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The HD-550 video endoscope system, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract.

The EG-550 Series Video Gastroscope has been designed to be used with the image processor. Iight source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).

The EC-550 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).

The HD-550 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.

The VLS-55 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.

The proposed device, HD-550 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.

HD-550 Video Endoscope System can be offered in several configurations with the options of different models of primary components.

The EG-550 Series Video Gastroscope/ EC-550 Series Video Colonoscope is the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract.

The HD-550 Series Image Processor is a video processing system which is designed to be used with endoscopes, light source, monitor of the proposed system. Apart from the image processing functions, it also provides power supply for the endoscopes.

The VLS-55 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.

The SonoScape Medical Corp. HD-550 Video Endoscope System (K222020) is found to be substantially equivalent to its predicate device (K211882) based on non-clinical performance data. No clinical study was performed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence determination based on an identical predicate device, the "acceptance criteria" are effectively the specifications and performance of the predicate device, and the "reported device performance" is the claim that the proposed device is identical to the predicate device in these aspects.

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

• Sample size for the test set: Not applicable. The submission states, "No clinical study is included in this submission." The evaluation relies on the equivalence of the proposed device to the predicate device, which itself would have had its performance demonstrated through testing. The current submission focuses on non-clinical tests to demonstrate that the proposed device is identical to the predicate device in all relevant aspects, except for a reprocessing change.
• Data provenance: Not explicitly stated for the non-clinical tests. However, the manufacturer is Sonoscape Medical Corp. in Shenzhen, Guangdong, China. The non-clinical tests (electrical safety, EMC, performance, biocompatibility) are typically performed by the manufacturer or accredited labs on their behalf. The liquid chemical sterilization test reports were submitted to support the reprocessing change.

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

Not applicable. No clinical study with a "test set" requiring expert ground truth was conducted for this specific submission. The submission is based on substantial equivalence to a predicate device.

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

Not applicable. No clinical study requiring adjudication of a test set was conducted for this submission.

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

Not applicable. This device is an endoscope system, not an AI-assisted diagnostic tool for interpretation of images by human readers. The document makes a note that "The prospective clinical value of the enhanced imaging modes has not been demonstrated, and no clinical claims are made" regarding the enhanced imaging modes (EWL, SFI, VIST).

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

Not applicable. This is not an algorithm-only device. It is a medical device system (endoscope, image processor, light source) used by a human operator.

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

Not applicable. No clinical study with a "ground truth" was conducted for this submission. The demonstration of performance relies on compliance with recognized standards (IEC, ISO) and comparison of specifications with a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven submission that would involve a "training set."

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

Not applicable. As above, no training set was used.

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The HD-550 video endoscope system, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract.

The EG-550 Series Video Gastroscope has been designed to be used with the image processor. Iight source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).

The EC-550 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).

The HD-550 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.

The VLS-55 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.

The proposed device, HD-550 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.

HD-550 Video Endoscope System can be offered in several configurations with the options of different models of primary components

The EG-550 Series Video Gastroscope/ EC-550 Series Video Colonoscope is the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract.

The HD-550 Series Image Processor is a video processing system which is designed to be used with endoscopes, light source, monitor of the proposed system. Apart from the image processing functions, it also provides power supply for the endoscopes.

The VLS-55 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.

The provided text is a 510(k) Summary for the Sonoscape Medical Corp. HD-550 Video Endoscope System. It outlines the regulatory process for demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance criteria. Therefore, the document does not contain the information required to answer the prompt for acceptance criteria and a study proving the device meets those criteria, specifically concerning an AI component or complex performance metrics beyond equivalence.

The document states:

• "No clinical study is included in this submission." (Page 7)
• The non-clinical tests were conducted to "verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." (Page 6)
• The comparison focuses on "same intended use, comparable product specification and optical performance" with the predicate device. (Page 14)

The "acceptance criteria" discussed are largely about meeting established safety and performance standards relevant to Class II endoscopes and demonstrating equivalence to a previously cleared device (K173921 HD-500 Video Endoscope System). The performance metrics tested (e.g., color reproduction, resolution, depth of field) are for comparison with the predicate device, not against specific pre-defined acceptance thresholds for a novel AI or diagnostic capability.

