(95 days)
Dome Sx line, model Dome S6c is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
Model Dome S6c is not intended for mammography use.
The Dome model S6c is a widescreen 30-inch 6 megapixel color monitor. Its sleek design, high brightness and bezel free separation between two 3MP displays makes Dome model S6c ideal for read of patient images acquired from multiple medical imaging modalities.
The provided text describes NDS Surgical Imaging's Dome® S6c color monitor, a 6-megapixel display intended for displaying and viewing medical images. The submission focuses on demonstrating substantial equivalence to a predicate device, the Dome model C3 color.
However, the document does not contain the following information regarding acceptance criteria and performance studies:
- A table of acceptance criteria and reported device performance (beyond basic specifications and regulatory compliance). The document primarily compares the technical specifications to a predicate device for the purpose of demonstrating substantial equivalence, not against specific performance acceptance criteria for diagnostic tasks.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human reader improvement with AI assistance. This device is a display monitor, not an AI-powered diagnostic tool.
- Whether a standalone performance study was done. This device is a display monitor, not an AI-powered diagnostic tool.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The core of the submission is a comparison of technical specifications and regulatory compliance, and not a clinical performance study using patient data and expert ground truth.
Based on the provided text, here is what can be extracted:
The device is a medical display monitor, and the "acceptance criteria" discussed are primarily related to its technical specifications and compliance with safety and EMI standards, rather than diagnostic performance metrics. The study presented is a technical comparison for substantial equivalence.
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the context of a performance study with diagnostic outcomes. Instead, it compares the technical specifications and regulatory approvals of the Dome® S6c with a predicate device (K032638 Dome model C3 color). The argument for acceptance is based on demonstrating substantial equivalence in these technical and regulatory aspects.
| Characteristic Items | Predicate device K032638 (Dome C3 Color) | Reported Device Performance (Dome® S6c K133609) |
|---|---|---|
| Intended Use | Displaying and viewing medical images for review and analysis by trained medical practitioners. | Displaying and viewing medical images for review and analysis by trained medical practitioners. (Not for mammography use) |
| Screen diagonal | 20.8" Diagonal (528 mm) | 30" Diagonal (762 mm) |
| Resolution | 1536 x 2048 pixels (portrait) / 2048 x 1536 pixels (landscape) | Dual 1536 x 2048 pixels (portrait) (future implementation) / Dual 1640 x 2048 pixels (portrait) / 3280 x 2048 pixels (landscape) |
| (Equivalent resolution of dual 3MP radiology displays, described as 6MP) | ||
| Pixel pitch | 0.207 mm | 0.197 mm |
| Contrast ratio | 600:1 - typical | 1000:1 - typical |
| Brightness | 235 cd/m² typical | 800 cd/m² typical |
| Pixel rise/fall time | 50 ms | 30 ms typical |
| Viewing angle (CR 10:1) | +/- 85° (170°) horizontal / +/- 85° (170°) vertical | +/- 85° (170°) horizontal / +/- 85° (170°) vertical |
| Stabilization, calibration, automated QA | Built in RightLight rear sensor for backlight stabilization. Factory calibrated. QA through manual external photometer. | Built in RightLight rear sensor for backlight stabilization. Factory calibrated. QA through embedded RightCheck front sensor and manual external photometer. |
| Look up table | 10/12 bit | 10/12 bit |
| Digital Video Input | 1x DVI Revision 1.0 single channel connector | 1x DVI Revision 1.0 digital dual-channel connector |
| Input Formats (Landscape) | 2048x1536 (8 bits per pixel, 24 bit color) | 3280x2048 (8 or 10 bit per pixel, 24 bit or 30 bit color) |
| Input Formats (Portrait) | 1536x2048 (8 bits per pixel, 24 bit color) | 2x 1536x2560 or 2x 1640x2048 (8 or 10 bit per pixel, 24 bit or 30 bit color) |
| Power Supply | 100 | 100 |
| Safety | EN 60601-1 Part 1. General requirements for safety | IEC 60601-1: 2005 |
| EMI | EN 55011 Class B | EN 60601-1-2: 2007 |
| Primary Claim of Equivalence | The Dome model C3 color, a 3MP display. | The Dome model S6c ("6MP display device, equivalent to the resolution of dual 3MP radiology displays"). The difference is that S6c is "one package that replaces two Dome model C3 color side by side displays in use." The device meets IEC/EN60601-1 and 60601-1-2 standards for safe design and operation. |
2. Sample size used for the test set and the data provenance: Not applicable. This is a technical comparison for a display device, not a study of diagnostic performance using a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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 device is a display monitor, which does not incorporate AI or directly assist human readers in diagnostic interpretation in the manner of an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a display device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is adherence to technical specifications and regulatory standards.
8. The sample size for the training set: Not applicable. This is a display device, not an AI algorithm requiring 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).