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The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III Surgical Imaging System is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation and supports the function of high definition (HD) videoscopes and is Camera Head (CH) compatible.

The following devices of the VISERA ELITE III Surgical Imaging System are the subject of this premarket notification submission:

• VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model: OLYMPUS OTV-S700) - A video system center that processes electronic signals transmitted from a video endoscope or a camera head and outputs the image signal to a monitor.

  • VISERA ELITE III 3D Upgrade Pack (Model: MAJ-2511) - A function activation portable memory key accessory that unlocks the 3D software function when connected with OTV-S700 to enable the observation of 3D mode.

• VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model: OLYMPUS CLL-S700) - A LED light source provides examination light to a video endoscope and a camera head.

• 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (Model: OLYMPUS CH-S700-XZ-EA) - A 4K Inline camera head is intended to be used with Olympus endoscopes, the video system center, and other ancillary equipment for the visualization of internal organs (endoscopic diagnosis), treatment and observation.

Based on the provided FDA 510(k) clearance letter and documentation for the Olympus VISERA ELITE III Surgical Imaging System, here's a description of the acceptance criteria and the study proving the device meets them:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and exhaustive study results as might be found in a full clinical trial report or a PMA submission. For a device like this (endoscopic video imaging system), performance is typically evaluated through a combination of internationally recognized standards, bench testing, and comparison to predicate devices, rather than clinical efficacy studies in the way you might see for an AI diagnostic tool. Therefore, some of the requested information (especially regarding statistical metrics like sensitivity/specificity, sample sizes for training/test sets, expert adjudication, or MRMC studies) is not explicitly stated or applicable in the context of this 510(k) summary for an imaging system that primarily focuses on image quality and safety.

The summary emphasizes "substantial equivalence" based on similar intended use and technological characteristics, and that the differences do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

For an endoscopic video imaging system, acceptance criteria are primarily related to image quality, safety (electrical, EMC, photobiological, laser), and functional performance in accordance with recognized industry standards. The reported "performance" is generally that the device meets these standards and functions as intended, with specific measurements taken during bench testing.

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

• Test Set Sample Size: The document does not provide details on specific "sample sizes" in terms of number of patients or images for the performance tests. The testing described (bench testing, electrical safety, EMC, software V&V, reprocessing validation) typically involves testing of the physical devices themselves and their components, rather than a dataset of patient images.
• Data Provenance: The testing was conducted in support of a 510(k) submission from Olympus, with manufacturing in Japan. The testing described is bench testing and laboratory validation, not human clinical data. Therefore, the concept of "country of origin of the data" or "retrospective/prospective" does not apply in the typical sense of clinical studies.

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

• Ground Truth Experts: Not applicable in this context. The "ground truth" for an imaging system like this is its ability to accurately capture and display images according to objective physical and electrical parameters, as measured through engineering and quality control tests (e.g., resolution targets, color charts, electrical signal analysis). It's not about expert interpretation of medical images.
• Qualifications of Experts: The testing would be performed by qualified engineers, technicians, and quality assurance personnel with expertise in electrical engineering, optics, software testing, and medical device regulations.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human rating or judgment that requires adjudication for the types of tests described (bench tests, safety, EMC). The results are objective measurements against predefined engineering specifications and regulatory standards.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for AI-driven diagnostic tools to assess how human reader performance (e.g., diagnostic accuracy) changes with and without AI assistance. This device is a foundational imaging system, not an AI diagnostic tool, so such a study would not be relevant for its clearance.

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

• Standalone Performance: Not applicable. This is a hardware imaging system, not an algorithm, so the concept of "standalone performance" of an AI algorithm does not apply. Its "performance" is inherently tied to its function as a tool for human use.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance relies on objective engineering specifications, standardized test targets (e.g., resolution charts, color references), and regulatory safety standards. It's not based on expert consensus, pathology, or outcomes data in a clinical sense. For example, to test resolution, a known resolution target is imaged, and the system's ability to resolve details is measured.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a hardware imaging system and does not involve machine learning or AI models that require a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, the 510(k) process for a device like the VISERA ELITE III Surgical Imaging System primarily relies on demonstrating technical performance, safety, and substantial equivalence to legally marketed predicate devices through rigorous engineering testing (bench testing, electrical safety, EMC, software validation) against established standards, rather than clinical studies or AI model validation studies. The "acceptance criteria" are compliance with these standards and the "proof" is the successful completion of these tests.

