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The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal and pulmonary endoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.

The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.

The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

The provided FDA 510(k) clearance letter for the PENTAX Medical Video Processor (EPK-i8020c) does not contain the information requested regarding acceptance criteria and the detailed study proving the device meets those criteria.

This document primarily focuses on establishing substantial equivalence to a predicate device based on minor software modifications and changes to instructions for use. It states that "The changes to the subject device were evaluated through performance testing in design validation/verification. This testing did not raise any issues regarding the safety and effectiveness of the device, as these differences do not affect the performance, function, or general intended use of the device."

However, it does not provide any specific acceptance criteria, reported device performance metrics against those criteria, or the details of the study methodology (sample size, data provenance, expert involvement, adjudication, MRMC, standalone performance, ground truth, training set specifics).

Therefore, based on the provided text, I cannot complete the requested information. The document explicitly states:

• "NON-CLINICAL PERFORMANCE DATA" section, point iii. "System Performance": "The system performance of the subject device demonstrated the equivalence to the predicate device."
• This suggests that the performance verification for this 510(k) relied on demonstrating equivalence to an already cleared predicate, rather than a de novo clinical or rigorous standalone performance study with specific acceptance criteria that would then be detailed.

Without access to the actual design validation/verification reports that were submitted to the FDA detailing the performance testing, it's impossible to answer the specific questions about acceptance criteria and the study that proves the device meets them.

The sections for acceptance criteria, study details, and related information would be empty or marked as "Not Provided in Document" if I were to adhere strictly to the given text.

In summary, the provided FDA 510(k) clearance letter does not describe the acceptance criteria or a dedicated study proving device performance against those criteria in the level of detail requested.

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The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.

The PENTAX Medical Video Upper Gl Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems: esophagus, stomach, and duodenum.

This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.

The PENTAX Medical Video Colonoscope EC38-120cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.

This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.

The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.

The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is supposed to be found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

The PENTAX Medical Video Upper GI Scope EG29-i20c is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the upper gastrointestinal tract.

The PENTAX Medical Video Colonoscope EC38-i20cL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract. The device is equipped with stiffness setting mechanism for the insertion tube. This feature enables the physician to choose the stiffness of the insertion tube, depending on the preferred level.

The document provides information on the PENTAX Medical EPK-i8020c Video Imaging System, including its components (Video Processor EPK-i8020c, Video Upper GI Scope EG29-i20c, and Video Colonoscope EC38-i20cL) and their intended uses. It also details the non-clinical performance data used to support the substantial equivalence determination to predicate devices.

However, the document does not contain the specific details required to answer all parts of your request, particularly regarding detailed acceptance criteria, reported device performance metrics in a table, an AI component, and the specifics of a study proving the device meets acceptance criteria in the way you've outlined.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through various technical and performance tests, rather than setting and meeting a specific set of quantitative acceptance criteria for a new clinical performance claim or an AI algorithm.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance Study (Based on provided document)

The document describes various non-clinical performance tests to demonstrate substantial equivalence, rather than a single study with specific acceptance criteria for a novel AI feature. The "acceptance criteria" here are generally compliance with recognized standards or demonstration of equivalence to predicate devices.

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

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

The document does not specify a "test set" in the context of clinical images or patient data for an algorithm. The non-clinical tests mentioned rely on physical devices, simulated use, and animal models.

• For Reprocessing Validation: Simulated use testing. Sample size not specified.
• For Biocompatibility: Materials assessed in accordance with ISO standards. Sample size not specified.
• For Animal Image Capture Study: Animal model used. Sample size not specified.

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

Not applicable as there is no mention of a human-expert-annotated "test set" for an AI algorithm or clinical performance study. The ground truth for the non-clinical tests is based on objective measurements, standards, or comparison to established predicate devices/methods.