Thus, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance (in the context of an AI/diagnostic study).
2. Sample sizes used for a test set or data provenance for an AI study.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to a traditional medical device (endoscope system) seeking 510(k) clearance based on substantial equivalence, not a device incorporating AI or requiring a new clinical performance study to establish specific diagnostic or therapeutic efficacy.

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HD-500 Video Endoscope System
The HD-500 Video Endoscope System, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopies examination, diagnosis and treatment of the disease of the upper and lower gastrointestinal tract.

HDL-500 Series Light Source, HDL-500E, HDL-500X
The HDL-500 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.

HD-500 Series Image Processor, HD-500, HD-500S, HD-330Plus
The HD-500 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.

EG-500 Series Video Gastroscope, EG-500, EG-500L
The EG-500 Series Video Gastroscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).

EC-500 Series Video Colonoscope, EC-500, EC-500T, EC-500L, EC-500L/T
The EC-500 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).

The proposed device, HD-500 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.
HD-500 Video Endoscope System can be offered in several configurations with the options of different models of primary components
The EG-500 Series Video Gastroscope/ EC-500 Series Video Colonoscope is the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract.
The HD-500 Series Image Processor is a video processing system which is designed to be used with endoscopes, light source, monitor of the proposed system. Apart from the image processing functions, it also provides power supply for the endoscopes.
The HDL-500 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.

The provided text is a 510(k) summary for the HD-500 Video Endoscope System. It describes the device, its intended use, and a comparison to a predicate device (EVIS EXERA II 180 System) to demonstrate substantial equivalence.

However, this document does not describe a study that proves the device meets specific acceptance criteria related to AI or a "human-in-the-loop" performance study. The entire document focuses on non-clinical tests and a comparison to a predicate device to establish substantial equivalence for a medical endoscope system, which is a hardware device, not an AI/software as a medical device (SaMD).

Here's a breakdown of why the requested information cannot be fully provided from the given document:

• No AI Component: The document clearly describes a traditional video endoscope system, including gastroscopes, colonoscopes, image processors, and light sources. There is no mention of any artificial intelligence, machine learning, or software for diagnosis/analysis.
• No Clinical Study for Performance Benchmarking: The document explicitly states: "No clinical study is included in this submission." (Page 6, Section 7). This means there is no data on human-in-the-loop performance, MRMC studies, or standalone algorithm performance.
• Focus on Substantial Equivalence: The entire submission is built around demonstrating that the new device is "substantially equivalent" to an existing, legally marketed predicate device. This is primarily done through feature-by-feature comparison and non-clinical engineering tests (electrical safety, EMC, optical performance, physical/functional performance, imaging performance) against established standards (IEC, ISO).

Therefore, I cannot populate the table or answer most of your specific questions related to AI acceptance criteria, data provenance, expert ground truth establishment, MRMC studies, or training sets. The document simply doesn't contain that information.

What the document does provide in terms of "acceptance criteria" and "performance" (though not AI-related):

The "acceptance criteria" in this context are the standards and benchmarks the device needs to meet to be considered safe and effective and "substantially equivalent" to predicate devices. These are primarily engineering and technical specifications.

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Traditional Device Focus)

2. Sample size used for the test set and the data provenance: Not applicable. This is a non-clinical submission. The "test set" refers to the specific units of the device that underwent engineering tests (e.g., optical performance, physical performance). The data provenance is these lab tests themselves, conducted by the manufacturer (Sonoscape Medical Corp.) likely in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the AI/clinical context, is not established for this type of non-clinical device test. The "ground truth" for these tests would be the established engineering standards and specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study involving human readers or interpretation.

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, explicitly stated "No clinical study is included in this submission." (Page 6, Section 7). No AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, explicitly stated "No clinical study is included in this submission." (Page 6, Section 7). No AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/clinical sense. The "ground truth" for engineering tests are the industry standards (IEC, ISO) and the specifications of the predicate device for comparison.

8. The sample size for the training set: Not applicable. No AI/ML model.

9. How the ground truth for the training set was established: Not applicable. No AI/ML model.

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VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R : These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 : This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 : This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system with the compatible cystscopes is intended for endoscopic diagnosis, treatment and video observation of the bladder, urethra, ureter, and kidney.