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The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with endoscopes, video endoscopes, camera heads, monitors and other ancillary equipment for endoscopic surgery, is intended to receive and process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor.

Also, the VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with rhinolaryngeal stroboscopes, is intended to observe the intralaryngeal phenomenon of phonation (speech) for endoscopic observation to examine the correct functioning of the vocal apparatus (glottis) and to examine voice disorders.

The OLYMPUS OTV-S500 is a "universal platform" which offers compatibility with various endoscopes for different medical specialties and enables efficient operation to meet the clinical needs of the ENT field; the device has been cleared by FDA for use with OLYMPUS urology/gynecology endoscopes (including CYF-VH, CYF-VHR, URF-V2, URF-V2R, URF-V3. URF-V3R. WA2T400A. WA2T412A. WA2T430A. WA2T43WA. WA2T470A. WA2UR11A, WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, WA2UR32A, CYF-5, CYF-5R, URF-P6, URF-P6R, URF-P7, URF-P7R and HYF-XP) under K241371.

The OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units (cooling fan, unit power supply, and control panel), harnesses between circuit boards, and optical components (lens and optical filter). A microprocessor is built into the OLYMPUS OTV-S500 which controls processing of observation images, user interface (front panel switch, indicator LEDs, warning buzzer etc.) and menu. These functions are implemented in the embedded software. Scopes including flexible videoscopes or fiberscopes and rigid videoscopes with camera heads and light source are directly connected to the Subject system. When connected, the endoscope (fiberscopes and rigid videoscope without camera head) acquires and displays images directly to the user or output onto a monitor when using a flexible endoscope or scope and camera head.

The Subject devices submitted for clearance include one (1) major component: the Video System Center (OLYMPUS OTV-S500) with Foor Holder (MAJ-2552), and five (5) optional accessories: an HDMI cable (MAJ-2551); the OTV-S500 Upgrade Pack Strobe (MAJ-2547), which activates the stroboscopy function of the OTV-S500; an Air Microphone (MAJ-2548); a Throat Microphone (MAJ-2549); and the Microphone Extension Cable (MAJ-2550).

The OLYMPUS OTV-S500 is compatible with the following OLYMPUS ENT endoscopes: ENF-VH, ENF-VH2, ENF-V3, ENF-V4, ENF-VT3, ENF-XP, ENF-GP2, WA4KS400, WA4KS430, WA4KS431, WA4KS445, WA4KS446, WA4KS471, WA4KS471, WA96100A and WA96105A.

The provided text is a 510(k) Summary for the OLYMPUS OTV-S500 (VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500).

The 510(k) Summary states that no clinical data were collected to support the performance of the subject device. Therefore, a study proving the device meets acceptance criteria in a clinical setting is not available from this document.

However, the document does describe non-clinical performance data and acceptance criteria based on standard compliance and specified tests.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly mentions performance testing, but does not provide specific acceptance criteria in numerical or qualitative form alongside reported device performance for each criterion. Instead, it states that "all testing passed/met the acceptance criteria."

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

This information is not provided in the document. The document refers to "Performance Testing Bench" with the subject device and compatible endoscopes, but does not specify the number of devices or endoscopes tested. Data provenance (country of origin, retrospective/prospective) is also not mentioned for the non-clinical tests.

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

This information is not applicable as the described tests are non-clinical, bench-top performance, electrical safety, and software validation tests, which do not typically involve human expert establishment of ground truth in the same way clinical or diagnostic studies do. The "truth" for these tests comes from objective measurements against defined standards and specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the non-clinical tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed for ground truth.

