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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 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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The Columbus Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Columbus Guidewire is intended to facilitate the selective placement of therapeutic catheters. This device is not intended for use in coronary arteries.

The Columbus guidewire is a 0.014" diameter steerable guidewire with a deflectable tip to aid in accessing vasculature. The guidewire is supplied sterile (ETO sterilization) and is for single use only. The Columbus guide wire is comprised of a Nitinol braided flexible distal cable, a proximal shaft, an inner core wire and a handle. The braided cable is attached to the proximal shaft via inner connector. The inner core wire runs inside the shaft and the cable from the distal end of the cable to the handle. The distal end of the inner core wire is flattened, looped around and joined to the tip of the distal cable, forming a deflectable tip. In order to actuate the tip deflection in two directions, the Columbus guidewire handle contains a tube assembly section which enables continuous stroke by a self-locking feature. The handle is assembled to the proximal end of the core wire and controls the movement of the distal tip by pulling/pushing the inner moveable core wire, allowing the bending of the distal tip in two directions. Two models are available, Columbus LR (large radius) PN: GWPP4464 which has radius curvature of 4mm and Columbus SR (small radius) PN: GWPP4463 which has radius curvature of 2mm. The Columbus guidewire is provided with a torque accessory to facilitate use of the guidewire and is not intended to contact the patient's body.

The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed in the document provided, specifically for the Columbus Guidewire (K200374).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria (Non-Clinical Performance Tests) and Reported Device Performance:

The document lists various performance bench tests that the Columbus Guidewire underwent, along with the standards they followed and the results. The acceptance criteria for these tests are implied by the "Pass" result, indicating that the device met the requirements outlined in the specified FDA Guidance or ISO standards.

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

• Animal Testing (Pre-Clinical GLP Studies):

  • Sample Size: "a total of 5 swine" were used across two controlled GLP studies.
  • Data Provenance: The studies were conducted in "domestic swine," which implies prospective animal studies. The country of origin is not explicitly stated but is likely where Rapid-Medical Ltd. or its contract research organization operates, given that the company is based in Israel. The studies are described as "controlled GLP studies," indicating a high standard of preclinical research.

• Bench Tests: The document does not specify the exact sample sizes (e.g., number of guidewires tested for each parameter). The data provenance is laboratory-based non-clinical testing.

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

• Animal Testing: The document states "assessments by well qualified experts in accordance with recognized methods, standards, and guidelines." While the exact number of experts is not specified, their qualification is noted as "well qualified experts." This likely refers to veterinary professionals, pathologists, or interventional specialists involved in the animal studies. Specific experience levels (e.g., "10 years of experience") are not provided.

• Bench Tests: The "ground truth" for bench tests is established by adherence to specified engineering standards and internal requirements, not typically by human expert consensus in the same way as clinical or image-based studies. The "experts" involved would be the engineers and quality assurance personnel conducting and interpreting the tests.

4. Adjudication Method for the Test Set:

• Animal Testing: The document does not explicitly state an adjudication method (e.g., 2+1, 3+1) for the expert assessments in the animal studies. It implies a direct assessment by "well qualified experts" following recognized methods, which inherently requires agreement on the observed outcomes (e.g., presence/absence of perforations, thrombus).

• Bench Tests: Adjudication is not typically applicable in the classical sense for bench tests. The "ground truth" is determined by measured physical properties against predefined acceptance criteria.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study (comparing human readers with and without AI assistance on various cases) is generally relevant for AI/imaging devices. The Columbus Guidewire is a mechanical medical device, and its evaluation focuses on physical performance, safety, and functional equivalence rather than diagnostic performance aided by AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

This question is not applicable to the Columbus Guidewire. This device is a physical, mechanical medical guidewire, not an algorithm or AI system. Its "performance" is inherently human-in-the-loop, as it requires a physician to operate it. The bench tests evaluated the device's inherent mechanical properties and functionality.

7. The Type of Ground Truth Used:

• Animal Testing: The ground truth was established through direct observation and assessment by "well qualified experts" during and after the animal procedures. This included angiographic assessment for perforations/dissections/thrombus, and macroscopic assessment of internal organs for thrombi. This can be considered a form of outcomes data (in vivo biological response) from a controlled study.

• Bench Tests: The "ground truth" for bench tests was based on engineering specifications, physical measurements, and adherence to established national and international standards (e.g., FDA Guidewire Guidance, ISO 11070).

8. The Sample Size for the Training Set:

This information is not applicable and not provided in the document. The Columbus Guidewire is a physical medical device, not an AI/machine learning model that requires a training set.

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

This information is not applicable as there is no training set for a physical medical device like the Columbus Guidewire.

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