The primary components of the subject system are:
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R (CYF-V2, CYF-VA2, CYF-V2R)
EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180

The provided document is a 510(k) premarket notification for the "EVIS EXERA II 180 SYSTEM". This document is a regulatory filing for a medical device and describes its intended use, technological characteristics, and a comparison to a predicate device to demonstrate substantial equivalence. It does not contain information about the performance or study results of a device in the context of acceptance criteria as would be found in a clinical study report or a robust performance evaluation for an AI/ML device.

The relevant sections are:

• Section 7. Summary of Non-clinical Testing: States that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."
• Section 8. Conclusion: States that the device is "substantially equivalent" to predicate devices and does not change fundamental scientific technology or intended use.

Based on the provided text, I cannot provide the specific details requested regarding acceptance criteria and a study proving the device meets them in the manner of an AI/ML device performance evaluation because:

1. The document is a 510(k) submission, not a performance study report. It aims to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to independently prove specific numerical performance metrics against defined acceptance criteria using a test set with ground truth.
2. The device appears to be a traditional endoscopic imaging system, not an AI/ML-powered device. The questions regarding AI/ML-specific details (like human reader improvement with AI assistance, standalone algorithm performance, training set size, etc.) are therefore not applicable to this document.
3. The "acceptance criteria" mentioned are related to design verification tests and risk analysis based on ISO 14971:2007, which pertains to quality management systems and risk management for medical devices, not clinical performance metrics for diagnosis or treatment. The document does not list specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) as acceptance criteria for functionality or effectiveness in the way an AI/ML device would.

Therefore, I must state that the requested information cannot be extracted from the provided text. The document describes a regulatory pathway for a conventional medical device (an endoscope system) and refers to manufacturing and risk management standards rather than specific diagnostic performance studies with acceptance criteria and test set details.

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EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180: This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N: These instruments have been designed 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 transoral or transnasal endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).

EVIS EXERA II. GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180, OLYMPUS GIF TYPE H180: These instruments have been designed 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 within the upper digestive tract (including the esophagus, stomach, and duodenum).

EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, QLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180Al (Pediatric), These instruments have been designed 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 within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.

The primary components of the subject system, which are part of this submission, are:

• EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
• EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
• EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180
• EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N .
• EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180 .
• EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180
• EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL
• EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AI .
• EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL
• EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI
• . EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AL (PEDIATRIC)
• EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AI (PEDIATRIC)
• EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (PEDIATRIC)
• EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AI (PEDIATRIC)

The EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI), employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band.

The EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject gastrointestinal videoscopes and colonovideoscopes. The CV-180 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 incorporates Image Enhancement and NBI Observation features.

The provided text is a 510(k) summary for the OLYMPUS EVIS EXERA II 180 SYSTEM, and its primary purpose is to establish substantial equivalence to a predicate device. It primarily focuses on comparing technological characteristics and intended use, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not present in this type of regulatory submission. The document explicitly states: "The clinical literatures provided in this submission support new sales promotional claims for Barrett's esophagus, colorectal polyp detection and histology prediction." However, these clinical literatures are not included in the provided text.

Based on the provided information, I can only provide limited answers as the core data regarding performance studies is absent.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in terms of acceptance criteria with numerical performance targets. The submission establishes substantial equivalence by demonstrating that the subject device is "basically identical to its predicate device in intended use, and similar in specifications." The performance is implicitly accepted if it is similar to the predicate device. The tables provided (Table 16-2 to 16-11) compare specifications between the subject device and its predicate devices. For most specifications, the subject device is stated as "Identical to the Predicate Device," or minor differences in size/weight are noted.

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

Not specified in the provided text. The submission references "clinical literatures" to support new claims, but these studies themselves are not detailed.

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

Not specified.

4. Adjudication Method for the Test Set

Not specified.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not specified. The document mentions that "The clinical literatures provided in this submission support new sales promotional claims for Barrett's esophagus, colorectal polyp detection and histology prediction." However, the details of these clinical literatures (including whether they were MRMC studies or involved AI assistance) are not provided in the submitted text. Given the filing date (2010), advanced AI assistance in clinical endoscopy studies was less common than today.

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

Not applicable. This device is an endoscopic video imaging system, not an AI algorithm designed for standalone performance. The NBI feature (Narrow Band Imaging) enhances images for human interpretation, it's not described as standalone diagnostic software.

