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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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FUJIFILM Ultrasonic Endoscopes EG-580UT and EG-580UR are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. These products are intended to be used with a FUJIFILM ultrasonic processor. These products are not intended for use on children and infants.

FUJIFILM Ultrasonic Endoscopes EG-580UT and EG-580UR 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 flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a chargecoupled 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 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 into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K181763.

The provided text is a 510(k) summary for the FUJIFILM Ultrasonic Endoscopes EG-580UT and EG-580UR. It describes the device, its intended use, and a comparison to predicate devices, focusing on the substantial equivalence argument.

However, the document does NOT contain information about an AI-powered device or an AI performance study. Instead, it describes a medical device undergoing a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through engineering performance, electrical safety, biocompatibility, and reprocessing validation.

Therefore, for the specific questions related to AI device acceptance criteria and performance study details (sample size for test set, data provenance, number of experts, adjudication, MRMC studies, standalone performance, ground truth, training set size), the provided text does not contain the information required to answer them.

The document primarily focuses on the physical and functional aspects of the endoscopes, such as control portion, insertion, umbilicus, and their compatibility with other FUJIFILM equipment. The performance data mentioned are related to:

• Electrical safety: evaluated using standards like ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, etc.
• Biocompatibility: evaluated using standards like ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• Endoscope specific testing: evaluated using standards like ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.
• Cleaning, high-level disinfection, and sterilization: evaluated according to AAMI TIR12:2010, AAMI TIR30:2011.
• Additional functional testing: including field of view, resolution, bending capability, working length, diameter of forceps channel, rates of suction, air supply, water supply, balloon water supply, balloon suction, viewing direction, LG output, axial resolution, lateral resolution, and penetration depth.

These are all standard tests for a physical medical device and do not involve AI or machine learning algorithms.

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FUJIFILM Endoscope Model EG-760CT is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Endoscope Models EC-760P-V/L and EC-740T/L are 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 Models EG-760CT, EC-760P-V/L and EC-740T/L are comprised of three general sections: a control portion, an insertion portion and an umbilicus. The 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 either a complementary metal-oxide-semiconductor (CMOS, in 760 series models) or charged-coupled device (CCD, in EC-740T/L) 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 CMOS or 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 into the video processor and the light source. The endoscopes are used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K172916.

This document is a 510(k) summary for FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L, and EC-740T/L. It does not describe a study proving the device meets acceptance criteria related to AI or algorithm performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various non-clinical performance tests and adherence to regulatory standards.

Therefore, many of the requested details about acceptance criteria for AI algorithms, sample sizes for test sets, expert involvement, and MRMC studies are not applicable to the information provided.

However, I can extract the information related to the performance data presented to support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance for clinical outcomes. Instead, it lists various types of engineering and safety tests and states that the device "met performance specifications" or "are substantially equivalent in performance."

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

Not applicable. The document describes engineering and bench testing, not 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

Not applicable. This document pertains to device engineering and safety testing, not clinical evaluation requiring expert ground truth for a test set.

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

Not applicable. Adjudication methods are typically for clinical study outcomes and expert consensus, which are not described here.

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

No. This document does not mention any MRMC studies or AI assistance. The devices are endoscopes, and the evaluation focuses on their physical and functional characteristics.

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

No. The devices are physical endoscopes, not standalone algorithms.

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

For the bench and engineering tests, the "ground truth" was established by technical specifications, consensus standards (e.g., ISO, AAMI, IEC, ANSI/AAMI), and established testing protocols. For comparative tests, the predicate device's performance served as a reference for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI-driven device being evaluated for a machine learning model.

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

Not applicable. As there is no training set mentioned, this question is not relevant.

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This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, and rectum.

FUJIFILM Double Balloon Endoscope EI-580BT is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control 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 assist in delivering air/suction as well as endoscope accessories, such as forceps and balloons. 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. All of these combinations were previously cleared in K143556 and K172916.

The provided text describes the regulatory clearance of the FUJIFILM Double Balloon Endoscope EI-580BT and outlines the performance data submitted to demonstrate substantial equivalence to a predicate device. However, it does not contain information related to a study proving the device meets specific acceptance criteria based on human-in-the-loop performance, AI assistance, or an algorithm's diagnostic accuracy.

The performance data mentioned in the document focuses on:

• Electrical safety: Compliance with standards like ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, etc.
• Biocompatibility: Compliance with ISO 10993 standards.
• Endoscope specific testing: Compliance with ISO 8600 standards.
• Cleaning, high-level disinfection, and sterilization: Compliance with AAMI TIR standards and FDA guidance.
• Usability testing: Compliance with IEC 62366-1:2015.
• Bench testing: Validation of features like "Advanced Force Transmission" and "Adaptive Bending," and performance specifications for field of view, bending capability, rates of air/water/suction, working length, channel diameter, viewing direction, resolution, and LG output.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving the device meets these criteria in the context of diagnostic accuracy, human-in-the-loop performance, AI assistance, or algorithm-only performance, as this information is not present in the provided text.

