(29 days)
The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to the PACS system. These images can be aimed at images helping the surgeon plan the actual prosthetic implant. These plans can also be shown to surgical placement of the implant. They will undergo and to help them understand the pathology present. The application consists of an Impax Diagnostic Workstation and templates. The application consists of guides intended for selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
Concentrating within the specialty of joint replacement, the IMPAX® OT3000 will provide an orthopedic surgeon with the ability to produce presurgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and and operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons surgiour ownershow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper pre-surgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.
The provided text does not contain any information about acceptance criteria, study details, or performance metrics for the Agfa IMPAX® OT3000 Orthopedic Workstation.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study. It states that "Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate device."
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or MRMC studies.
Summary of what is missing from the provided text:
- Acceptance Criteria and Reported Performance: No specific performance metrics or thresholds are mentioned.
- Study Details: No study is described that evaluates the device's accuracy or effectiveness. The 510(k) submission relies on substantial equivalence to a predicate device (Siemens' EndoMap).
- Sample Sizes: No information on test sets or training sets.
- Data Provenance: No details on where any data (if used for testing) originated.
- Experts and Ground Truth: No mention of experts, how ground truth was established, or adjudication methods.
- MRMC Study: No information about a comparative effectiveness study with human readers.
- Standalone Performance: No standalone performance study is described.
- Type of Ground Truth: Not applicable since no performance study is detailed.
- Training Set Sample Size and Ground Truth: Not applicable since no training or performance study is detailed.
§ 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).