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The MantaRay Reperfusion Catheters, with the Imperative Care Aspiration Tubing Set and Imperative Care Aspiration Pump (or equivalent vacuum pump), are 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) or who fail IV t-PA therapy are candidates for treatment.

The Imperative Care Aspiration Tubing Set is intended to connect the Imperative Care Reperfusion Catheter to the canister of the Imperative Care Aspiration Pump and to allow the user to control the fluid flow.

The MantaRay Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source generated from the Imperative Care Aspiration Pump using the Imperative Care Aspiration Tubing. The MantaRay Reperfusion Catheter will be offered with various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.

The MantaRay Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.

The distal section of the MantaRay Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.

The MantaRay Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.

This document describes the premarket notification (510(k) summary) for the MantaRay Reperfusion Catheters and Imperative Care Aspiration Tubing Set. The study primarily relies on a "substantial equivalence" argument by comparing the subject device to a predicate device (Penumbra System Reperfusion Catheter) through various bench, lab, and animal tests, rather than a standalone clinical study demonstrating a specific clinical outcome or a multi-reader, multi-case study for human-AI improvement.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comprehensive table (Table 4) detailing various test attributes and their corresponding specifications, which serve as acceptance criteria. The "Results" column in this context indicates that all tests passed or met these specifications, demonstrating the device's performance.

Biocompatibility Test Summary (Table 5)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Description: The document focuses on bench, lab (in-vitro), and animal testing for substantial equivalence. There isn't a "test set" in the traditional clinical trial sense with human patient data.
• Sample Size:
  • Bench and Lab Testing: The largest and smallest diameter catheter sizes for both the subject and predicate devices were tested for the various performance attributes. The exact number of units per test is not specified, but the testing was conducted per "company approved protocols and test methods based primarily on catheter performance standard ISO 10555-1."
  • Animal Studies: Performed in a porcine model. The number of animals used is not specified directly for the main animal study, but the thrombogenicity test was "Performed in duplicate."
  • Biocompatibility Testing: Guinea pigs and rabbits were used for sensitization and irritation tests, respectively. Mice were used for acute systemic injection tests. The number of animals per test is not explicitly stated in the summary table.
  • Physician Validation Study: Active US physicians experienced in interventional neuroradiology and neurovascular surgery were recruited. The number of physicians is not specified.
• Data Provenance: Not explicitly stated as country of origin of the data. All studies were conducted to support a US FDA 510(k) submission, implying they meet US regulatory standards. The animal and lab tests are pre-clinical. The physician validation study involved "US physicians." The nature of these studies is prospective as they were designed specifically to evaluate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Bench and Lab Testing: The "ground truth" for these tests are the defined engineering specifications (acceptance criteria) and physical measurements. These are established by engineering standards (e.g., ISO 10555-1) and internal company protocols. No external "experts" in the sense of clinical specialists are mentioned for establishing ground truth for these quantifiable measures.
• Animal Studies: The evaluation of vascular response and pathological findings was "histologically comparable" to the predicate device. This implies assessment by experts (likely veterinary pathologists), but their number and specific qualifications are not detailed.
• Physician Validation Study: "Active US physicians experienced in interventional neuroradiology and neurovascular surgery" participated. They performed clot retrieval procedures, and their performance/feedback constituted the evaluation. Their number and years of experience are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• There is no mention of an adjudication method in the context of expert consensus or dispute resolution for a "test set" of clinical cases. The various performance tests are against defined specifications or compared to a predicate device in controlled environments.
• For the physician validation study, the "results... were analyzed and compared," implying a statistical comparison rather than an expert adjudication process for ground truth.

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 MRMC comparative effectiveness study was done in the context of AI assistance. This document describes a medical device (catheter and aspiration system), not an AI device for diagnostic imaging or interpretation.
• The Physician Validation Study (Section L) involved physicians performing procedures with both the subject and predicate devices, demonstrating usability and comparable performance, but it was not a comparative effectiveness study designed to measure the improvement of human readers with AI assistance. It was a usability/performance study for a physical medical device.

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

• This question is not applicable. The device described, the MantaRay Reperfusion Catheter and Aspiration Tubing Set, is a physical medical device (catheter system) for mechanical thrombectomy, not an algorithm, AI, or software-only device. Its performance is inherently tied to human use (human-in-the-loop) and the mechanical action of aspiration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Bench and Lab Testing: Engineering specifications, physical measurements, and performance against industry standards (e.g., ISO 10555-1).
• Animal Studies: Histological analysis of vascular response and pathological findings; direct observation of successful revascularization, absence of perforation, dissection, or thrombosis. Comparison to the predicate device served as the control.
• Biocompatibility Testing: Standardized biological test methods (e.g., ISO 10993-x series) with defined pass/fail criteria.
• Physician Validation Study: Direct observation of procedural success in a simulated model (clot retrieval), and comparison of performance metrics between the subject and predicate devices.

8. The sample size for the training set

• This question is not applicable as the studies described are for regulatory clearance of a physical medical device. There is no mention of machine learning or an "AI" component requiring a training set in the document.

9. How the ground truth for the training set was established

• This question is not applicable, as there is no "training set" for an AI or machine learning model in this submission.

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