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The PrimeSight™ UNITY 9000 Series Video Processors, when used in conjunction with a Cogentix Medical flexible videoscope, are indicated for the display and management of video and images during trans-nasal esophagoscopy, cystoscopy, bronchoscopy and nasopharyngoscopy procedures.

The PrimeSight™ UNITY 9000 and PrimeSight™ UNITY 9100 Video Processors (herein referred to as "UNITY 9000", "UNITY 9000 Processor" or "UNITY 9000 Series Video Processors") are video processing units designed to work exclusively with the Cogentix Medical TNE-5000, CST-5000, CST-5000i. BRS-5100 and ENT-5000 models of flexible videoscopes (herein referred to as "5000 Series Videoscopes") to display images and videos during endoscopic procedures. The UNITY 9000 Processor consists of two modules which are physically connected with a hinge mechanism. The all-inone computer (AIO PC) unit is used for the presentation and display of images and includes a large 19'' wide screen display with an integrated touchscreen. The Camera Interface Module (CIM) base unit allows for the connection of a videoscope or camera to the Processor, as well as any endoscopic peripherals being used during the procedure, as well as image processing.

There are two different model configurations available for the UNITY 9000. These models are offered specific to the type of endoscopic procedure being performed. The Base Configuration model (UVP-9000) supports urology and bronchoscopy applications, while the Airway Configuration model (UVP-9100) offers an integrated air pump for trans-nasal esophagoscopy and a stroboscopy interface for use during Ear, Nose, and Throat (ENT) stroboscopy examinations.

The provided document, a 510(k) summary for the PrimeSight™ UNITY 9000 Series Video Processors, describes the device's functional performance and compliance with various standards. However, it explicitly states that clinical data was not used to demonstrate substantial equivalence because the subject device and predicate device are considered very similar in design and functionality. This means the study did not involve human readers, ground truth establishment, or multi-reader multi-case comparative effectiveness.

Therefore, many of the requested details about acceptance criteria related to clinical performance metrics and associated study parameters (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies) are not applicable or provided in this document.

The acceptance criteria mentioned are primarily focused on functional performance, compliance with electrical safety and electromagnetic compatibility standards, software requirements, environmental testing, and usability.

Here's a breakdown of the available information:

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

Since the document focuses on demonstrating substantial equivalence through non-clinical testing, specific quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) are not stated, nor is there reported clinical device performance in terms of these metrics.

Instead, the "acceptance criteria" are implied by the successful completion and positive results of the various engineering and regulatory compliance tests. The "reported device performance" is that the device meets these criteria and is "safe and effective and performs in a manner making it substantially equivalent to its predicate device."

2. Sample size used for the test set and the data provenance:
Not applicable for this type of non-clinical testing. The "test set" consisted of the physical device and its components undergoing various engineering, software, and regulatory compliance tests. There is no mention of a "data provenance" in the clinical sense (e.g., country of origin, retrospective/prospective).

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 context of clinical studies, refers to definitive diagnoses or findings. This document describes engineering and regulatory compliance testing. Usability evaluation (TR 013-18) was performed, which likely involved human users, but details on the number or qualifications of "experts" to establish a clinical ground truth are not provided because it's not a clinical study.

4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies to resolve disagreements among human readers or evaluators when establishing ground truth. This document does not describe such a study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, a MRMC comparative effectiveness study was not done. The device is a video processor for endoscopes, not an AI-powered diagnostic tool, and the document explicitly states that "Clinical data was not used to demonstrate substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a video processor, which is inherently a "standalone" piece of hardware and software designed to display and manage images from endoscopes for human interpretation, not an algorithm providing diagnostic output on its own.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the clinical sense. The "ground truth" for the various engineering and regulatory compliance tests would be the established specifications, standards, and documented requirements that the device needed to meet.

8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device requiring a dataset for model training.

9. How the ground truth for the training set was established:
Not applicable, as there was no training set.

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