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The device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

The Fujinon G5 Colonoscopes are medical endoscopes used for visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. The G5 colonoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 Scopes do not have a lens wash port. The J-Port was repositioned. A G5 forceps inlet port was modified. The jet wash line check valve was removed. The suction and air/water cylinders and valves were upgraded. The G5 colonoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. Upgrade to CA-500 cleaning adaptor. The G5 colonoscopes are used with a processor (EPX-201 for EC-250HL5 and VP-402 for EC-450HL5), a colonoscopy unit, and a cart. Each colonoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, adapters, valves, and the Operation Manual. The Fujinon G5 colonoscopes 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fujinon G5 Colonoscopes:

Overview:

The provided document is a 510(k) summary for the Fujinon G5 Colonoscopes. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will differ significantly from what would be found in a PMA (Premarket Approval) application.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicit acceptance criteria defined in a quantitative, measurable manner for the performance of the Fujinon G5 Colonoscopes as a standalone device. Instead, the entire submission hinges on demonstrating substantial equivalence to existing predicate devices.

The "performance" is implicitly defined by the device's technological characteristics and its similarity to the predicate.

2. Sample Size for Test Set and Data Provenance

The document does not describe a "test set" in the traditional sense of evaluating a new device's performance against ground truth data. Instead, it relies on demonstrating equivalence to predicate devices which have already been cleared.

• Sample Size: Not applicable in the context of this 510(k) submission for direct performance testing. The "sample" is the device itself and its technical specifications compared to the predicate.
• Data Provenance: Not applicable for performance data generation. The data provenance relevant here refers to the previous clearance of the predicate devices (K944620 and K944759), and the previous clearance of the G5 upgrade in K040048. These are regulatory clearances, not clinical study data provenance.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. Ground truth, in the context of clinical performance, was not established for this 510(k) submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess reader performance with and without an AI aid, or to compare different diagnostic methods. The Fujinon G5 Colonoscopes are endoscopes, primarily tools for visualization and intervention, not an AI-assisted diagnostic system.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone performance study was not done. This device is a physical endoscope with minor design changes, not a standalone algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for this 510(k) submission. The "ground truth" for the predicate devices' safety and effectiveness would have been established through their initial clearances (which might have involved clinical data, engineering analyses, etc.), but this document relies on similarity to those cleared devices. For the G5 colonoscopes themselves, the "truth" being established is their equivalence to the predicate via technical specifications and existing regulatory clearances.

8. Sample Size for Training Set

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

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable.

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