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The Visera Elite II Video System Center (OLYMPUS OTV-S300) is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

The subject device is a video system center (OTV-S300) to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment used with endoscopes. The subject device is an update to the Visera Elite II Video System Center cleared under K201200 to add an infrared (IR) function. The IR light source (CLV-S200-IR) uses the existing software in the subject device to enable the connection and ensure IR compatibility. The subject device has both a processor function and light source function. By switching on the illumination lamp in the subject device, the device provides light through the endoscopes directly for endoscopic observation. There are two modes: WLI (White light imaging) mode for normal observation and NBI (Narrow-band imaging) mode. By driving the CCD equipped in the endoscope, the subject device displays an endoscopic image on a monitor.

Acceptance Criteria & Device Performance: OLYMPUS OTV-S300 (Visera Elite II Video System Center)

Summary of Device Modification: The OLYMPUS OTV-S300 (Visera Elite II Video System Center) is an update to a previously cleared device (K201200) with the primary modification being the addition of infrared (IR) functionality.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document describes bench testing and design verification and validation activities. It does not specify a sample size for a "test set" in terms of patient data or clinical images. The data provenance is related to in-house engineering and testing, not patient demographics or clinical data from specific countries. The studies conducted are design verification and validation tests, primarily technical in nature, rather than clinical studies using patient data.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

Not applicable. This submission relies on engineering and technical performance testing, not clinical evaluation requiring expert consensus on ground truth for a test set of images/data derived from patients.

4. Adjudication Method for the Test Set:

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

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on technical performance and safety/effectiveness equivalence to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The device is a "Video System Center" (hardware and integrated software) that provides imaging capabilities for endoscopes, not a standalone AI algorithm. Its performance is evaluated as an integrated system component.

7. Type of Ground Truth Used:

The "ground truth" for the performance criteria appears to be established through engineering design specifications and recognized international and national standards (e.g., ANSI/AAMI, IEC). Compliance with these standards and the device's own design specifications forms the basis of the "ground truth" for its technical performance.

8. Sample Size for the Training Set:

Not applicable. This device is a video system center for endoscopic imaging, not an AI model that undergoes "training" in the machine learning sense with a data set.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no "training set" in the context of this device.

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This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

The subject device is a video system center to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment used with endoscopes. The subject device is an update to the Visera Elite II Video System Center cleared under K193026 to add a 2D observation function. The subject device has both a processor function and light source function. By switching on the illumination lamp in the subject device, the device provides light through the endoscopes directly for endoscopic observation. There are two modes: WLI (White light imaging) mode for normal observation and NBI (Narrow-band imaging) mode for enhanced optical image observation. By driving the CCD equipped in an endoscope, the subject device displays an endoscopic images on a monitor.

The provided document is a 510(k) Premarket Notification for the VISERA ELITE II VIDEO SYSTEM CENTER. It describes the device, its intended use, and provides a comparison to a predicate device. It also briefly mentions performance data.

However, the document does not contain the detailed information required to answer all parts of your request, especially regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study results. The document focuses on technological similarities and differences with a predicate device to establish substantial equivalence for regulatory clearance.

Based on the information available, here's what can be extracted:

I. Acceptance Criteria and Reported Device Performance

The document states that bench testing was conducted to ensure the device performs as intended and meets appropriate design specifications. However, the specific acceptance criteria and detailed quantitative performance results for each of the listed image quality parameters are not provided in this regulatory submission summary.

II. Sample Size and Data Provenance for Test Set

The document mentions "Bench testing" for performance evaluation.

• Sample size used for the test set: Not specified. It's likely that "test set" refers to physical setups and controlled environments used for bench testing, rather than a dataset of patient images.
• Data provenance: Bench testing suggests controlled laboratory conditions. The document does not specify country of origin for any data or whether it's retrospective or prospective.

III. Number of Experts and Qualifications for Ground Truth

• Number of experts: Not specified.
• Qualifications of those experts: Not specified.
• Method of establishing ground truth: For bench testing, ground truth would typically be established by calibrated measurement devices and reference standards, not human expert consensus on diagnostic images.

IV. Adjudication Method for the Test Set

Not applicable/Not specified as the performance testing described is "Bench testing" of system characteristics (e.g., image quality parameters, electrical safety) rather than diagnostic performance involving human interpretation of clinical cases.

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

• Was an MRMC study done? No, the document does not indicate that an MRMC comparative effectiveness study was done. The focus is on technical performance and substantial equivalence to a predicate device, not on improving human reader performance.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was described.

