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FUJIFILM Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.

Never use this product for any other purposes.

FUJIFILM Endoscope Model EB-710P is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion is flexible and contains glass fiber bundles, several channels, and a complementary metal-oxide semiconductor (CMOS) image sensor in its distal end. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The channels in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation and rotation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart.

The provided text describes the 510(k) premarket notification for the FUJIFILM Endoscope Model EB-710P. It details the device, its intended use, comparison to predicate/reference devices, and performance data. However, the document does not describe an AI/ML-driven device or a study involving human readers and AI assistance.

Therefore, many of the requested criteria related to AI/ML performance, human reader studies, ground truth establishment for AI models, and sample sizes for training/test sets for AI are not applicable to this document. This document pertains to a traditional medical device (an endoscope) and its clearance based on substantial equivalence.

I will address the applicable criteria based on the information provided in the document.

Analysis of Acceptance Criteria and Device Performance (FUJIFILM Endoscope Model EB-710P)

This document describes the 510(k) premarket notification for a physical medical device, the FUJIFILM Endoscope Model EB-710P, not an AI or software-as-a-medical-device (SaMD) product. Therefore, the acceptance criteria and study described are for the physical performance and safety of the endoscope itself, primarily through bench testing and compliance with recognized standards, rather than clinical performance metrics of an AI model like sensitivity, specificity, or reader improvement.

The "acceptance criteria" here refer to meeting performance specifications and regulatory standards demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance specifications and states that the proposed device met them. It does not present a formal "acceptance criteria vs. reported performance" table in the way one might for an AI model's accuracy metrics, but rather as statements of compliance.

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

The document does not specify a "sample size" in the context of clinical studies for diagnostic accuracy, as it is a device clearance for an endoscope based on engineering and bench testing, and demonstrating substantial equivalence. The "test set" here refers to the physical units and materials used for various engineering and safety tests. No patient data or clinical imagery is referenced for performance testing in this document.

• Sample Size: Not applicable in the context of a clinical test set for AI/ML. The tests are performed on the device itself and components.
• Data Provenance: Not applicable in the context of clinical data. The tests are laboratory/bench tests on the device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth for an AI/ML model for diagnostic purposes is not relevant for the clearance of a physical endoscope itself. The "ground truth" for this device's performance would be the objective measurements and accepted standards in engineering and medical device testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where human readers interpret medical images, often to establish ground truth or evaluate reader performance. This is not describing such a study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not mention an MRMC study. MRMC studies are typically performed for AI-assisted diagnostic devices to assess how AI affects reader performance.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's regulatory clearance is established by:

• Performance Specifications: The defined objective measurements and technical requirements for the endoscope's functions (e.g., resolution, field of view, bending capability).
• Consensus Standards: Adherence to recognized national and international standards for medical device safety, biocompatibility, electrical safety, software, and reprocessing (e.g., ISO, IEC, ANSI/AAM).
• Predicate Device Performance: The performance characteristics of the previously cleared predicate device, which the proposed device must be substantially equivalent to.
• Bench Testing Data: Direct measurements obtained from laboratory testing of the device.

8. The Sample Size for the Training Set

Not applicable. This is not describing an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process as defined for AI/ML.

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EC-760Z-V/L is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

FUJIFILM Endoscope Model EC-760Z-V/L is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor in its distal end. The insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.

The provided text describes the regulatory clearance for the FUJIFILM Endoscope Model EC-760Z-V/L, asserting its substantial equivalence to a predicate device. However, this document does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance using AI assistance, human readers, or detailed ground truth establishment for AI models.

The document describes performance testing for an endoscope, which is a physical device, not an AI or software device. The performance data section refers to:

• Electrical safety
• Biocompatibility
• Reprocessing validation
• Photobiological safety
• Bench testing for "Advanced Force Transmission" and "Adaptive Bending" features
• Comparative bench testing for suction rate
• Other physical performance aspects like field of view, bending capability, air/water supply rates, working length, forceps channel diameter, viewing direction, resolution, and LG output.

For these tests, it states, "In all cases, the device met the pre-defined acceptance criteria for the test." However, the actual acceptance criteria values and the detailed results are not provided in this public summary.

Therefore, I cannot provide the requested information, particularly items 1 through 9, because the provided text pertains to the regulatory clearance of a physical medical device (an endoscope) and does not describe any AI/ML model performance evaluation, human-in-the-loop studies, or detailed ground truth methodologies relevant to AI.

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