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This product 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 insertion portion of the device has a bending mechanism and a flexible tube consisting of the bending portion and an operating portion with a knob to control the bending. A forceps channel runs through the operating portion to the tip for inserting surgical instruments. The insertion portion's tip, called the "Distal end," contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section. The flexible portion, between the bending and control portions, contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The control portion/operating section provides a grip and mechanical parts to operate the endoscopes, including a Forceps inlet. The Scope connector links the endoscopes to the light source and video processor.

The provided FDA 510(k) clearance letter and summary for the FUJIFILM Endoscope Models EC-860P/M, EC-860P/L, and EC-860S/L primarily focus on demonstrating substantial equivalence to predicate devices through bench testing and compliance with various consensus standards. It does not describe a clinical study in the traditional sense, where device performance is measured against specific acceptance criteria in a human subject population using metrics like sensitivity, specificity, or accuracy, often seen with AI or diagnostic imaging devices.

Instead, the submission relies on demonstrating that the new endoscope models meet established performance specifications and safety standards through non-clinical testing.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each item. Instead, it refers to the subject device meeting "performance specifications" or demonstrating "substantially equivalent in performance to the predicate devices" for various parameters.

2. Sample size used for the test set and the data provenance

No human or patient test set is described. The "test set" consists of the physical endoscope models themselves, subjected to various bench tests and standard compliance evaluations. The data provenance is derived from these non-clinical tests performed by the manufacturer, rather than patient data.

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

Not applicable. This is not a study requiring expert readers to establish ground truth for clinical performance. The "ground truth" for the non-clinical tests is established by the specifications and standards themselves, and verified by testing personnel.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication process described for clinical interpretation. The compliance with standards and performance specifications is determined through objective measurements and validated test methods.

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 an endoscope, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned. The clearance is for the physical endoscope models.

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

Not applicable. There is no AI algorithm involved in this device submission.

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

For this submission, the "ground truth" is defined by:

• Consensus standards: e.g., electrical safety (ANSI/AAMI ES 60601-1), biocompatibility (ISO 10993-1), medical device software (IEC 62304), endoscope-specific standards (ISO 8600 series).
• Manufacturer's internal performance specifications: These are the benchmarks against which specific performance parameters (e.g., field of view, resolution, bending capability) are measured.
• Predicate device performance: The "bench testing data regarding 'Optical performance' demonstrated that the subject devices are substantially equivalent in performance to the predicate devices." This implies that the performance of the predicate devices serves as a comparative ground truth for equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set is described.

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