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The HD-Camera HDC1000 is intended to be used during diagnostic and operative endoscopic procedures to provide illumination and visualization of body cavities, hollow organs and to allow for image recording and documentation. The HD-Camera HDC1000 is indicated for use with compatible rigid or flexible endoscopes and other video equipment and endoscopic accessories.

The HD-Camera HDC1000 is a video-management system that consists of a camera, an integrated light source and a capture module for storing and compressing video and still images. It is used in conjunction with an endoscope or microscope, a light cable and other endoscopic accessories to illuminate surgical sites and to view the surgical sites on video monitors during diagnostic and operative endoscopic procedures. The camera of the proposed device consists of a camera control unit (CCU), a coupler, and a camera head with an integral cable that connects to the camera control unit (CCU). The optical image is transferred from the surgical site to the camera head by compatible rigid and flexible endoscopes that are attached to the camera head using an optical coupler. The camera head including camera cable and the coupler are reusable devices and must be sterilized using the STERRAD ® advanced sterilization process or may be used with a sterile cover or sleeve. The camera control unit (CCU) is not intended to enter the sterile field, and cannot be sterilized.

This document describes the regulatory submission for the HD-Camera HDC1000, a medical device intended for diagnostic and operative endoscopic procedures to provide illumination, visualization, image recording, and documentation. The submission focuses on demonstrating substantial equivalence to a predicate device, the OVS1 Video System.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the device's technical specifications in a table format. Instead, it describes performance testing conducted to demonstrate conformance to standards and substantial equivalence to a predicate device. The performance data section refers to various standards that the device conforms to, which implicitly represent the acceptance criteria for those specific aspects.

Based on the information provided, here's a summary of the performance claims and an attempt to infer "acceptance criteria" from the comparative bench testing with the predicate device, where the implied criterion is comparability.

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

The document states that "comparative bench testing was performed." However, it does not specify any sample size for this test set (e.g., number of devices tested, number of images/videos analyzed).
The data provenance is not explicitly mentioned but can be inferred as arising from bench testing conducted by independent laboratories. There is no indication of patient data or clinical studies; it is likely an engineering/technical evaluation.

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

This information is not provided in the document. The comparative bench testing described here appears to be a technical comparison against a predicate device and industry standards, rather than an evaluation requiring expert clinical interpretation to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the described testing (bench testing against technical standards and a predicate device). No human-based adjudication for ground truth 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?

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a camera system for endoscopic visualization, not an AI diagnostic tool. The document focuses on the camera's technical performance and equivalence to a predicate device.

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

This question is not applicable as the device is an HD-Camera, a hardware system for image and video capture, not an algorithm or AI system for standalone performance evaluation.

7. The Type of Ground Truth Used

For the safety, EMC, software, cleaning, sterilization, and general design verification tests, the "ground truth" implicitly refers to the requirements specified in the respective international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62304, AAMI/ANSI/ISO 14937, AAMI TIR12) and conformity to FDA guidance documents.

For the comparative bench testing (SNR, resolution, latency, shading correction accuracy, white balance accuracy, maximum light source intensity), the "ground truth" is likely derived from measured technical specifications of both the proposed device and the predicate device, with the aim to demonstrate substantial equivalence. It refers to objective, measurable physical properties rather than subjective clinical diagnoses or pathology.

8. The Sample Size for the Training Set

This information is not applicable. The HD-Camera HDC1000 is a hardware device for image acquisition, not a machine learning or AI model that requires a training set.

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

This information is not applicable for the same reason as above; there is no training set for this type of device.

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