VI. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? The performance data mentioned (image quality, video latency) relate to the standalone technical performance of the device's video system, specifically the added 2D observation function. However, this is not an "algorithm-only" performance in the context of an AI/CADe device, but rather the performance of the optical and electronic components of an endoscope video system. The document does not describe any specific algorithm or AI component in the device.

VII. Type of Ground Truth Used

• For the bench testing described, the "ground truth" would be objective measurements obtained using calibrated equipment against known physical standards (e.g., for brightness, color accuracy, signal-to-noise ratio, latency). It is not pathology, outcomes data, or expert consensus on clinical findings.

VIII. Sample Size for the Training Set

• Not applicable/Not specified. The document does not describe the use of machine learning or AI algorithms that would require a "training set" of data.

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

• Not applicable, as no training set for an AI algorithm is mentioned.

Summary of Device and Study Focus:

This 510(k) submission primarily focuses on demonstrating the substantial equivalence of the "VISERA ELITE II VIDEO SYSTEM CENTER" to a predicate device (K193026). The key change for this submission (K201200) is the addition of a 2D observation function to a device that previously only offered 3D observation. The performance data section describes "Bench testing" of standard technical parameters (electrical safety, EMC, software, and image quality aspects like brightness, intensity, color, SNR, and video latency) to affirm that the device functions as intended and meets design specifications for its intended use as an endoscopic video system. It is a general medical device focused on video processing and illumination, not an AI or diagnostic decision support system.

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The VISERA ELITE II Infrared Imaging System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. The VISERA ELITE II Infrared Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels. blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the VISERA ELITE II Infrared Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

[VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200]
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

[VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR]
The light source has been designed to be used with Olympus endoscopes, video system centers, light guide cables, and other ancillary equipment for endoscopic observation through visible and near-infrared fluorescence imaging with fluorescence agent.

[HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EA]
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

[HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB]
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

[TELESCOPE IR/ULTRA WAIR500A,WAIR530A,WAIR100A,WAIR130A]
These endoscopes are intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal natural orifice surgery. In combination with a compatible infrared imaging system, the telescope allows for fluorescence imaging.

The subject devices OTV-S200, CH-S200-XZ-EA, and CH-S200-XZ-EB were cleared in 510(k) K190449. After clearances, no technological modification for the subject devices were made. Therefore, the above devices have been omitted from the device description in this pre-market notification.

CLV-S200-IR: This device consists of the source circuit, the control circuit, the illumination lamp, and the optical filter. The control circuit connects to the diaphragm to regulate the light intensity, the source circuit supplies the power to the illumination lamp, the operation panel and the rear panel. By switching on the illumination lamp, this device provides the light for endoscopic observation. This device regulates the endoscopic image brightness constantly from the video system center. The observation mode can be switched by the optical filter extracting the specific wavelengths.

WAIR100A, WAIR130A, WAIR500A, WAIR530A: The "IR" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The "IR" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before the first and each subsequent use of the device, it must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The "IR" Telescopes are available with different directions of view to allow use for various applications in accordance with the intended use as submitted with this 510(k).

This document describes the VISERA ELITE II Infrared Imaging System components (Xenon Light Source, Telescopes, Video System Center, and Camera Heads). There is no explicit "device" (like an AI algorithm) for which acceptance criteria and a study proving the device meets those criteria are directly provided in the format you described.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a novel device meets specific performance acceptance criteria for a new function. Therefore, much of the requested information regarding an AI study or specific performance metrics linked to acceptance criteria is not present.

However, I can extract information related to the device's validation and compliance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions several types of performance testing and compliance with standards. It does not provide a table with quantitative acceptance criteria and corresponding reported performance values for a specific device feature that would typically be seen in an AI performance study (e.g., sensitivity, specificity for disease detection). Instead, it lists validation activities.

The subsequent points (2-9) are generally applicable to studies for AI/CADe devices and are not fully addressed by this document, which pertains to a general surgical imaging system rather than a specific AI-driven diagnostic or assistive tool.

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

• Test Set Sample Size: Not applicable. The document describes an animal study but does not specify a "test set" in the context of an AI algorithm evaluation. For the animal study, it mentions "canines and swines" but does not give a specific number of animals.
• Data Provenance: The animal study involved "canines and swines." It's a prospective study as it involved taking videos to validate performance. Country of origin is not specified.

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

• For the animal study videos, evaluation was done by an "independent Health Care Professional." The number of professionals and their specific qualifications (e.g., radiologist with X years of experience) are not detailed.

4. Adjudication method for the test set:

• Not specified. It only mentions evaluation by "an independent Health Care Professional."

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 or comparative effectiveness study involving human readers with and without AI assistance was described. This document is not for an AI-assisted device in that context.

