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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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This device is intended for the visualization of the lower digestive tract, specifically. for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

Fujinon Colonoscope EC-530HL2 and EC-530LS2 are modified versions of our previouslycleared Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5 as described in K041903. The modified models are intended for observation, diagnosis, and endoscopic treatment of the lower digestive tract, which includes rectum, sigmoid colon, and large intestine, which remains the same as K041903.

The endoscopes are comprised of three general sections: an operation section, a flexible portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The flexible insertion portion contains glass fiber bundles, several channels and a charged couple device (CCD). The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity thereby providing enough light to the CCD to capture an image and display the image on the monitor. The endoscope also contains several channels to deliver air/water, provide suction and a working channel. The forceps channel or working channel is used to introduce endoscope accessories such as biopsy forceps. The umbilicus contains electronic components needed to operate the endoscope when plugged to the video processor and the light source.

The modified models are used in combination with Fujinon's video processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices.

This 510(k) premarket notification describes the Fujinon Colonoscopes EC-530HL2 and EC-530LS2, which are modified versions of previously cleared devices (K041903). The submission asserts substantial equivalence to the predicate devices and does not describe a new AI/ML-based device or a clinical study that evaluates its performance against acceptance criteria.

Therefore, most of the requested information cannot be found in the provided document.

Here's what can be extracted based on the input:

This submission did not involve an AI/ML device. It is for a medical device (colonoscope) and thus the following information is not applicable in the context of an AI/ML study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria for diagnostic performance in the context of an AI/ML algorithm. Instead, it refers to compliance with safety and performance requirements for the colonoscope.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test was conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test was conducted.

4. Adjudication method for the test set: Not applicable. No clinical test was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: Not applicable. No clinical test was conducted. The ground truth for device safety and performance here would be compliance with the cited international standards and successful third-party validation for reprocessing.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary from the provided document:

The submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5, K041903). The modifications are described as minor dimensional changes, material changes, and relocation of the water jet inlet, which are stated not to adversely affect safety and effectiveness.

The "studies" mentioned are primarily focused on compliance with recognized international safety and performance standards for medical electrical equipment and biocompatibility, along with validation of reprocessing instructions. No clinical tests were conducted for this 510(k) submission to evaluate diagnostic performance of a new feature or an AI algorithm, as this is a device modification submission.

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The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, light source, monitor, recorder and various peripheral devices.

The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, video processor, monitor, recorder and various peripheral devices.

This system is intended to be used in conjunction with Fujinon endoscopes to provide illumination, visual display and data storage during endoscopic procedures.

The EPX-4440HD Digital Video Processor consists of three components used in conjunction with one another:

The VP-440HD Video Processor: The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor also incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor also provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 120V/60MzJO.8A. The Processor is housed in a steel-polycarbonate case measuring 390X105X460mm.

The XL-4450 Light Source: The Fujinon endoscope employs fiber bundles to transmit light from the light source and subsequently to the body cavity. The Light Source employs a 300W Xenon lamp with a 75W emergency back-up Halogen lamp. Brightness control is performed by the user. The device is AC operated at a power setting of 120V/60MzJ3.3A. The Processor is housed in a steel-polycarbonate case measuring 390X155X485mm.

The DK-440E Keyboard: The Keyboard is used to enter pertinent procedural information (patient, physician, date, etc) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-4440HD Processor. The Keyboard resembles a standard computer keyboard in size and shape.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fujinon EPX-4440HD Digital Video Processor:

NOTE: The provided 510(k) summary focuses primarily on the safety and performance aspects of a modified device compared to a predicate device, rather than defining and proving specific acceptance criteria in the way one might for a novel AI/software-as-a-medical-device (SaMD) product. The "acceptance criteria" discussed are more about meeting established regulatory and engineering standards, and the "study" is functional testing with physician evaluators for general performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "physician evaluators" without specifying how many cases, images, or evaluation instances were part of their assessment.
• Data Provenance: Not explicitly stated. The context suggests general functional testing, likely performed in a controlled environment by the manufacturer. It does not mention country of origin or whether clinical patient data was used. It's likely simulated or controlled test conditions given the nature of the evaluation.
• Retrospective/Prospective: Not explicitly stated, but given it's functional testing for a device modification, it would typically be a prospective evaluation of the new device's capabilities in a controlled setting.

