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This instrument has been designed to be use with Olympus Endo-therapy Accessories. The instrument is used as guidwire of endoscopic accessories for billiary duct, including not only common bile but cystic, pancreatic, right and left hepatic ducts

G-201-35-45, G-202-35-45 are resin-treated coated gidwire. Removal of the guidewire is not necessary during sphinctecterotomy . G-201-35-45 is straight distal portion type, G-202-35-45 is angle distal portion type. These instruments have been designed to be used with Olympus Endo-Therapy Accessories. which are applicable for φ0.89mm (0.035 inch) diameter guidewires. These instruments are equipped with Laser-markers at the distal portion to conform guidewire placement under fluoroscopy endoscopic maneuvering.

This document is a 510(k) premarket notification for the Olympus Disposable Guidewire, models G-205-3545S and G-205-3545A. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for a new AI/software device. Therefore, much of the requested information regarding acceptance criteria, study methodologies, and AI-specific details is not present in this document.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria or specific performance metrics for the device. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device.

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

This information is not provided. The document describes a comparison to a predicate device and notes "non-clinical tests" but does not detail the methodology or sample sizes of these tests.

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)

This information is not applicable and not provided. The device is a physical guidewire, not an AI/software device that requires expert-established ground truth for performance evaluation in the context of this 510(k).

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

This information is not applicable and not provided.

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

This information is not applicable and not provided. The device is a physical guidewire, not an AI product.

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

This information is not applicable and not provided.

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

This information is not applicable and not provided.

8. The sample size for the training set

This information is not applicable and not provided. The device is not an AI/machine learning product.

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

This information is not applicable and not provided.

Summary of what can be gleaned from the document regarding the device's assessment:

• Device Name: Olympus Disposable Guidewire, Models G-205-3545S and G-205-3545A.
• Purpose of filing: 510(k) premarket notification to demonstrate substantial equivalence.
• Predicate Device(s):
  • Guide Wire G35-2LB (Olympus Optical Co.,Ltd.) #K933110
  • Climber (Terumo) #K971937
  • Lagwire 5658-1/5659-1 (Boston Scientific) #K922302
• Method of demonstrating equivalence: "Summary including Conclusions drawn from Non-clinical Tests" (Section F).
• Conclusion of non-clinical tests: "When compared to the predicate device, Disposable Guidewire G-205-3545S, G-205-3545A does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness."
• Intended Use: To be used with Olympus Endo-therapy Accessories as a guidewire for endoscopic accessories in the biliary duct, including common bile, cystic, pancreatic, right, and left hepatic ducts.

In essence, this document is a regulatory submission for a physical medical device. It does not contain the type of detailed information requested for a software or AI-driven diagnostic device. The "study" mentioned is likely a series of non-clinical bench tests and comparisons to predicate devices to confirm the new device's safety and effectiveness are equivalent, without providing specific acceptance criteria or performance numbers in this summary document.

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