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a. Processor EP-8000

• The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.
• This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals.
• It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment.
• BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis.

b. Endoscope Model EG-860R

This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Video Processor EP-8000 is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.

FUJIFILM Video Processor EP-8000 relays the image from an endoscope to a video monitor. The projection can be either analog or digital at the user's preference. The processor employs fiber bundles to transmit light from four LED lamps (Violet, Blue, Green, and Amber), with a total power of 79.2W lamps, to the body cavity.

The EP-8000, like the VP-7000 and BL-7000, has additional image processing options called BLI, BLI-bright, and LCI that provide endoscopic assistance for white light imaging (WLI). There is also an additional image processing option called "ACI"(Amber-red Color Imaging).

ACI is an image processing function that simultaneously emphasizes the brightness and color difference of red information in endoscopic images and serves as an adjunct to white light imaging (WLI).

Compared to WLI mode, ACI relatively increases the ratio of amber red light and decreases the ratio of violet light.

Relatively high-saturation red information such as blood-like red in the image signal digitized by the camera unit is enhanced by signal processing.

The EP-8000 also has a Multi Observation option that allows endoscopic images to be displayed in the main screen area and sub-screen area by switching image processing options at every frame. This allows each image frame to be displayed in the main screen area and sub-screen area 1 with a different combination of image processing options applied [WLI+(LCI), LCI+(WLI), BLI+(WLI), WLI+(BLI)].

The device is AC operated at a power setting of 100-240V/50-60Hz/ 3.0-1.5A. The processor is housed in a steel-polycarbonate case measuring 395x210x515mm

The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument.

The insertion portion of the endoscopes comes into contact with the mucosal membrane.

The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, Objective lens, and Light guide.

The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.

The Flexible portion refers to the long insertion area between the Bending portion and the Control portion (a part of Non-insertion portion). This portion contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.

The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source and video processor, respectively.

The provided FDA 510(k) clearance letter and summary for FUJIFILM Processor EP-8000 and FUJIFILM Endoscope Model EG-860R focus on establishing substantial equivalence to predicate devices, primarily through engineering performance testing rather than clinical study data involving human readers or AI algorithms. The document explicitly states that the various imaging modes (BLI, LCI, ACI, FICE) are "adjunctive tools" and "not intended to replace histopathological sampling as a means of diagnosis." This indicates that the device operates as an image enhancement and visualization tool, not a diagnostic AI that makes independent claims.

Therefore, the study described in the document is a non-clinical engineering performance evaluation comparing the new device's image quality and functional parameters to those of existing predicate devices. It is not a clinical study involving an AI algorithm and human readers.

Here's an attempt to answer the questions based on the provided text, recognizing that many details typically requested for AI/human reader studies are not applicable or not provided in this type of 510(k) submission:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format typical of standalone AI performance studies. Instead, it states that "the devices met the pre-defined acceptance criteria for the test" for the EG-860R, and for the EP-8000, "EP-8000 demonstrated substantial equivalence to VP-7000 and BL-7000 in Image performance and color reproduction." The acceptance criteria were "engineering requirements listed in this section" and "identical to those assessed for the predicate devices."

The "performance (of) Image and the performance of the WLI, FICE, BLI, BLI-bright, LCI and ACI imaging modes" was evaluated for the EP-8000. For the EG-860R, a range of performance characteristics was evaluated.

Table of Performance Evaluation (Based on provided text, not explicit acceptance criteria):

Study Details:

1. Sample size used for the test set and the data provenance:
   This section describes engineering performance testing, not a clinical test set with patient data. The "test set" would refer to the physical devices and various test setups (e.g., optical phantoms, standardized targets) used to evaluate the specified engineering parameters. The document does not specify a "sample size" in terms of number of patient cases or images, as it is evaluating hardware and its image generation capabilities directly through engineering tests.

   • Provenance: Not applicable in the context of patient data. The tests were "conducted in combination with representative FUJIFILM gastroscopes."

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

   • Not applicable. Ground truth in this context is established by the engineering specifications and calibrated measurement equipment, not clinical expert consensus. The device produces images; it does not make a diagnosis that would require expert ground truth.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This relates to clinical interpretation and consensus, which is not part of this engineering performance evaluation.

4. 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:

   • No. An MRMC study was not performed. The submission describes engineering performance comparisons to predicate devices, not an evaluation of human reader performance with or without AI assistance. The new imaging modes (BLI, LCI, ACI, FICE) are explicitly stated as "adjunctive tools...not intended to replace histopathological sampling as a means of diagnosis."

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

   • No. This is not an AI algorithm making independent diagnostic claims. The performance evaluated is that of the hardware (processor and endoscope) and its image enhancement capabilities.