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

No MRMC study or AI assistance claim is described in the provided document. The device includes "digital post-processing imaging enhancement technology (PENTAX i-Scan™)" and "optical imaging enhancement technology (OE)", but this is described as an "optional adjunct following traditional white light endoscopy" and "not intended to replace histopathological sampling." It is not presented as an AI-assisted diagnostic tool that would typically undergo an MRMC study to compare human performance with and without AI.

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

This document does not describe the performance of a standalone algorithm for diagnostic purposes. The imaging enhancements (i-Scan, OE) are adjuncts for visual inspection by a clinician.

7. The type of ground truth used

For the non-clinical performance tests:

• Reprocessing Validation: AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency.
• Biocompatibility: ISO 10993-1:2018 (toxicity, sensitization, intracutaneous reactivity).
• Electrical Safety and EMC: IEC and ISO standards.
• Optical Performance/Animal Image Capture Study: Comparison against predicate and reference devices' images and visualization capabilities.

No histological pathology or specific clinical outcomes data are mentioned as ground truth for a diagnostic performance study.

8. The sample size for the training set

Not applicable. There is no mention of an AI algorithm requiring a training set in this submission. The imaging enhancement technologies are likely rule-based image processing or optical filtering techniques rather than deep learning AI.

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

Not applicable.

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The PENTAX Medical Video Colonoscope EC34-i10cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 5kg of body weight.

The PENTAX Medical Video Colonoscope EC38-110cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.

The PENTAX Medical Video Upper GI Scope EG29-i10c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, and duodenum.

This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.

The PENTAX Medical Video Processor EPK-i5500c is intended to be used with the PENTAX Medical camera heads, endoscopes, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. It processes signals transmitted from a video endoscope into images that are displayed on an inspection monitor. This processor has air/water pump function.

This device includes PENTAX i-scan™, a digital, post-processing imaging enhancement technology. i-scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.

PENTAX Medical Video Processor EPK-i5500c
The PENTAX Medical Video Processor EPK-i5500c consists of a video system, monitor and ancillary equipment. This processor is intended for endoscopic diagnostic, treatment and video observation. The PENTAX Medical Video Processor EPK-i5500c contains a contrast enhancement feature: PENTAX i-scan technology. All visualization is done with the white light mode first. White light (RGB) illuminates the tissue and transfers the captured light through the Complementary MOS (CMOS) of the video scope. Note that the white light visualization mode is always used first by the physician. For i-scan image enhancement, the modification of the combination of RGB components for each pixel occurs when the i-scan function is turned on in the PENTAX Medical Video Processor EPK-i5500c. The resulting i-scan image is then displayed on the observation monitor. The EPK-i5500c is compatible with PENTAX Medical endoscopes EG29-i10c, EC34-i10cL and EC38-i10cL.

PENTAX Medical Video Upper GI Scope EG29-i10c
The PENTAX Medical Video Upper GI Scope EG29-i10c is used with PENTAX Medical Video Processor EPK-i5500c.The PENTAX Medical Video Upper GI Scope EG29-i10c is composed of the following main parts: an Insertion Portion, Control Body and Scope Connector. The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Control Button, Magnification Control Lever, and Instrument Channel Inlet. The Air/Water Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Scope Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the Air/Water Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed, the fluid and air are suctioned. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle. The Light Guide of the Distal End is used to illuminate the body cavity with LEDs. The CMOS built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.

PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-i10cL
The PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-i10cL are used with PENTAX Medical Video Processor EPK-i5500c. The endoscopes are composed of the following main parts: an Insertion Portion, Control Body and Scope Connector. The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Button, Suction Selector Cylinder, and Instrument Channel Inlet. The Air/Water Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Suction Channel Selector is attached to the Suction Selector Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Scope Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the Air/Water Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, the air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed, the fluid and air are suctioned. The endoscopes have two channels; the primary channel and secondary one. Suction Channel Selector is used to switch between the primary and secondary channels as necessary. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle. The Light Guide of the Distal End is used to illuminate the body cavity with LEDs. The CMOS built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is, displayed on the Monitor.

