(55 days)
Acculmaging is a software module capable of taking an X-ray image generated by a CR or DR and producing a digitally enhanced image for projection radiography applications. Acculmaging is not indicated for use in mammography.
Acculmaging is a Dynamic Link Library (DLL) module that takes a raw X-rav image generated by a CR or DR as its input and produces a fidelity-quality image for diagnostic purposes. It interfaces with radiological software to analyze digital image data and optimize the processing parameters applied to enhance detail and thus images' diagnostic quality. Acculmaging is not a standalone module and does not implement any user interfaces; it provides a dedicated image processing function to a top-level application running in the Microsoft Windows operating system. It is bound into a parent application that provides user interfaces and dynamically loads the DLL module, forming an integrated process; and, it can also be linked to a service module to provide the image processing service to other top-level applications.
Here's an analysis of the acceptance criteria and study as described in the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Criteria/Question | Proposed Device Performance (Expert Opinion) |
|---|---|
| 1. Are both sets of images (proposed device vs. predicate) of diagnostic-quality? | Expert's comparative review supports that both sets of images are of diagnostic-quality. |
| 2. Are the images' features equivalent in terms of detail? | Expert's comparative review supports that the images' features are equivalent in terms of detail. |
Study Details:
-
Sample Size used for the test set and the data provenance:
- Sample Size: Eight image sets were presented.
- Data Provenance: Not explicitly stated, but the context implies these were existing X-ray images, likely retrospective. No country of origin is mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One expert.
- Qualifications of Experts: The document states "an expert." No specific qualifications (e.g., years of experience, subspecialty) are provided.
-
Adjudication method for the test set:
- Adjudication Method: Not applicable. Only one expert reviewed the images, so no adjudication among multiple readers was performed.
-
If a multi-reader multicase (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:
- MRMC Study: No, an MRMC study was not done. The study involved a single expert comparing image sets processed by the proposed device and the predicate. It did not assess human reader performance improvement with AI assistance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Yes, in a sense. The core of the study was a qualitative comparison of the output images from the Acculmaging software (proposed device) against images processed by the predicate device. The expert's role was to evaluate these processed images for diagnostic quality and detail equivalence, rather than using the software for a diagnostic task.
-
The type of ground truth used:
- Ground Truth: Expert opinion/consensus (from a single expert). The expert's answers to the two questions (diagnostic quality and equivalence of detail) served as the basis for the conclusion.
-
The sample size for the training set:
- Training Set Sample Size: Not provided. The submission focuses on the performance comparison for regulatory clearance, not on the development or training of the algorithm itself.
-
How the ground truth for the training set was established:
- Training Set Ground Truth: Not provided. As no information about a training set is given, the method for establishing its ground truth is also not mentioned.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).