7. The Type of Ground Truth Used

Not specified in the provided text for any performance studies. For the comparative effectiveness claims mentioned (Barrett's esophagus, colorectal polyp detection and histology prediction), it is implied that there would be some form of clinical ground truth (e.g., pathology, expert diagnosis), but details are absent.

8. The Sample Size for the Training Set

Not applicable. The device is a hardware system, not an AI algorithm trained on a dataset in the typical sense. The NBI feature uses an optical filter and image processing to enhance visuals, not machine learning from a training set.

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

Not applicable. See point 8.

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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 endoscopic diagnosis and treatment within the abdomen and thoracic cavities including the female reproductive organs.

The HD EndoEYE - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy The HD Lhoon is "Thigh Dominal cavities which is basically identical to the predicate device, OES Laparo- Thoraco Videoscope, for the same application areas.

The major difference from the predicate device is only the NBI function added to the subject device.

When the CLV-180 and CV-180 or the OTV-S7Pro and CLV-S40Pro are combined with HD EndoEYE, both an endoscopic image by white light illumination and that by NBI illumination can be observed within the thoracic and abdominal cavities. The CV-180 identifies when an NBI-compatible scope is connected, by using the Scope ID function provided with the scopes.

The provided text is a 510(k) summary for the Olympus HD EndoEYE, a high-definition digital video laparoscope. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria in the way a clinical trial report would.

Here's an analysis based only on the provided text, as if it were a direct answer to your request. However, it's crucial to understand that this 510(k) summary does not contain the detailed study information you've requested regarding acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies (MRMC or standalone proficiency studies).

The document primarily relies on a comparison of specifications to demonstrate substantial equivalence, implying that if the new device's technical characteristics are similar or improved without introducing new safety/effectiveness concerns compared to legally marketed devices, it meets regulatory requirements.

Based on the provided K090980 510(k) Summary for the HD EndoEYE:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the form of performance thresholds for a study. Instead, it compares the technical specifications of the subject device (HD EndoEYE) to its predicate devices. The "reported device performance" is essentially presented as its specifications, which are deemed acceptable because they are similar or superior to the legally marketed predicate devices without significant changes affecting safety or effectiveness.

Study Proving Acceptance Criteria:

The "study" presented here is a comparison of specifications between the subject device and its predicate devices. The conclusion states: "When compared to the predicate devices, the HD EndoEYE does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that by being substantially equivalent or demonstrating comparable technical performance to already-approved devices, it meets the inherent "acceptance criteria" for regulatory clearance.

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

• The document does not specify a test set sample size or any clinical data provenance (e.g., country of origin, retrospective/prospective study) in the context of device performance testing.
• The review is based on a comparison of technical specifications and an assessment of substantial equivalence.

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

• The document does not mention experts being used to establish ground truth for a test set in the context of a performance study.
• The "ground truth" for this 510(k) submission is the functional equivalence and safety assessment against legally marketed devices.

4. Adjudication Method for the Test Set:

• Not applicable. No test set performance study with adjudication is described in the provided text.

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

• No MRMC comparative effectiveness study is mentioned. The document does not describe any human reader studies, either comparing human readers with AI assistance or in general. The device is a laparoscopic imaging system, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This device is an imaging instrument (hardware), not a standalone algorithm. Its performance is assessed through its physical and optical specifications, not an algorithmic output.

7. Type of Ground Truth Used:

• For this 510(k) submission, the "ground truth" is primarily technical specifications and functional characteristics of already legally marketed predicate devices, against which the new device is compared to establish substantial equivalence. No clinical outcome or pathology data is presented for this purpose.

8. Sample Size for the Training Set:

• Not applicable. This document is for a medical device (laparoscope), not an AI algorithm requiring a training set.

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

• Not applicable. As above, no training set or AI algorithm is discussed.

Summary of what is not found in the document regarding your request:

The provided 510(k) summary is a regulatory filing for substantial equivalence, not a detailed clinical or performance study report in the traditional sense described by your questions. It focuses on comparing the new device's technical characteristics and intended use to existing predicate devices. Therefore, specific details about acceptance criteria derived from a performance study, sample sizes for test/training sets, expert qualifications, ground truth establishment (other than general device specifications), or clinical study methodologies (like MRMC or standalone performance evaluations) are not present in this document.

