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The device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

The Fujinon G5 Bronchoscopes are medical endoscopes used for the observation, diagnosis, and endoscopic treatment of the trachea and broncho. The G5 Bronchoscopes are offered in a 200 and 400 series. The EB-250S represents the G5 Bronchoscope 200 series and the EB-470S represents the G5 Bronchoscope 400 series. The G5 Bronchoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons. The J-Port was repositioned. The J-Port is used as a jet water wash port. The J-Port was repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging. A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage. The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable. The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same. The G5 Bronchoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning. The G5 Bronchoscopes are used with the same processors, monitors, hard carts as the predicate devices. Each Duodenoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual. The Fujinon G5 Bronchoscopes are used in conjunction with other peripherals specified in the Operation Manual such as: Light Source, Processor, Cart, Data Keyboard, Foot Switch, Monitor, Video Printer, Camera and Hard Copy Unit, VCR, ElectroSurgical Instruments.

The provided text describes a 510(k) submission for Fujinon G5 Bronchoscopes (Models EB-470S, EB-250S, and EB-270P). However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (Fujinon EB-310S, K954707) by outlining changes and similarities in technical characteristics, indications for use, and material composition.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
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 present in the provided text.
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 present in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided text.
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 present in the provided text. The device is an endoscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present in the provided text. The device is an endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present in the provided text.
8. The sample size for the training set: This information is not present in the provided text.
9. How the ground truth for the training set was established: This information is not present in the provided text.

The document states under "Performance Data [21 CFR 807.92(b)(1)]":
"The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device."

This indicates that some performance testing was conducted, but it's limited to electrical safety, thermal, and EMC, and the specific acceptance criteria and detailed results of these tests are not provided in the summary. The core of the submission is demonstrating equivalence, not necessarily a new performance study against specific criteria beyond safety and basic physical characteristics.

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