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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 PACS 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 in patients with a Cobb's angle > 50 degrees and 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 patient younger than 15 years old.

The sterEOS Workstation is a 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 EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs.

Here's a breakdown of the acceptance criteria and study information for the sterEOS Workstation, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" with specific thresholds for accuracy or precision. Instead, it describes a "performance data" section that generally asserts the device's capabilities and equivalence. The key performance claim is for the lower limb measurement tools.

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

• Test Set Sample Size: The document does not explicitly state a separate "test set" sample size for the lower limb accuracy and precision validation.
  • The "3D reconstruction method" for the lower limb mentions a "database of clinical descriptors measured in 45 lower limbs of healthy adult subjects." This dataset seems to be used for defining the statistical inference and forming a priori models, rather than a distinct testing set for device validation after model creation. It's unclear if these 45 limbs were also part of the "X-ray clinical images" used for performance confirmation.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "X-ray clinical images."

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth for the lower limb measurements. It only mentions "conventional measurement methods" as the comparison for "equivalent performance."

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned for the lower limb measurements, nor is any effect size of human readers' improvement with AI assistance discussed. The performance data focuses on the device's standalone measurements compared to conventional methods.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance assessment was done. The "Performance Data" section explicitly states: "Accuracy and precision of the automatic measurements computed from the 3D model of the lower limbs have been confirmed... Results validate the interactive 3D measurement tools for lower limb assessment and demonstrate the equivalent performance of the device with conventional measurement methods performed on native X-ray images." This indicates an evaluation of the algorithm's output against a reference standard.

7. Type of Ground Truth Used

The ground truth for evaluating the lower limb measurements seems to be based on:

• "Conventional measurement methods performed on native X-ray images." This implies manual measurements made by experts directly on the images, which serves as a clinical reference.

8. Sample Size for the Training Set

• Spine Model: 175 patients (91 normal, 47 moderate idiopathic scoliosis, 37 severe idiopathic scoliosis) and 1628 cadaveric vertebrae. This dataset was used to derive the "a priori image data set" for the spine's 3D model.
• Lower Limb Model: 45 lower limbs of healthy adult subjects. This dataset was used to define the "statistical inference" for the parametric models of the tibia and femur.

9. How Ground Truth for the Training Set Was Established

The ground truth for the training sets (for both spine and lower limb models) was established through:

• Clinical descriptors/measurements: Data was derived from patient populations (e.g., normal, moderate/severe idiopathic scoliosis, healthy adults) and cadaveric vertebrae. These "clinical descriptors" would have been established measurements or observations relevant to bone structures and deformities.
• A priori image data set: This refers to the collection of pre-existing data from these patient populations that the models learned from.
• Morpho-realistic models: These are meshed CT volumes of spine/lower limbs, regionalized according to the parametric models, likely serving as detailed anatomical references during model development.

Essentially, the models were developed using a database of known anatomical and pathological characteristics. The document doesn't detail the process of how each individual "clinical descriptor" was established for the training data (e.g., if it was expert consensus on each patient's image, or from medical records, etc.), but it clearly states these were "measured" or derived from a database.

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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 PACS 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 Biospace 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 in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities.

The sterEOS Workstation is a general picture archiving and communications storage 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 Biospace 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.

The provided text indicates that the sterEOS Workstation is a general PACS device with 2D and 3D measurement tools, particularly for scoliosis and spinal deformities. The performance data section broadly mentions "Accuracy studies of the 3D measurements were performed by using either anthropomorphic phantoms or patient images acquired with EOS system in hospitals. Results of these studies validate the 3D measurement tools of the software and demonstrate the equivalent performance of the device in both adult and pediatric populations."

However, the input does not contain specific acceptance criteria (e.g., minimum accuracy percentages, confidence intervals, comparison to a gold standard with numerical thresholds) or the detailed results of these studies. It also lacks information on sample sizes for test sets, data provenance, expert qualifications, adjudication methods, details of MRMC studies, standalone performance specifics, training set size, or how its ground truth was established.

Therefore, many parts of your request cannot be directly answered from the provided text.

Here's a summary of what can be extracted or inferred based on the given document, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document mentions an "a priori image data set from 175 patients" used for a model of bone structures, but this is explicitly not the test set for performance evaluation of the 3D measurement tools themselves. This 175-patient dataset likely contributed to the development of the model, not necessarily the independent verification of its accuracy against new data.
• Data Provenance: "patient images acquired with EOS system in hospitals." The country of origin is not specified.
• Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified. The document does not mention the use of experts for ground truth establishment in the performance studies.

4. Adjudication method for the test set

• Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not mentioned. The document focuses on the software's 3D measurement accuracy rather than its impact on human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The performance studies seem to focus on the accuracy of the "3D measurement tools of the software," implying a standalone evaluation of the algorithm's output for these measurements. However, the exact methodology (e.g., whether a human user manually applied the tools, or if it was fully automated) is not detailed. The device is described as having "interactive 3D measurement tools," which might suggest human interaction is part of its intended use and thus part of its performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For studies using anthropomorphic phantoms, the ground truth would be based on the known, precise dimensions of the phantom.
• For studies using patient images, the type of ground truth is not explicitly stated. Given it's measuring 3D anatomical structures from 2D X-rays, the ground truth would likely involve highly precise 3D imaging (e.g., CT, MRI) or a manual gold standard obtained by expert measurement using high-resolution 3D data if available, or direct measurements on the phantoms.

8. The sample size for the training set

• The document mentions "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." This 175-patient dataset, along with dry isolated vertebrae data, served as the basis for developing the bone structure model used by the 3D measurement tools. This would be considered the data used for training/development of the model.