The provided document is a 510(k) Pre-market Notification from the FDA regarding several PENTAX Medical devices. It outlines the substantial equivalence to predicate devices based on intended use, technological characteristics, and performance testing. However, the document does not contain information about a study that describes acceptance criteria for an AI device, the device's performance against those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies for an AI component.

The only mention of "AI" or "imaging enhancement technology" related to AI is:

"This device includes PENTAX i-scan™, a digital, post-processing imaging enhancement technology. i-scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling."

This statement describes a feature of the PENTAX Medical Video Processor EPK-i5500c, but the document does not provide any specific study details, acceptance criteria, or performance metrics for this "i-scan" technology as if it were a separate AI device requiring standalone validation. The 510(k) summary focuses on the substantial equivalence of the entire endoscopy system (processor and scopes) to previous PENTAX models, citing general performance testing like "Optical Characterization," "Backflow Prevention," "Compatibility," and "Product Life," along with standard regulatory considerations such as reprocessing, biocompatibility, software, EMC, and electrical safety.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them from the provided text for an AI component. The document is primarily a regulatory filing asserting substantial equivalence of hardware devices, not a detailed performance study of a specific AI feature.

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The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.

The PENTAX EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX EPK-i5010 includes PENTAX i-Scan™, a digital post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.

The PENTAX Medical EPK-i7010 Video Processor and PENTAX EPK-i5010 Video Processor each consist of a video system, integrated light source, monitor, and ancillary equipment. These processors are intended for gastrointestinal endoscopic diagnostic, treatment and video observation.

The PENTAX Medical EPK-i7010 Video Processor contains two types of contrast enhancement techniques: PENTAX i-Scan technology, and optical enhancement (OE) technology. The PENTAX EPK-i5010 Video Processor contains only PENTAX i-Scan. The PENTAX i-Scan technology is a digital post-processing image enhancement technique with three modes, i-Scan 1, 2 and 3.

The provided text is a 510(k) summary for the PENTAX Medical EPK-i7010 and EPK-i5010 Video Processors, with a focus on a minor design change related to the Water Bottle Assembly OS-H5. It is NOT a study proving the device meets acceptance criteria for an AI/imaging diagnostic device.

The document discusses performance testing in a general sense, but this testing relates to the physical and functional characteristics of the water bottle accessory and its reprocessing, not to the diagnostic accuracy or clinical performance of the imaging enhancement technologies (i-Scan and OE) with human readers.

Therefore, many of the requested criteria for describing an AI/imaging diagnostic study (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size) cannot be found in this document because the document does not describe such a study.

The closest relevant information relates to the performance of the Water Bottle Assembly OS-H5.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

Acceptance Criteria and Study for PENTAX Medical EPK-i7010/EPK-i5010 (Water Bottle Assembly OS-H5)

The provided document (510(k) summary) does not describe a study related to the diagnostic performance of the PENTAX i-Scan or Optical Enhancement (OE) technologies, especially in conjunction with human readers or AI algorithms. Instead, it focuses on demonstrating the substantial equivalence of the PENTAX Medical EPK-i7010 and EPK-i5010 Video Processors, specifically addressing a minor design change: the replacement of a disposable water bottle system with the reusable PENTAX Water Bottle Assembly OS-H5.

The "acceptance criteria" and "study" described pertain to the safety and functional performance of the reusable water bottle accessory and its reprocessing methods, not the diagnostic utility of the imaging processors themselves or any associated AI.

1. Table of Acceptance Criteria and Reported Device Performance (Specific to Water Bottle Assembly OS-H5)

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The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for bronchoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK -7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX video bronchoscopes.

The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for bronchoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i7010 Video Processor contains PENTAX i-Scan and Optical Enhancement (OE) technologies.

