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The BraidE Embolization Assist Device is indicated for use in the peripheral vasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked peripheral aneurysms with a neck width ≤ 10 mm. A wide-necked peripheral aneurysm defines the neck width as > 4 mm or a dome-to-neck ratio

The BraidE Embolization Assist Device is a sterile single use endovascular device intended to provide temporary assistance for the coil embolization of wide-necked peripheral aneurysms. The BraidE is comprised of a nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The braided mesh at the distal portion of the device is shown in Figure 2. 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. Because the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the aneurysm neck morphology and vessel requirement.

This document describes the regulatory acceptance of the BraidE Embolization Assist Device, leveraging data primarily from the Comaneci Embolization Assist Device due to shared design features. The core of the acceptance criteria and supporting studies are presented below:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls" section, which outlines the requirements for clinical, animal, and non-clinical performance, as well as biocompatibility and labeling. The reported device performance is extracted from the "Summary of Clinical Information" and "Summary of Nonclinical/Bench Studies" sections.

• N=63 patients (64 intracranial aneurysms) treated.
• Technical Success: 93.65% (59/63 patients) had successful coil embolization without coil entanglement, ensnarement, prolapse, or protrusion into the parent vessel. (Table 6)
• Adverse Events: 11.1% (7/63) of patients experienced a serious neurological AE within 3 months post-procedure. (Table 5) Specific AEs detailed in Table 4 (e.g., symptomatic thrombotic event, vasospasm, hemorrhage). No mortality or subject device-coil entanglements reported.
  Peripheral Case Studies (Comaneci Device):
• 6 patients with peripheral VRAAs reported across 3 publications.
• Effectiveness: All visceral aneurysms completely excluded/occluded. All but one procedure concluded with complete patency of parent and branch vessels. (Table 7)
• Safety: Generally no immediate or periprocedural complications reported, except for one case of coil entanglement leading to non-target embolization of the splenic artery. (Table 7) |
  | 2. Animal Testing: Must demonstrate device delivery to target, compatibility with coils, and evaluate adverse events (vessel/tissue damage). | Rabbit Model Study (Comaneci Device):
• Evaluated acute (4 days) and chronic (28 days) safety and performance.
• Delivery & Performance: Successful delivery and coil embolization in 23 aneurysms (20 animals). No post-procedural mortalities, no angiographically-visible coil protrusions (acute). Patent parent vessels with normal aneurysmal sac embolization (chronic).
• Adverse Events: No morbidity, thrombosis, infection, hemorrhage, or downstream ischemia (acute). Mild embolic coil protrusion in 2 Comaneci-treated aneurysms (chronic). No perforations, dissections, erosions, or thrombus formation in device contact zones. Absence of thrombus in distal skeletal muscles. |
  | 3. Non-clinical Performance Testing: Demonstrates device performs as intended, including:
  a. Mechanical testing (tensile, torsional, compressive, tip deflection forces).
  b. Mechanical testing (radial forces).
  c. Simulated use testing (delivery in tortuous vasculature, coil compatibility).
  d. Dimensional verification.
  e. Radiopacity testing. | Bench Testing (leveraged from Comaneci):
• a. Mechanical: Tensile Strength (verified compliance of joints), Kink Resistance (ability to reach tortuous vasculature), Tip Flexibility (maximum force deflected), Tracking Force/Torque (withstand typical forces/torquing). (Table 2)
• b. Radial Forces: Radial Force/Crush (withstand external forces, retain integrity, measure outward forces to ensure no serious vessel damage). (Table 2)
• c. Simulated Use: Functional and Microcatheter Compatibility (delivery in recommended microcatheter through tortuous silicone model), Simulated Use (device performance in in vitro anatomical model through femoral artery to target site). (Table 2, 4)
• d. Dimensional Verification: Verified various dimensional attributes. (Table 2)
• e. Radiopacity: Clinical study evaluated radiopacity (can be visualized under fluoroscopic guidance). |
  | 4. Biocompatibility: Patient-contacting components must be demonstrated to be biocompatible. | Biocompatibility Testing (leveraged from Comaneci):
• Classified as external communicating, limited contact (

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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. The Tigertriever Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neurointerventional procedures and the treatment of ischemic stroke.

This document is a 510(k) summary for the Tigertriever 21, 17, and 13 Revascularization Devices. It largely references predicate devices and non-clinical testing for substantial equivalence, rather than a de novo clinical study with specific acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence to predicate devices and non-clinical testing, explicit numerical acceptance criteria and a single overall "device performance" metric are not presented in the same way they would be in a de novo clinical trial. Instead, the "acceptance criteria" are implied by successful completion of each test method as summarized in the tables below. The reported performance is that the device "met acceptance criteria" or "demonstrated acceptable performance."

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

• Test Set Sample Size: The document does not specify a numerical sample size (e.g., number of devices, number of clots, number of anatomical models) for the bench tests. It refers to "devices" being tested. For biocompatibility, it refers to "a representative Tigertriever device."
• Data Provenance: The data is based on non-clinical (bench and in vitro) testing conducted by the manufacturer, Rapid Medical Ltd. The country of origin for the testing is not explicitly stated, but the manufacturer is based in Yokneam, Israel. The data is prospective in the sense that these tests were performed for this submission to demonstrate substantial equivalence.

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

• This information is not provided as the submission relies on non-clinical (bench) testing, not on human expert evaluation of images or clinical outcomes that would typically require ground truth establishment by experts.
• The simulated use test involved an "anatomical model," and the interpretation of its "effectiveness" would have been by the testers, not external experts establishing ground truth in the context of diagnostic performance.

4. Adjudication Method for the Test Set

• Again, this is not applicable as there was no clinical test set requiring expert adjudication. The tests described are engineering and chemical performance tests.

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: "A clinical study was not deemed necessary to evaluate the modifications to the Tigertriever Revascularization Device." Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, this entire submission is for a physical medical device (stentriever), not an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

• For the bench tests, the "ground truth" is established by the physical and chemical properties of the device meeting predetermined engineering specifications and international standards (e.g., ISO 10555-1 for tensile strength, USP limits for pyrogenicity). For the simulated use, the "ground truth" is the observed successful performance (clot retrieval, flow restoration) in the in vitro model.
• For biocompatibility tests, the ground truth is based on recognized biological endpoints and standard testing methodologies (e.g., Grade 0 reactivity for cytotoxicity/sensitization, specific SC5b-9 concentrations, non-hemolytic results, acceptable temperature rise for pyrogenicity).

8. The Sample Size for the Training Set

• This is not applicable. The device is a physical stentriever, not an AI model that requires 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 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 13 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 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. The Tigertriever 13 Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.

The provided document does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device called the "Tigertriever 13 Revascularization Device," which is a stentriever used to remove thrombus in ischemic stroke patients. This type of device is a physical medical instrument, not an AI/ML software.

The document discusses non-clinical performance data, including biocompatibility, sterilization, shelf life, and various bench tests for the Tigertriever 13 Revascularization Device. It also mentions pre-clinical animal testing.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device based on the given input.

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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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