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 was done. The document explicitly states: "No clinical data were collected to support performance of the Subject device." The device itself is a video system center for endoscopes, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable in the context of an "algorithm only" performance. The OLYMPUS OTV-S500 is a hardware device (video system center) with embedded software. The software validation tests mentioned would assess the functionality and safety of the embedded software itself, which is part of the device's standalone operation. However, this is not a standalone "algorithm" in the typical sense of a diagnostic AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical tests described, the "ground truth" or reference for performance is established by technical standards and specifications. For instance:

• Performance Testing Bench: ISO standards (e.g., ISO 8600-3:2019 for Field of View, ISO 15739:2017 for Image Noise and Dynamic Range), and internal product specifications (e.g., for Brightness, Latency, etc.). The FDA Color Performance Review (CPR) Tool for Endoscopy Devices would provide a standard reference for color analysis.
• Electrical Safety/EMC Testing: Compliance with various IEC/ANSI AAMI standards (e.g., ES60601-1, IEC 60601-1-2).
• Software Validation/Cybersecurity: Compliance with IEC 62304, ISO 14971, and FDA guidance documents.

8. The Sample Size for the Training Set

This information is not applicable. As no clinical data was collected and the device is a hardware system with embedded software, there's no mention of a "training set" in the context of machine learning.

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

This information is not applicable due to the absence of a training set as described above.

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The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with endoscopes, video endoscopes, camera heads, monitors and other ancillary equipment for endoscopic surgery, is intended to receive and process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor.

The OLYMPUS OTV-S500 is a "universal platform" which offers compatibility with various endoscopes for different medical specialties and enables operation to meet the clinical needs in the fields of urology and gynecology. The Subject device is intended to be used in conjunction with ancillary equipment for endoscopic diagnosis, treatment and observation.

The OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units (cooling fan, unit power supply, and control panel), harnesses between circuit boards, and optical components (lens and optical filter). A microprocessor is built into the OLYMPUS OTV-S500 which controls processing of observation images, user interface (front panel switch, indicator LEDs, warning buzzer etc.) and menu. These functions are implemented in the embedded software. Scopes including flexible videoscopes or fiberscopes and rigid videoscopes with camera heads and light source are directly connected to the Subject system. When connected, the endoscope (fiberscopes and rigid videoscope without camera head) acquires and displays images directly to the user or output onto a monitor when using a flexible endoscope or scope and camera head.

The Subject devices submitted for clearance include one (1) major component: the Video System Center (OLYMPUS OTV-S500); and two (2) auxiliary components: Foot Holder (MAJ-2552) for the OLYMPUS OTV-S500 that are shipped with the Video System Center, and an optional HDMI cable (MAJ-2551).

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)". This document does not contain information about a study proving the device meets acceptance criteria for an AI/algorithm-driven device, as the device is an endoscope video system center, not an AI device.

Therefore, the requested information regarding acceptance criteria and performance study details for an AI/algorithm-driven medical device, including sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, and effect sizes, cannot be extracted from this document.

The document primarily focuses on non-clinical performance data to demonstrate substantial equivalence to a predicate device (OLYMPUS CV-170), covering aspects like:

• Performance Testing Bench: Field of View, Resolution, Image Noise and Dynamic Range, Brightness, Image Intensity Uniformity, Color Performance, Latency, and Contrast Enhancement.
• Electrical Safety/EMC Testing
• Software Validation/Cybersecurity

The summary explicitly states: "No clinical data were collected to support performance of the Subject device." This further confirms that the type of study you are asking about (often involving clinical performance, human readers, and AI output) was not conducted for this device.

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The RenaFlex™ Single-use Flexible Ureteroscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra. bladder, ureter, calvces and renal papillae) via transurethral or percutaneous access routes. It can also be used with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Video System Center for Single Use Endoscopes is intended to provide illumination and receive, process, and output images from the compatible Olympus endoscope for diagnostics, treatment, and observation.

The RenaFlex Single-use Flexible Ureteroscope System will provide visualization and access for diagnostic and therapeutic applications, including urinary system biopsy and kidney stone treatment and removal. The RenaFlex Single-use Flexible Ureteroscope and compatible Video System Center for Single-use Endoscopes provide a means for direct visualization, diagnosis, and treatment of various diseases in the urinary tract and kidneys. The ureteroscope component of the system is intended as a single-use device that works to access the anatomy and to guide accessory devices for diagnostic and therapeutic applications in the urinary tract and kidneys. The compatible Video System Center for Singleuse Endoscopes is a reusable software-driven device that provides illumination and receives, processes, and outputs images from the endoscope using field upgradable software for diagnosis, treatment, and observation.

