(54 days)
OrthoPACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
eTrauma's OrthoPACS is a Digital Info-Imaging System for orthopaedic specific applications in office, private practice, surgery and clinics. The system allows orthopaedic surgcons to navigate quickly through a typical office day by using an efficient and fast system for viewing clinical images and retrieval of information regarding patient historicals whether tocal or residing on other digital information systems such as electronic medical record and/or practice management software. The four general classes of users for OrthoPACS include x-ray technicians, office managers, physicians and nurses. OrthoPACS consists of the following components: Acquisition and Transmission Modules, Viewing Station Module, Storage Module, RemoteImage Accessibility.
The provided 510(k) summary for the OrthoPACS device (K033825) does not contain performance data or a study that establishes acceptance criteria for the device's specific functions as a medical image management system or for its use with prosthetic templates.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states:
"#### 7. PERFORMANCE DATA: The subject device is developed according to ISO 9001:1994 and complies with ISO 13485:1996."
This statement indicates compliance with general quality management system standards (ISO 9001 and ISO 13485). It does not provide specific quantitative performance metrics, acceptance criteria, or a study demonstrating clinical or technical performance of the device's image manipulation, display, or prosthetic templating functions.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not mentioned. Since no specific performance study is detailed, there is no mention of a test set, its sample size, or data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not mentioned. No performance study is detailed, therefore no ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable/Not mentioned. No performance study is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention an MRMC study or any comparative effectiveness study with human readers, either with or without AI assistance. The device's description is that of an image management system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No. The document does not describe any standalone performance study of an algorithm.
7. Type of Ground Truth Used
Not applicable/Not mentioned. No performance study is detailed.
8. Sample Size for the Training Set
Not applicable/Not mentioned. As this is an image management system and not an AI/ML device relying on a training set, this information is not relevant or provided.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not mentioned. (See point 8)
Summary of Device and Regulatory Context for K033825:
The K033825 submission for OrthoPACS is for an image archiving and communication system (PACS) with specific orthopaedic applications, including the use of templates for prosthetic devices. The key aspects of the submission are:
- Intended Use: Manipulation and display of medical images by a qualified healthcare professional, showing images from different modalities, interfacing with storage/printing devices, and using templates for prosthetic device planning.
- Predicate Devices: Sectra Orthopedic Package (K031590) and Cedara I-SoftView (K022881).
- Regulatory Determination: The FDA determined that OrthoPACS was substantially equivalent to its predicate devices based on the information provided, which likely focused on the functional equivalence of its image display, manipulation, and storage features, as well as its existing quality certifications (ISO 9001, ISO 13485). For this type of device (a PACS system), specific clinical performance studies demonstrating diagnostic accuracy are typically not required unless new functionalities or AI algorithms are introduced that make diagnostic claims. The "performance data" referred to in section 7 is limited to compliance with quality management systems, which is common for PACS predicate device submissions.
§ 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).