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The SpyGlass Discover Balloon Dilation Catheter is indicated for laparoscopic and open surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.

The SpyGlass Discover Balloon Dilation Catheter is a sterile, single use device. The device is a double-lumen catheter manufactured with a nylon copolymer shaft. The distal tip of the catheter consists of a NyBax™ balloon and is available in diameters of 6, 7, and 8 millimeters, and a length of 40 millimeters. The SpyGlass Discover Balloon Dilation Catheter accepts a 0.035-inch diameter guidewire.

The provided text is a 510(k) summary for a medical device called the "SpyGlass Discover Balloon Dilation Catheter." This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria for an AI/algorithm-driven system. Therefore, most of the requested information regarding acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies for an AI/algorithm is not applicable or present in this document.

The document primarily focuses on bench testing to demonstrate the physical and mechanical characteristics of the catheter.

Here's a breakdown of what can be extracted from the text in relation to your request, and what cannot:

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

The document describes tests conducted and generally states "Test results indicated an acceptable..." for each. It does not provide specific quantitative acceptance criteria values or the quantitative reported performance values. The closest it comes to "criteria" are the "pre-defined performance specifications" mentioned vaguely for biocompatibility testing.

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

• Sample Size: Not specified. The document states "Non-clinical performance bench testing was completed," implying lab-based tests, but no number of samples tested for each criterion is given.
• Data Provenance: Not applicable in the context of clinical data for a 510(k) for a physical device. These are bench tests.

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

• Not applicable. This is not an AI/algorithm submission requiring expert-established ground truth. The "ground truth" for these tests would be the measurement results against engineering specifications.

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

• Not applicable. This concept is relevant for clinical studies with human assessors, not for bench testing of a physical device.

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 medical device, not an AI/algorithm-driven system.

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

• Not applicable. This is a physical medical device.

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

• Not applicable in the sense of clinical "ground truth." For bench testing, the "ground truth" is typically defined by engineering principles, industry standards, and the device's design specifications.

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

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

• Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (a balloon dilation catheter), not an AI/algorithm product. Therefore, most of the questions pertaining to acceptance criteria and studies for AI/algorithm performance are not addressed or are irrelevant to this specific submission. The "study that proves the device meets the acceptance criteria" in this context refers to a series of bench tests demonstrating the physical and mechanical performance of the catheter, and the "acceptance criteria" are implied engineering specifications that the device's performance must meet (e.g., "acceptable balloon diameter").

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