diagnostic imaging or similar AI/ML applications. The "truth" for this physical device is established by objective, measurable engineering and biological test standards and protocols. For example, for tensile testing, the "ground truth" is a certain force in Newtons, not a diagnostic interpretation by an expert.

4. Adjudication Method for the Test Set

This question is not applicable as there is no need for expert adjudication in the context of physical medical device performance testing as described. The tests have objective pass/fail criteria.

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 question is not applicable. This is a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.

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

This question is not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is established by:

• Engineering Specifications: Predetermined performance targets and specifications (e.g., maximum deflection force, torque transmission ratio, peel strength values).
• Established Test Standards: Compliance with recognized international or national standards for medical device testing (e.g., ISO standards for biocompatibility).
• Predicate Device Performance: Performance data from the legally marketed predicate device (K112404) often serves as a benchmark for substantial equivalence, implying that the modified device must perform at least as well as the predicate for critical characteristics.
• Biological/Chemical Standards: For biocompatibility, established thresholds for toxicity, sensitization, hemolysis, etc. are the "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device; there is no "training set" in the context of AI/ML model development.

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

This question is not applicable for the same reason as above.

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