(70 days)
The intended user of this device is a DICOM software package that will enable any hospital PC with adequate radiographic monitor and enough memory to be utilized with Radiological image viewer. This uson as the Lumisys, Lumiscan film Quality scanners, such as the Lambyo, . digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.
The Film Express software is a DICOM software package that will enable any hospital PC with adequate radiographic monitor and enough memory to be utilized with Radiological image viewer. This uson as the Lumisys, Lumiscan film Quality scanners, such as the Lambyo, . digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.
This 510(k) summary for K970652 does not contain the detailed information typically provided in a study to establish acceptance criteria and device performance. The device, "Film Express," is a teleradiology system (a DICOM software package) for archiving and transmitting radiological images. It explicitly states, "Software is only used for control purposes and has no bearing on image quality. There is no image processing used with this software." This strongly implies that the device is not an AI/CADe/CADx device that performs image analysis or provides diagnostic assistance.
Therefore, many of the requested categories for AI/CADe/CADx devices, such as "acceptance criteria and reported device performance" in the sense of diagnostic accuracy, ground truth, expert consensus, MRMC studies, or standalone performance, are not applicable in this context. The document focuses on demonstrating substantial equivalence to other teleradiology systems based on functional specifications and adherence to standards like DICOM.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not applicable:
Acceptance Criteria and Study for K970652: Film Express Teleradiology System
Based on the provided 510(k) summary, the "Film Express" software is a teleradiology system designed for archiving and transmission of radiological images. It explicitly states that it "has no bearing on image quality" and "no image processing is used with this software." Therefore, its "acceptance criteria" and "device performance" are focused on its functionality, adherence to standards, and safety as an image management system, rather than diagnostic accuracy or image analysis.
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/CADe/CADx device, the "acceptance criteria" revolve around functional equivalence and compliance, not diagnostic metrics. The "performance" is demonstrated through functional specifications and comparison to predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence and Device Description) | Reported Device Performance (From Specifications and Comparison Chart) |
|---|---|
| Functional Equivalence: Ability to perform core teleradiology functions. | Graphical User Interface: Yes |
| Scanner Support: Compatibility with specified radiological quality scanners. | Scanners Supported: Radiological Quality scanners, such as Lumisys 20/50/75/85/100/150/200 |
| Patient Demographics Handling: Ability to manage patient data. | Patient Demographics: Yes |
| Display Resolution Support: Capable of displaying images at common resolutions. | Display Resolution: 1024x768 |
| Communication Protocol: Adherence to standard communication protocols. | Communications: TCP/IP |
| Image Review Functions: Essential image manipulation capabilities. | Image Review: Flip/Rotate/Pan/Zoom |
| Temporary Image Storage: Provision for temporary image storage. | Temporary Image Storage: Yes |
| Platform Compatibility: Operates on common computing platforms. | Platform: PC |
| Image Compression Support: Ability to handle common image compression formats. | JPEG: Yes |
| DICOM Printing: Support for DICOM Basic Printing. | DICOM Basic Printing: Yes |
| DICOM Conformance: Adherence to DICOM standard, especially for compression identification. | Images compressed are properly identified as specified by the DICOM standard; compression identification remains with the image. |
| Safety: No expectation of death or injury due to software failure. | "No software component... whose failure or latent design flaw would be expected to result in death or injury to a patient." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document mentions "Extensive testing of the software package has been performed by programmers, by non-programmers, and by potential customers," but it does not specify a quantifiable "test set" in terms of images or patient cases, nor does it detail data provenance. The testing appears to be functional and user acceptance testing rather than a clinical study with a specific image sample set.
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 applicable/not provided. As the device does not perform image analysis or provide diagnostic information, there is no "ground truth" to be established by experts in the context of diagnostic accuracy. The testing focused on functional integrity and adherence to technical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Given that the device does not involve diagnostic interpretation or ground truth establishment by experts, adjudication methods for clinical performance are irrelevant.
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
This information is not applicable. The "Film Express" is a teleradiology system for image management and transmission, not an AI or CAD system. Therefore, MRMC studies evaluating human reader performance with or without AI assistance are not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is not an algorithm for image analysis. Its performance is its ability to manage and transmit images as intended.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. As a teleradiology system without image analysis functions, there is no "ground truth" in the clinical diagnostic sense for this device. The "truth" for this device lies in its functional correctness (e.g., successful transmission, correct display, adherence to DICOM standards).
8. The sample size for the training set
This information is not applicable/not provided. This device is a software application, not a machine learning model that requires a "training set" in the AI sense. Its development involved traditional software development, testing, and validation.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As this is not an AI/ML device, there is no "training set" or "ground truth" established for it in that context.
§ 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.