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This device is used for endoscopic removal of stones in the biliary system and for contrast injection.

The subject device is composed of a latex balloon mounted at the distal end of a nylon triple lumen catheter. The balloon can be inflated to four sizes: 8.5 mm, 10 mm, and 15 mm diameters. Radiopaque bands are placed on the catheter to provide fluoroscopic visualization of the catheter and balloon location. The nylon catheter length is 200 cm with a diameter of 6.6 Fr. There is an injection port on the catheter either above the balloon or below the balloon depending on the device model. The catheter also has black ink markings for direct visualization.

This document describes the regulatory clearance (K200247) of the "Fusion Quattro Extraction Balloon" by Wilson-Cook Medical, Inc. It does NOT contain information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for an AI/ML medical device.

The device described is a physical medical device (a balloon catheter for stone extraction), not an AI/ML algorithm. Therefore, many of the requested categories like sample size for test/training sets, data provenance, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

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

The document mentions "performance requirements" but does not detail specific quantitative acceptance criteria or their corresponding reported values in a table. It generally states that the device "met the performance requirements" and "will function as intended."

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

Not applicable. This is a physical device undergoing bench testing, not a clinical study with a patient test set or data provenance in the typical sense for AI/ML. The "testing" refers to non-clinical bench testing.

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):

Not applicable. "Ground truth" in the context of expert consensus or pathology is not relevant for bench testing of a physical device.

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

Not applicable. No expert adjudication process is described for this type of device testing.

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 is a physical device, not an AI system.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. The "truth" for bench testing of this device would be established by engineering specifications and measurement standards, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a physical device, not an AI algorithm.

Summary of available information as it pertains to the request, re-framed for a physical device:

The document describes a 510(k) premarket notification for a medical device called the "Fusion Quattro Extraction Balloon." The clearance is based on substantial equivalence to a predicate device (Fusion Quattro Extraction Balloon XL K063677). The modification involved a change in balloon inflation diameters (8.5 mm, 10 mm, 12 mm, and 15 mm).

Performance Data and Testing:

• Type of Study: Non-clinical bench testing.
• Purpose: To demonstrate the subject device met performance requirements and functions as intended, and does not raise new questions of safety or effectiveness compared to the predicate.
• Tests Conducted:
  • Design Verification Testing
  • Dimensional Verification
  • Functional Testing
  • Fluoroscopic Visibility

The core statement is: "Performance testing consisting of non-clinical bench testing demonstrates the subject device met the performance requirements to fulfill the intended use." However, the document does not provide the specific quantitative "acceptance criteria" or the "reported device performance" values for each test. It simply states that they were met.

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Used for endoscopic removal of stones in the biliary system and for contrast injection.

The subject extraction balloon represents modifications made to existing extraction balloons currently marketed by Cook Endoscopy. The Fusion Quattro Extraction Balloon XL is supplied sterile and intended for single use only.

This document is a 510(k) summary for the Cook Endoscopy Fusion Quattro Extraction Balloon XL. It describes a medical device, and the information provided does not include details about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or ground truth establishment.

Based on the provided text, I am unable to answer your request as the document does not contain the necessary information about acceptance criteria, study details, or performance data for a device in the manner you've described. The document is a regulatory submission for a medical device (a balloon catheter for stone extraction), and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

The "Performance Data" section explicitly states: "We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Process. We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility." This indicates that the submission relies on design control and equivalence to a predicate device, not on a new, detailed performance study with specific acceptance criteria that would typically be described in the format you provided.

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