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The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The Aspiration Catheter, Delivery Catheter, and Base Camp Sheath comprise the Route 92 Medical HiPoint Reperfusion System. The Route 92 Medical HiPoint Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set and the Route 92 Medical Base Camp Sheath System.

The Aspiration Catheter has a single-lumen, coil-reinforced polymer distal shaft section connected to a proximal control wire. The Delivery Catheter is a single-lumen variable stiffness catheter. Both catheters have hydrophilic coating. 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.

The Route 92 Medical Base Camp Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8 French (F) or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.

The provided text describes a 510(k) clearance for the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set. This is a medical device for treating acute ischemic stroke, not an AI/software device. Therefore, the requested information regarding AI acceptance criteria, data provenance, expert ground truth, MRMC studies, standalone performance, and training set details for an AI model cannot be extracted from this document, as it does not pertain to an AI device.

The document focuses on non-clinical and clinical studies (SUMMIT MAX trial) to demonstrate the safety and effectiveness and substantial equivalence of the mechanical device to a predicate device.

However, I can provide the acceptance criteria and performance data for the mechanical device as presented in the document:

Device: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set

Study: SUMMIT MAX, a prospective, multi-center, randomized, controlled, interventional, open-label clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The efficacy endpoint was met with superiority (implied by p-value < 0.0001 in superiority context and the large positive difference outside the non-inferiority margin), and the safety endpoint met non-inferiority.

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

• Test Set Sample Size:
  • Effectiveness Endpoint (primary):
    • Route 92 arm: N=89
    • Vecta arm: N=77
  • Safety Endpoint (primary):
    • Route 92 arm: N=84 (denominator for sICH, based on sICH calculation out of 89 total patients in Route 92 arm and 77 in Vecta arm)
    • Vecta arm: N=75 (denominator for sICH, based on sICH calculation out of 89 total patients in Route 92 arm and 77 in Vecta arm)
  • The "mITT" (Modified Intent to Treat) cohort comprised 166 participants (N=89 Route 92 arm, N=77 Vecta arm), which was used for primary endpoint analysis.
• Data Provenance: Prospective, multi-center clinical trial. Country of origin not explicitly stated but implied to be multinational given "applicable country regulations" and "IRB / Ethics Committee" implies regulatory approval beyond a single nation. The medical history table includes "Maori" as a race category, suggesting participation from New Zealand.

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

• For mTICI (Effectiveness Endpoint): Adjudicated by an "independent blinded core lab." Specific number and qualifications of experts not detailed.
• For sICH (Safety Endpoint): Identified by the "core lab" and adjudicated by the "clinical events committee." Specific number and qualifications of experts not detailed beyond being "independent" and "blinded."

4. Adjudication Method for the Test Set

• Effectiveness (mTICI): "Adjudicated by an independent blinded core lab."
• Safety (sICH): "Identified by the core lab and adjudicated by the clinical events committee."
• The specific structure of the adjudication (e.g., 2+1, 3+1) is not provided. It simply states "core lab" and "clinical events committee" for adjudication.

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

• No. This was a clinical trial comparing two mechanical devices (reperfusion systems), not an AI device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.

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

• Not applicable. This is a mechanical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Effectiveness: Angiographic outcome (modified Thrombolysis in Cerebrovascular Infarction (mTICI) score ≥ 2b), adjudicated by an independent blinded core lab. This can be considered a form of expert consensus/adjudicated imaging outcome.
• Safety: Clinical outcome (symptomatic intracranial hemorrhage), identified by an independent blinded core lab and adjudicated by an independent blinded clinical events committee. This is based on clinical events and imaging findings interpreted by experts.
• Other Outcomes: Modified Rankin Scale (mRS) at 90 days (patient-reported outcome/clinical assessment), time from groin puncture to final angiogram, etc., all based on clinical trial data collection.

8. The Sample Size for the Training Set

• Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not applicable. This is a mechanical device, not an AI model.

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