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• Endoscopes (OLYMPUS BF-Q190, OLYMPUS BF-H190, OLYMPUS BF-1TH190 EVIS EXERA BRONCHOVIDEOSCOPE)
  This instrument 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. This instrument is indicated for use within the airways and tracheobronchial tree.

• OLYMPUS CV-190 EVIS EXERAIII VIDEO SYSTEM CENTER
  This video system center is intended 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.

• OLYMPUS CLV-190 EVIS EXERATI XENON LIGHT SOURCE
  This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

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

• Video System Center OLYMPUS CV-190
• XENON LIGHT SOURCE OLYMPUS CLV-190
• RENON ENOVIDEOSCOPE OLYMPUS BF-Q190, BF-H190, BF-H190, BF-1TH190

The CV-190 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS CV-190 allows image display on HDTV (16:9).

The XENON LIGHT SOURCE OLYMPUS CLV-190 is intended for endoscopic diagnosis, treatment and video observation.

In addition, both the CV-190 and CLV-190 can be used with any specified Olymous flexible and rigid including gastroscopes, ultrasound gastroscopes, duodenoscopes, endoscope models, colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes.

The subject endoscopes are 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.

The provided document, K121959 for the EVIS EXERA III VIDEO SYSTEM, is a 510(k) premarket notification. This type of submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical trials with specific acceptance criteria and performance metrics for new or significantly altered functions.

Therefore, based on the provided text, I can extract information regarding non-clinical testing and general acceptance of safety and effectiveness through substantial equivalence, but I cannot provide a table of acceptance criteria and reported device performance related to a specific study proving those criteria, nor can I provide information on sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not detailed in this type of regulatory submission.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, a detailed table with specific performance metrics against acceptance criteria from a clinical study is not available in this 510(k) summary. The document 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." However, the specific acceptance criteria and the numerical results of these design verification tests are not provided in the summary.

The primary method for demonstrating safety and effectiveness in this 510(k) is through substantial equivalence to predicate devices. The conclusion states: "When compared to the predicate device, the EVIS EXERA III VIDEO 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."

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

This information is not available in the provided document. The submission focuses on non-clinical testing and substantial equivalence, not clinical testing with a "test set" in the context of AI/algorithm performance.

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

This information is not available in the provided document. As there is no "test set" described for performance evaluation, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not available in the provided document.

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

This information is not available in the provided document. The device described is an endoscopic video imaging system, not an AI-assisted diagnostic tool.

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

This information is not applicable/available as the device is an imaging system, not a standalone algorithm.

7. The Type of Ground Truth Used

Based on the document, the "ground truth" for the device's acceptable performance is primarily established through:

• Compliance with recognized standards: Such as IEC 60601-1, ISO 14971, ASTM E1837-96, ANSI/AAMI/ISO 11135-1, ISO 10993-1, ISO 10993-5, ISO 10993-10.
• Risk analysis: "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007."
• Design verification tests: The design verification tests and their acceptance criteria were identified and performed as a result of the risk analysis assessment.
• Reprocessing validation: "Reprocessing validation was carried out in accordance with 'Labeling Reusable Medical Devices Reprocessing Vallaulton was camose of the FDA Reviewer Guidance - April 1996.'"
• Software validation: "The software validation activities were performed in accordance with the FDA Guidance 'for the Contained of Premarket Submissions for Software Contained in Medical Devices.' The device software is considered a 'Minor Level of Concern.'"
• Substantial Equivalence to Predicate Devices: The overall conclusion of the 510(k) is that the device is substantially equivalent to legally marketed predicate devices, implying its safety and effectiveness are comparable.

8. The Sample Size for the Training Set

This information is not available/applicable. The device is an endoscopic video system, not an AI algorithm that would typically have a "training set" in the context of machine learning.

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

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

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