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

• Number of Experts: Not explicitly stated. The document refers to "physician evaluators" (plural), but the exact number is not provided.
• Qualifications of Experts: Not explicitly stated beyond "physician evaluators." No specialty (e.g., gastroenterologist who performs endoscopy) or years of experience are listed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The statement "In all cases they passed the required testing regimens" suggests a unanimous agreement or a pass/fail criterion that was met by all evaluators, rather than a formal adjudication process between conflicting interpretations.

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

• Was an MRMC study done? No, a traditional MRMC comparative effectiveness study as typically understood for AI algorithms (i.e., comparing human readers with and without AI assistance on diagnostic accuracy) was not performed. The study mentioned was a functional performance test for a hardware/software update, not an AI-assisted diagnostic tool.
• Effect size of human readers with vs. without AI assistance: Not applicable, as no such study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, in a sense. The "software validation" and "electrical safety" testing would represent a standalone evaluation of the device's technical functionality. The "performance testing using physician evaluators" also tested the device itself, although with human interaction. However, this is not an AI algorithm performing a diagnostic task. The spectral and structural enhancements are "achieved through proprietary software," implying an algorithm, but its performance was evaluated by physicians using the system, not as a standalone diagnosis.

7. Type of Ground Truth Used

• Type of Ground Truth: For the "visual comparison tests conducted using physician evaluators," the ground truth was essentially the expert opinion/consensus of the physician evaluators regarding the successful functionality and acceptable image quality produced by the system. This is not pathology, outcomes data, or a pre-established clinical diagnosis.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a video processor and light source, not a machine learning model that requires a "training set" in the conventional AI sense. While there is proprietary software for "spectral and structural enhancements," the document does not describe the development of this software in terms of machine learning training, but rather as a feature set of the device.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for a machine learning model. If the "proprietary software" involved some form of learned enhancement, the document does not provide details on how such a model would have been trained or its ground truth established.

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The Fujinon ultrasonic processor SU-8000 is intended to be used in combination with Fujinon/Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: General Application
Specific: Tran-esoph. (non-Card.), Other (Specify)
Mode of Operation: B, M, PWD, Color Doppler, Combined1
Other includes gastro-intestinal tract and surrounding organs

Fujinon Ultrasonic Processor SU-8000 is a new ultrasonic processor, which can be used with the previously-cleared ultrasonic gastrointestinal endoscopes, EG-530UR and EG-590UT via K063847.

Fujinon Ultrasonic Processor SU-8000 consists of a scan engine and a function box and SU-8000 is controlled by keyboard (model: CP-8000) SU-8000 connects to ultrasonic endoscopes, which emits ultrasound in a body cavity by driving ultrasonic transducers of the endoscope. SU-8000 also processes the reflection of ultrasonic signals the transducer and converts it to an ultrasound image.

SU-8000 is used in combination with ultrasonic endoscopes, video processor, light source, cart, recorder, foot switch and other peripheral devices (e.g. external monitor and printer), which is the same as the legally marketed device, SU-7000.

I am unable to provide a structured response about acceptance criteria and study details based on the provided text. The document is a 510(k) summary for the Fujinon Ultrasonic Processor SU-8000, which states:

• "No clinical test was conducted."
• The device was evaluated in accordance with various IEC safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, etc.).
• Substantial equivalence to a legally marketed device (SU-7000) was established based on having the same Indications for Use and very similar Functional and Technical requirements.

This type of submission focuses on demonstrating safety and effectiveness through adherence to recognized standards and substantial equivalence to existing devices, rather than through a new clinical study with specific acceptance criteria and performance metrics typically associated with AI/algorithm validation. Therefore, the requested information (such as sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth details for test/training sets) is not present in this document.

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The sterile overtubes are intended to be used as accessories with the Fujinon Enteroscopes and Colonoscopes cleared for use with overtubes. The overtubes are used to assist with the movement of the scopes inside the upper or lower digestive tract.

The sterile overtubes are intended to be used as accessories with the Fujinon Double Balloon Enteroscopy system, which is used for the optical visualization of the gastrointestinal tract

The Fujinon double balloon enteroscopy system (K040048) and EC-450B15 (K090116) utilize specialized overtubes to ensure complete positioning of the enteroscope or colonoscope in the digestive tract and to ensure the tip of the scope can be smoothly inserted to reach the area of diagnosis.

The overtube (TS-12140) was included in the original 510(k) K040048 and the overtube (TS-13101) was included in 510(k) K090116 with the EC-450BI5.