The PENTAX i-Scan technology is a digital filter-based image enhancement technique with three modes, i-Scan 1, 2, and 3. PENTAX i-Scan™ is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels.

In addition to i-Scan, OE is intended to provide alternative methods to improve blood vessel visibility by using band limited light illumination source. The OE technology emphasizes mucosal microvasculature and fine mucosal structures on the bronchial surface.

The following accessories are provided for use with the PENTAX Medical EPK-i7010 Video Processor and EB Family of Scopes:

• . Keyboard - input device for the video processor.
• . Foot Switch - used to remotely control processor functions.
• . White Balance Adjuster - used as the object of white balance feature.
• Condenser Earth Cable - used to reduce high-frequency noise generated during highfrequency electro cautery device use with Pentax endoscopes.

The provided text describes the 510(k) premarket notification for the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes. However, it does not contain a table of acceptance criteria or a detailed study that proves the device meets specific performance acceptance criteria in terms of clinical efficacy or diagnostic accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device (PENTAX Medical EPK-i5010 Video Processor with EB Family) and a reference device (PENTAX Medical EPK-i7010 Video Processor with GI Family), primarily through bench testing comparing optical parameters and a qualitative animal study to show similar visual experience.

Here's a breakdown of the requested information based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is NOT explicitly provided in a table format within the document. The document describes various tests performed but does not list specific numerical acceptance criteria for each test or a direct comparison demonstrating the device "meets" those criteria in a quantitative sense. Instead, it states that the performance of the subject and predicate devices are "equivalent" or show "similarity of visual experience."

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

• Test Set Sample Size:
  • Bench Testing (Optical): Not specified (e.g., number of scopes, measurements taken).
  • Animal Testing: "A library of images was captured." The exact number of images or individual animal cases is not specified.
• Data Provenance:
  • Bench Testing: In-house testing, likely derived from laboratory measurements.
  • Animal Testing: Porcine animal study (not human data). No specific country of origin is mentioned, but "PENTAX Medical performed a porcine animal study" implies it was conducted by the manufacturer or a contracted lab. The study type is prospective for the animal model.

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

This information is NOT provided. The studies described (bench testing and animal testing) do not mention the use of experts to establish a "ground truth" in a clinical diagnostic sense. The animal study focused on showing "similar visual experience" which would likely involve subjective assessment, but expert involvement and their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is NOT provided. Given the nature of the tests described (bench and animal studies focusing on optical/visual similarity rather than diagnostic accuracy), a formal adjudication method like "2+1" or "3+1" for clinical ground truth establishment is not mentioned or applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was NOT done. This device is an endoscope video processor with image enhancement technologies (i-Scan and OE), not an AI-assisted diagnostic tool for which human reader improvement would typically be measured. The study focused on demonstrating optical equivalence and similar visual experience compared to a predicate device.

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

Not directly applicable in the typical sense of a diagnostic algorithm. The i-Scan and OE technologies are "imaging enhancement technologies" intended to be an "optional adjunct following traditional white light endoscopy." They are not standalone diagnostic algorithms that provide a diagnosis without human interpretation. The "performance testing" described (bench and animal) assesses the technical performance of the imaging system itself, not the diagnostic performance of the enhancement algorithms in a standalone mode.

7. The Type of Ground Truth Used

• Bench Testing: Physical properties and measurements (e.g., signal-to-noise ratio, resolution, color accuracy, light distribution). The "ground truth" would be the standard physical measurements or specifications for these parameters.
• Animal Testing: Visual observation of pig laryngeal anatomy. The "ground truth" here is the visual appearance of the anatomy as rendered by different processors, to assess "similarity of visual experience." It is not a pathological or outcomes-based ground truth for disease detection.

8. The Sample Size for the Training Set

This information is NOT provided and is not applicable. The document describes a video processor with image enhancement technologies, not a machine learning or AI-based system that would typically require a "training set" in the context of diagnostic algorithm development. The "software verification and validation" (IEC 62304:2006) refers to standard software engineering practices for medical devices, not machine learning model training.

