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The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).

The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

The provided document is a 510(k) summary for the Millipede 088 Access Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a standalone clinical study to prove the device meets those criteria.

Therefore, the document does not contain the information requested in points 2, 3, 4, 5, 8, and 9, and only partially addresses points 1, 6, and 7.

Here's a breakdown of what can be extracted:

1. Acceptance Criteria and Reported Device Performance

The document lists various performance tests and their conclusions, indicating that the device met "established specifications" or was "suitable for its intended use." However, the specific quantitative acceptance criteria for each test are not provided. The reported device performance is qualitative rather than quantitative in most cases.

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

The document does not specify the sample sizes for the individual performance tests beyond implicitly suggesting multiple samples were tested (e.g., "test specimens," "test articles"). For the Animal Testing, it states "two studies in a porcine model."

The data provenance for the in vitro and animal studies isn't explicitly stated beyond "Good Laboratory Practices" for the animal studies, which is a standard of conduct rather than a geographic origin. No human data is presented.

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)

This information is not provided as the submission relies on objective performance testing, biocompatibility studies, and animal studies rather than expert-derived ground truth from human data for this type of device.

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

Not applicable. The evaluation methods described are objective performance tests and animal studies, not human data requiring expert 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

Not applicable. This device is an access catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

Yes, the performance testing described (mechanical, dimensional, coating integrity, etc.) and the animal studies represent "standalone" evaluations of the device's physical and functional properties without human interpretation of data in a clinical context.

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

For the performance and biocompatibility tests, the "ground truth" is defined by the established specifications, relevant ISO standards, and comparison to control devices or predicate devices. For example:

• "The device met established specifications."
• "The test article is non-cytotoxic."
• "The particulate size and count were similar to control devices."
• "The radiopacity of the Millipede 088 Access Catheter was similar to a control device."
• For animal testing, "Usability, radiopacity, thromboresistance, and vessel injury were assessed," and "The results for the subject device were comparable to a control device."

8. The sample size for the training set

Not applicable. This device is a medical catheter and does not involve a "training set" in the context of machine learning or AI. Its performance is evaluated through engineering and biological testing.

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

Not applicable (as above).

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The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Tubing Kit is intended 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.

The SOFIA Plus Aspiration Catheter is a single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during navigation in the vasculature. A luer fitting on the microcatheter hub is used for the attachment of accessories. The strain relief at the hub provides kink resistance for the proximal end. A steam shaping mandrel and introducer sheath are also packaged with the catheter. The SOFIA Plus Aspiration Catheter is used to remove thrombus/embolus from the neurovasculature using aspiration tubing and pump.

The provided text describes a 510(k) premarket notification for a medical device, the SOFIA Plus Aspiration Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided does not align with the typical structure of an AI/ML medical device study demonstrating algorithmic performance against acceptance criteria.

The document primarily details the pre-clinical testing on the device itself and an animal study to evaluate its aspiration performance and safety. It does not describe an AI/ML algorithm or a study of its performance.

However, I can extract and structure the information about the acceptance criteria and performance of the physical device based on the provided text, while acknowledging that this is not an AI/ML study.

Here's an interpretation of the request using the available information:

The SOFIA Plus Aspiration Catheter underwent extensive pre-clinical testing to demonstrate its performance and substantial equivalence to a predicate device. The acceptance criteria for these tests were typically defined by established specifications, industry standards (e.g., ISO), or direct comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for each bench test. Instead, it refers to "test articles" and general results (e.g., "Test articles achieved a rating...") and in some cases, "two out of two test sites" for the animal study.

• Test Set Provenance: The tests are pre-clinical bench tests performed by the manufacturer (MicroVention, Inc., Tustin, California, USA) and an animal study (swine model). The information does not specify the country of origin of data in terms of retrospective/prospective human patient data, as this is not a human clinical trial. All tests would have been performed prospectively as part of the device development and submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the document describes pre-clinical physical device testing and an animal study, not an AI/ML algorithm study that requires expert adjudication of image-based ground truth. For the simulated-use tests, the performance ratings (e.g., $\geq3$) would be based on qualitative assessment by trained personnel, but they are not referred to as "experts" in the context of clinical ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/ML algorithm study involving interpretation of clinical data by multiple readers, there is no need for an adjudication method like 2+1 or 3+1.

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

No, this was not done. This document pertains to the 510(k) clearance of a physical medical device. MRMC studies are typically performed for AI-driven diagnostic or assistive technologies to assess their impact on human reader performance.

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

No, this was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering Specifications and Standards: For dimensional, mechanical, and safety properties (e.g., ISO standards, specified psi limits, force at break criteria).
• Comparative Performance to Predicate Devices: Performance attributes (e.g., stiffness, vacuum pressure, torque response) were compared to the legally marketed predicate device (Penumbra Reperfusion Catheter ACE64 and ACE68).
• Animal Study Observations: For aspiration performance and histopathological evaluations in a swine model.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML study, therefore there is no training set for an algorithm.

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

Not applicable. As there is no AI/ML algorithm training set.

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