This submission includes the following items:
TS-12140 Over Tube Originally included in the K040048 as non-sterile.
TS-13140 Over Tube
TS-13101 Over Tube Including in K090016.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Acceptance Criteria for Fujinon Sterile Overtubes",
    "headers": ["Acceptance Criteria (Performance Standard)", "Reported Device Performance"],
    "rows": [
      ["Biocompatibility requirements (per ISO standards)", "Passed"],
      ["Sterilization process validation (per ISO standards)", "Validated"],
      ["Same indications for use as predicate devices", "Met"],
      ["Same dimensions as predicate devices", "Met"],
      ["Same material composition as predicate devices", "Met"]
    ]
  },
  "study_details": {
    "sample_size_test_set": "Not applicable, as the submission describes a change to a sterile version of an existing device, not a new diagnostic algorithm using a test set.",
    "data_provenance": "Not applicable.",
    "number_of_experts_ground_truth_test_set": "Not applicable.",
    "qualifications_of_experts": "Not applicable.",
    "adjudication_method": "Not applicable.",
    "mrmc_comparative_effectiveness_study": false,
    "effect_size_human_readers_ai_vs_without_ai": "Not applicable.",
    "standalone_performance_study": false,
    "type_of_ground_truth_used": "Not applicable. The study focuses on demonstrating sterility and biocompatibility, not diagnostic accuracy requiring a ground truth.",
    "sample_size_training_set": "Not applicable.",
    "ground_truth_for_training_set_establishment": "Not applicable."
  },
  "additional_information": "This 510(k) submission ([K091773](https://510k.innolitics.com/search/K091773)) is for Fujinon Sterile Overtubes, which are a sterile version of previously cleared non-sterile overtubes ([K040048](https://510k.innolitics.com/search/K040048) and [K090116](https://510k.innolitics.com/search/K090116)). The submission aims to establish substantial equivalence by demonstrating that the sterile devices meet biocompatibility and sterilization standards, and maintain the same intended use, dimensions, and material composition as their non-sterile predicates. The document does not describe a study involving diagnostic performance, AI algorithms, or human readers, but rather focuses on the safety and effectiveness aspects related to the sterilization of the device."
}

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The device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.

The device is intended for the optical visualization of the gastrointestinal tract. This includes the recturn, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.

The Fujinon double balloon enteroscopy system utilizes specialized balloons and over-tube to ensure complete positioning of the colonoscope. The tip of the scope can be smoothly inserted to reach the area of diagnosis. This allows for access to hard to reach areas within the bottom portion of the small intestine.

The EC-450B15 consists of the following portions / parts:

• . Control portion - to provide grip for holding the endoscope and for the operation of the endoscope.
• LG Flexible Portion Contains the light guide, air/water supply tube, suction tube, . and cables.
• Bending Portion .
• Distal End Contains objective lens, air/water nozzles, forceps channel. .

The EC-450Bl5 is used with balloons (BS-1 or BS-2) and an Over-Tube (TS-13101), as well as the balloon pump. The balloon pump, balloons and over-tube were introduced and included as part of the Double Balloon Enteroscopy 510(k).

The EC-450BI5 is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.

The provided text is a 510(k) summary for the Fujinon EC-450BI5 Colonoscope. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not directly applicable or present in this specific 510(k) summary.

Here's an analysis based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission. The implicit acceptance criterion is that the new device is "as safe and effective as the predicate device" and shares "the same indications for use, material composition, characteristics, reprocessing/sterilization method."
• Reported Device Performance: The document states, "The materials in the endoscope are identical to the materials used in the predicate device. Additionally, the device contains the same electrical configurations as the predicate devices." This implies that the performance is expected to be identical to the predicate given the design similarities. No specific performance metrics (e.g., sensitivity, specificity, accuracy) are provided, as would be expected for a de novo device.

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

• Not Applicable. No test set or performance study data with human subjects or cases is mentioned. The submission relies on the established safety and effectiveness of the predicate devices and the similarity of the new device's design.

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)

• Not Applicable. No ground truth establishment by experts is described as no new performance study was performed.

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

• Not Applicable. No test set or adjudication method 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

• Not Applicable. This is a medical device (colonoscope), not an AI-based diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

• Not Applicable. This is a physical medical device; there is no standalone algorithm performance to evaluate.

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

• Not Applicable. No ground truth is established for a new clinical performance claim. The basis for approval is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, and no training set is mentioned or implied.

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

• Not Applicable. As above, no training set or ground truth establishment for a training set is described.

Summary of what the document DOES state regarding performance:

The basis for the Fujinon EC-450BI5 Colonoscope's approval relies on its substantial equivalence to two predicate devices: Fujinon EG-450HL5 (K041903) and Fujinon EN-450P5/20 (K040048).