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

This information is NOT provided and is not applicable. As noted above, this device does not appear to be an AI/ML system that requires a "training set" with established ground truth.

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Fuse Colonoscopy System: The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes, in conjunction with the FuseBox® processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The system includes Lumos, a digital post processing inage enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

Fuse 1G Gastroscopy System: The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

The Fuse Endoscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the digestive tract. The system labeled for healthcare facilities/hospitals enables physicians to view a high-resolution wide field of view. The FuseBox is responsible for image processing, transferring video signals from the endoscope, pneumatic control, and outputting high definition (HD 1080p) video signal. The current FuseBox version, unlike the version used with the two predicate devices, includes image post processing algorithm as an adjunct tool to white light visualization.

The feature provides real-time enhancement and will be used as an adjunctive tool. to supplement the white light endoscopic examination. The new feature may enhance appearance of surface vessels, visualization of the mucosal surface texture and visibility of borders of areas of interest when present.

The provided text describes the Fuse® Endoscopy System with FuseBox® Processor, which includes a digital post-processing image enhancement technology called Lumos. The information primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval, rather than detailed acceptance criteria and a specific study proving it meets those criteria.

However, I can extract the available information and structure it as requested, making note of where specific details are not provided in the document.

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

The document does not explicitly state numerical acceptance criteria for the Lumos feature. Instead, it refers to overall device safety and effectiveness. The performance characteristics mentioned are comparisons to predicate devices for the white light aspects of the system. For Lumos, it states its function as an "enhancement feature."

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 mentions "Clinical Survey on videos with the Lumos compared to white light" was performed. However, it does not provide any details regarding:

• The sample size of videos or cases used in this clinical survey.
• The provenance of the data (e.g., country of origin).
• Whether the data was retrospective or prospective.

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)

The document does not specify the number of experts or their qualifications used to establish ground truth for the "Clinical Survey on videos." It only states that a clinical survey was conducted.

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

The document does not provide any information about the adjudication method used for the "Clinical Survey on videos."

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

The document mentions a "Clinical Survey on videos with the Lumos compared to white light." While this implies a comparison, it does not explicitly state that it was a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Furthermore, it does not provide any effect size or quantitative measure of how much human readers improve with AI (Lumos) vs. without AI assistance. It only broadly states that the feature "may enhance appearance of surface vessels, visualization of the mucosal surface texture and visibility of borders of areas of interest."

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

The document describes Lumos as an "optional adjunct" and an "adjunctive tool to supplement the white light endoscopic examination." This strongly suggests that it is not intended for standalone performance but rather for human-in-the-loop use. No standalone algorithm performance study is described.

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

The document does not explicitly state the type of ground truth used for the "Clinical Survey on videos." Given the context of "diagnostic visualization" and "adjunct following white light endoscopy," it's plausible that expert interpretation/consensus of standard white light imagery or potentially pathological findings serve as an implicit ground truth, but this is not mentioned. It specifically states that Lumos "is not intended to replace histopathological sampling as a means of diagnosis."

8. The sample size for the training set

The document does not provide any information regarding the sample size for a training set. The descriptions focus on the device's function and comparison to predicate devices, not on the development or training of the Lumos algorithm.

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

Since no training set details (including sample size) are provided, the document does not describe how ground truth for a training set was established.

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The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK -7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE).These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX video gastrointestinal endoscopes.

The PENTAX Medical EPK-i7010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor is intended for endoscopic diagnostic, treatment and video observation.

The PENTAX Medical EPK-i7010 video processor contains two types of contrast enhancement techniques: PENTAX i-Scan technology, and optical enhancement (OE) technology.

White light is captured from a 300 Watt xenon lamp housed in the PENTAX Medical EPKi7010 video processor. All visualization is done with the white light mode first. White light (BGR) illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician.