9. How the ground truth for the training set was established

• For the "a priori image data set from 175 patients," the method for establishing ground truth for training the bone structure model is not detailed.
• For "dry isolated vertebrae data," the ground truth would likely be established through precise physical measurements of these specimens.

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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 PACS 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 Biospace EOS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of scollosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 16 vears 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 in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities

The SterEOS Workstation is a general picture archiving and communications storage 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 Biospace 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.

The provided FDA 510(k) summary for Biospace med's sterEOS Workstation does not explicitly state acceptance criteria or provide a detailed study report with specific performance metrics against those criteria. Instead, it describes a "comparative study" to demonstrate accuracy and equivalent performance. Therefore, I will extract what is available and highlight what is missing.

Here's the information based on the provided document:

Acceptance Criteria and Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. It generally states: "A comparative study was conducted in a clinical setting to demonstrate accuracy of clinical parameters calculated in the 3D space. The results of this study validate the 3D reconstruction software and demonstrate the equivalent performance of the device."

Without explicit acceptance criteria (e.g., "3D reconstruction accuracy must be within X mm of ground truth for Y% of cases"), it's impossible to create the requested table.

Study Details

1. Sample size used for the test set and the data provenance:

   • The document mentions 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)" which was used to derive the model of bone structures for the 3D measurement tools. This dataset appears to be part of the training/development of the model, not explicitly a test set for evaluating the final device's performance.
   • The document does not specify the sample size of the "clinical setting" comparative study used to "demonstrate accuracy of clinical parameters calculated in the 3D space."
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.

3. Adjudication method for the test set: Not specified.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • An MRMC study is not explicitly mentioned. The "comparative study" focuses on the accuracy of device-calculated parameters rather than human reader improvement with aid.
   • Therefore, no effect size for human reader improvement is provided.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • The "comparative study" appears to assess the accuracy of the device's 3D measurement tools, which implies a standalone performance evaluation of the algorithm's output (measurements) compared to some form of ground truth. However, the details are sparse.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The document implies that the "accuracy of clinical parameters calculated in the 3D space" was demonstrated. This suggests that the ground truth would likely be established by clinical experts (e.g., orthopedic surgeons, radiologists) using established manual measurement techniques or potentially more advanced imaging modalities for comparison (though not specified).
   • The mention of "dry isolated vertebrae data" contributing to the model could imply some physical measurement ground truth for model development, but not necessarily for the clinical performance test set.

7. The sample size for the training set:

   • The "model of bone structures" used by 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." This dataset of 175 patients (plus dry vertebrae data) serves as the primary training/development data for the 3D model.

8. How the ground truth for the training set was established:

   • The document states the model was "derived from an a priori image data set." It does not explicitly state how the "ground truth" (e.g., true 3D shape, vertebral parameters) for these 175 patients or the dry isolated vertebrae was established. It's inferred that these would have been meticulously measured or reconstructed using high-fidelity methods during the model development phase.

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The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.

EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously. The diagnostic images are stored in a database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving. This device employs the same technological characteristics as the predicate devices differing only in the specifics of subassembly component composition.

The provided text for Biospace Med's EOS (K071546) does not contain detailed information about specific acceptance criteria, a dedicated clinical study proving the device meets those criteria, or most of the requested performance data points. The submission relies primarily on a claim of substantial equivalence to predicate devices, stating that its "Performance data demonstrate that EOS is as safe and effective as common radiography systems."

Therefore, I cannot populate most of the requested fields definitively with information from the provided text. However, I can extract what is available and highlight what is missing.

Here's a breakdown based on the provided text, indicating where information is present and where it is lacking:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The text does not provide information on the sample size used for any test set or the data provenance. It generally refers to "performance data" and "additional testing" without specifics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• The text does not provide information on the number or qualifications of experts used for establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• The text does not provide information on any adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as a "Digital Radiography System," not an AI-assisted diagnostic tool in the sense of providing algorithmic interpretations for human readers to review.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The text describes the EOS as a "Digital Radiography System" that generates images for diagnostic purposes to be "displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed." This implies human interpretation. The text does not indicate that any standalone algorithmic performance (without human-in-the-loop) was evaluated, nor does it present the device as having such a standalone diagnostic function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The text does not specify the type of ground truth used for any performance evaluation. It broadly mentions "performance data" that demonstrated equivalence.

8. The sample size for the training set

• The text does not provide information on any training set sample size. The submission focuses on the system's design and equivalence to predicate devices, rather than a machine learning model's training.

9. How the ground truth for the training set was established

• The text does not provide information on how ground truth was established for any training set.

Summary of what's provided related to "study" and "acceptance":

The submission for K071546 does not detail a specific clinical study with explicit acceptance criteria and corresponding numerical performance metrics for the EOS device. Instead, it relies on a substantial equivalence claim. The core argument is that:

• The EOS has the "same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices."
• "The minor technological differences between EOS and its predicate devices raise no new issues of safety or effectiveness."
• "Additional testing confirmed the equivalent performance of the EOS as compared to the claimed predicate devices."
• "Performance data demonstrate that EOS is as safe and effective as common radiography systems."
• "EOS is designed to comply with IEC 60601-1 and collateral standards."

This regulatory strategy indicates that the acceptance criteria are implicitly tied to demonstrating that the EOS performs equivalently to already legally marketed and established radiography systems, thereby being "as safe and effective." The "study" in this context is likely a series of technical and comparative evaluations (referred to as "additional testing" and "performance data") rather than a formal, prospective clinical trial designed to prove specific numerical efficacy metrics against a pre-defined ground truth in a clinical population. The absence of details on patient numbers, expert reads, ground truth, or statistical methods suggests a non-clinical performance evaluation focused on demonstrating technological equivalence to predicates.

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