(368 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 (K071546), 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 measurement . 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 (K071546), 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 the sterEOS Workstation, a device for processing 2D X-ray images, and its 3D measurement tools for spine and lower limb deformities. The performance data section is brief and focuses on the validation for severe scoliosis, but it does not specify clear acceptance criteria or detailed study methodologies beyond what is presented below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalent performance with conventional measurement methods on native X-ray images for scoliosis assessment. | "Accuracy and precision of the automatic measurements computed from the 3D model of the spine in patients with Cobb’s angle > 50° have been confirmed with X-ray clinical images. Results validate the interactive 3D measurement tools for a severe scoliosis assessment and demonstrate the equivalent performance of the device with conventional measurement methods performed on native X-ray images." |
| Safety and effectiveness as the predicate device (sterEOS Workstation, K080529, K090050, K101398) for expanded indications (Cobb's angle > 50°). | "Performance data demonstrate that the device is as safe and effective as the company's cleared sterEOS device and, thus, is substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance evaluation of the interactive 3D measurement tools for Cobb's angle > 50°. It only refers to "X-ray clinical images."
The provenance of the data (e.g., country of origin, retrospective or prospective) for this specific validation is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts used or their qualifications for establishing ground truth specifically for the test set used to validate the performance for Cobb's angle > 50°. It only refers to "conventional measurement methods performed on native X-ray images" as the comparison.
4. Adjudication Method for the Test Set
The adjudication method for the test set is not described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The performance evaluation focuses on comparing the device's automatic measurements with "conventional measurement methods," implying a comparison against established, presumably manual, measurement techniques rather than an AI-assisted human reader study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation appears to have been done. The text states: "Accuracy and precision of the automatic measurements computed from the 3D model of the spine...have been confirmed." This indicates that the algorithm's performance (automatic measurements) was evaluated against conventional methods. While the tool is interactive, the reported performance is for the "automatic measurements."
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation of the 3D measurements for scoliosis appears to be based on conventional measurement methods performed on native X-ray images. This implies expert-derived measurements using traditional techniques as the reference standard.
8. The Sample Size for the Training Set
The model of bone structures for the spine and lower limbs was 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." This describes the data used to develop the underlying 3D models which the interactive tools use. It can be considered the training data for the model generation.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the 175-patient a priori image data set was established. It only mentions the composition of the dataset (normal, moderate idiopathic scoliosis, severe idiopathic scoliosis). It can be inferred that these classifications would have been based on clinical assessment and measurements by medical professionals.
§ 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).