(80 days)
Shared Vision is a computerized, enhanced electronic Image Display Software System designed for clinical applications to allow physicians or other health care providers to remotely view and analyze patient Image Display data. This system is suited for various computer networks.
Shared Vision is a computerized, enhanced electronic Image Display Software System designed for clinical applications to allow physicians or other health care providers to remotely view and analyze patient Image Display data. This system is suited for various computer networks. Both devices use a computer program to display a pre-digitized patient image file. Both devices nun under a computer operating system. Both devices use the computer operating system to access the displayed image. Both devices output a display image that resembles a conventional image. Both devices retain an electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a computer operating system.
This document provides a summary of safety and effectiveness for a medical device called "Shared Vision™ Image Display Software." However, it does not include the detailed information needed to answer your specific questions regarding acceptance criteria, study design, and performance metrics.
Here's why and what's missing:
The document is a "Summary of Safety & Effectiveness" for an FDA 510(k) submission. This type of document primarily focuses on demonstrating "substantial equivalence" to a predicate device. It typically highlights similarities in intended use, technology, and performance, rather than presenting detailed experimental protocols and results that would establish specific acceptance criteria and prove performance against them.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document states the device "has performance characteristics substantially equivalent to its predicate device" and "has been tested to confirm safety and efficacy," but it provides no specific metrics (e.g., sensitivity, specificity, accuracy, latency, image quality scores) or thresholds for acceptance.
- Sample size used for the test set and the data provenance: No information about a test set, its sample size, or the origin of data is present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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: Not mentioned. This device is described as an "Image Display Software" and not explicitly as an AI diagnostic tool, though it uses "mathematical computations" and a "proprietary algorithm." Even if it were AI, no such study is detailed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
What the document does state and implies about performance:
- Intended Use & Equivalence: The primary claim is that Shared Vision is "substantially equivalent" to the predicate device (Winrad Teleradiology System) for "remotely view and analyze patient image data."
- Technology Equivalence: Both devices "use a computer program to display a pre-digitized patient image file," "run under a computer operating system," "use the computer operating system to access the displayed image," "output a display image that resembles a conventional image," "retain an electronically stored sample," "act on that sample using mathematical computations," and "use a proprietary algorithm."
- Performance Claim: "This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate the various clinical applications for which it is intended."
- Safety & Effectiveness: "This device is safe and effective for the applications for which it is intended and has been tested to confirm safety and efficacy."
- Disclaimer: "Neither device has claims, or is offered as having the reproduction equivalent of a radiographic image." This implies its performance is adequate for display and analysis, but not necessarily a perfect reproduction.
To answer your specific questions, you would need to review a more detailed technical report, a design validation report, or a clinical study report that would typically be part of a full regulatory submission, but is not present in this "Summary of Safety & Effectiveness."
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.