For i-Scan image enhancement, the modification of the combination of RGB components for each pixel occurs when the i-Scan function is turned on in the PENTAX Medical EPKi7010 video processor. The resulting i-Scan image is then displayed on the observation monitor. For OE image enhancement, one of the two optical filters corresponding to Mode1 and Mode2 are inserted into illumination light path when the OE function is turned on in the PENTAX Medical EPK-i7010 video processor. The resulting OE image is then displayed on the observation monitor.

The provided document describes the Pentax Medical EPK-i7010 Video Processor with GI Family, which includes digital (PENTAX i-Scan™) and optical (OE) imaging enhancement technologies for use as an adjunct to traditional white light endoscopy in gastrointestinal endoscopic diagnosis, treatment, and video observation.

However, the document does not provide specific acceptance criteria or an explicit study proving the device meets those criteria in the typical sense of a diagnostic performance study with sensitivity, specificity, or similar metrics. Instead, the performance data focuses on establishing substantial equivalence to a predicate device (PENTAX Medical EPK-i5010 Video Processor) and a reference device (OLYMPUS EVIS EXERA III Video System) through compliance with standards and non-clinical testing.

Here's an attempt to answer your questions based on the available information:

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

The document does not present a table of acceptance criteria with corresponding performance metrics like sensitivity or specificity for its imaging enhancement technologies. Instead, the performance is demonstrated through compliance with electrical safety, EMC, software standards, and non-clinical (optical bench and animal) testing to show comparability with 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)

• Test Set Sample Size: The document refers to "a library of images" from porcine gastrointestinal mucosa for the animal study and "images from the porcine gastrointestinal location" for the bench testing. No specific numerical sample size (e.g., number of images, number of animals) is provided.
• Data Provenance: The animal study used porcine (pig) gastrointestinal mucosa. The country of origin for the data is not specified. The nature of the image acquisition for the animal and bench studies would be prospective as these were generated specifically for the 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)

The document mentions "image evaluation" for the animal study but does not specify the number of experts, their qualifications, or how they established ground truth for the test set. Given the context of a 510(k) summary focused on substantial equivalence and non-clinical data, it's likely that a formal expert review for diagnostic accuracy wasn't the primary endpoint.

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

The document does not describe any adjudication method for establishing ground truth for a test set, as the performance evaluation in this 510(k) application focuses on technical and comparative performance, not a human reader diagnostic accuracy study.

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

A multi-reader multi-case (MRMC) comparative effectiveness study assessing human reader improvement with or without AI (or in this case, imaging enhancement technologies) was not explicitly mentioned or described in the provided text. The document focuses on demonstrating substantial equivalence through technical performance and animal/bench testing, not direct clinical or reader performance improvement studies.

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

The document describes the device as including "digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE)." These technologies process images to enhance visualization. The "performance data" section focuses on "Optical Performance Testing (Bench and Animal non-clinical testing)" and states "The optical data analysis demonstrate that the PENTAX Medical EPK-i7010 Video Processor performs comparably to the predicate device." This implies an assessment of the algorithm's output (images) in a standalone fashion, determining features like resolution, artifact analysis, and enhancement capabilities without direct human diagnostic decision-making as the primary endpoint for the 510(k). The "image evaluation and quantitative data analysis" of porcine images would fall under this.

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

For the animal study, the ground truth explicitly stated or implied is for "image evaluation and quantitative data analysis" comparing white light, PENTAX OE, and Olympus NBI images from "porcine gastrointestinal mucosa." This likely refers to inherent characteristics of the mucosa as visualized under different modalities or technical imaging quality parameters, rather than a diagnostic 'ground truth' in the clinical sense (e.g., presence/absence of disease confirmed by pathology). The focus is on the imaging enhancement capability, not the diagnostic accuracy of the enhancement itself.

