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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 include 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 modeling. The 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 (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, which describes modifications to an already cleared device. It explicitly states, "Additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS compared to the predicate sterEOS workstation." However, it does not provide specific acceptance criteria or detailed study results (like sensitivity, specificity, accuracy, or effect size for MRMC studies). It generally refers to verification and validation activities.

Therefore, many of the requested details about acceptance criteria, study specifics, and ground truth establishment are not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not list specific numerical acceptance criteria (e.g., "accuracy > 90%"). Instead, it states that testing confirmed equivalent performance to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for performance testing. The "a priori image data set" used for model training includes 175 patients (91 normal, 47 moderate idiopathic scoliosis, 37 severe idiopathic scoliosis) but it's not explicitly stated this was the test set for the specific device modifications.
• Data Provenance: Not specified for the performance testing. For the model training data, it comes from an "a priori image data set," but specific country of origin or whether it's retrospective/prospective is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The document focuses on demonstrating substantial equivalence of the modified device to its predicate, rather than comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: The description of "Performance Data" and "Software modifications have been verified at the unit level. After integration, system software V&V testing was performed..." implies standalone verification of the software's functionality. However, specific performance metrics for this standalone evaluation (e.g., accuracy of model-based measurements compared to ground truth) are not provided. The device itself is described as providing "interactive 3D measurement tools," suggesting a human-in-the-loop use case.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated for the device's performance testing. For the model of bone structures used in the 3D measurement tools, the data set included "dry isolated vertebrae data for spine modeling," which would serve as a form of anatomical ground truth for the model's development. However, how the ground truth for evaluating the measurements produced by the device was established is not detailed.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The "model of bone structures" used in the 3D measurement tools 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 for spine modeling." This dataset served for the development of the model, which is analogous to a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: For the "model of bone structures," the ground truth was established using an "a priori image data set" from 175 patients and "dry isolated vertebrae data." The "dry isolated vertebrae data" implies direct anatomical measurement as a ground truth for the morphology of individual vertebrae. For the patient image data, the method for establishing ground truth measurements (e.g., expert manual measurements) is not explicitly described, but the context implies that these images and associated clinical conditions (normal, moderate, severe scoliosis) served as the basis for model development.

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