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FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor.

This product is not intended for use on children and infants.

FUJIFILM Ultrasonic Endoscope EG-740UT 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 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 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.

Here's an analysis of the acceptance criteria and study information for the FUJIFILM Ultrasonic Endoscope EG-740UT, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify a "test set" in the context of clinical data for performance evaluation. The performance data presented are primarily from bench testing and compliance with established standards for various aspects like resolution, biocompatibility, electrical safety, etc. It does not appear to involve human patient data or a clinical study test set in the traditional sense.

Therefore, information on sample size for a test set and data provenance (country, retrospective/prospective) is not applicable or not provided in this document for evaluating device performance against clinical outcomes. The studies cited are for engineering, safety, and reprocessing validations.

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

As there's no clinical "test set" with ground truth established by experts for diagnostic performance, this information is not applicable or not provided in this document. The evaluations are against technical specifications and regulatory standards.

4. Adjudication Method for the Test Set

Since there is no clinical "test set" requiring expert judgment for ground truth, an adjudication method is not applicable or not provided.

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

No MRMC study is mentioned in the provided text. The document focuses on the technical performance and safety of the device itself, not on differences in human reader performance with or without AI assistance. Therefore, information on effect size for human readers is not applicable or not provided.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study is mentioned. The device is an endoscope, a medical instrument, not an AI algorithm. Therefore, this is not applicable or not provided.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation in this document is established by:

• Technical specifications/measurements: For metrics like resolution, field of view, bending capability, flow rates, etc. These are objective measurements against predefined engineering targets.
• Compliance with consensus standards: For biocompatibility (ISO 10993), electrical safety (IEC 60601), laser safety (IEC 60825, IEC 62471), endoscope specifics (ISO 8600-1), usability (IEC 62366-1), and reprocessing (FDA guidance). These standards themselves define the acceptable "truth" for device characteristics and safety.

8. Sample Size for the Training Set

As this is a medical device (endoscope) undergoing 510(k) clearance, and not an AI/ML algorithm, there is no concept of a "training set" in the context of learning data. The device's design and manufacturing are based on established engineering principles and prior device models, not on a machine learning training process.

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

Since there is no "training set," this information is not applicable or not provided.

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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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EB-530US is intended for the observation, diagnosis, and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with a FUJIFILM ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.

FUJIFILM Ultrasonic Endoscope EB-530US is an ultrasonic bronchoscope that emits ultrasound waves and scans the reflected signals to provide ultrasonic images when used in combination with an ultrasonic processor.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify human clinical trials or a "test set" in the context of patient data. The performance testing appears to be entirely non-clinical (engineering and laboratory tests), likely using a sample of the manufactured device itself or components. Therefore, information about human data provenance is not applicable.

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

Not applicable. The reported performance testing is non-clinical and does not involve expert evaluation for ground truth in a clinical context.

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

Not applicable, as no clinical test set requiring adjudication by experts is described.

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 MRMC comparative effectiveness study was done, and the device is an ultrasonic endoscope, not an AI-assisted diagnostic tool. Therefore, the effect size of human readers improving with AI assistance is not applicable.

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

This is not an AI algorithm. The device is a medical instrument. Therefore, this question is not applicable.

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

For the non-clinical performance tests, the "ground truth" would be established by objective measurements against engineering specifications, calibrated instruments, and established safety and performance standards (e.g., IEC standards for electrical safety, ISO standards for biocompatibility).

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device requiring a training set.

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

Not applicable, as this is not an AI/machine learning device.

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EG-530UT2 and EG-530UR2 are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. The product is intended to be used with a Fujifilm ultrasonic processor. This product is not intended for use on children and infants.

FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 are upper gastrointestinal endoscopes that emit ultrasound waves and scan the reflected signals to provide ultrasonic images when used in combination with an ultrasonic processor.

The provided text describes a 510(k) premarket notification for FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a new AI/software device meets specific performance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria for an AI/software device and a study to prove it meets them cannot be fully extracted from this document. The document lists performance tests for the physical endoscopic devices (e.g., field of view, bending capability, resolution, air/water supply rates), but these are for hardware performance, not AI/software performance.

