(83 days)
The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.
The ME and CCL Series Medical Displays are displays for medical use. ME Series are monochrome LCD displays consists of the following models. ME181L (Model No. MDL1809A), ME201L (Model No. MDL2006A), ME203L (Model No. MDL2004A). CCL Series are color LCD displays consists of the following models. CCL182 (Model No. CDL1808A), CCL202 (Model No. CDL2005A), CCL314 (Model No. CDL2103A).
This 510(k) summary for the Totoku Electric Co., Ltd. Flat Panel Displays, ME Series and CCL Series, primarily focuses on demonstrating substantial equivalence to a predicate device and compliance with regulatory standards. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way medical AI or diagnostic software devices typically would.
Here's a breakdown of why the requested information cannot be found in the provided text:
- Device Type: The device is a medical display, not an AI algorithm or a diagnostic software. Its performance is typically assessed by meeting technical specifications (e.g., resolution, luminance, color accuracy) and compliance with safety and EMC standards, rather than clinical performance metrics like sensitivity, specificity, or AUC.
- Regulatory Pathway: A 510(k) for a display device emphasizes "substantial equivalence" to a predicate device and compliance with established standards (like UL, CSA, IEC, FCC, VCCI, MDD/CE). This is different from the rigorous clinical efficacy studies often required for novel diagnostic devices.
Therefore, for your specific requests, based only on the provided text:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): Compliance with various safety and EMC standards (UL2601-1, CSA No. 601-1, IEC60601-1 for medical safety; IEC60601-1-2, FCC-B/A, VCCI-B/A for EMC; UL1950, CSA No.950, LVD/CE(EN60950) for IT safety; EN55022, EN55024 for EMC). Substantial equivalence to the Totoku ME311L predicate device (K012099) in terms of principal characteristics (which are not detailed in this excerpt but referred to in Appendix 1).
- Reported Device Performance: The document states, "All ME Series are complies with following standards," and "All CCL Series are complies with following standards." This implies the devices successfully met the requirements of these standards. No specific performance numbers (e.g., specific luminance readings, contrast ratios) are provided in this summary, but rather a statement of compliance.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or not provided. This information is typically for diagnostic algorithms tested on patient data, not for display hardware.
-
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 or not provided. Ground truth is not established for a display device in the clinical performance sense.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not provided.
-
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 a display, not an AI or diagnostic tool that assists human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a display device. The "ground truth" for a display would relate to its technical specifications and performance characteristics, which are verified against engineering standards and measurement tools, not clinical "ground truth."
-
The sample size for the training set: Not applicable. This is hardware; it does not involve training data.
-
How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) submission for a medical display device focuses on regulatory compliance and substantial equivalence rather than clinical performance metrics measured in studies with patient data and expert ground truth, which are typically associated with diagnostic software or AI algorithms.
§ 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).