(24 days)
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general device for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools.
When using 2D X-ray images obtained with the EOS Imaging EOS System, the sterEOS Workstation provides interactive 3D measurement tools:
- To aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 7 years and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use to assess individual vertebral abnormalities.
- To aid in the analysis of lower limbs alignment and related disorders and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.
The sterEOS Workstation is a general system for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system, including interactive 2D measurement tools.
When used with 2D X-ray images obtained with the EOS imaging's EOS System (K120721 and K123740), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs.
The provided text is a 510(k) summary for the sterEOS Workstation. It describes the device, its intended use, and states that performance data demonstrate substantial equivalence to predicate devices, but lacks detailed acceptance criteria and a specific study proving the device meets them.
Therefore, I cannot provide the requested information. The document states:
- "Software modifications have been verified at the unit level."
- "After integration, system software V&V testing was performed to ensure compliance with specifications, performance and non-regression."
- "Additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS compared to the predicate sterEOS workstation."
- "Performance data demonstrate that the device is as safe and effective as the company's cleared sterEOS device and, thus, is substantially equivalent."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or details about ground truth establishment for a test set.
- Information on expert usage or adjudication methods for ground truth for a test set.
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
- Type of ground truth used for performance evaluation (e.g., pathology, outcomes data).
- Sample size for training set or how ground truth was established for a training set.
This 510(k) emphasizes substantial equivalence through verification and validation of software modifications and functional testing, rather than a clinical performance study with specific acceptance criteria and detailed reporting of performance metrics. The information about the "a priori image data set from 175 patients" is described as supporting the model of bone structures used for interactive 3D measurement tools, not as a test set for performance evaluation of the sterEOS workstation itself.
§ 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).