However, I can extract the information related to the device performance and acceptance criteria for the physical endoscopy device as described in the document.

Here's a breakdown of what can be extracted and what cannot be, based on the provided text:

What Can Be Extracted (for the physical endoscope device):

1. A table of acceptance criteria and the reported device performance:
   The document states: "Fujifilm conducted the following performance testing on the proposed devices EG-530UT2 and EG-530UR2 to ensure that the modified devices perform equivalently to the predicate devices:

   • Field of view
   • Viewing direction
   • Bending capability
   • Resolution
   • Air supply rate
   • Water supply rate
   • Axial resolution
   • LG output
   • Suction rate
   • Working length
   • Lateral resolution
   • Penetration depth
   • Forceps channel diameter

   In all cases, the devices met the pre-defined acceptance criteria for the test."

   Therefore, the table would look like this (specific values are not provided in the document, only the claim of meeting criteria):

   Acceptance Criteria (Measured Parameter)	Reported Device Performance
   Field of view	Met pre-defined criteria
   Viewing direction	Met pre-defined criteria
   Bending capability	Met pre-defined criteria
   Resolution	Met pre-defined criteria
   Air supply rate	Met pre-defined criteria
   Water supply rate	Met pre-defined criteria
   Axial resolution	Met pre-defined criteria
   LG output	Met pre-defined criteria
   Suction rate	Met pre-defined criteria
   Working length	Met pre-defined criteria
   Lateral resolution	Met pre-defined criteria
   Penetration depth	Met pre-defined criteria
   Forceps channel diameter	Met pre-defined criteria

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

   • Sample Size: Not explicitly stated for each performance test. The document refers to "the proposed devices EG-530UT2 and EG-530UR2" performing these tests, suggesting testing on the physical devices themselves rather than a separate dataset of patient cases.
   • Data Provenance: Not specified. This is a pre-market submission, and the tests are likely internal lab/bench testing of the device hardware.

What Cannot Be Extracted (as it's not an AI/software performance study):

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance typically comes from engineering specifications and measurements, not expert human interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 document does not describe an AI-assisted diagnostic device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/software context. Ground truth for physical device specs (like resolution, field of view) is based on engineering measurements against design specifications.
8. The sample size for the training set: Not applicable. This document is not about AI training.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided FDA 510(k) clearance document for FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 pertains to demonstrating substantial equivalence of a physical medical device (endoscope) to a predicate, primarily through engineering performance testing (e.g., field of view, bending capability, resolution, fluid rates), electrical safety, and biocompatibility. It is not a document describing the validation of an AI/software device, and therefore the specific criteria related to AI performance studies cannot be found within it.

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Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 and EG-530UT2, are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.

Fuiinon/Fujifilm Ultrasonic Endoscopes EG-530UR2 and EG-530UT2 are modified versions of our previously-cleared EG-530UR and EG-530UT via K063847. The modified models are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment when used with a Fujinon/Fujifilm's ultrasonic processor, which remains the same as K063847. The modified models are used in combination with a Fujinon/Fujifilm's ultrasonic processor. video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EG-530UR2 and EG-530UT2 model emits ultrasound wave and scans the reflected signals to provide ultrasonic images.

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and supporting studies, as per your request:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not contain a specific table or detailed discussion of acceptance criteria for the performance of the Fujinon/Fujifilm Ultrasonic Endoscope (EG-530UR2 and EG-530UT2) in terms of image quality metrics (e.g., resolution, contrast, penetration depth) or diagnostic accuracy. Instead, the focus of this submission is on demonstrating substantial equivalence to previously cleared devices.

The "acceptance criteria" can be implicitly understood as compliance with relevant safety and performance standards, and the ability to reproduce the performance of the predicate devices. The device "performance" is implicitly deemed acceptable if it meets these standards and is substantially equivalent.

Study Details:

It's crucial to understand that this is a 510(k) submission focused on demonstrating substantial equivalence for modified versions of existing devices. Therefore, the types of studies typically associated with novel AI devices (like detailed performance studies, MRMC studies, training set details) are not present here. The document explicitly states: "No clinical test was conducted."