The key performance claims and rationale for substantial equivalence are:

• Same Indications for Use: "The device is intended for the optical visualization of the gastrointestinal tract... It is intended for observation, diagnosis, and endoscopic treatment." This is identical to the predicates.
• Identical Materials: "The materials in the endoscope are identical to the materials used in the predicate device."
• Same Electrical Configurations: "the device contains the same electrical configurations as the predicate devices."
• Same Processor and Peripherals: "The subject device uses the same processor and peripherals as the predicate device."
• Minor Changes: The main difference mentioned is the "use of a colonoscope for with the double balloon enteroscopy accessories or retrograde application of the double balloon enteroscopy system." The submitter concludes these changes are minor and do not alter the safety or effectiveness.

In the context of a 510(k) for a physical medical device demonstrating substantial equivalence, the "acceptance criteria" are effectively that the device functions as intended (optical visualization, diagnosis, treatment within the GI tract) and is as safe and effective as its predicates, primarily due to shared design characteristics and materials. No specific quantitative performance study is typically required or presented for such a submission if the changes are deemed minor and do not raise new questions of safety or effectiveness.

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The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.

The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.

The EG-530N consists of the following portions / parts:

• Control portion to provide grip for holding the endoscope and for the operation of the endoscope.
• LG Flexible Portion - Contains the light guide, air/water supply tube, suction tube, and cables.
• Bending Portion
• Distal End - Contains objective lens, air/water nozzles, forceps channel.

The EG-530N is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.

The provided text is a 510(k) summary for the Fujinon EG-530N Gastroscope. It describes the device, its intended use, comparison to a predicate device, and a conclusion on substantial equivalence. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets performance criteria in the way a clinical trial or algorithm validation study would.

The "Performance Data" section states: "The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device." This indicates engineering and materials testing, but not clinical performance metrics like diagnostic accuracy, sensitivity, or specificity.

Therefore, many of your requested items cannot be extracted from this document, as it is a regulatory submission focused on substantial equivalence rather than a clinical performance study report.

Here's a breakdown of what can and cannot be answered 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: Not applicable. This document does not describe a test set or clinical study for evaluating diagnostic performance. The "testing" mentioned refers to engineering and safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment by experts for clinical performance is described.

4. Adjudication method 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 device is a gastroscope, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope, not an algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" here is the device's adherence to engineering standards and technical specifications, not clinical outcomes or pathology.

8. The sample size for the training set: Not applicable. As this is not an AI/algorithm-based device, there is no training set in that context.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document implies about "meeting acceptance criteria":

The document effectively states that the Fujinon EG-530N Gastroscope meets its "acceptance criteria" by demonstrating substantial equivalence to existing legally marketed devices (predicates). This is the primary regulatory pathway used here. The criteria for acceptance by the FDA were that the device is as safe and effective as its predicates, which was argued based on:

• Similar indications for use.
• Identical material composition.
• Similar viewing direction, image size, bending, reprocessing/sterilization methods.
• Use of the same processor and peripherals.
• Minor differences (e.g., smaller diameter, field of view) were deemed not to raise new safety or effectiveness concerns.
• The addition of transnasal indication was supported by existing FDA clearance for similar devices.
• Passing of standard engineering safety tests (electrical, thermal, EMC).

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The EG-530UR and EG-530UT ultrasonic endoscopes are intended to be used with the SU-7000 ultrasound I ho system is used for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas), as well as observation and diagnosis of submucosal and peripheral organs using ultrasonic images, and endoscopic treatment.

The EG-530UR and EG-530UT are medical ultrasonic gastrointestinal endoscopes. They are intended for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas) using an Ultrasonic endoscope, observation and diagnosis of submucosal and perioheral organs using ultrasonic images, and endoscopic treatment at medical facilities under the management of physicians. These endoscopes are used in combination with a processor, light source, cart, ultrasonic processor (SU-7000), and video printer. The endoscopes are used with a single use balloon. The endoscopes have a groove on the tip to hold the balloon in place. The SU-7000 is an ultrasonic processor that is used with a medical ultrasonic endoscope (EG-530UR or EG-530UT). The processor connects to the ultrasonic endoscope, which emits ultrasound in a body cavity by driving an ultrasonic transducer of the endoscope. It also processes the reflection ultrasonic signal received by the transducer and coverts it to an ultrasonic image.

The provided document is a 510(k) summary for a medical device (Fujinon Ultrasonic Endoscope & Processor), which focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/software component.

