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The EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a video system center, light source, documentation equipment, monitor, endo therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

The EVIS EXERA III DUODENOSCOPE TJF-Q190V has been designed to be used with an video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. The TJF-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)." TJF-Q190V is also compatible with Olympus system "EVIS X1 Video System Center OLYMPUS CV-1500 (K222584)."

The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (CCD) chip which delivers images.

The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal.

There is an instrument channel located inside of the flexible insertion section. EndoTherapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion section to elevate endo therapy accessories for endoscopic treatment.

A sterile, single-use distal cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182, K202661 and K220587.

The provided 510(k) clearance letter for the Olympus TJF-Q190V Duodenoscope indicates that the clearance is based on adhesive modifications to the device. This implies that the acceptance criteria and the study proving the device meets these criteria would primarily relate to the durability and safety of the new adhesive material and its impact on the overall performance of the endoscope, particularly concerning reprocessing and material integrity.

However, the provided text does not contain the detailed information typically found in a clinical study report or a summary of non-clinical performance data that would explicitly list acceptance criteria and device performance in the format requested. The document states:

• "Verification/validation activities were performed subsequent to a risk assessment evaluation of the device modifications per the Olympus Quality Management System."
• "Results of the following testing demonstrate that the changes to the device do not adversely affect device performance: Performance Testing - Bench, Sterilization and Shelf-Life - Residual Toxicity of Reprocessing Chemicals, Biocompatibility Evaluation."
• "No clinical data were collected."

This means the clearance was based on non-clinical (bench) testing. Therefore, I cannot provide information on clinical performance metrics, multi-reader multi-case studies, or the establishment of ground truth by human experts, as these were not part of the submission for this particular change.

Given the limited information, I will infer the implied acceptance criteria based on the described non-clinical tests.

Implied Acceptance Criteria and Reported Device Performance

Based on the provided information, the acceptance criteria would be related to the non-clinical performance of the device with the new adhesive, ensuring it is equivalent or superior to the predicate device, especially concerning durability against reprocessing and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance (Inferred)

Study Proving Device Meets Acceptance Criteria:

The study involved non-clinical, bench-level verification and validation activities.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. For bench testing, this would typically involve a defined number of devices or components subjected to various tests (e.g., durability cycles, chemical exposure). The exact number of units or test replicates is not provided in the summary.
• Data Provenance: The manufacturing site is Aizu Olympus Co., Ltd., Japan. The testing would have been conducted in a controlled lab environment. This was a retrospective evaluation of a design modification, and the data would be laboratory-generated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This question is not applicable as "No clinical data were collected." The "ground truth" for non-clinical bench testing would be defined by engineering specifications, material standards, and validated test methods, rather than expert human interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set:

• Not applicable. As no clinical data or human evaluations were involved for this specific submission.

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

• No, a MRMC study was not done. The document explicitly states, "No clinical data were collected." Therefore, there is no information on how human readers might improve with or without AI assistance, as AI is not mentioned and no human reading study was conducted.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a duodenoscope, a physical medical instrument, not an AI algorithm. There is no mention of a software algorithm or standalone performance in the context of AI.

7. Type of Ground Truth Used:

• For the non-clinical testing, the "ground truth" would be based on:
  • Engineering Specifications: Device design parameters, material specifications.
  • Regulatory Standards: ISO standards for biocompatibility (e.g., ISO 10993), sterilization, and other relevant performance standards for endoscopes.
  • Validated Test Methods: Established laboratory protocols for evaluating material durability, chemical resistance, and device functionality.
  • Predicate Device Performance Baseline: The performance characteristics of the legally marketed predicate device (K202661) served as a benchmark for substantial equivalence.

8. Sample Size for the Training Set:

• Not applicable. This submission focuses on a hardware modification (adhesive) to an existing device, not the development or training of a software algorithm.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there was no training set for a software algorithm.

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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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