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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 biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the biliary tract.

The XCHF-T160, is a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract. The XCHF-T160 is basically identical to the predicate device, Olympus CHF-B20 Choledochoscope, hereinafter referred to as CHF-B20 in intended use, specifications, performance.

The optical system of the XCHF-T160 is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.

The new endoscope is basically identical to each predicate device shown in Table 14-1 in intended use, and similar in specifications, performance and materials.

The provided text is a 510(k) summary for the VIDEOSCOPE XCHF-T160, which is primarily a medical device submission to the FDA. Such documents focus on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for a new, innovative device that would typically undergo a rigorous clinical trial.

Therefore, the document does NOT contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The submission is based on demonstrating that the VIDEOSCOPE XCHF-T160 is "basically identical" in intended use, specifications, and performance to the predicate device, Olympus CHF-B20 Choledochoscope. This approach typically relies on engineering and performance comparisons rather than new clinical effectiveness studies with explicit acceptance criteria for performance metrics.

Here's what can be extracted based on the provided text, and what is explicitly not available:

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

• Not Available. The document does not specify quantitative acceptance criteria or reported device performance metrics in the format requested. Instead, it provides a comparison of specifications to predicate devices to demonstrate substantial equivalence.

  Here's a table showing the comparison of technical specifications, which serves as the basis for demonstrating similarity to predicate devices rather than direct performance results against acceptance criteria:

  Specifications	Subject Device XCHF-T160	Predicate Device 1 CHF-B20	Predicate Device 2 GIF-Q160Z
  Field of View	90°	100°	140°
  Depth of Field	1-50mm	3-50mm	WIDE : 8-100mmTELE : 1.5-3mm
  Direction of View	Forward	Forward	Forward
  Type of CCD Chip	Inter color CCD (37071)	(Not specified)	Inter color CCD (3704)
  Outer Diameter of Distal End	φ 5.7mm	φ 4.1mm	φ 10.8mm
  Outer Diameter of Insertion Tube	φ 5.5mm	φ 4.5mm	φ 10.9mm
  Angulation UP/DOWN	U 160° D 100° R 100° L 100°	U 160° D 100°	U 210° D 90° R 100° L 100°
  Working Length	1330mm	1870mm	1030mm
  Inner Diameter of Instrument Channel	φ 2.0mm φ 1.2mm	φ 1.7mm	φ 2.8mm

  The conclusion states: "When compared to the predicate device, the CHF-B20 does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that the device meets "acceptance criteria" by being substantially equivalent to prior approved devices, rather than through a new set of defined performance metrics.

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

• Not Available. The document does not describe any specific test set of data with a sample size or provenance for evaluating the device's clinical performance. The focus is on comparing physical and technical specifications.

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

• Not Available. No test set or ground truth establishment by experts is mentioned in this 510(k) summary.

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

• Not Available. No test set or adjudication method is described.

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 / Not Available. This device is a videoscope, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be relevant or expected for this submission. The document does not mention any such study.

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

• Not Applicable / Not Available. This device is a videoscope, which is an instrument operated by a human. There is no "algorithm only" performance to evaluate in this context.

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

• Not Available. No specific ground truth methodology is mentioned as there isn't a stated clinical study to evaluate a specific performance claim. The "ground truth" for this 510(k) essentially relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not Applicable / Not Available. This submission does not describe a machine learning or AI model that would require a training set.

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

• Not Applicable / Not Available. No training set is implied or discussed.

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