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

• Not applicable. This device is an imaging system, not an AI algorithm. Its performance is demonstrated as an imaging tool used by surgeons.

7. The type of ground truth used:

• For the animal study, the "ground truth" for demonstrating substantial equivalence in IR observation was based on the performance observed and evaluated by a healthcare professional in a simulated body environment. This is closer to expert assessment/observation in a controlled animal setting, rather than pathology or outcomes data.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm.

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

• Not applicable. This is not an AI algorithm.

In summary:

This 510(k) pertains to an endoscopic imaging system. It demonstrates substantial equivalence to predicate devices through various engineering, safety, and limited performance tests (bench and animal study). It does not involve a software-based AI algorithm for image interpretation or diagnosis that would typically require validation against a test set with established ground truth by multiple experts. Therefore, many of the requested points related to AI device evaluation are not applicable or cannot be extracted from this document.

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OLYMPUS OTV-S300: This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A, WA50082A: This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs. The device is also indicated for visualization during transanal and transvaginal natural orifice surgery.

The subject VISERA ELITE II consists of the following primary components:

• VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S300
• VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A/ WA50082A

A) VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTY-S300: The subject device has both a processor function and light source function. By switching on the illumination lamp in the subject device provides light through the endoscopes directly for endoscopic observation. This device also constantly regulates the endoscopic image brightness from the video system center. The observation mode can be switched by the optical filter and LED extracting the specific wavelengths. There are two modes: WLI (White light imaging) mode for normal observation and NBI (Narrow-band imaging) mode for an optical image enhancement technology. By driving the CCD equipped in the endoscopes, the images are transduced into electrical signals from the optical signals, and the subject device displays the endoscopic images on the monitors.

B) VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3DWA50080A/ WA50082A: The subject devices are designed to transfer optical images from a body cavity via a lens system directly to an imager for further electrical signal transmission to a video processor. The video telescope is designed for examination, diagnosis, and visualization of treatment (treatment can only be performed by using endoscopic accessories in combination). For illumination of body cavities, the transfer of light from a supply unit to the body cavity is achieved by means of a light guide. The subject device, ENDOEYE 3D, is a design variant of the predicate ENDOEYE HD II video endoscope offering a 3D observation mode. The 3D effect enables the surgeon to perceive significant spatial information which is beneficial in terms of optimized speed, accuracy and precision of surgical procedures by users of all skill levels. It may also shorten the learning curve for surgical tasks. The ENDOEYE 3D is used with a 3D video system and a 3D monitor with dedicated polarization glasses. For laparoscopic applications, the video telescope is inserted via a trocar into the patient. The ENDOEYE 3D is used with a video system center, light source and monitor to achieve its intended function. In addition, the ENDOEYE 3D can be placed in compatible instrument trays for reprocessing. The ENDOEYE 3D can provide an image with either white light or narrow band imaging.

This document is a 510(k) summary for the Olympus VISERA ELITE II VIDEO SYSTEM CENTER OTV-S300 and VISERA ELITE II VIDEO TELESCOPE ENDOEYE 3D WA50080A, WA50082A. It describes various performance data gathered to support the substantial equivalence determination but does not include an AI algorithm. Therefore, many of the requested fields are not applicable (N/A) or not provided in the document.

Acceptance Criteria and Device Performance for Non-AI Devices

For the Olympus VISERA ELITE II Video System Center and Video Telescope, the acceptance criteria are based on compliance with established in-house criteria derived from international and FDA guidelines, as well as satisfactory performance in bench testing and other validations. Since this is not an AI device, there are no reported performance metrics like accuracy, sensitivity, or specificity in the conventional sense of an AI study. Instead, performance is demonstrated through successful completion of various engineering and functional tests.

Here's a breakdown of the requested 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

• Sample Size: Not explicitly stated for specific tests. The tests refer to the devices themselves (OTV-S300 and WA50080A/WA50082A). The "test set" in this context refers to the manufactured devices undergoing various bench and validation tests.
• Data Provenance: The studies are internal performance validation tests conducted by Olympus, a manufacturer based in Japan and Germany, likely representing prospective testing of the devices to meet regulatory requirements prior to market entry.

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

• Not Applicable (N/A): This is not an AI device that requires expert-established ground truth for its performance evaluation in the context of diagnostic accuracy. The assessments are based on engineering specifications and adherence to standards.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): No adjudication method is described as this is not a study assessing human or AI diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

• Not Applicable (N/A): No AI is involved, and therefore no MRMC study or AI-assisted human performance evaluation was conducted.

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

• Not Applicable (N/A): No AI algorithm is part of this submission, so no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

• Not Applicable (N/A) in the AI context: For this medical device, "ground truth" is established by engineering specifications, validated test methods, adherence to international standards (e.g., ISO, IEC), and functional requirements for safe and effective endoscopic imaging. It's about meeting designed-in performance parameters, not an external diagnostic reference.

