(49 days)
RSA-CMS has been developed for the objective and reproducible analysis on digital roentgen images (DICOM CR or DX) or digitised images in a PACS environment.
Orthopedic specialist and core labs use the RSA-CMS standalone analytical software package in image post-processing for the evaluation of new implant designs, coatings and new cementation techniques in clinical trials.
When interpreted by trained physicians these parameters may be useful to derive conclusions from these clinical trials.
RSA-CMS is a software package that "automatically" performs Roentgen Stereophotogrammetric Analysis (RSA) in digital images. This software package runs on a PC with the Windows 2000 or XP operating system.
Here's an analysis of the provided text to extract the requested information about the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state defined acceptance criteria in a quantitative manner (e.g., minimum accuracy, sensitivity, or specificity). Instead, it relies on demonstrating substantial equivalence to a predicate device and highlighting the inherent accuracy of the underlying methodology (RSA).
However, the document does report on the general "accuracy" of RSA, which the device implements:
| Acceptance Criteria (Implied) | Reported Device Performance (Reference to RSA) |
|---|---|
| Ability to accurately assess 3D micromotion of orthopaedic implants. | Translations: 0.05 mm to 0.1 mm (95% CI) |
| Ability to accurately assess 3D micromotion of orthopaedic implants. | Rotations: 0.15° to 1.15° (95% CI) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size or its provenance for the RSA-CMS device itself. The reported accuracy figures are attributed to the general "RSA technique" developed by Selvik in 1974. It describes RSA-CMS as a software package that "automatically" performs this technique.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since a dedicated test set and its ground truth establishment are not described for RSA-CMS, this information is not available in the provided text. The accuracy figures for the RSA technique are described as "reported accuracy," implying they come from established literature or prior research on the technique, not a new study specific to this submission.
4. Adjudication Method for the Test Set
As no specific test set or ground truth establishment is detailed for RSA-CMS, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided document. The device is described as a standalone analytical software package.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Yes, the device is described as a "standalone analytical software package" that "automatically performs" the RSA analysis. Its reported accuracy is based on the inherent accuracy of the RSA technique itself. Therefore, the performance described is standalone (algorithm only).
7. The Type of Ground Truth Used
The ground truth for the reported accuracy figures of the RSA technique (which RSA-CMS implements) is not explicitly stated but implicitly refers to the inherent accuracy of the stereophotogrammetric analysis method itself, likely established through rigorous measurement and calibration standards in the field. It is a highly accurate method for dimensional measurement.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size for RSA-CMS. This suggests that the software's functionality is based on implementing a well-established and validated algorithm (RSA) rather than a machine learning model that requires a dedicated training phase with labeled data.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, information on how its ground truth was established is not available.
§ 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).