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The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA), or who fail IV t-PA therapy, are candidates for treatment.

The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. Two versions of the device are available. The standard version Tigertriever (TRPP7155) has a net length of 32mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.021 inches. The shorter version Tigertriever 17 (TRPP7166) has a net length of 23 mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.017 inches. The Tigertriever is provided with a 3.5 Fr peelable loading sheath.

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

Acceptance Criteria and Device Performance

The Tigertriever Revascularization Device's performance was evaluated against specific criteria established through a clinical trial (the TIGER study), with a performance goal derived from several other successful stroke device trials.

Table 1: Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that "the TIGER study was successfully met all pre-defined success criteria." The reported performance for both primary endpoints falls within the predefined acceptable ranges/thresholds.

Study Details for Device Performance

The clinical study conducted to demonstrate the device meets the acceptance criteria is the TIGER (Treatment with Intent to Generate Endovascular Reperfusion) clinical trial.

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: 148 patients in the modified Intent-to-Treat (mITT) Cohort.
   • Data Provenance: Not explicitly stated, but it is a multi-center clinical trial. Given the nature of medical device trials and FDA submissions, it would be considered prospective data collection. The document does not specify the country of origin of the data, but the sponsor is Rapid Medical Ltd. (Israel).

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

   • Ground Truth for Effectiveness (revascularization): The revascularization (mTICI scores) were adjudicated by a Core Laboratory. The number and specific qualifications of the experts within this Core Laboratory are not provided in this document.
   • Ground Truth for Safety (sICH): The symptomatic intracranial hemorrhage (sICH) events were adjudicated by the Clinical Events Committee (CEC). The number and specific qualifications of the experts within this CEC are not provided in this document.

3. Adjudication method for the test set:

   • Effectiveness (mTICI): Adjudicated by a Core Laboratory (specific method like 2+1 not detailed).
   • Safety (sICH): Adjudicated by a Clinical Events Committee (CEC) (specific method like 2+1 not detailed).

4. 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. This document describes a clinical trial for a physical medical device (thrombus retriever), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed or relevant in this context.

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

   • No. This device is a manual thrombus retriever, requiring direct human intervention and skill in its operation. There is no "algorithm only" performance component to be evaluated in a standalone manner.

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

   • Clinical Outcomes Data:
     • Revascularization (mTICI score): Based on angiographic imaging, adjudicated by a Core Laboratory (implies expert consensus).
     • Clinical Outcome (mRS ≤ 2 at 90 days): Direct patient outcome survey/assessment.
     • Safety (Mortality, sICH): Patient outcome data and clinical assessment, with sICH adjudicated by a Clinical Events Committee (implies expert consensus based on imaging and clinical presentation).

7. The sample size for the training set:

   • As this is a physical medical device used for treatment and not an AI/machine learning algorithm, there is no concept of a "training set" in the typical sense. The "training" for the device's design and preclinical development would come from engineering principles, in vitro testing, and animal studies, rather than a data-driven training set.

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

   • Not applicable as there is no "training set" in the context of an AI algorithm. The device's efficacy and safety were established through a combination of engineering design, non-clinical bench testing, pre-clinical animal testing, and finally, a human clinical trial.

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1. The Solitaire™ 2 Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
2. The Solitaire™ Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.

The Solitaire™ 2 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 2 Revascularization Device is designed for use in the neurovasculature such as the Internal Carotid Artery (ICA). M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ 2 Revascularization Device facilitates clot retrieval and has Iridium radiopaque markers on the proximal and distal ends. The devices are supplied sterile and are intended for single-use only.

The provided text describes the acceptance criteria and the study that proves the Solitaire™ 2 Revascularization Device meets those criteria. Here's a structured breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents two main categories of performance data: biocompatibility and bench testing. Clinical data is used for comparative effectiveness rather than direct acceptance criteria for the device itself in this specific section.

Biocompatibility Testing:

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

• Clinical Study (SWIFT PRIME):
  • Total Randomized Subjects: 196 (98 in each group: IV t-PA alone vs. IV t-PA + Solitaire)
  • Analysis Cohort (after exclusions): 161 subjects (84 in the IV t-PA + Solitaire™ group and 77 with IV t-PA only). Further refined to 144 subjects for primary and secondary efficacy endpoints after additional exclusions.
  • Data Provenance: Global, multicenter. The study was a prospective, randomized, open, blinded endpoint (PROBE) clinical study (IDE G120142).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not explicitly state the exact number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical study's endpoints. However, it does mention:

• Blinded evaluation of modified Rankin Scale (mRS) for neurological disability outcomes. This implies that the mRS scores, which serve as a critical component of the ground truth for effectiveness, were assessed by experts who were blinded to the treatment arm.
• Clinical Events Committee adjudication for adverse events. This indicates a panel of experts reviewed and categorized adverse events.
• Core Laboratory assessed data for symptomatic ICH, infarct volume, and reperfusion ratio. This suggests specialized facilities with expert staff were responsible for these assessments.

While the specific count and detailed qualifications are not provided, the involvement of blinded evaluators, a Clinical Events Committee, and a Core Laboratory indicates that ground truth was established through expert assessment according to established protocols.

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

The document mentions "Clinical Events Committee adjudication" for adverse events. While it doesn't specify a 2+1 or 3+1 method, "adjudication" implies a process where a committee of experts reviews and resolves discrepancies in event classification or assessment. It suggests a structured review by multiple parties, but the exact number of reviewers per case or tie-breaking mechanism is not detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any mention of AI assistance. This study compared a medical device (Solitaire™ 2 Revascularization Device) with or without IV t-PA, not an AI system.

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

No, a standalone algorithm performance study was not done, as this document is about a mechanical thrombectomy device, not an algorithm or AI.

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

The ground truth for the clinical study was established using a combination of:

• Clinical Outcomes Data: Primarily, the 90-day global disability assessed via the blinded evaluation of Modified Rankin Scale (mRS). This is a widely accepted functional outcome scale often based on trained interviewer assessment.
• Imaging-based Assessments: Volume of cerebral infarction, reperfusion ratio, and arterial revascularization (TICI 2b or 3) assessed by a Core Laboratory. This implies expert interpretation of medical images.
• Adjudicated Adverse Events: Reviewed and categorized by a Clinical Events Committee.

8. The sample size for the training set

The document does not describe the development or training of an algorithm or AI. Therefore, there is no training set sample size mentioned. The clinical study (SWIFT PRIME) is a comparative effectiveness study for a medical device in patients.

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

As there is no training set for an algorithm or AI described in the document, this question is not applicable.

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The 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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