8. The Sample Size for the Training Set

• Not Applicable (N/A): There is no AI algorithm, so no training set for an algorithm is involved.

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

• Not Applicable (N/A): No AI algorithm or training set is present.

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VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200: This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

VISERA ELITE IT HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EA: The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

VISERA ELITE II HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB: The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The OTV-S200 is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. The OTV-S200 has a light source and video processor function. The endoscope light guide cable is connected to the output socket on the subject device and the endoscope video connector or camera head is connected to video connector socket. The OTV-S200 emits light to the endoscope via the light guide cable and receives the electrical signal from the endoscope or camera head via the video connector. After processing, the OTV-S200 outputs endoscopic images on the monitor. The subject device provides white light imaging (WLI) and narrow band imaging (NBI). The OTV-S200 function is operated by a touch panel screen.

The CH-S200-XZ-EA and CH-S200-XZ-EB have been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The CH-S200-XZ-EA and CH-S200-XZ-EB are compatible with Olympus rigid endoscopes to be used to observe various anatomical locations. The subject devices are constructed with a camera head (body), camera cable and video connector and connected to an endoscope by the lock ring on the camera head. Light is supplied from the video system center to the rigid endoscope via a light guide cable and emitted from the distal end of the endoscope. The objective lens on the distal end of the endoscope receives the light from the object and the light guide inside the endoscope transfers the light to the eyepiece and 3CMOS (imager) inside the subject device. The imagers convert the light to an electrical signal and the signal is transferred to a video system center via the camera cable and video connector. Finally, an endoscopic image is outputted on the monitor after processing in the video system center. The subject devices provide white light imaging (WLI) and narrow band imaging (NBI). Zoom and focus are controlled by switches or rings on the camera head for the CH-S200-XZ-EA or CH-S200-XZ-EB, respectively. Three remote switches on the camera head provide operation of the video system center function by setting the functions prior to the procedure.

The provided text describes a 510(k) premarket notification for the "Visera Elite II Video System Center" (OTV-S200) and associated camera heads (CH-S200-XZ-EA, CH-S200-XZ-EB) by Olympus Medical Systems Corp.

The submission is for a medical device that does not include AI or machine learning components. Therefore, many of the requested criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set sample size," and "ground truth for training set" are not applicable.

Here's the information that is available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is an endoscopic video system and camera heads. The acceptance criteria are based on compliance with various safety and performance standards, and the reported performance indicates that these criteria were met through non-clinical testing.

• Difference for Emergency Lamp
• NBI Observation
• Image Quality
• Photobiological safety
• NBI Color Adjustment
• Function of Switching of the "iris area"
• Laser mode
• Confirmation of Full HD image
• FOV |
  | Risk Analysis | Risk analysis for all devices was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. Design verification tests and their acceptance criteria were identified and performed as a result of this assessment. |
  | Voluntary Standards Compliance (Examples) | The devices comply with various voluntary standards, including:
• AAMI / ANSI ES 60601-1
• IEC 60601-1-2
• IEC 60601-2-18
• ISO 14971
• IEC 62304 (for OTV-S200)
• ISO 17665-1 (for CH-S200-XZ-EA)
• ISO 14937 (for CH-S200-XZ-EA and CH-S200-XZ-EB) |

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

This information is not explicitly stated as the testing involved performance bench tests and compliance with standards rather than a test set of patient data. The provenance for the bench test results would be Olympus's internal testing facilities (Japan, where the manufacturing site is located). The studies are non-clinical (laboratory/bench).

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

Not applicable. The device is hardware (video system and camera heads) and software that manages its functions, not an AI diagnostic tool that requires expert-established ground truth on patient data. The "ground truth" for the device's performance would be the specifications and requirements defined for the hardware and software, verified through engineering tests.

4. Adjudication Method for the Test Set

Not applicable, as no external "test set" requiring adjudication by experts to establish ground truth was used in the context of diagnostic assessment.

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 does not incorporate AI or machine learning for diagnostic assistance, nor was it evaluated in an MRMC study.

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

Not applicable. The device is a video system and camera heads for visualization, intended to be used with a human endoscopist. There is no standalone algorithm performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is adherence to engineering specifications, safety standards, and functional requirements established by the manufacturer and recognized regulatory bodies. This is verified through various non-clinical performance tests (bench testing, electrical safety, EMC, reprocessing validation, software validation, risk analysis) rather than clinical outcomes or expert consensus on medical images/data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product developed with a training set of data.

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

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

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