The document pertains to the clearance of an endoscope, which is a medical instrument for direct visualization, not an AI or image-analysis diagnostic device. The "performance data" discussed are engineering and safety specifications typical for such a device, not metrics like sensitivity, specificity, AUC, or reader performance improvement often associated with AI/diagnostic software.

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

FUJIFILM Duodenoscope Model ED-580XT 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 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. All of these combinations were previously cleared in K152257 and K172916.

The provided text describes the regulatory clearance of the FUJIFILM Duodenoscope Model ED-580XT and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.

The document primarily focuses on technical aspects, such as electrical safety, biocompatibility, endoscope-specific testing, cleaning/disinfection validation, and usability. It confirms that the device met performance specifications in various categories (field of view, bending capability, air/water/suction rates, working length, etc.), but these are standard engineering and safety performance metrics for a physical medical device, not AI performance metrics.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving "device performance" in the AI context based on the given text. The questions regarding sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth are not applicable to the type of device and information presented.

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This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm's endoscopy system.

FUJIFILM Endoscopic CO2 Regulator GW-100 supplies CO2 gas to insufflate the gastrointestinal tract. The GW-100 supplies water to wash the endoscope lens during an examination.

FUJIFILM Endoscopic CO2 Regulator GW-100 is comprised of the following components: Main Unit, Water Tank, and Gas Tube. The Main Unit utilizes a solenoid/decompression valve mechanism to dispense CO₂ from the Water Tank via the Gas Tube and the air/water channel in the endoscope into the body cavity. The Main Unit also supplies sterile water Tank via the air/water channel in the endoscope.

The provided text describes a 510(k) premarket notification for the FUJIFILM Endoscopic CO2 Regulator GW-100. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that an AI/ML powered device meets specific performance criteria.

Therefore, the information required to answer the prompt (acceptance criteria, study details for an AI/ML device, sample sizes, expert involvement, etc.) is not present in this document. This document is for a medical device (a CO2 regulator for endoscopy) that is an accessory and does not appear to involve AI/ML.

The "Performance Data" section (Page 5) describes engineering and safety tests for the device itself and its accessories, not clinical performance or diagnostic accuracy. It mentions:

• Electrical safety testing: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18.
• Biocompatibility testing: ISO 10993-1, ISO 10993-5, ISO 10993-10 for an optional accessory.
• Software testing: IEC 62304 (for the predicate device, with the proposed device adopted into it).
• Cleaning, high-level disinfection, and sterilization validation testing: Per FDA guidance.
• "Performance testing" on CO2 gas supply and Water supply: Stated that "In all cases, the device met the pre-defined acceptance criteria for the test" but does not specify the criteria or the results.

Since the requested information pertains to AI/ML device performance and clinical validation, and this document describes a hardware medical device's engineering and safety testing for substantial equivalence, a complete answer to your prompt cannot be generated from the given input.

However, if we assume, for the sake of demonstrating the structure of the answer you're looking for, that the "CO2 gas supply" and "Water supply" tests were the "performance tests" for this device, a highly speculative and incomplete answer based on the limited provided text would look like this:

Based on the provided document, the device in question (FUJIFILM Endoscopic CO2 Regulator GW-100) is a hardware medical device, not an AI/ML powered device. As such, the comprehensive details typically required for AI/ML device validation (e.g., ground truth establishment, reader studies, effect sizes) are not applicable or provided in this 510(k) submission.

The document states that "performance testing" was conducted for "CO2 gas supply" and "Water supply," and that "In all cases, the device met the pre-defined acceptance criteria for the test." However, the document does not specify what these criteria were or the actual reported device performance values for these parameters.

Therefore, most of the specific questions regarding AI/ML device validation cannot be answered from this document.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that the device "met the pre-defined acceptance criteria" but does not explicitly list the criteria or the quantitative results of the performance.

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

• Sample Size: Not specified for the "CO2 gas supply" and "Water supply" performance tests. This would typically involve engineering test units rather than patient data.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are engineering/device performance tests.

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

• Not applicable. Ground truth as typically defined for AI/ML (e.g., diagnosis, abnormality detection) is not established for this type of device's performance testing. The "ground truth" for the performance tests would be the accurate measurement of CO2 gas and water supply.

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

• Not applicable. This is not a study requiring human adjudication of clinical data.

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:

• No. This is not an AI-powered device, and therefore, no MRMC study was conducted.

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

• Not applicable. This is not an AI-powered device.

7. The type of ground truth used:

• For the "CO2 gas supply" and "Water supply" tests, the "ground truth" would be the engineering specifications and calibrated measurement of the device's output, rather than clinical outcomes or expert consensus.

8. The sample size for the training set:

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

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

• Not applicable. This is not an AI/ML device.

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