(34 days)
CS Orthodontic Imaging and CS OMS Imaging software is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images. including digital photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions.
CS Orthodontic Imaging and CS OMS Imaging software is a modification of currently legally marketed Kodak Orthodontic and OMS Imaging v8.0 software (K043104). The software is intended for installation at orthodontic or oral surgery clinics and offices on general purpose off-the-shelf computers systems (PCs) running Microsoft Windows in a peer-to-peer network.
Both the modified and unmodified devices consist of imaging software for orthodontic and oral surgery practices. The software provides the ability to connect satellite offices and may be marketed as a base system, with additional modules offered as options. The base system includes the storage, annotation and display of images. The optional Analysis module enables the user to trace the cephalometric x-rays using standard analyses. The optional Planner module enables the user to simulate orthodontic or surgical treatment in order to communicate treatment objectives or demonstrate and explain potential surgery to the patient.
When used with Carestream's panoramic, cephalometric, and other imaging systems, the device provides an interface that enables the practitioner to acquire radiographic images of the dentomaxillofacial region. The software then allows the user to visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program. CS Orthodontic and OMS Imaging software includes records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data. The software also enables the user to retrieve an electronic copy of an x-ray image from other imaging systems.
The device includes options for image viewing or presentation, including thumbnail viewing, single image viewing, and merging images into a letter (i.e., as part of a written communication to the patient). The image manipulation options include grayscale, invert, emboss, brightness, contrast, gamma, sharpen, median, d-speckle, hue, saturation, equalize, flip, mirror, masking, and rotate functions. Image annotation functions allow the user to add text to images, to measure distances and angles, magnify images, and other functions.
CS Orthodontic and OMS Imaging software can be integrated with Carestream's dental and dental sub-specialty practice management system software or used as a stand-alone product.
The provided text does not contain detailed acceptance criteria, a specific study, device performance data, sample sizes for test or training sets, information on ground truth establishment, expert qualifications, or adjudication methods for the "CS Orthodontic Imaging and CS OMS Imaging software".
This 510(k) summary is for a device that is a modification of a previously legally marketed device (Kodak Orthodontic and OMS Imaging v8.0, K043104). The submission relies on establishing substantial equivalence to this predicate device rather than presenting a standalone clinical trial with detailed performance metrics against specific acceptance criteria.
Missing Information from the Provided Text:
- No specific acceptance criteria are mentioned for device performance.
- No details about a specific study proving the device meets acceptance criteria are provided. The document primarily focuses on demonstrating substantial equivalence through non-clinical testing.
- No table of acceptance criteria and reported device performance.
- No sample sizes (test or training set) or data provenance.
- No information on the number or qualifications of experts used for ground truth.
- No adjudication method.
- No mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
- No standalone algorithm performance study details.
- Type of ground truth used is not specified.
- No sample size for the training set.
- No details on how ground truth for the training set was established.
Key statements from the document regarding testing:
- "Verification and validation testing of the CS Orthodontic Imaging and CS OMS Imaging software has been performed, including verification of all specified software and hardware interfaces. Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use." (Section 8. Non-Clinical testing)
This statement indicates that verification and validation were performed, but it does not provide the specific metrics, criteria, or study results that would allow for a detailed analysis as requested. The primary method for demonstrating safety and effectiveness in this 510(k) appears to be through the comparison table showing features and functionalities are "Same" or enhanced compared to the predicate device, implying that the established safety and effectiveness of the predicate device extend to this modified, substantially equivalent device.
§ 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).