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The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is indicated for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

The Aspiration Catheter and Tenzing 7 Delivery Catheter comprise the Route 92 Medical Full Length 070 Reperfusion System. The Route 92 Medical Full Length 070 Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set.

The Aspiration Catheter is a single-lumen, coil-reinforced variable stiffness catheter. The Tenzing 7 Delivery Catheter is a single-lumen variable stiffness catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.

The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.

For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set, along with a legally marketed canister and accessories kit.

The provided document, a 510(k) K223530 Premarket Notification for the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set, does not contain information about an AI-powered device or a study involving AI assistance for human readers. It describes a medical device (a catheter system for stroke treatment) and a series of non-clinical, benchtop, and animal studies to demonstrate its safety and effectiveness.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device's performance, as the document does not pertain to an AI device.

However, I can provide a summary of the acceptance criteria and the studies conducted for the medical device described in the document, as it meets the general structure of the request for device performance and testing.

Acceptance Criteria and Study for the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

This document describes the testing and acceptance criteria for a physical medical device, not an AI-powered one. The studies focus on the physical and functional performance of the catheter system.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various tests and their corresponding results, with the acceptance criterion implicitly being "PASS" for all samples meeting pre-determined criteria.

2. Sample Size and Data Provenance:

• Sample Size: The document repeatedly states "All samples" met predetermined acceptance criteria for the non-clinical (benchtop) tests. Specific numerical sample sizes are not provided for these tests. For the animal studies, it mentions "Two chronic animal studies."
• Data Provenance: The data is derived from controlled laboratory and animal studies, not patient data. The country of origin is not explicitly stated, but the company is based in San Mateo, California, implying the studies were likely conducted in the US or under US regulatory standards. The studies are by nature prospective, as they are designed to test the device's performance according to predefined protocols.

3. Number of Experts and Qualifications for Ground Truth for the Test Set:

• This device clearance is based on demonstrable physical and functional properties, guided by engineering standards and biological testing, rather than human expert interpretation of data for ground truth (like in an AI imaging study).
• Therefore, the concept of "experts establishing ground truth for the test set" in the context of human interpretation of medical images (which is relevant for AI) does not apply directly to this type of device testing. Ground truth here is established through objective measurements, chemical analyses, and direct observation of physical performance against established engineering and biological standards (e.g., ISO standards, GLP for animal studies).

4. Adjudication Method for the Test Set:

• Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where human readers provide subjective assessments that need to be aggregated or resolved.
• For the non-clinical and animal studies described, no such adjudication method is mentioned or relevant. The results are quantitative measurements or observations against predefined pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to assess the impact of an AI system on human reader performance, typically in diagnostic imaging.
• The document describes testing for a physical medical device (catheter and tubing), not an AI system. Its "effectiveness" is demonstrated through its physical performance (e.g., ability to retrieve clots in a simulated environment, biocompatibility, durability) and successful outcomes in animal models.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No, a standalone study in the context of an "algorithm only" was not done. As stated, this is a physical medical device. The "performance testing" sections describe the standalone performance of the physical device components (e.g., tensile strength, lumen patency).

7. Type of Ground Truth Used:

• Objective Test Results: For non-clinical (benchtop) tests, the "ground truth" is established by direct measurement and observation against pre-defined engineering specifications and international standards (e.g., ISO standards).
• Biological Outcomes: For biocompatibility, ground truth is established through standardized biological assays (e.g., cytotoxicity, sensitization, irritation tests) with clear pass/fail criteria.
• Animal Study Observations: For animal studies, ground truth involves in-life observations, and post-mortem assessment of relevant tissues, as well as the demonstration of safety and predetermined performance parameters (e.g., clot retrieval). The studies were conducted according to Good Laboratory Practices (GLP), which ensures scientific rigor and documented results as "ground truth."

8. Sample Size for the Training Set:

• Not applicable. This document describes the clearance of a medical device based on its physical and biological performance, not an AI model that requires a training set.

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

• Not applicable. There is no training set mentioned or implied in this document as it does not relate to an AI device.

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