(125 days)
The Clinton Electronics Corp. DL Series II Flat-Panel Displays are intended for use in displaying and viewing digital images by trained medical practitioners. The Displays are not intended for and should not be used for primary diagnosis in digital mammography.
The DL Series II Displays are Digital Monochrome LCD flat panel displays. The series II are capable of Displaying 2 mega-pixel and 3 mega-pixel formats dependent upon model type.
This submission is for a medical display device, not an AI/ML algorithm. Therefore, many of the requested criteria (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or ground truth types) are not applicable.
The submission focuses on establishing substantial equivalence to predicate devices for its intended use, which is displaying medical images for review by trained medical practitioners.
Here's the information that can be extracted or deduced from the provided documents:
1. A table of acceptance criteria and the reported device performance:
The documents do not explicitly list "acceptance criteria" in the typical sense for an AI/ML or diagnostic device (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating substantial equivalence to existing predicate devices for the specified intended use. The "performance" is inherently tied to meeting the display specifications and being comparable to the predicates.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Display medical images for review by trained medical practitioners | DL Series II Displays are Digital Monochrome LCD flat panel displays. Capable of Displaying 2 mega-pixel and 3 mega-pixel formats (dependent on model type). Intended for use in displaying and viewing digital images by trained medical practitioners. |
| Compliance with 21 CFR 892.2050 (Picture archiving and communications system) and product code LLZ | Device falls under 21 CFR 892.2050, Product Code LLZ. |
| Technical specifications comparable to predicate devices (e.g., resolution) | Models DL2XXX (2 megapixel) and DL3XXX (3 megapixel) are comparable to predicate devices of the same resolution. |
| Note: The documents explicitly state, "The Displays are not intended for and should not be used for primary diagnosis in digital mammography." This acts as a scope limitation rather than a performance metric. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a display device, not a diagnostic algorithm that processes medical data. There is no "test set" of medical images in the context of algorithm performance. The evaluation would involve technical specifications and potentially image quality assessments, but not in the way an AI algorithm is tested on a dataset of patient cases.
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. As this is a display device, there's no "ground truth" established by medical experts for a test set of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 is not an AI-powered device, and no MRMC studies are mentioned or relevant for its intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable.
8. The sample size for the training set:
Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).