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EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180: This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

VISERA URETERO-RENO VIDEOSCOPE OLYMPUS XURF TYPE V: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

The EVIS EXERA II 180 System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation. The primary components of the subject system, are: EVIS EXERA II Xenon Light Source Olympus CLV-180 and EVIS EXERA II Video System Center Olympus CV-180. The endoscope to be added for the system, is: VISERA Uretero-Reno Videoscope Olympus XURF type V.

The provided text is a 510(k) summary for the OLYMPUS EVIS EXERA II 180 SYSTEM. It describes the device, its components, intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria, specific performance studies, sample sizes, ground truth establishment, or expert adjudication that typically relate to the performance proof of a device.

This document focuses on demonstrating that the new device is "substantially equivalent" to existing legally marketed devices based on technological characteristics and intended use, rather than presenting a detailed clinical or performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to answer based on the available information, noting what isn't provided:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document primarily focuses on comparing specifications to predicate devices to demonstrate substantial equivalence, not on specific performance metrics against pre-defined acceptance criteria.

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

This information is not provided in the document. No specific test set or data provenance is mentioned.

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

This information is not provided in the document. No ground truth establishment involving experts for a test set is mentioned.

4. Adjudication method for the test set

This information is not provided in the document. No adjudication method is mentioned.

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 is not mentioned in the document. This device is an endoscopic video imaging system, not an AI-assisted diagnostic tool, so such a study would not be relevant in this context.

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

A standalone algorithm performance study is not mentioned in the document. This device is a hardware system for image capture and processing, not an autonomous algorithm.

7. The type of ground truth used

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" as this is not an AI/ML device.

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

This information is not provided in the document. There is no mention of a "training set" or ground truth establishment for such a set.

Summary of what the document does convey regarding "proof":

The "proof" for this device's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices, not on a standalone performance study against specific acceptance criteria. This is a common pathway for medical device clearance under 510(k).

• Comparison of Technological Characteristics: The document provides tables (Table 15-2, 15-3, and implied for the XURF-V) comparing the specifications of the subject devices (EVIS EXERA II 180 System components) to their predicate devices.
• Key Finding: The conclusion states: "When-compared to the predicate device, the EVIS EXERA II 180 System does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device."
• NBI Feature: The key new feature, Narrow Band Imaging (NBI), is described as providing "greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes" when compared to conventional white light observation. However, no quantitative studies are presented to support this claim or define specific acceptance criteria for its performance.

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EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180: This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, XCYF TYPE VQ: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

The EVIS EXERA II 180 System consists of Olympus camera heads, endoscopes, video r no ENET and The 100 - , monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the bladder, urethra, ureter, and kidney.

The primary components of the subject system, which are part of this submission, are:

• EVIS EXERA 11 Xenon Light Source Olympus CLV-180, •
• EVIS EXERA II Video System Center Olympus CV-180, .
• VISERA Cysto-Nephro Videoscope Olympus CYF type V2, CYF type VA2, and XCYF . type VQ (hereinafter referred to as CYF-V2, CYF-VA2 and XCYF-VQ)

The EVIS EXERA II Xenon Light Source Olympus CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 is substantially identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-180 has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI), employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-180. In comparison to conventional white light observation, NBI observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.

The EVIS EXERA II Video System Center Olympus CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-180 Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images, The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A. cleared under K051645 except that the device size has been slightly changed.

The CV-180 incorporates the following features:

1. The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscopes.
2. The CV-180 processes the NBI image, generated by the CLV-180 light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.

The provided document is a 510(k) summary for the OLYMPUS EVIS EXERA II 180 SYSTEM, which is an endoscopic video imaging system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a new AI/CAD device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, and AI comparative effectiveness cannot be extracted from this document, as it describes a non-AI or CAD system. The document states that the new system is "basically identical to each predicate device ... in intended use, and similar in specifications, performance and materials" with the primary change being the addition of a Narrow Band Imaging (NBI) function, which is an optical filtering technique, not an AI/CAD algorithm.

However, I can extract the specific performance characteristics that are compared between the subject device and the predicate device, which can be seen as the "reported device performance" in the context of demonstrating substantial equivalence.

