(88 days)
CDL Series Medical Displays are intended for use in viewing digital medical images.
CDL Series Medical Displays are displays for medical use.
This 510(k) summary is for a medical display device, not an AI-powered diagnostic tool. Therefore, the typical acceptance criteria and study designs that would be applicable to an AI device (focusing on sensitivity, specificity, clinical outcome, etc.) are not present in this document.
The "acceptance criteria" for this device are its compliance with various medical safety and EMC standards, and its substantial equivalence to a predicate device. The "study" proving it meets these criteria is essentially a comparison of its specifications to those of the predicate device and a statement of compliance with relevant regulatory standards.
Here's the information as requested, adapted to what is available in the provided text for a medical display:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard (as implied or stated) | Reported Device Performance/Compliance |
|---|---|---|
| Medical Safety | UL2601-1 | Complies (CDL Series) |
| CSA No. 601-1 (CSA C22.2 No. 601.1 for CDL) | Complies (CDL Series) | |
| MDD/CE (EN60601-1, IEC60601-1) | Complies (CDL Series) | |
| Electromagnetic Compatibility (EMC) | MDD/CE (EN60601-1-2), IEC60601-1-2 | Complies (CDL Series) |
| FCC-B (FCC Class B for CDL) | Complies (CDL Series) | |
| DOC-B | Complies (CDL Series) | |
| BSMI | Complies (CDL Series) | |
| Substantial Equivalence | Similar intended use to predicate device | Intended use: "viewing digital medical images." This is identical to the implicit intended use of a diagnostic display. |
| Similar technological characteristics to predicate device | Specifications (display area, input signal, maximum display pixels, scanning frequency, maximum image clock, maximum brightness, power supply) are compared to the predicate ME311L. Differences are noted but deemed equivalent for the stated use. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable to this type of device submission. This document describes a medical display, which is a hardware component. Its performance is assessed through engineering specifications and compliance with standards, not through clinical trials with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no "ground truth" in the clinical sense for a medical display. Its performance is objectively measured against technical specifications and regulatory standards by engineers and compliance bodies.
4. Adjudication Method for the Test Set
Not applicable. Performance is based on technical measurements and compliance checks, not expert adjudication of clinical findings.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
Not applicable. The "ground truth" for a medical display is its adherence to specified technical standards and performance metrics, measured by test equipment, not clinical outcomes or expert consensus on medical images.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 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).