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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 AXS Catalyst™ Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices.

The AXS Catalyst™ Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neuro vascular system. The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostastic Valve (RHV) and Tuohy Borst valve with sideport for flushing, insertion of catheters and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst.

The medical device in question is the AXS Catalyst™ Distal Access Catheter.

Here's an analysis of its acceptance criteria and the studies that prove its compliance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present acceptance criteria in a quantitative table format for all tests. Instead, it states conclusions for each test, indicating whether the device "meets acceptance criteria" or for biocompatibility, "PASS" and a conclusion.

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

• Bench Testing: The document does not specify the exact sample size for each bench test beyond "Prepare sample for test" or "test sample." However, bench tests are inherently prospective, performed on newly manufactured devices. No country of origin for the data is specified, but as the submitter is Stryker Neurovascular in Fremont, California, the testing likely occurred in the USA or through contracted labs.
• Animal Study: The document states "An animal study was conducted... to evaluate performance design attributes... in an acute animal model." The sample size (number of animals) is not specified. The study was conducted "in compliance with applicable requirements in the GLP regulation (21 CFR Part 58)," typically indicative of prospective, controlled studies, likely in the USA.
• Biocompatibility Testing: The document doesn't explicitly state the sample size for each biocompatibility test (e.g., number of replicates for MEM Elution, number of animals for Sensitization tests). However, these are standard biological tests performed on material samples from the device. These tests are prospective. No specific country of origin is listed for the data, but compliance with ISO 10993 implies internationally recognized standards.

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

This information is not applicable and therefore not provided in the document. The studies conducted are primarily bench (in vitro physical and chemical) and animal (in vivo non-human) performance tests, and biocompatibility tests. These types of studies do not typically involve human expert adjudication of "ground truth" in the same way clinical image interpretation or diagnostic performance studies would. The "ground truth" for these tests is based on objective physical measurements, chemical analyses, or biological reactions against established scientific and regulatory standards (e.g., ISO, EN standards, GLP regulations).

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus building among human experts, usually radiologists or clinicians, to establish ground truth in diagnostic studies. The studies presented here (bench, animal, biocompatibility) rely on objective measurements and established protocols rather than human 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

No MRMC comparative effectiveness study was done. This device is a physical medical device (catheter), not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not relevant.

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

No standalone (algorithm only) performance study was done. This question is relevant to AI/software as a medical device, which this device is not.

7. The Type of Ground Truth Used

• Bench Performance Tests: The ground truth is based on objective physical and mechanical measurements, as compared to pre-defined engineering specifications and relevant international standards (e.g., EN ISO 10555-1, EN 1707). For instance, for Dimensional Verification, the truth is the actual measured dimension compared to a design specification. For Tensile Strength, the truth is the force at which failure occurs compared to a minimum required force.
• Animal Study: The ground truth is derived from in vivo physiological observations and assessments of performance design attributes in an acute animal model, conducted under GLP regulations. This includes direct observation of the device's behavior and effects within the animal's neurovascular system.
• Biocompatibility Tests: The ground truth is based on biological reactions and analytical measurements as defined by the specific protocols in ISO 10993 series of standards. For example, for cytotoxicity, the ground truth is the observed cellular response (e.g., cell lysis grade); for pyrogenicity, it's the temperature rise in rabbits; for hemolysis, it's the percentage of red blood cell lysis.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical catheter, not a machine learning model. Therefore, there is no "training set."

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

This is not applicable, as there is no training set for this device.

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