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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.

Ask a specific question about this device