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072 Aspiration Catheter: As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction 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, 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 therapy are candidates for treatment.

Aspiration Tubing: As part of the 072 Aspiration System, the Aspiration Tubing is intended to connect the 072 Aspiration Catheter to a compatible suction pump.

The 072 Aspiration Catheter is a single lumen, variable stiffness catheter. The catheter has a hydrophilic coating to reduce friction during use. The catheter includes radiopaque markers on the distal end for angiographic visualization and a Luer hub on the proximal end allowing attachments for flushing and aspiration. The Delivery Tool is an optional accessory for use with the 072 Aspiration Catheter and should be removed prior to aspiration. The 072 Aspiration Catheter, Delivery Tool. Rotating Hemostasis Valve, and Flow Switch are included in the package. The Aspiration Tubing is provided in a separate package. For the aspiration source, the 072 Aspiration Catheter is used in conjunction with a compatible suction pump with prespecified performance parameters that is connected using the Aspiration Tubing.

Here's a breakdown of the acceptance criteria and study information for the Q'Apel Medical, Inc. 072 Aspiration System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally phrased as meeting "predetermined acceptance criteria" or specific ISO standards. The reported device performance for all bench tests and animal studies is "Pass," indicating that all samples met the defined criteria.

Note: For bench tests, specific numerical acceptance criteria are not detailed in the provided summary, only the general statement that "All samples met the predetermined acceptance criteria." For biocompatibility, the specific numerical acceptance criteria are listed.

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

• Bench Testing: The document consistently states "All samples met the predetermined acceptance criteria" for each bench test. However, the exact numerical sample size for each specific bench test is not provided.
• Animal Study: The study involved a "porcine model." The exact number of animals used is not specified. The study was conducted "according to Good Laboratory Practices (GLP) per 21 CFR Part 58," which indicates controlled experimental conditions.
• Data Provenance:
  • Bench Testing: In-house testing by Q'Apel Medical, Inc.
  • Animal Study: Experimental, prospective study in a porcine (animal) model.

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

• Bench Testing: Not applicable in the context of expert ground truth. These tests likely involved technicians or engineers following standardized protocols.
• Animal Study: The document doesn't specify the number or qualifications of experts (e.g., veterinarians, pathologists) involved in establishing ground truth (e.g., assessing vessel histology or clot aspiration results). It mentions that "Sub-chronic and chronic time points were assessed" and that "Clot aspiration and wedge assessment were comparable between the test and control catheters, and both were shown to be safe in porcine vessels via angiography and vessel histology." This implies expert assessment of the outcomes, but details are absent.

4. Adjudication Method for the Test Set

• Bench Testing: Not applicable. Bench tests typically rely on objective measurements against predefined specifications.
• Animal Study: Not specified. While the results were declared "comparable" and "safe," it's not explicitly stated if multiple experts reviewed the outcomes and how any discrepancies were resolved.

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

• No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes and to support the substantial equivalence of the 072 Aspiration System." Therefore, there is no effect size reported for human readers with and without AI assistance.

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

• Not applicable. The device is a physical medical instrument (an aspiration catheter system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance reviewed is the device's physical function.

7. The Type of Ground Truth Used

• Bench Testing: Reference standards (e.g., ISO standards), design specifications, and comparison to a reference device (K211564 for simulated use particulates) were used to establish "ground truth" (i.e., expected performance).
• Animal Study: Angiography and vessel histology were used as ground truth for assessing safety and effectiveness (clot aspiration, wedge assessment, tissue response) in the porcine model. These are objective measures collected during and after the animal procedures.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical instrument, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data used to train an AI model.

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

• Not applicable. As stated above, this is not an AI device, so there is no training set or ground truth for a training set.

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