(82 days)
The Quality Control Workstation allows radiologist technicians to enter patient information and/or correct erroneous patient information, exam information, and if necessary, the image look and/or image orientation. It allows them to route it to different locations to give greater flexibility to physicians in analyzing patient images.
Kodak's Quality Control Workstation is a Sun Microsystems based workstation for the display, printing, and manipulation of medical images. The Quality Control Workstation is designed with an ethernet interface to interface with other Kodak products or digital systems using ACR/NEMA compatible interfaces and or DICOM.
The provided text describes a 510(k) submission for the KODAK Digital Science Quality Control Workstation, primarily focusing on its features and how it compares to a predicate device. However, it does not contain information typically found in a study proving a device meets acceptance criteria.
The purpose of this 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a specific performance claim against predefined acceptance criteria through a formal study with detailed statistical analysis.
Therefore, many of the requested details, such as sample size, ground truth establishment for a test set, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not present in the provided document.
Here's an analysis of the available information:
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in the sense of quantitative performance thresholds for a clinical study. Instead, it focuses on demonstrating that the new device's features are comparable to the predicate device and that its functionality is safe and effective for its stated indications for use.
The "device performance" reported is primarily a feature comparison, showing that the new device either matches or improves upon the predicate device's capabilities.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| General Functionality: Image enhancement, productivity improvement, proper display for diagnostic purposes, elimination of film cassettes/darkroom processing/sterilization need. | KODAK Digital Science Quality Control Workstation: |
- Image enhancement for proper display for diagnostic purposes.
- Productivity improvement, eliminates film cassettes and darkroom processing, eliminates the need to sterilize film cassettes.
- New Image Processing Library. |
| Hardware/Environmental Compatibility: Power, environmental conditions, acquisition unit, disk storage, network, video inputs, image capture/store time. | KODAK Digital Science Quality Control Workstation: - Power: 90-132vac/47-63Hz, 180-264vac/47-63Hz (matches predicate).
- Environmental: 4-45 degrees C/15-90% RH non-condensing (matches predicate).
- Acquisition Unit: 2.5" Hard Drive (matches predicate).
- Disk Storage: 2.0GB Boot Disk, 4GB, 8GB, 12GB, 16GB Removable Disk (Exceeds predicate's 30, 60 Mbytes).
- Network: Ethernet (matches predicate), DICOM v3.0 format (ACR NEMA) (matches predicate).
- Video Inputs: Monochrome: RS-170/CCIR; Red, Green, Blue (RGB) (matches predicate).
- Image Capture Time: Less than 1 second (Faster than predicate's 1/30 second).
- Image Store Time: Less than 1 second (Faster than predicate's 1/30 second). |
| Image Presentation Capabilities: Number of images per frame. | KODAK Digital Science Quality Control Workstation: - 1,2,4,6,8,9,12,15,16,24,35 images per frame, plus slides (matches predicate). |
| Safety: Patient isolation, non-manipulation of primary diagnosis data, human intervention for hard copy output. | KODAK Digital Science Quality Control Workstation: - Patient is electrically isolated from the workstation.
- Does not manipulate data for primary diagnosis except to enhance portions of images for a clearer view.
- Images displayed are not for primary diagnosis; hard copy output or images on other workstations are for primary diagnosis, allowing for "adequate opportunity for competent human intervention."
- Primary function: display with no corruption; level of concern is minor, as failures would not result in patient injury. |
| Image Processing: Non-destructive modification, raw data preservation, multiple enhanced versions. | KODAK Digital Science Quality Control Workstation: - Adaptive unsharp masking and tonescaling (non-destructive).
- Copy of original data kept until approved.
- Raw data is never changed.
- Generates at least one enhanced version; user can create more. |
| Interoperability: Network support, image format. | KODAK Digital Science Quality Control Workstation: - ACR/NEMA and/or DICOM format over TCP/IP. |
Details of the Study (or lack thereof)
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device, not on presenting a detailed clinical or performance study with quantified acceptance criteria. Therefore, most of the following requested information is not available in the provided text.
- Sample size used for the test set and the data provenance: Not mentioned. The submission relies on a comparison of features and intended use, not a performance study on a specific test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. No test set requiring expert ground truth is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
- 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 workstation for image display and manipulation, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a workstation for human use, and explicitly states that displayed images are not for primary diagnosis and that "competent human intervention" is part of the diagnostic process for hard copies.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no mention of a ground truth established for a performance study. Its primary function is "to display with no corruption of the image information."
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set. The "image processing routines" (adaptive unsharp masking and tonescaling) are described as using "computed or user-specified values," implying traditional algorithms rather than trained models.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text is a 510(k) premarket notification focusing on substantial equivalence through feature comparison and intended use rather than a detailed performance study with explicit acceptance criteria and supporting data for algorithmic performance.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.