8. The sample size for the training set

The document does not provide any information about a training set size. The device uses "digital post-processing imaging enhancement technology" and "optical imaging enhancement technology." These might be based on pre-defined algorithms rather than machine learning models that require explicit training sets in the sense of supervised learning.

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

Since no training set is mentioned in the context of machine learning, there is no information on how its ground truth might have been established. The technologies are described as "imaging enhancement," likely relying on fixed algorithms or optical filtering techniques rather than a trained AI model in the typical sense that would necessitate a labeled training set for diagnostic classification.

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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). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/Fujifilm medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastromtestination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.

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

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

The VP-4440HD 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 incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor 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/60MzJ0.8A. The Processor is housed in a steel-polycarbonate case measuring 390x105x460mm.

The XL-4450 Light Source: The Fujinon/Fujifilm 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 Light Source is housed in a steel-polycarbonate case measuring 390x155x450mm.

The DK-4440E 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.

The VP-4440HD Digital Video Processor with FICE and light source is the same as the cleared EPX-4440HD Digital Video Processor and Light source (K102466) device, with the exception of the addition of the imaging algorithm termed "FICE" (Flexible spectral-Imaging Color Enhancement). As with the predicate device, the subject processor receives an image from the endoscope via a connector cable. The subject processor is capable of bi-directional communication that allows importation and exportation of various patient and procedural data between EMR (Electronic Medical Record) systems.

FICE is an image processing feature that a licensed medical practitioner (user) can utilize, as an adiunctive tool, to supplement the white light endoscopic examination. FICE extracts spectral images of specific wavelength components from the original full spectral (white light) image through an image processing algorithm that, assigns a spectral wavelength component in the Red (R), Green (G) and Blue (B) spectrum and displays the enhanced color image. FICE may enhance color contrast to improve visibility of the selected structures, borders of areas of interests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Clinical Study): Each subject underwent two (2) gastrointestinal endoscopic examinations during a single clinical procedure. The document doesn't explicitly state the total number of subjects or individual images in the test set.
• Data Provenance: Prospective clinical trial. The country of origin of the data is not specified.

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

• Number of Experts: Multiple blinded investigators. The exact number is not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Images were analyzed independently by "multiple blinded investigators using a 4-point Likert scale." The document does not specify a formal adjudication method (e.g., 2+1, 3+1 consensus). It appears to rely on the "overall means between all readers."

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: Yes, a reader concurrence study was performed, which is a type of MRMC study comparing FICE (an AI/image processing feature) to optical filtering (NBI).
• Effect Size: The study aimed to establish "substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate optical filtering method." The reported outcome is that "Overall means between all readers demonstrated at least comparable image quality of each FICE setting in one or more locations within the gastrointestinal tract." This indicates FICE performed similarly to or as well as NBI for image quality; a specific quantitative effect size of human reader improvement with AI assistance vs. without is not provided, as the study focused on comparability rather than improvement. The FICE feature itself is described as an "adjunctive tool," not necessarily a comprehensive AI diagnosis system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Based on the provided text, the FICE feature is described as an "adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy." The clinical study focused on readers evaluating image quality generated by FICE. There is no indication of a standalone performance study of the FICE algorithm without human interpretation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The clinical study compared the "overall image quality" observed by multiple blinded investigators using a Likert scale. This suggests a form of expert consensus/reader perception for image quality as the ground truth. It's important to note that the FICE feature is "not intended to replace histopathological sampling as a means of diagnosis," indicating that the "ground truth" for diagnosis in a clinical sense would still be pathology. However, for the purpose of this study measuring the effectiveness of the FICE image processing, reader evaluation of image quality served as the primary measure.

8. The Sample Size for the Training Set

• The document describes performance testing for an image processing feature (FICE) which is integrated into a video processor. It does not explicitly mention a "training set" in the context of machine learning model development. This suggests the FICE algorithm might be based on pre-defined spectral filters or rule-based image processing rather than a deep learning model that requires a dedicated training set. If there was a training phase for the algorithm, its sample size is not disclosed.

