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This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopic surgery within the biliary tract and pancreatic duct in conjunction with DUODENOSCOPE with an instrument channel with a minimum diameter of ¢ 4.2mm.

The XCHF-BP160F Choledochoscope is basically identical to the predicate device, OES Transduodenal Choledochofiberscope CHF type B20 except that the subject device is equipped with the high resolution CCD in the control section, in addition to the fiber bundle in the insertion tube. Images are transmitted through the fiber bundle and converted by the CCD in the control section to video signals. This is a hybrid technology and substantially equivalent to another Olympus predicate device, Olympus bronchoscope, model BF type XP160F(K033225).

The XCHF-BP160F Choledochoscope is used in conjunction with the TJF-duodenoscope with an instrument channel with a minimum diameter of ¢ 4.2mm, such as Olympus TJF type 100. TJF type 140, TJF type 160F/VF and TJF type M20 duodenoscopes. The XCHF-BP160F Choledochoscope is safety and effectively delivered through the upper gastrointestinal (G) tract to the Papilla of Vater) by traveling through the instrument channel of the TJF-duodenoscopes. At this point, XCHF-BP160F Choledochoscope can directly observe the billiary tract or pancreatic duct.

The provided document is a 510(k) premarket notification for the Olympus Choledochoscope Model XCHF-BP160F. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive original studies.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not typically included in a 510(k) summary for a device like this. The submission primarily relies on the established safety and effectiveness of the predicate devices and demonstrates that the new device does not introduce new risks or questions of effectiveness.

Here's a breakdown based on the information available and the nature of a 510(k) submission for this type of device:

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

• Acceptance Criteria: The document does not explicitly list quantitative acceptance criteria in the format typically seen with performance studies (e.g., minimum sensitivity, specificity, accuracy). Instead, acceptance is based on demonstrating substantial equivalence to predicate devices and adherence to voluntary safety standards.

• Reported Device Performance:

  • Imaging System: CCD (compared to Optical fiber bundle for primary predicate, and CCD for secondary predicate). This is a technological characteristic, not a performance metric in the traditional sense, but it upgrades the imaging capability.
  • Insertion diameter: ϕ 2.9 – 3.7mm (smaller than primary predicate's ϕ 4.5mm).
  • Channel diameter: ϕ 1.2mm (smaller than primary predicate's ϕ 1.7mm, same as secondary predicate's ϕ 1.2mm).
  • Angulation (U / D): U=70°, D=70° (different from predicates' ranges).
  • Compliance with Standards: Meets IEC60601-1:1998+ Amendment 1:1991+Amendment 2:1995, IEC 60601-1-1:2000 and IEC60601-2-18: 1996+ Amendment1:2000.
  • Non-clinical Tests Performed: Thermal safety, optical performance, reprocessing, mechanical durability, mechanical safety, risk analysis. (No specific quantitative results are provided in this summary).
  • Biocompatibility: Patient contacting materials completed biocompatibility studies with the predicate device.

  No specific metrics like sensitivity, specificity, or inter-reader agreement are reported as this is not a diagnostic algorithm.

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

• Not applicable. The document states, "Therefore, no clinical tests have been conducted on this device." The evaluation is based on non-clinical tests and comparison to predicate devices, not on a test set of patient data.

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. No clinical test set or ground truth established by experts for performance evaluation was conducted.

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

• Not applicable. No clinical test set.

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 choledochoscope, which is an imaging and interventional tool, not an AI-powered diagnostic device. Therefore, MRMC studies or AI assistance effect sizes are not relevant here.

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

• Not applicable. This is a medical instrument, not a standalone algorithm.

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

• Not applicable. As no clinical studies were performed for this 510(k) submission, there was no ground truth established using patient data. The "ground truth" for the non-clinical tests would be the established industry standards and manufacturer's specifications for design, materials, and safety.

8. The sample size for the training set

• Not applicable. This is a medical instrument, not an AI/ML device that requires a training set.

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

• Not applicable. This is a medical instrument; there is no training set as understood in the context of AI/ML.

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