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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

Explanation: The acceptance criteria are implicitly stated by the "Conclusion" column in the "Testing Summary" and "Biocompatibility" tables, which consistently reports that the device "meets acceptance criteria." The specific quantitative acceptance criteria are not explicitly detailed (e.g., what is the exact tensile strength required), but the summary confirms they were met.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices, number of tests, or number of simulated emboli) used for the various physical and simulated use tests.
• Data Provenance:
  • Simulated Use: The test used a "silicone neurovascular model cast from actual human neurovascular arteries," replicating tortuosity, diameter, and location of arteries. This indicates a benchtop, in vitro model.
  • Other Tests: The other tests (dimensional, tensile strength, radial force, durability, radiopacity, deliverability, curl resistance) are laboratory benchtop tests performed on physical device samples.
  • All testing was conducted by Concentric Medical, Inc. (the submitter), implying an internal, controlled testing environment.
  • The tests are prospective in nature, as they were conducted specifically for this submission.
  • The country of origin of the data is not explicitly stated but is implicitly the country where Concentric Medical, Inc. conducts its R&D and testing, likely the USA given the submission to the FDA.

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

This information is Not Applicable to this submission. The Modified Trevo ProVue Retriever is a physical medical device, not an AI diagnostic algorithm. Ground truth for the performance characteristics of the device is established through physical and simulated benchtop testing, not through expert review of clinical data or images. The "Radiopacity" test mentions "visual assessment," which likely implies assessment by trained personnel (e.g., engineers, quality control specialists) using fluoroscopy, but no details on their qualifications or number are provided, as it's a standard engineering/device performance check.

4. Adjudication Method for the Test Set

This information is Not Applicable to this submission, as it pertains to expert consensus for clinical ground truth in AI studies. The tests conducted are objective physical and performance measurements.

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 information is Not Applicable. This is a submission for a physical medical device. There is no AI component or human-in-the-loop performance being evaluated in this K132641 summary.

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

This information is Not Applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through objective, quantifiable physical and mechanical tests, and simulated use in a validated in vitro model. This implicitly serves as the "ground truth" for its functional characteristics.

• Physical/Mechanical Properties: Measurements directly obtained during testing (e.g., force, dimensions, durability cycles) compared against predetermined specifications.
• Simulated Use: The ability of the device to successfully retrieve simulated thrombus in a anatomically correct (cast from human arteries) silicone neurovascular model.
• Biocompatibility: Laboratory test results (cytotoxicity, hemolysis, physicochemical properties) compared against ISO 10993-1 standards and internal specifications.

8. The Sample Size for the Training Set

This information is Not Applicable. The device is a physical medical device; there is no AI training set involved.

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

This information is Not Applicable. There is no "training set" for this physical medical device.

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