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The indications for use of the VIEWSEND Medical System, as described in its labeling, are the same as the previously cleared devices marketed and distributed by KLT telecom, Inc. (K-962225). The VIEWSEND Medical System has the same intended use as the originally cleared device.

When installed on an appropriate PC-based platform, the VIEWSEND Medical System is intended to provide the medical professional with the capability to comnare, manipulate, annotate, collaborate, and/or transmit medical images in order to render a diagnosis. Digital image storage in system RAM and hard drive standard is with lossless compression or without data compression. Options include teleradiology, telemedicine, videoconferencing, communications, viewer, customizable database, DICOM 3.0, stand-alone or client/server or web-based, compression, and/or security.

Communications between systems can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or servers.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA

The VIEWSEND Medical System is a modular software program providing telemedicine, teleradiology, and videoconferencing capabilities. The system may also utilize some or all of the following components: (1) DICOM, (2) Zydacron, (3) Canon Communication Camera, (4) COHERENT Call Port Display Audio Conferencing System, (5) Canon RE-650 MKH Video Visualizer Document Camera.

This document appears to be a 510(k) premarket notification for the VIEWSEND Medical System. It focuses on demonstrating substantial equivalence to a predicate device and discussing software development and safety, rather than presenting a study specifically designed to establish acceptance criteria for device performance. As such, much of the requested information regarding acceptance criteria, study methodologies, and performance metrics is not directly available in this text.

However, I can extract information related to the device's technical specifications and safety evaluation.

Here's a breakdown of the available information based on your request:

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

The document does not provide a formal table of "acceptance criteria" and "reported device performance" in the typical sense of a clinical or performance study. Instead, it describes compliance with industry standards and internal software development policies, as well as the technical specifications of the integrated components.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail a specific "test set" in the context of a performance study with a defined sample size (e.g., number of images, patients). The testing mentioned is for software verification and validation of incremental revisions, not for image analysis performance. There is no information regarding data provenance (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 (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document primarily discusses the technical capabilities and software development process of the system. While it mentions that "healthcare professionals shall exercise their own judgment when using the displayed information for diagnosis" and radiologists require specific monitors, it doesn't describe a process of establishing ground truth by medical experts for a test set to evaluate the device's diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document, as there is no described test set or study involving expert adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned. The VIEWSEND Medical System is described as a modular software for telemedicine, teleradiology, and videoconferencing, focusing on image transmission, storage, and viewing capabilities. It is not an AI-assisted diagnostic device designed to improve human reader performance.

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

A standalone performance study for an algorithm without human-in-the-loop was not performed. The device is a system for medical professionals to use for "compare, manipulate, annotate, collaborate, and/or transmit medical images in order to render a diagnosis." It explicitly states that it "does NOT...Provide a diagnosis recommendation or statement (such as an expert system)".

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not specify a type of ground truth used, as it doesn't describe a study to evaluate diagnostic accuracy. The safety evaluation matrix uses criteria like "Could software errors in this revision potentially lead to diagnostic or monitoring information to be missed or inaccurate?", but the "Hazard Level of Concern" for these is determined based on software analysis, not a comparison to a clinical ground truth.

8. The sample size for the training set

This information is not applicable/not provided. The VIEWSEND Medical System is not an AI/ML device that requires a training set. It's a software system built upon existing medical software (Osiris 2.5) and integrated components (DICOM routines from Merge Technologies, JPEG 2000 routines from Pegasus).

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

This information is not applicable/not provided for the same reasons as point 8.

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