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LOGIC 4K CAMERA CONTROLLER: The ENDOCAM® Logic 4K Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic 4K Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.

LOGIC 4K CAMERA HEAD: Logic 4K Camera Head 85525942 is used for applications in conjunction with the Logic 4K Camera Controller 5525301 for diagnostic and therapeutic interventions. This product is exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical doctors.

Richard Wolf's ENDOCAM® Logic 4K Camera System 5525 consists of the Logic 4K Camera Controller and Logic 4K Camera Head. The Logic 4K Camera System has been designed for highdefinition video endoscopy and is used in conjunction with other video equipment and endoscopic accessories.

The Logic 4K Camera Controller is the control center of the system, its primary performance characteristics are signal processing of the image data and image recording. The Logic 4K Camera Controller is equipped with various outputs (e.g. HDMI 4K and HDMI HD) and can process a 2K / HD or 4K resolution. The Logic 4K Camera Controller device parameters are controlled and set via the touchscreen, access to all control elements / parameters is possible in OSD via the PC keyboard the handheld remote control or via core.nova.

The Logic 4K Camera Controller housing is made of of powder-coated stainless steel measuring 300mm x 120mm x 416mm; the front foil consists of Polyester AUTOPEX.

The Logic 4K Camera Head is used in conjunction with the Logic 4K Camera Controller, its primary performance characteristic is to receive and transfer an optical image from a variety of endoscopes (rigid, semi-rigid, and flexible endoscopes).

The Logic 4K Camera Head housing is made of stainless steel measuring approximately 40mm x 47mm x 102mm. The camera head cable is securely attached and is 3.0m in length.

The LOGIC 4K Camera Controller and LOGIC 4K Camera Head are not intended to contact the patient directly or indirectly.

The LOGIC 4K Camera Controller and Logic 4K Camera Head are delivered non-sterile. The devices are reusable and do require processing during their use-life. Users are required to process the device for initial use and after each use. Methods of cleaning, disinfection, and sterilization are detailed in the Instruction for Use.

This document, a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA), describes the "LOGIC 4K CAMERA CONTROLLER LOGIC 4K CAMERA HEAD" (K180583) and its substantial equivalence to a predicate device. It primarily focuses on technical specifications, safety, and performance testing rather than a study designed to meet specific clinical acceptance criteria in the way one might evaluate an AI/CAD product.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a camera system and not an AI or diagnostic tool with typical performance metrics like sensitivity/specificity, the "acceptance criteria" are related to technical standards and functional performance.

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

• Sample Size for Test Set: This document does not describe a "test set" in the context of clinical data or imaging studies. The performance evaluation was primarily through bench testing and compliance with recognized electrical safety and EMC standards. Therefore, the "sample size" would refer to the number of devices tested in engineering labs rather than patient data. Specific numbers of units tested are not provided in this summary.
• Data Provenance: Not applicable in the context of patient data. The provenance of the engineering test data would be from internal testing labs of Richard Wolf Medical Instruments Corporation (USA) and Richard Wolf GmbH (Germany), as well as potentially external accredited testing facilities for standard compliance. The data is prospective in the sense that the testing was performed on the device itself to verify its performance against predefined standards.

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

• This information is not applicable as the document does not describe a clinical study involving experts to establish ground truth for a diagnostic outcome. The evaluation is focused on the device's technical functionality and safety compliance.

4. Adjudication method for the test set

• This information is not applicable as the document does not describe a clinical study requiring adjudication of expert interpretations.

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, an MRMC comparative effectiveness study was not done. This device is a 4K camera system, an imaging component, not an AI or CAD system. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.

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

• No, a standalone algorithm performance study was not done. This device is a camera system, not an algorithm.

7. The type of ground truth used

• This is not applicable in the context of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this device's evaluation was engineering specifications, international safety standards (electrical, EMC, usability), and functional requirements for an endoscopic video imaging system.

8. The sample size for the training set

• This information is not applicable. There is no mention of a "training set" as this device is a hardware camera system, not an AI or machine learning model.

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

• This information is not applicable. As there is no training set for a machine learning model, there is no ground truth relevant to a training set to be established.

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