The provided text focuses on the 510(k) summary for the RenaFlex Single-use Flexible Ureteroscope System and does not describe acceptance criteria, performance data, or study designs for an AI/software device. The document states that "Clinical studies were not necessary for substantial equivalence determination," indicating that the submission primarily relied on bench testing and comparison to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria, performance, or study details for an AI-powered device based on the given text. The device described is a physical medical instrument (ureteroscope) and its associated video system, not an AI software.

The document does not contain the information required to answer the prompt.

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The EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. The CV-1500 Video System Center is compatible with scopes within the EVIS 190 and 1100 families.

The BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

The BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

The CV-1500 video system center is indicated to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, and be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product also functions as a pump to supply air through the endoscope, a light source to the endoscope, and a controller/monitor of ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis.

RDI (Red Dichromatic Imaging) observation: RDI is optical-digital observation using red dichromatic narrow band light and green illumination light to enhance visibility of bleeding points in the endoscopic image due to the difference in light absorption.

TXI (TeXture and color enhancement Imaging): TXI emphasizes tonal changes, patterns, and image outlines. It also corrects the brightness of dark areas.

BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast): BAI-MAC maintains the brightness of the bright part of the endoscopic image and corrects the brightness of the dark part of the endoscopic image.

The BF-H1100 and BF-1TH1100 endoscopes consist of three parts: the control section, the insertion section, and the connector section. The endoscope receives the illumination light from light guide connector connected to the video system center (CV-1500). The illumination light is transferred to the distal end through the optical fiber bundle inside of the endoscope and illuminates the inside of the patient body through the illumination lens at the distal end.

The endoscope receives the reflected light from the inner lumen of a patient by objective lens at the distal end. The built-in charge-coupled device (CCD) at the distal end converts the light to the electrical signal, and the signal is sent to the video system center via the electrical cable and the video connector of the endoscope. The endoscope transfers the image signal and displays the observation image on the screen.

This FDA 510(k) summary focuses on establishing substantial equivalence for the EVIS X1 Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, and Bronchovideoscope Olympus BF-1TH1100 to their predicate devices. The listed performance data describes various bench tests and an animal study conducted. However, this document does not detail specific acceptance criteria or report device performance against those criteria in a tabular format. It also explicitly states that "No clinical study was performed to demonstrate substantial equivalence." Therefore, a comprehensive answer for all your requested points cannot be extracted from this particular document.

Here's what can be inferred and what information is missing:

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

This information is not explicitly provided in the document in a tabular format. The document states that "The design verification tests and the acceptance criteria were identified and performed as a result of the risk management," and lists various performance tests (e.g., Thermal Safety, Durability, Resolution, Depth of Field, RDI, TXI and BAI-MAC performance). However, it does not provide the specific acceptance thresholds for these tests or the quantitative results achieved by the device.

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

• Bench Testing: The document does not specify sample sizes for the bench tests.
• Animal Study: An "animal study" was performed for CV-1500 to confirm WLI, NBI, TXI, and BAI-MAC performance. The document does not specify the sample size (e.g., number of animals) or the country of origin for this study. It is implicitly a prospective study in an animal model.
• Clinical Study: "No clinical study was performed to demonstrate substantial equivalence." Therefore, there is no human test set or associated provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there was no clinical study involving human readers or expert-established ground truth mentioned in this 510(k) summary for device performance evaluation. For the animal study, the ground truth establishment method and expert involvement are not detailed.

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

This information is not provided as there was no clinical study involving human readers discussed in this 510(k) summary. For the animal study, the adjudication method is not detailed.

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

No MRMC comparative effectiveness study was done involving human readers or AI assistance, as explicitly stated: "No clinical study was performed to demonstrate substantial equivalence." The device described is an endoscopic imaging system, not an AI-powered diagnostic tool. The imaging modes (NBI, RDI, TXI, BAI-MAC) are described as "adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging" and "are not intended to replace histopathological sampling as a means of diagnosis."