Here's the information that can be extracted, framed within your request as much as possible for a non-AI device:

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

Since this is a 510(k) for substantial equivalence of a medical device (endoscopic system) and not an AI/CAD system, "acceptance criteria" are implicitly defined by the device's technical specifications matching or being similar to those of the predicate device, and demonstrating safety and effectiveness for similar intended use. There are no explicit "acceptance criteria" for a specific performance metric in the way one would define for an AI algorithm's accuracy, sensitivity, or specificity. The "reported device performance" is essentially the detailed specifications of the subject device.

Rather than "acceptance criteria," the document presents a comparison of specifications to show similarity.

Table: Comparison of Specifications (Selected Examples)

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

This information is not applicable and not provided in the document. This is a traditional medical device submission based on technical specifications and similarities to a predicate device, not a data-driven AI/CAD study.

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 applicable and not provided. No "ground truth" establishment by experts for a test set is mentioned, as this is not an AI/CAD device.

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

This information is not applicable and not provided. No adjudication method for a test set is mentioned.

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

This information is not applicable and not provided. No MRMC study or AI assistance is mentioned. The NBI function is an optical filter, not an AI method.

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

This information is not applicable and not provided. This is not an algorithm-only device.

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

This information is not applicable and not provided. No ground truth is established for this type of device submission.

8. The sample size for the training set

This information is not applicable and not provided. There is no training set for this device.

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

This information is not applicable and not provided. There is no training set mentioned.

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The EVIS EXERA 160A system consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.

EVIS EXERA Xenon Light Source Olympus CLV-160A: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA Video System Center Olympus CV-160A: This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for transoral or transnasal observation and surgery within the upper digestive tract (including the esophagus, stomach and duodenum).

EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5, XGIF-H160Y2: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).

EVIS EXERA Colonovideoscope XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).

The EVIS EXERA 160A System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.

The primary components of the subject system, which are part of this submission, are:

• EVIS EXERA Xenon Light Source Olympus CLV-160A,
• EVIS EXERA Video System Center Olympus CV-160A,
• EVIS EXERA Gastrointestinal Videoscopes XGIF-N160Y2, XGIF-Q160Y5, XGIF-H160Y2.
• EVIS EXERA Colonovideoscopes XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L

The EVIS EXERA Xenon Light Source Olympus CLV-160A is intended for endoscopic diagnosis, treatment and video observation. The CLV-160A is basically identical to the predicate device, EVIS Universal Light Source CLV-U40, with the exception that the CLV-160A has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI) employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A. In comparison to conventional white light observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.

The EVIS EXERA Video System Center Olympus CV-160A is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-160A Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images.

The provided document is a 510(k) summary for the Olympus EVIS EXERA 160A System, which is a premarket notification to the FDA for medical devices. This type of document is intended to demonstrate substantial equivalence to a predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study with quantitative performance metrics.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the way you've outlined for things like AI/ML models. It focuses on demonstrating that the new device is as safe and effective as previously cleared devices.

Here's why your requested information isn't present in this type of submission and what information is available:

• Acceptance Criteria and Reported Device Performance: This document describes comparisons of specifications between the new device and its predicate devices (Tables 16-3 to 16-10). It highlights similarities in intended use, specifications, performance, and materials, with the key difference being the addition of the Narrow Band Imaging (NBI) function. It asserts that the clinical literature supports the safety and efficacy of NBI imaging in endoscopy, but it does not provide a specific table of acceptance criteria a new study had to meet for the overall system or its NBI function.
• Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth: These details are typically associated with performance studies, especially for new diagnostic algorithms or AI/ML components. The provided document is for a hardware system (endoscopic video imaging system) and focuses on demonstrating substantial equivalence through comparison to existing products and referencing existing clinical literature. It does not describe a specific clinical performance study with these parameters for the EVIS EXERA 160A System itself. The NBI function is presented as an additional feature, and its safety and efficacy are supported by "clinical literatures" (plural), implying existing published research rather than a de novo study conducted for this 510(k).

Conclusion from the document:

The conclusion explicitly states: "When compared to the predicate devices, the EVIS EXERA 160A System does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the system." This is the core of a 510(k) submission – to show that the new device is substantially equivalent to already legally marketed devices, rather than establishing entirely new performance metrics via a dedicated study.

In summary, the provided 510(k) summary is not a clinical study report that would answer your specific questions about acceptance criteria and performance study details. It is a regulatory submission for substantial equivalence.

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