(195 days)
The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS).
The KODAK Ektascan Imagelink System is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit. These systems can exit together or independently on a network.
The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information.. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention.
This 510(k) summary describes a device, the KODAK Digital Science Medical Modality Acquisition Unit, which is a component of a Picture Archiving and Communications System (PACS). The submission focuses on comparing the new device's features to a substantially equivalent predicate device (KODAK Ektascan Imagelink System) rather than presenting a study where acceptance criteria are explicitly defined and performance is measured against them.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this document. The document primarily relies on the equivalence of the new device to the predicate device to establish safety and effectiveness.
Here's a breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document defines 'acceptance criteria' implicitly through the comparison to the predicate device, KODAK Ektascan Imagelink System. The "reported device performance" is the claim of equivalence in functionality and technical specifications. No explicit numerical performance metrics or acceptance thresholds are provided.
| Characteristic / Acceptance Criteria (Implied by Predicate) | Reported Device Performance (KODAK Digital Science Medical Modality Acquisition Unit) |
|---|---|
| Advertised Use: Productivity improvement, eliminate film cassettes and darkroom processing, eliminate need to sterilize film cassettes | Productivity improvement, eliminate film cassettes and darkroom processing, eliminate need to sterilize film cassettes |
| Input modalities advertised: C-Arm, Digital Subtraction Angiography, Nuclear Medicine, Ultrasound | C-Arm, Digital Subtraction Angiography, Nuclear Medicine, Ultrasound, and other video modalities |
| Power requirements: 90-132vac/47-63Hz, 180-264vac/47-63Hz | 90-132vac/47-63Hz, 180-264vac/47-63Hz |
| Environmental: 4-45 degrees C/15-90% RH non-condensing | 4-45 degrees C/15-90% RH non-condensing |
| Removable Disk: 2.5" Hard Drive | 2.5" Hard Drive |
| Disk Storage Capacity: 30, 60 Mbytes | 105, 30, 60, 80 Mbytes (Equal or greater) |
| Network Capability: Ethernet | Ethernet |
| Video Inputs: Monochrome: RS-170/CCIR; Red, Green, Blue (RGB) | Monochrome: RS-170/CCIR; Red, Green, Blue (RGB) |
| Image Capture Time: 1/30 second | 1/30 second |
| Image Store Time: Less than 1 second | Less than 1 second |
| Printer Interface Unit Inputs: Removable Disk Cartridge, Ethernet, DICOM v3.0 format (ACR_NEMA) | Removable Disk Cartridge, Ethernet, DICOM v3.0 format (ACR_NEMA) |
| Printer Interface Unit Outputs: SCSI, Video, RS-485, RS-422, RS-232 | SCSI, Video, RS-485, RS-422, RS-232 |
| Image Presentation: 1,2,4,6,8,9,12,15,16,24,35 images per frame, plus slides | 1,2,4,6,8,9,12,15,16,24,35 images per frame, plus slides |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document does not describe a clinical study with a test set of patient data. It is a technical comparison for substantial equivalence.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no clinical test set requiring expert ground truth was described.
4. Adjudication method for the test set
- Not applicable as no clinical test set requiring adjudication was 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
- No. This device is a PACS component (acquisition unit and printer interface unit) with the indication for "image management systems for image acquisition, printing, review, archive/retrieval, and communications." It is not an AI algorithm intended to assist human readers in diagnostic tasks, nor is there any mention of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a hardware/software system for imaging management, not an algorithm being evaluated for standalone diagnostic performance. The document explicitly states: "Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention."
7. The type of ground truth used
- Not applicable as no clinical study or diagnostic performance evaluation was described. The "ground truth" for the submission is the technical specifications and claimed functionality of the predicate device.
8. The sample size for the training set
- Not applicable as this is not an AI/machine learning device undergoing a training process with data.
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).