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The instrument has been designed to be used with Olympus endo-therapy accessories. The instrument is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

The Single Use Guidewire consists of a Nickle Titanium alloy core wire with a gold coil and hydrophilic, PTFE and silicone coatings. The distal portion of the wire has been specially processed, which includes thinning, to increase the flexibility. This wire has been designed to be used with the Olympus Endo-therapy Accessories.

The provided document is a 510(k) summary for a medical device called "Single Use Guidewire." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, study details, and ground truth establishment is not present in this document.

However, I can extract the information related to the device's performance claims and how equivalence was established.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it states that the performance of the Single Use Guidewire is "substantially equivalent" to a predicate device based on bench testing.

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

The document states that the equivalence was shown through "bench testing." It does not specify the sample size used for these tests, nor does it provide details about data provenance (e.g., country of origin, retrospective or prospective). Bench testing typically involves laboratory-controlled experiments rather than patient data.

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

This document does not describe the establishment of a "ground truth" using experts. Bench testing typically relies on engineering specifications and physical measurements, not expert consensus on clinical cases.

4. Adjudication method for the test set

Not applicable. There is no mention of an adjudication process for a test set, as this involves bench 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 device is a guidewire, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

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

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

For bench testing, the "ground truth" would be the engineering specifications, physical measurements, and performance benchmarks derived from the predicate device or established industry standards for guidewires. This is not explicitly detailed but inferred from the nature of "bench testing."

8. The sample size for the training set

Not applicable. As a physical device demonstrably equivalent through bench testing, there is no "training set" in the context of an algorithm.

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

Not applicable. There is no training set for this type of device.

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