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The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopediativ 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. 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, 47 patients with moderate idiopathic scoliosis and 37 patients with 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 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 appears to be a 510(k) summary for the sterEOS Workstation, a medical device for processing X-ray images, and not a study with detailed acceptance criteria and performance data. Therefore, the information requested in the prompt, especially regarding specific acceptance criteria, study methodologies, and quantitative results like sample sizes for test and training sets, number and qualifications of experts, and MRMC study effect sizes, is not present in the provided document.

The document discusses that the device has undergone software verification and validation testing to confirm compliance with specifications, performance, and non-regression. It also states that additional performance and functional testing was performed, and this testing "confirmed the equivalent performance of the modified sterEOS Workstation compared to the predicate sterEOS." However, it does not provide the details of these tests, such as the specific acceptance criteria, the actual performance metrics, or the study methodologies used.

The document states that the new device is "substantially equivalent" to its predicate device (K14137 sterEOS Workstation) due to having the same intended use, similar technological characteristics, and minor differences that do not raise new questions of safety or effectiveness. This suggests that the approval is based on demonstrating equivalence rather than meeting new, specific acceptance criteria through a standalone clinical study detailed in this summary.

Therefore, I cannot populate the table or answer the specific questions because the detailed information about acceptance criteria and the comprehensive study results are not provided in this 510(k) summary.

Here's a summary of what is available related to the request, and what is missing:

The 510(k) summary indicates that the sterEOS Workstation is a software upgrade to an existing device (K14137). The basis for approval is "substantial equivalence" to the predicate.

Missing Information:

• Detailed Acceptance Criteria and Performance Data: The summary states "performance data demonstrate that the device is as safe and effective," but it does not provide a table with specific acceptance criteria (e.g., minimum accuracy, precision, sensitivity, specificity for 3D measurements) or the reported device performance against those criteria.
• Sample sizes for test set and data provenance: Not mentioned.
• Number of experts and qualifications for ground truth: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned. The focus is on demonstrating equivalence to the predicate device.
• Standalone performance study: The document refers to "software verification and validation testing" and "additional performance and functional testing" which imply standalone testing, but no detailed results or methodology for such a study (beyond "equivalent performance") are provided.
• Type of ground truth used (for performance testing): Not specified.
• Sample size for the training set: The "model of bone structures" for spine analysis is derived from an a priori image data set from 175 patients (91 normal, 47 moderate idiopathic scoliosis, 37 severe idiopathic scoliosis) and dry isolated vertebrae data for spine modeling. This 175-patient dataset likely serves as the basis for the model, which could be considered training/development data for the model-based measurements. For lower limbs, it also mentions "a model of bone structures derived from an a priori image data set," but doesn't specify the size or nature of this dataset here.
• How ground truth for the training set was established: Not explicitly stated, though for the 175-patient spine data, it implies clinical diagnoses (normal, moderate/severe idiopathic scoliosis).

In conclusion, the provided document is a regulatory submission focused on demonstrating substantial equivalence rather than a detailed scientific study report. It states that performance testing confirmed equivalence but does not offer the granular data requested.

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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 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.

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