(87 days)
The VisiShare Imaging System and/or Software is a digital imaging viewing system that receives digital images and patient demographic information from various imaging sources. The incoming data formats are standard medical image formats, proprietary image formats, and common non-medical image formats. The VisiShare allows the operator to manage, view, retrieve and store images, modify image parameters and annotate image for the purposes of radiological interpretation.
The VisiShare Imaging System is designed to accept images from various modalities or digital image networks and allow the operator to view, retrieve, store and manipulate medical images in a variety of formats.
The VisiShare is a modular system that uses network and proprietary interfaces for communication between the modules. Network interfaces enable the various modules to reside on local or remote machines. System is designed for low-end and high-end systems, supporting single or multiple monitor configurations.
The provided text (K974130) is a 510(k) summary for the VisiShare Imaging System and/or Software. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results.
Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not provided in this regulatory submission.
Here's a breakdown of the information that can be extracted or inferred, and what is missing:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided 510(k) summary for the VisiShare Imaging System and/or Software does not detail specific acceptance criteria or a dedicated study designed to prove the device meets these criteria in the way one might expect for a diagnostic or AI-powered device. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means the primary "acceptance criterion" from a regulatory perspective is that the new device is as safe and effective as existing legally marketed devices, and any differences do not raise new questions of safety or effectiveness.
The document implicitly "proves" this equivalence through a comparison of design, composition, function, intended use, safety, and efficacy with the predicate devices. The listed predicate devices are:
- Magic View 50 Teleradiology System [Siemens]
- RadWorks Medical Imaging Software [Applicare Medical Imaging, B.V.]
- AutoRad [Cemax-Icon]
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Functional Equivalence: | |
| - Ability to view, retrieve, store, and manipulate medical images. | - "designed to accept images... allow the operator to view, retrieve, store and manipulate medical images in a variety of formats." |
| - Ability to modify image parameters and annotate images. | - "allows the operator to manage, view, retrieve and store images, modify image parameters and annotate image for the purposes of radiological interpretation." |
| - Compatibility with various imaging modalities/networks. | - "designed to accept images from various modalities or digital image networks." |
| - Support for standard medical image formats, proprietary, and common non-medical formats. | - "incoming data formats are standard medical image formats, proprietary image formats, and common nonmedical image formats." |
| System Performance Characteristics: | |
| - Designed for off-the-shelf, general purpose computing equipment. | - "designed to run on off-the-shelf, general purpose computing equipment." |
| - Maximum portability across operating systems and hardware platforms. | - "application software is designed for maximum portability across operating systems and hardware platforms." |
| - Performance primarily a function of network load, then hardware, then display controller. | - "Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform's computational speed and finally the performance of the display controller." |
| Safety and Efficacy: | |
| - No significant influence on safety or efficacy compared to predicate devices. | - "Any differences between the VisiShare Imaging System and/or Software and the predicate devices have no significant influence on safety or efficacy." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The 510(k) summary does not mention a specific "test set" of medical images or patient data used for a performance study. Its focus is on substantial equivalence based on design and intended use, not on a clinical performance evaluation using a dataset.
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)
Not applicable/Not provided. Since no specific "test set" for performance evaluation is described, there's no mention of experts or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No explicit test set or adjudication method is described.
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
Not applicable. This device is an imaging viewing system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an interactive viewing system with a human operator in the loop for radiological interpretation. It does not perform autonomous algorithmic diagnoses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. As there is no specified performance study with a test set, the concept of ground truth is not elaborated upon in this document. The "ground truth" for showing substantial equivalence relies on the known safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable/Not provided. As this is not an AI/machine learning device that requires training data, there is no mention of a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. Corresponding to point 8, this information is not relevant or provided.
§ 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.