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

• As a dedicated "training set" is not mentioned and the FICE algorithm's nature isn't fully detailed as a deep learning model, the method for establishing ground truth for a training set is not applicable or not provided in this document.

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The PENTAX EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX EPK-i5010 includes PENTAX i-Scan™ a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.

The PENTAX EPK-i5010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor is intended for endoscopic diagnostic, treatment and video observation. It is intended to process electrical signals from a video endoscope.

The PENTAX EPK-i5010 offers an optional digital, post-processing imaging enhancement technology called the PENTAX i-Scan™ modes 1, 2, and 3, which is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels. i-Scan 1 provides the user with a view that sharpens surface vessels and enhances surface texture of the mucosa. i-Scan 2 provides the user with increased visibility of blood vessels while also providing the same enhancements to the mucosa achieved in i-Scan 1. i-Scan 3 provides the user with increased visibility of blood vessels including dimly illuminated far-field regions while also providing the same enhancement to the mucosa achieved in i-Scan 1. The user can select either white light image or i-Scan modes by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a keyboard button. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.

The EPK-i5010 video processor incorporates the hardware of the EPK-i5020 video processor model (K 113873) and the PENTAX i-Scan™ technology.

The EPKi-5010 is compatible with PENTAX flexible and rigid k-Series and i-Series videoscopes. The subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes.

The provided text describes the PENTAX EPK-i5010 Video Processor and its i-Scan™ technology, intended for endoscopic diagnosis, treatment, and video observation. However, it does not contain specific acceptance criteria for "device performance" in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) or a detailed study specifically designed to prove these criteria are met for the i-Scan technology itself.

Instead, the document focuses on:

• Substantial Equivalence: The primary aim of the 510(k) submission is to demonstrate that the PENTAX EPK-i5010 is substantially equivalent to legally marketed predicate devices, meaning it does not introduce new questions of safety or effectiveness.
• Safety: The clinical studies mentioned are primarily to establish the safety of the device, not its diagnostic performance against specific acceptance criteria for imaging enhancement.

Based on the provided text, here is an analysis of the requested information:

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

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

The text mentions 7 clinical studies for safety evaluation:

• Sample Size: A total of 975 patients.
• Data Provenance:
  • Germany (3 studies)
  • Japan (1 study)
  • Korea (3 studies)
• Retrospective/Prospective: Not specified, but "clinical studies" typically imply prospective data collection for safety and efficacy endpoints. However, without further details, it cannot be definitively determined from this summary.

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)

The document does not provide this information. The clinical studies mentioned were for safety, and there's no indication of a diagnostic performance evaluation with expert-established ground truth for the i-Scan technology.

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

The document does not provide this information as it does not detail a diagnostic performance study requiring ground truth adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, the document does not describe a MRMC comparative effectiveness study. The i-Scan technology is described as an "optional adjunct" and "not intended to replace histopathological sampling," implying it's a visual enhancement tool rather than a diagnostic AI that would be compared with human performance or AI assistance.
• Effect Size: Not applicable, as no MRMC study or quantitative diagnostic performance study is described.

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

No, the document does not describe a standalone performance study for the i-Scan algorithm. The i-Scan is an imaging enhancement technology integrated into a video processor, intended to be used by a clinician during endoscopy. It's not presented as a standalone diagnostic algorithm.

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

The document does not specify a type of ground truth because it does not detail a diagnostic performance study where ground truth would be needed for evaluating the i-Scan's diagnostic accuracy. The safety studies would primarily rely on adverse event reporting and clinical observation for safety endpoints.

8. The sample size for the training set

The document does not provide this information. As a post-processing imaging enhancement technology, the i-Scan likely uses algorithms that are developed and refined, but the document does not specify a "training set" in the context of machine learning model development or validation.

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

The document does not provide this information as it does not mention a training set or the establishment of ground truth for it.

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