(237 days)
Radlink GPS Pro Imaging is an image-processing software intended to assist in hip procedures by measuring the acetabulum's position relative to local bone structures identified from radiological images. The device allows for overlaying digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
The Radlink® GPS Pro Imaging is an image processing software designed to assist orthopedic surgeons in positioning hip, knee, and trauma components. The software leverages advanced geographic measurement and stitching technologies, which have been previously FDA cleared, ensuring precise and reliable image handling. These foundational technologies continue to be the primary features of software. Additionally, Radlink GPS Pro Imaging software supports complete image acquisition and DICOM transmission capabilities, facilitating seamless integration with existing hospital systems. It is compatible with Windows operating system, and requires minimal hardware specifications, making it a versatile solution for different clinical setups.
The provided text describes the Radlink GPS Pro Imaging device and its substantial equivalence to predicate devices, but it does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria with statistical significance.
The "Performance Data" section ([6]) states: "Comprehensive cybersecurity testing and software verification activities were conducted in accordance with applicable FDA guidance and recognized standards. These assessments confirm that the device's software meets the required performance, safety, and security criteria." However, it does not specify what those "required performance... criteria" are in quantifiable terms, nor does it provide a study with specific results.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's what can be gathered and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document vaguely states "required performance... criteria" but does not define them or report specific device performance metrics against these criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided document. No information is given regarding the sample size of any test set or the provenance of the data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not available in the provided document. There is no mention of experts or how ground truth might have been established for a test set.
4. Adjudication Method for the Test Set
Not available in the provided document. The document does not describe any adjudication methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available in the provided document. The document does not mention an MRMC study or any effect size for human reader improvement with AI assistance. The "Indications for Use" section ([3]) explicitly states, "Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation." and "The software is not for use on mobile phones.", which suggests it is an assistive tool, but no comparative study is detailed.
6. Standalone Performance Study
Not available in the provided document. While "software performance, segmentation accuracy" are mentioned as being tested ([6]), no specific standalone performance study results, metrics, or methods are provided. The statement that "Clinical judgment and experience are required to properly use the software" ([3]) reinforces that it's not intended for standalone interpretation.
7. Type of Ground Truth Used
Not available in the provided document. The document broadly states "segmentation accuracy" was part of testing ([6]), implying some form of ground truth for segmentation, but the specific type (e.g., expert consensus, pathology, outcome data) is not detailed.
8. Sample Size for the Training Set
Not available in the provided document. The document does not provide any information about a training set or its size.
9. How the Ground Truth for the Training Set was Established
Not available in the provided document. As there is no information about a training set, the method for establishing its ground truth is also not provided.
In summary, the provided FDA 510(k) clearance letter and summary discuss the device's function, intended use, and its substantial equivalence to predicate devices, but they do not disclose the detailed technical performance data, acceptance criteria, or study methodologies that would typically be found in a full submission or scientific publication. The document focuses on regulatory compliance and the claim of substantial equivalence rather than explicit performance metrics and supporting study details.
§ 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).