Therefore, the document does not contain the information needed to fill out the requested table and answer the specific questions about acceptance criteria, study details, ground truth, and AI-related metrics.

The document states:

• "The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements." This refers to general safety and operational standards, not performance in a clinical context for a specific AI function.
• "The materials in the endoscope are biocompatible and are identical to the materials used in the predicate device." This is a material safety claim.
• "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device." This is the core claim of a 510(k) based on substantial equivalence.

It does not describe a study that involves:

• Reporting device performance against quantifiable clinical acceptance criteria (e.g., sensitivity, specificity, accuracy).
• A test set with defined sample size, data provenance, ground truth established by experts, or adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
• A training set with an established ground truth.

This document is a regulatory submission focused on demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices. It does not provide the kind of performance data (e.g., for an AI algorithm) that would typically involve specific acceptance criteria and detailed study designs as requested in your prompt.

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The device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

The Fujinon G5 Bronchoscopes are medical endoscopes used for the observation, diagnosis, and endoscopic treatment of the trachea and broncho. The G5 Bronchoscopes are offered in a 200 and 400 series. The EB-250S represents the G5 Bronchoscope 200 series and the EB-470S represents the G5 Bronchoscope 400 series. The G5 Bronchoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons. The J-Port was repositioned. The J-Port is used as a jet water wash port. The J-Port was repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging. A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage. The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable. The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same. The G5 Bronchoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning. The G5 Bronchoscopes are used with the same processors, monitors, hard carts as the predicate devices. Each Duodenoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual. The Fujinon G5 Bronchoscopes are used in conjunction with other peripherals specified in the Operation Manual such as: Light Source, Processor, Cart, Data Keyboard, Foot Switch, Monitor, Video Printer, Camera and Hard Copy Unit, VCR, ElectroSurgical Instruments.

The provided text describes a 510(k) submission for Fujinon G5 Bronchoscopes (Models EB-470S, EB-250S, and EB-270P). However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (Fujinon EB-310S, K954707) by outlining changes and similarities in technical characteristics, indications for use, and material composition.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided text.
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 information is not present in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided text.
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 information is not present in the provided text. The device is an endoscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present in the provided text. The device is an endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present in the provided text.
8. The sample size for the training set: This information is not present in the provided text.
9. How the ground truth for the training set was established: This information is not present in the provided text.

The document states under "Performance Data [21 CFR 807.92(b)(1)]":
"The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device."

This indicates that some performance testing was conducted, but it's limited to electrical safety, thermal, and EMC, and the specific acceptance criteria and detailed results of these tests are not provided in the summary. The core of the submission is demonstrating equivalence, not necessarily a new performance study against specific criteria beyond safety and basic physical characteristics.

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

The Fujinon GS Gastroscopes are medical endoscopes used for visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The G5 Gastroscopes are offered in a 200 and 400 series. The EG-250WR5 represents the G5 Gastrooscope 200 series and the EG-450WR5 represents the G5 Gastroscope 400 series. The G5 Gastroscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons. A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage. The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection. The valves are now external and removable. The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same. The G5 Gastroscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning. The G5 Gastroscopes are used with the same processors, monitors, hard copy units, and carts as the predicate devices. Each Gastroscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual. The Fujinon G5 Gastroscopes are used in conjunction with other perified in the Operation Manual such as: Light Source / Processor / Cart / Data Keyboard / Foot Switch / Monitor / Video Printer / Camera and Hard Copy Unit / VCR / Electrosurgical Instruments.

The provided text describes a 510(k) submission for Fujinon G5 Gastroscopes, focusing on minor design changes compared to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI performance or diagnostic accuracy.

The submission aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices rather than proving performance against specific acceptance criteria for a novel AI or diagnostic system. The changes are described as "minor" and related to usability, ergonomics, and cleaning, not to the fundamental diagnostic or treatment capabilities that would typically require extensive performance studies with defined acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• No specific, quantitative performance acceptance criteria are mentioned (e.g., sensitivity, specificity, accuracy for a detection task).
• No quantitative device performance metrics (e.g., specific accuracy rates) are provided.

2. Sample size used for the test set and the data provenance: Not applicable. This submission is about minor design changes to an existing device, not a performance study on a test set (clinical or imaging data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No such performance study was conducted or described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No such performance study was conducted or 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: Not applicable. This submission is for a gastroscope, not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This submission is for a gastroscope, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established as part of a performance study described in this document. The "ground truth" for the clearance is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set or ground truth establishment for such a set.

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