Search Results

The Image Technologies Corporation SteriCam and TroView Imaging System consists of a CCD camera, coupler and a computer-based documentation system. The SteriCam is intended to attach to a standard commercially available endoscope for visualization of body cavities, hollow organs, and canals. The System includes a Coupler-Drape Assembly which is intended to couple the SteriCam to a standard commercially available endoscope. The TroView System is intended to provide documentation/storage of the image in the field of view of the SteriCam.

The Image Technologies Corporation's SteriCam, SteriCam Coupler-Drape and TroView Imaging System consists of a CCD camera, coupler and a computer based documentation system. The SteriCam takes the image that normally would be seen by the naked eye, and displays it on a color monitor. The SteriCam provides imaging through standard commercially available endoscopes and is designed to be used with the sterile SteriCam Coupler-Drape. The Coupler-Drape includes a sterile drape component. The SteriCam is placed within the sterile drape of the Coupler-Drape to prevent contamination in the sterile field. The video signal cable connects the SteriCam to the TroView Documentation System.

The SteriCam Coupler-Drape's distal end attaches to the eyepiece of a conventional endoscope and uses the SteriCam CCD camera to display the image on the computer monitor. The SteriCam Coupler-Drape simply connects the conventional endoscope to the SteriCam. The SteriCam Coupler-Drape is sterile and includes the drape so that the non-sterile SteriCam Camera and cable are covered during the surgical procedures. Although the SteriCam Coupler-Drape attaches to various endoscopes, it is designed to be used only with the SteriCam camera.

The TroView System is a non-sterile reusable unit that is intended to provide real time image displays as well as storage of the image in the field of view of the SteriCam. As the TroView receives and displays the SteriCam digitized video output, the images can be adjusted for brightness, hue, contrast and saturation. The TroView System allows for printing to a dedicated printer or saving the image in to a 1.44 MB 3.5" floppy disk or other storage medium. A software based zoom is also permitted.

A sterile disposable Remote Controller is also offered with the TroView System which permits remote control access to key camera and computer functions. The Remote Controller looks and performs identically to the controller pad located on the faceplate of the computer. The physician is able to place the sterile Remote Controller in the sterile field whereas the faceplate of the computer is non-sterile and situated outside the sterile field.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device Name: Image Technologies Corporation SteriCam, Coupler-Drape and TroView System

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a "test set" in the context of clinical or image-based evaluation with a defined sample size of distinct images or cases.

• Sample Size: Not specified in terms of number of images, cases, or patients. The testing involved a standard target rather than biological samples.
• Data Provenance: Not applicable in the context of this performance testing, as it used a standardized test target rather than patient data.

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

Not applicable. The ground truth for resolution testing using a USAF 1951 Test Target is inherent in the design of the target itself (known line pairs per millimeter). No human experts are used to establish this specific ground truth for this type of technical performance measurement.

4. Adjudication Method for the Test Set:

Not applicable. As the testing involved a technical resolution target and not clinical interpretation, there was no need for an adjudication method by experts.

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

No, an MRMC comparative effectiveness study was not done. The document describes a technical performance test, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance test was done for resolution. The "Image Quality testing" performed on the system measures the device's intrinsic resolution capability using a standardized target, independent of human interpretation or interaction beyond operating the device to capture the image.

7. The Type of Ground Truth Used:

The ground truth used for the image quality testing was a standardized physical target (USAF 1951 Test Target designed to MIL-STD-150). The resolution values (lines per mm) are objectively measurable from this target.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. It is an imaging system (camera, coupler, documentation system) for visualization.

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

Not applicable. As mentioned, this device does not involve an AI/ML algorithm requiring a training set with established ground truth.

Ask a specific question about this device