(56 days)
15-inch (38cm) Color LCD Monitor CDL1576A is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
CDL1576A is a 15-inch (38cm) Color LCD monitor with high luminance (350cd/ m² (typ.)) and high contrast screen (700:1 contrast ratio). 15-inch (38cm) Color LCD monitor is to be used with FUJINON endorscope system, and is manufactured exclusive for FUJINON.
The provided K080952 510(k) Summary pertains to a 15-inch (38cm) Color LCD Monitor CDL1576A, which is a medical image display device. The summary focuses on establishing substantial equivalence to a predicate device (CDL1566A, K060961) based on device description and intended use.
No study proving the device meets specific performance acceptance criteria is detailed in the provided document. The 510(k) summary for a display monitor typically focuses on technical specifications aligning with industry standards for medical displays and comparison to a legally marketed predicate device, rather than patient-outcome or diagnostic performance studies involving expert readers.
Therefore, most of the requested information (points 1-7, and 9 for the test set) is not applicable or cannot be extracted from this document, as it describes a technical comparison rather than a clinical performance study of the device's diagnostic accuracy or impact on human performance.
Here's a breakdown of what can be inferred or stated from the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria for diagnostic performance or clinical effectiveness are stated in the document. The "performance" described relates to the monitor's technical specifications as a display device, compared to its predicate.
| Criterion (Implicit - Technical Specification) | Reported Device Performance (CDL1576A) |
|---|---|
| Luminance | 350 cd/m² (typ.) |
| Contrast Ratio | 700:1 |
| Screen Size | 15-inch (38cm) |
| Intended Use | Displaying and viewing medical images for diagnosis by trained medical practitioners (excluding digital mammography) |
| Equivalence to Predicate | Shares same characteristics as CDL1566A (K060961) except for front bezel, back enclosure, and power supply. |
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. The document does not describe a test set or data from a clinical or performance study involving human interpretation of images. The evaluation is based on technical specifications and comparison to a predicate device.
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. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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 document is for a medical display monitor, not an AI-powered diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm; it's a display device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for image interpretation or diagnosis is used in this submission. The "ground truth" for a display monitor would relate to its technical specifications meeting design requirements and industry standards.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is a display monitor, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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).