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The YOGA Microcatheter is intended for use in peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.

The YOGA Microcatheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. The catheter shaft is composed of a variable pitch stainless steel braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with a polymer material, which encapsulates the stainless steel braid construction. The distal end of the catheter has a radiopaque marker band and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a hub and an ID band is placed at the distal end of the hub over a strain relief. A steam shaping mandrel is provided in the package. The two new YOGA Microcatheters are provided in back up (XB) and extra backup (XXB) configurations, i.e. a stiffer distal end to provide additional support.

The provided text is for a 510(k) premarket notification for a medical device called the "YOGA Microcatheter". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study described in the prompt.

Therefore, the document does not contain the detailed information necessary to answer the prompt's questions. The prompt is designed to elicit information about a study that assesses AI/algorithm performance (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance), which typically involves a test set, ground truth experts, and statistical analysis against predefined acceptance criteria. This 510(k) submission, however, details the physical and functional characteristics of a medical catheter and demonstrates its similarity to a previously approved device through bench testing, not a diagnostic study involving AI or image analysis.

Here's why the information isn't present:

• Device Type: The YOGA Microcatheter is a physical medical device (a catheter), not a software algorithm, diagnostic imaging tool, or AI system. Its performance is evaluated through physical and functional characteristics (e.g., stiffness, trackability, biocompatibility, sterilization) rather than diagnostic accuracy metrics.
• Regulatory Pathway: A 510(k) submission seeks to establish "substantial equivalence" to a predicate device. This often involves demonstrating similar technological characteristics and performance through bench testing, not necessarily conducting large-scale clinical trials or diagnostic accuracy studies like those performed for AI/CAD devices.
• Nature of Testing: The "Performance Data" section describes "Bench Test Summary" including Linear Stiffness, Lateral Stiffness, and Track Testing. These are engineering tests, not studies involving human readers, ground truth consensus for imaging data, or AI performance metrics.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria for an AI/algorithm, sample sizes for test/training sets, expert qualifications, or MRMC studies, as this information is not present in the provided 510(k) document.

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The YOGA Microcatheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.

The YOGA Microcatheter is a variable stiffness, end to end braided single lumen catheter designed to access small, tortuous vasculature. The microcatheter has an outer hydrophilic coating that provides lubricity during navigation of vessels. The lubricious PTFE lined inner lumen is designed to facilitate movement of guide wires and other devices. A radiopaque marker band is provided at the catheter tip to aid fluoroscopic visualization. A luer fitting located on the proximal end of the catheter hub is used to attach accessories. A steam shaping mandrel is provided in the package.

The provided document describes the substantial equivalence determination for the YOGA Microcatheter (K162563) based on its comparison to a predicate device, the ENVOY DA Guiding Catheter (K140080), and other reference devices. The focus of the provided text is on demonstrating the device's functional integrity and biological compatibility through various performance tests, rather than clinical efficacy as would be seen with an AI/ML device.

Here's an analysis of the "acceptance criteria and the study that proves the device meets the acceptance criteria" based on the provided text, structured to address your specific points:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the YOGA Microcatheter are implicitly defined by the "PASS" results for each of the performance tests listed. The device is deemed to meet these criteria if its performance matches or is equivalent to established standards or those of the predicate device.

Study Details

The provided document describes physical and biological performance testing for a medical device (microcatheter), not an AI/ML device. Therefore, many of your specific questions regarding AI/ML studies (like ground truth, experts, MRMC, standalone performance) are not applicable to this submission. However, I will answer the relevant points based on the provided text.

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document states that "All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures." However, specific sample sizes for each test are not provided in this document.
   • Data Provenance: The tests are "bench" (in vitro) and "animal" (in vivo) tests conducted by the manufacturer, Codman & Shurtleff, Inc. The document does not specify the country of origin for the animal studies, but the manufacturer is based in Raynham, Massachusetts, USA. The studies are prospective as they were conducted to support the 510(k) submission.

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

   • This question is not applicable as the document describes performance testing for a physical medical device, not an AI/ML algorithm requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests is based on established engineering and biological standards (e.g., ISO, ASTM, USP).

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

   • This is not applicable. Adjudication methods are typically relevant for human review of AI/ML outputs or clinical endpoints with subjective interpretation. For the physical and biological tests described, the determination of "PASS" or "FAIL" would be based on objective measurements against pre-defined acceptance criteria, not an adjudication process involving multiple human reviewers.

4. 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:

   • This is not applicable. This document describes the clearance of a physical medical device and does not involve AI or human readers.

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

   • This is not applicable. The device is a microcatheter, a physical instrument, not an algorithm.

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

   • The "ground truth" for the device's performance is based on established engineering standards, international standards (ISO, ASTM, USP), and validated internal design control procedures. For example, tensile strength is measured against engineering specifications, biocompatibility against ISO 10993 standards, and flow rates against ISO 10555-1. For radiopacity, the ground truth is the visual confirmation by a qualified individual (presumably a radiologist or veterinarian during the animal study) that the catheter is visible under fluoroscopy.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is not an AI/ML device.

8. How the ground truth for the training set was established:

   • This is not applicable. There is no "training set" for this physical device.

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