(112 days)
- The 2MP Monochrome LCD Monitor HMD2G21S is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners.
The device does not support the display of mammography images for diagnosis.
2)The 3MP Monochrome LCD Monitor HMD3G21S is intended to be used in displaying and viewing digital images for diagnosis X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Hisense HMD2G21S, HMD3G21S LCD monitor complies with the DICOM Part 14 standard and is applicable to DSA, MRI, DR, CR, CT, and PET medical imaging. It is intended for trained medical practitioners and provides the image viewing and medical diagnostic functions.
Here's a breakdown of the acceptance criteria and study information for the Hisense LCD monitors (HMD2G21S, HMD3G21S), based on the provided document.
It's important to note that this document, a 510(k) Premarket Notification, primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the way a novel diagnostic algorithm might. In this case, the "acceptance criteria" largely refer to compliance with technical standards and equivalence to existing cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
For medical display monitors, the "acceptance criteria" are generally based on meeting industry standards for display performance for diagnostic radiology. The reported device performance is presented as compliance with these standards and comparison to predicate devices.
| Acceptance Criteria (Guidance/Standard) | Applicable Device | Reported Device Performance |
|---|---|---|
| General Safety and EMC | HMD2G21S, HMD3G21S | Compliance with IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) and EN 60601-1:2006+A1:2013+A12:2014 |
| HMD2G21S, HMD3G21S | Compliance with IEC 60601-1-2:2014 & EN 60601-1-2:2015 (Medical electrical equipment - Part 1-2: Electromagnetic disturbances - Requirements and tests) | |
| Display Performance (AAPM TG18 / FDA Guidance) | HMD2G21S, HMD3G21S | Bench tests performed in accordance with "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)" and FDA guidance "Display devices for Diagnostic Radiology". Specific tests include: |
| - Spatial resolution (Modulation Transfer Function) | HMD2G21S, HMD3G21S | Reported. |
| - Pixel defects (maximum counts, allowed types, locations) | HMD2G21S, HMD3G21S | Reported as "Maximum number allowed for each type." |
| - Artifacts (using TG18) | HMD2G21S, HMD3G21S | Measured. |
| - Temporal response (rise/fall time for 5-95% and 40-60% luminance transitions) | HMD2G21S, HMD3G21S | Measured. |
| - Luminance (maximum, minimum, achievable, recommended) | HMD2G21S, HMD3G21S | Measured. |
| - Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF) | HMD2G21S, HMD3G21S | Luminance Response by AAPM-TG18. |
Specific quantitative performance metrics (e.g., exact measured contrast ratio, brightness, or MTF values) are indicated as "reported" or "measured" in the testing section, but the actual numerical results are not provided in this summary. The comparison tables (Table 02 and Table 04) show that the proposed devices meet or exceed the performance specifications of the predicate devices for key display parameters like contrast ratio and maximum brightness.
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a medical display monitor, not a diagnostic algorithm that processes medical image data. Therefore, there is no "test set" of medical images or patient data in the conventional sense for evaluating diagnostic performance. The testing involved evaluating the physical and electrical characteristics of the monitors themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As described above, there is no "test set" of medical images requiring expert-established ground truth for diagnostic performance evaluation for a display monitor. The testing involves objective measurements of display characteristics against technical standards.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" requiring adjudication.
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 for a display monitor, not a diagnostic AI algorithm. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a display monitor, not a standalone algorithm.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for a display monitor is its physical and electrical characteristics conforming to established technical standards (like DICOM Part 14 and AAPM TG18 guidelines), not a clinical diagnosis or outcome.
8. The Sample Size for the Training Set
Not applicable. This is a physical device (monitor), not a software algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as 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).