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

   • Engineering specifications and measurements. The "ground truth" for the performance tests (e.g., resolution, color reproduction, geometric distortion) would be derived from precisely known physical targets, measurement instruments, and established engineering standards. It is not clinical ground truth (e.g., pathology, clinical outcomes, or expert consensus) because the device's function is image generation and enhancement, not diagnostic interpretation.

7. The sample size for the training set:

   • Not applicable. This device is an endoscope and processor system, not a machine learning model that requires a training set in the conventional sense.

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no "training set" for this hardware device.

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EB-530H, EB-530S, and EB-530T are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

FUJIFILM Video Bronchoscopes EB-530H, EB-530T are comprised of three general sections: a control portion, an insertion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary Charge-Coupled Device (CCD) 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 to illuminate the body cavity. This provides enough light to the CCD 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 a 510(k) summary for the FUJIFILM Video Bronchoscopes EB-530H, EB-530S, and EB-530T. The scope of this document is a substantial equivalence determination based on minor modifications to an already cleared predicate device.

Here's an analysis of the requested information based only on the provided text:

1. Table of acceptance criteria and reported device performance

The document states that the devices met pre-defined acceptance criteria, but it does not explicitly list the specific quantitative acceptance criteria for each performance test. It only states that the devices "met the pre-defined acceptance criteria for the test."

In addition, the following were evaluated for compliance, not performance:

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

The document does not provide information regarding sample sizes for the test set or data provenance (e.g., country of origin, retrospective/prospective). The performance testing described appears to be bench testing on the physical devices rather than clinical studies with patient data.

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

This information is not provided in the document. The performance tests mentioned (field of view, bending capability, etc.) are objective technical measurements of the device itself, not assessments requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication method for the test set

This information is not provided in the document. As noted above, the tests described are objective technical measurements, not clinical assessments requiring adjudication.

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

An MRMC comparative effectiveness study was not performed because this submission is for minor modifications to a bronchoscope, not an AI-enabled device. The document does not mention any AI components.

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

A standalone algorithm performance test was not performed because this device is a bronchoscope, not an algorithm or AI system.

7. The type of ground truth used

For the performance tests conducted (field of view, bending capability, etc.), the "ground truth" would be established by objective engineering specifications and measurement standards. It's not a ground truth derived from expert consensus, pathology, or outcomes data, as these are technical performance measurements of the physical device.

8. The sample size for the training set

This information is not provided in the document. As this is not an AI/algorithm-based device, a "training set" in that context is not applicable.

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

This information is not provided in the document. As this is not an AI/algorithm-based device, there is no "training set" with associated ground truth to establish in this context.

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FUJIFILM Endoscope Model EG-740N is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. The device can be inserted orally or transnasally.

FUJIFILM Endoscope Model EG-740N 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 portion contains glass fiber bundles, several channels and a complementary Charge-Coupled Device (CCD) image sensor in its distal end. The channels in 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 CCD 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 document is a 510(k) premarket notification for a medical device, the FUJIFILM Endoscope Model EG-740N. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or superiority through extensive clinical studies, especially those involving AI algorithms or human reader performance.

Therefore, much of the requested information regarding AI algorithm performance, multi-reader multi-case studies, and detailed ground truth establishment methods for large datasets is not applicable to this specific submission. The document primarily reports on bench testing, electrical safety, and biocompatibility to demonstrate that the new device performs similarly and is as safe as the predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting what is and is not present:

1. A table of acceptance criteria and the reported device performance

The document states that the subject device met performance specifications in various tests. While it lists the categories, it does not provide specific numerical acceptance criteria or reported performance values in a table format. It simply states that the device "met performance specifications" or that "bench testing data demonstrated that the subject device is substantially equivalent in performance to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "bench testing" and "comparative bench testing" without specifying a sample size in terms of number of patients or images. These tests would involve physical testing of the device prototypes. Data provenance and whether it's retrospective or prospective are not relevant for this type of physical device testing.

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 is not applicable. The "ground truth" for this device's testing relates to engineering specifications (e.g., does the endoscope bend to the correct angle, is the resolution within specification, does it pass the electrical safety tests). It does not involve human expert interpretation of medical images or clinical outcomes data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are used to establish ground truth in clinical data interpretation, typically in studies involving human readers or AI algorithms assessing medical conditions. This submission focuses on engineering and safety performance.

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 is not applicable. This submission is for a physical endoscope, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.

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

This is not applicable. This device is a physical endoscope, not a standalone algorithm.

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

The "ground truth" for this submission are the engineering specifications, consensus standards (e.g., ISO, IEC, AAMI), and regulatory guidance documents used for electrical safety, biocompatibility, software validation, and reprocessing validation. For example, the device must meet the specified lumens for light output or specific angles for bending capability, which are objective engineering parameters.

8. The sample size for the training set

This is not applicable. This is a 510(k) for a physical endoscope, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.

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

This is not applicable for the same reasons as #8.

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