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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 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.

Based on the provided text, the document describes the substantial equivalence of the FUJIFILM Duodenoscope Model ED-580XT, not a study evaluating an AI-powered diagnostic device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device studies, are not present in this document.

The document mainly focuses on the physical and functional aspects of the duodenoscope and its safety and performance standards.

Here's a breakdown of what can be extracted, and what cannot:

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

The document lists performance specifications that were tested and states the device met the "pre-defined acceptance criteria for the test." However, the specific numerical or descriptive acceptance criteria themselves are not provided, nor are the reported raw performance values.

Information NOT available in the document:

2. Sample sizes used for the test set and the data provenance: Not applicable as this is not an AI/ML study with a "test set" in that context. The "tests" refer to engineering performance validations.
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 an AI/ML algorithm is not established for this type of device.
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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a medical device (a duodenoscope) and details its engineering performance, biocompatibility, and sterilization, rather than the clinical performance of an AI/ML-powered diagnostic tool.

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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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ED-530XT 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-530XT 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.

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 Data Provenance

The provided text does not explicitly state the sample size for the test set regarding the functional performance tests (e.g., field of view, bending capability, etc.). It only mentions that Fujifilm conducted "performance testing on the proposed device ED-530XT." Also, the provenance of the data (e.g., country of origin, retrospective or prospective) is not specified.

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

The provided document does not mention the use of experts to establish ground truth for the performance tests. The nature of the tests (e.g., measuring field of view, bending capability) suggests objective measurements rather than expert interpretation.

4. Adjudication Method for the Test Set

Since experts are not mentioned in the establishment of ground truth for performance tests, an adjudication method is not applicable and not mentioned.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device in question is an endoscope, and the performance tests focus on its physical and functional attributes, not on its assistance to human readers in interpretation. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not relevant or reported here.

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

This is a physical medical device (an endoscope), not an AI algorithm. Therefore, a standalone performance study in the context of "algorithm only without human-in-the-loop performance" is not applicable and not mentioned. The tests performed are on the device itself.

7. Type of Ground Truth Used

The ground truth used for the performance tests appears to be objective measurements against pre-defined engineering and performance specifications. For electrical safety and biocompatibility, the ground truth is established by the relevant international consensus standards (e.g., IEC, ISO).

8. Sample Size for the Training Set

Since this is a physical medical device and not an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable and not mentioned.

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

As there is no training set for an AI algorithm, this information is not applicable. The "ground truth" for the device's performance is established by its adherence to specified engineering parameters and relevant safety and performance standards.

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The Fujifilm Duodenoscope Model ED-530XT 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.

The Fujifilm Duodenoscope Model ED-530XT is comprised of three main sections: an operation section, an insertion portion, and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion portion contains glass fiber bundles, several channels and a CCD image sensor. 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 sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water and provide suction, as well as a forceps channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source.

The provided text is a 510(k) summary for a medical device called the Fujifilm Duodenoscope Model ED-530XT. It primarily focuses on demonstrating substantial equivalence to a predicate device (Fujinon G5 Duodenoscope ED-450XT5 / ED-250XT5) rather than detailing specific acceptance criteria and a study proving device performance against those criteria in a typical clinical or AI context.

Therefore, many of the requested categories (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with AI, and specific ground truth types) are not applicable or not explicitly detailed in this document, as the submission relies on bench testing and comparison to an existing predicate device rather than a clinical trial demonstrating new performance metrics against specific acceptance thresholds.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific acceptance criteria with quantifiable metrics (e.g., sensitivity, specificity, accuracy) that are typically seen for diagnostic devices or AI algorithms. Instead, the performance is demonstrated through various engineering and safety tests, with the implied "acceptance criterion" being that the device meets the standards and performs comparably to the predicate.

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

• Sample Size: Not specified. The performance data described are primarily from bench testing of the device itself and its components, rather than a "test set" of patient data or clinical cases.
• Data Provenance: Not applicable in the context of clinical data. The tests are lab-based, engineering performance tests.

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

• Not applicable. The ground truth for these engineering and safety tests is established by adherence to industry standards, measurement protocols, and physical testing, not by expert medical interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints, not for bench testing of physical device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. This type of study is typically done for diagnostic aids or AI algorithms where human reader performance is a key outcome. This 510(k) submission focuses on the safety and functional equivalence of an endoscope.

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

• Not applicable. This device is an endoscope, which is a physical medical instrument, not an AI algorithm. Therefore, "standalone" performance in the AI sense is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for the tests described is based on engineering specifications, established consensus standards (e.g., ISO, AAMI, IEC), and documented test methods for device performance, safety, and biocompatibility.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm that undergoes "training."

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

• Not applicable, as there is no training set for this type of device submission.

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