(320 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. The 3D measurement tools interactive analysis based either on identification of anatomical landmarks for postural assessment, or 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 for spine model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
- · 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 (K152788), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs.
The provided text describes a 510(k) premarket notification for the sterEOS Workstation, a device for processing 2D X-ray images and providing 3D measurement tools for skeletal deformities. The submission focuses on revisions to contraindications for spine modeling and minor software/hardware modifications.
However, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance based on a rigorous study. The "Performance Data" section primarily discusses functional testing and verification of software modifications, rather than a clinical study with specific performance metrics against acceptance criteria.
Here's an analysis of what is available and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
- Missing. The document mentions "compliance with specifications, performance and non-regression" for software modifications, and that "additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS Workstation compared to the predicate sterEOS." However, it does not specify what those specifications, performance metrics, or acceptance criteria were, nor does it provide quantified results of the performance against said criteria.
2. Sample size used for the test set and the data provenance:
- For the modification related to contraindications: "functional testing of the spine 3D modeling workflows for the no longer contraindicated types of spine with extra vertebra, spine with missing vertebra, and spine with spondylolisthesis." This implies a test set composed of such cases, but the exact sample size is not stated. The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective).
- For the training set of the original model: "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 for spine modeling." This refers to the data used for the original 3D spine model, not necessarily a test set for the modifications presented in this 510(k). This data would likely be considered retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the functional evaluation study on revised contraindications: "a functional evaluation study conducted by internal experienced radiographers from EOS imaging."
- Number of experts: Not specified, but plural ("radiographers") implies more than one.
- Qualifications: "internal experienced radiographers from EOS imaging." Further specific qualifications (e.g., years of experience, board certification) are not provided.
- For the original model (when establishing its ground truth): Not stated in this document.
4. Adjudication method for the test set:
- Not specified. The document mentions a "functional evaluation study conducted by internal experienced radiographers," but does not detail how their findings were reconciled or adjudicated.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The functional evaluation study was to verify "ease to perform a 3D modeling and to obtain an adjusted outline," not a comparative effectiveness study involving human readers' diagnostic accuracy or efficiency with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "functional testing of the spine 3D modeling workflows" evaluated the software's ability to model specific spine types. While this involves the algorithm's performance, it's not described as a formal standalone performance study with specific quantitative metrics like sensitivity, specificity, or comparable clinical endpoints. The "functional evaluation study" involved radiographers, indicating a human-in-the-loop component for verification.
7. The type of ground truth used:
- For the functional evaluation of revised contraindications: The ground truth appears to be the ability of the software to successfully perform 3D modeling and provide an adjusted outline that matches the vertebrae for the previously contraindicated spine types. This is based on expert visual assessment ("internal experienced radiographers"). It's more of a qualitative "functional" ground truth rather than a clinical diagnostic ground truth like pathology or long-term outcomes.
- For the original model: Ground truth for the "model of bone structures" was derived from "an a priori image data set from 175 patients" and "dry isolated vertebrae data for spine modeling." How the ground truth for these foundational datasets was established is not detailed in this document.
8. The sample size for the training set:
- "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 for spine modeling." This refers to the data used to build the original 3D model, which serves as a training or development set for the model itself.
9. How the ground truth for the training set was established:
- Not detailed in this document. It states the model was "derived from an a priori image data set," but how the ground truth for those 175 patient cases or the dry isolated vertebrae was established (e.g., manual annotation by experts, specific measurements, pathology) is not described here.
§ 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).