Here's a breakdown based on your requested information:

1. A table of acceptance criteria and the reported device performance: See table above. The performance evaluation primarily relied on compliance with standards and a detailed comparison matrix (not provided in this summary) to demonstrate equivalence.

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

   • Test Set Sample Size: Not applicable. No clinical tests or performance validation studies using patient data (test sets) are mentioned.
   • Data Provenance: Not applicable, as there's no patient data involved in the studies described.

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):

   • Number of Experts/Qualifications: Not applicable. No ground truth establishment for a test set is discussed, as no clinical performance study was conducted.

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

   • Adjudication Method: Not applicable. No test set requiring ground truth adjudication was used.

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:

   • MRMC Study: No. This device is an ultrasonic endoscope, not an AI-powered diagnostic tool, and the submission explicitly states "No clinical test was conducted." Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or reported.

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

   • Standalone Study: No. This device is an imaging instrument, not an algorithm. Its operation inherently involves a human operator (the endoscopist) interpreting the images.

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

   • Type of Ground Truth: Not applicable. No clinical performance study requiring ground truth was conducted. For the reprocessing validation, the ground truth would be chemical/microbiological testing results confirming effectiveness. For the safety standards, the "ground truth" is adherence to the specified requirements of each standard.

8. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This device is hardware (an endoscope) and not an AI/machine learning algorithm that requires a training set.

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

   • Ground Truth for Training Set: Not applicable. No training set was used.

Summary of the Study:

The primary "studies" conducted for this 510(k) submission were engineering verification and validation studies to ensure compliance with international safety and performance standards (IEC, ISO) and reprocessing validation by a third party. The core argument for clearance is substantial equivalence to existing, legally marketed predicate devices, meaning the new device is as safe and effective as the older ones, with documented modifications. There is no evidence of clinical studies involving patient data or evaluation of diagnostic accuracy.

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The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.

Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. EB-530US is used in combination with the Fujinon/Fujifilm's ultrasonic processor, video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EB-530US emits ultrasound wave and scans the reflected signals to provide ultrasonic images. For ultrasound procedure, EB-530US can be used with a single-patient-use balloon inflated with sterile water for an ultrasonic endoscope eliminates air between the ultrasonic transducer and target tissue so that the ultrasound wave can travel with little interference. Additionally EB-530US supports ultrasound guided needle aspiration.

Here's a breakdown of the acceptance criteria and study information for the Fujinon/Fujifilm Ultrasonic Endoscope EB-530US, based on the provided 510(k) summary:

This device did not conduct clinical testing to prove its performance against acceptance criteria. Instead, it demonstrated substantial equivalence to a legally marketed predicate device (OLYMPUS BF type UC160F-OL8, K042140) by comparing technical features and conforming to relevant safety and performance standards.

Therefore, many of the requested fields related to clinical study design and performance metrics will be marked as "Not Applicable (N/A)" or "Not Reported" because the submission relies on a different pathway for clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Since no clinical testing was conducted to establish performance metrics against specific acceptance criteria for diagnostic accuracy, the acceptance criteria here are derived from the device's conformance to recognized standards and its equivalence to a predicate device. The "Reported Device Performance" refers to the technical specifications of the proposed device.

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

• Sample Size for Test Set: Not Applicable (No clinical performance or diagnostic accuracy study reported for this device in the 510(k) summary).
• Data Provenance: Not Applicable (No clinical data set used for performance evaluation).

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

• Number of Experts: Not Applicable (No clinical performance or diagnostic accuracy study reported).
• Qualifications of Experts: Not Applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not Applicable (No clinical performance or diagnostic accuracy study reported).

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

• MRMC Study Done: No.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not Applicable (No AI component, no MRMC study).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Standalone Study Done: No. This device is an endoscope, not an algorithmic device requiring standalone performance evaluation in the context of AI. The performance is assessed through its physical and electrical specifications and safety standards.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not Applicable. For this 510(k) pathway, the "ground truth" for substantial equivalence is derived from compliance with recognized consensus standards and direct comparison of design and technological characteristics to a legally marketed predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not Applicable (No AI/machine learning component requiring a training set was reported for this device).

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

• How Ground Truth was Established: Not Applicable (No AI/machine learning component, therefore no training set or associated ground truth for such a set).

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