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The Slinky Catheter is indicated for general intravascular use. including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents and therapeutic devices. It is not intended for use in coronary arteries.

The Slinky® Catheter is a single lumen, variable stiffness catheter with a coil and braid reinforcement. It has a radiopaque marker at the distal tip for enhanced fluoroscopic visualization, a lubricious inner, and a hydrophilic coating on the distal 35 cm to enhance lubricity and vascular navigation. The Slinky® Catheter is provided sterile via Ethylene Oxide (EO) sterilization, non-pyrogenic, and is for single use only.

This document describes the premarket notification (510(k)) for the Anoxia Medical, Inc. Slinky Catheter. The primary purpose of the submission is to demonstrate substantial equivalence to a predicate device, the SOFIA PLUS/Distal Access Catheters (K150366). The document does not describe a study involving an AI component or the improvement of human readers with AI assistance. Instead, it focuses on the engineering and biocompatibility performance of the Slinky Catheter.

Since the prompt asks for details related to AI performance, multi-reader multi-case (MRMC) studies, and the use of expert consensus for ground truth in an AI context, and the provided text describes a medical device (a catheter) and its physical and biological performance, I will interpret the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, adapting the categories to fit the provided information on a physical medical device rather than an AI or software product.

Here's an analysis based on the provided text for the Slinky Catheter, focusing on its performance criteria and the studies conducted:

1. A table of acceptance criteria and the reported device performance

The document provides a table of various tests, their methods, and conclusions. The "Conclusions" column effectively serves as the "reported device performance" and implicitly indicates that the acceptance criteria were met, as all conclusions state the device performed as intended, met established criteria, or was comparable to the predicate.

2. Sample size used for the test set and the data provenance

• Sample Size for Bench Tests:
  • Simulated Use, Product Compatibility, Torque Strength, Dynamic Burst, Peak Tensile Force, Freedom from Leakage, Durability/Lubricity: Not explicitly stated as a number, but "Test articles" and "Devices" implies multiple units were used for each test.
  • Simulated Use, Product Compatibility: "Test articles were used by three trained interventional neuroradiologists."
• Sample Size for Biocompatibility Tests: Not explicitly stated as numbers (e.g., how many guinea pigs, how many cell cultures). The phrase "Study animals" is used.
• Data Provenance: The document does not specify the country of origin for the data. The tests performed are standard bench tests and regulated biocompatibility studies, following ISO and ASTM standards. The studies were conducted in accordance with 21 CFR Part 58 Good Laboratory Practices, which are US regulations. It's a prospective test in the sense that these tests are performed on the manufactured device models to demonstrate their performance characteristics for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• For Simulated Use and Product Compatibility bench testing: three trained interventional neuroradiologists were used. Their specific years of experience are not mentioned, but they are identified as "trained interventional neuroradiologists."
• For other tests, "ground truth" is established by adherence to specified test methods (e.g., ISO, ASTM standards) and their quantitative or qualitative pass/fail criteria, rather than expert consensus on, for example, image interpretation.

4. Adjudication method for the test set

• The document does not describe an adjudication method in the context of multiple expert readers or interpretations. For the "Simulated Use" and "Product Compatibility" tests where three neuroradiologists participated, it's not stated how disagreements, if any, were resolved; however, the conclusion states the device "performed as intended" and "was found to be compatible," suggesting a consensus or successful outcome observed by all. This is not a formal adjudication process as would be seen in an imaging study.

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, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (a catheter), not an AI or software device. Therefore, the concept of human readers improving with AI assistance is not applicable to this document. The "three trained interventional neuroradiologists" participated in simulated use bench testing to evaluate the physical interaction and performance of the catheter in a model, not to read images or interpret data generated by the device in terms of AI output.

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

• This question is not applicable as the device is a physical catheter, not an algorithm or AI product.

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

• The "ground truth" for the catheter's performance is established through bench testing against established engineering and biocompatibility standards (ISO, ASTM) and comparison to the predicate device's characteristics.
  • For dimensional and physical properties: direct measurement and adherence to specifications.
  • For functional properties (e.g., kink resistance, torque strength, flow rate): performance against defined quantitative criteria or qualitative observations (e.g., performs as intended).
  • For biocompatibility: results from standardized biological assays performed on animal models, cell cultures, or blood samples, with pass/fail criteria defined by the ISO 10993 series and other relevant standards.
  • For simulated use: observation by trained physicians against expected performance.
• The overall "ground truth" for regulatory clearance is substantial equivalence to the predicate device, demonstrated by meeting comparable performance characteristics through these tests.

8. The sample size for the training set

• This question is not applicable. This document describes performance testing for a physical medical device, not the development or validation of an AI/ML algorithm that requires a training set.

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

• This question is not applicable for the same reason as above.

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The CEREGLIDE™ 71 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE™ 71 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

The CEREGLIDE™ 71 Intermediate Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the end of the catheter hub. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a Tuohy Borst rotating hemostasis valve (RHV) with a side port and two slit introducers as accessories. The RHV with side port is used for flushing and insertion of catheters. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter.

The CEREGLIDE™ 71 Intermediate Catheter is a medical device for facilitating neurovascular interventions. The document provided outlines the non-clinical performance data to demonstrate its substantial equivalence to a legally marketed predicate device, the CERENOVUS Large Bore Catheter (K191237).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CEREGLIDE™ 71 Intermediate Catheter are implicitly defined by a series of bench tests and biocompatibility tests, with the reported performance consistently being "PASS" or "Samples met the established acceptance criteria," sometimes exceeding comparator devices.

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

The document states: "All testing was conducted using sampling methods as required by internal procedure." Specific sample sizes for each test are not explicitly provided.

The data provenance is non-clinical bench testing and in-vitro testing. There is no mention of human clinical data or patient data. Therefore, there is no country of origin or retrospective/prospective distinction for patient data.

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

Not applicable. This device's evaluation relies on objective engineering and material science tests (bench and in-vitro, and biocompatibility tests), not expert interpretation of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" established by experts in this context.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required for ambiguous cases. As the studies described are bench and biocompatibility tests, human adjudication is not relevant.

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 conducted as this is a device clearance based on substantial equivalence using non-clinical performance data, not an AI or diagnostic imaging device requiring human reader interaction.

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

Not applicable. This pertains to an intermediate catheter, which is a physical medical device, not a software algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the non-clinical tests is established by pre-defined engineering specifications, material properties, and regulatory standards (e.g., ISO standards, ASTM methods, USP guidance). The device's performance is compared against these objective criteria. For the biocompatibility tests, the "ground truth" is typically the absence of adverse biological reactions as defined by the specific test (e.g., no cytotoxicity, no sensitization, no irritation).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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