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

The document does not describe the device as an standalone algorithm. The device is a video system center and bronchoscopes. The performance evaluation focuses on the technical characteristics and imaging capabilities of the hardware and integrated imaging modes.

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

For the "Performance testing - Bench", the ground truth would be established by controlled experimental conditions and measurements against known physical standards. For the "Performance testing - Animal," the ground truth likely involved direct visual assessment and possibly histopathological examination of tissues within the animal model, though this is not explicitly stated.

8. The sample size for the training set

This is not applicable as the device is a hardware endoscopic system, not a machine learning algorithm that requires a training set in the typical sense. The "training set" concept does not apply to this type of device submission.

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

This is not applicable for the same reason as point 8.

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EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500: The EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. The CV-1500 Video System Center is compatible with scopes within the EVIS 190 and 1100 families.

COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL & CF-HQ1100DI: The COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I is intended to be used with an Olympus video system center, endoscope position detecting unit, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The COLONOVIDEOSCOPE CF-HQ1100DL &CF-HQ1100DI (product codes may be combined into a shorter code: CF-HQ1100DL/I) is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100: The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 is intended to be used with an Olympus video system center, Light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The GASTROINTESTINAL VIDEOSCOPE GIF-1100 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

This video system center is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis.

RDI (Red Dichromatic Imaging) observation: RDI is optical-digital observation using red dichromatic narrow band light and green illumination light to enhance visibility of bleeding points in the endoscopic image due to the difference in light absorption.

TXI (TeXture and color enhancement Imaging): TXI emphasizes tonal changes, patterns, and image outlines. It also corrects the brightness of dark areas.

BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast): BAI-MAC maintains the brightness of the bright part of the endoscopic image and corrects the brightness of the dark part of the endoscopic image.

EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500: This video system center is indicated to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, and be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product also functions as a pump to supply air through the endoscope, a light source to the endoscope, and a controller/monitor of ancillary equipment.

COLONOSCOPE OLYMPUS CF-HQ1100DL &CF-HQ1100DIGASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100: The endoscope receives the illumination light from light guide connector connected to the video system center (CV-1500: part of this submission). The illumination light is transferred to the distal end through the optical fiber bundle inside of the endoscope and illuminates the inside of the patient body through the illumination lens at the distal end. The endoscope receives the reflected light from the inner lumen of a patient by objective lens at the distal end. The built-in CCD at the distal end converts the light to the electrical signal, and the signal is sent to the video system center via the electrical cable and the video connector of the endoscope. The endoscope transfers the image signal and displays the observation image on the screen. The endoscope consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the endoscope is identical to that of the predicate device.

The provided text is a 510(k) Summary for the Olympus Evis X1 Video System Center and associated endoscopes. It describes the device, its intended use, and comparisons to predicate devices. However, it does not contain information about a study that proves the device meets specific acceptance criteria in terms of AI performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task).

The document lists "NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis." This statement, particularly "adjunctive tools" and "not intended to replace histopathological sampling," indicates that these features are image enhancement tools, not AI-powered diagnostic algorithms that would typically require performance studies against specific diagnostic acceptance criteria.

The "Performance Data" section (Page 28) mentions:

• "Performance testing - Animal": "Animal study was performed for CV-1500 to confirm the White Light Imaging (WLI) and Narrow Band Imaging (NBI) performance, and the effectiveness of Red Dichromatic Imaging (RDI) and TeXture and color enhancement Imaging (TXI)." This suggests evaluation of the visual output, not a diagnostic AI.
• "Performance testing - Clinical": "No clinical study was performed to demonstrate substantial equivalence." This explicitly states that clinical performance against diagnostic criteria was not assessed in a study.

Therefore, because the device features described (NBI, RDI, TXI, BAI-MAC) are presented as image enhancement tools and not AI for diagnostic interpretation, and the document explicitly states no clinical study was performed to demonstrate substantial equivalence (which would be necessary for a diagnostic AI), I cannot fill out the requested table regarding AI performance acceptance criteria and study details.

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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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