(119 days)
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.
The Micro Dose feature is indicated for imaging with a patient entrance dose of 10 to 90 µGy for assessing global skeletal deformities in follow-up pediatric examinations. Micro Dose is not indicated for focal skeletal abnormalities and/or other pediatric abnormalities. Micro Dose is not indicated for use in patients with a Body Mass Index over 30.
EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and Xray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. A new acquisition feature named Micro Dose allows image acquisition with a patient entrance dose of 10 to 90 µGy for assessing global skeletal deformities in follow-up pediatric exams. The diagnostic images are stored in a local 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.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: EOS System
Feature under evaluation: Micro Dose
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to generate very low X-ray dose images. | The Micro Dose feature enables imaging with a patient entrance dose of 10 to 90 µGy. |
| Sufficient image quality for follow-up assessment of global skeletal deformities in pediatric patients. | 1. Visibility of anatomical landmarks: The image quality was assessed by "rating the visibility of the anatomical landmarks used for the measurement of the clinical parameters for spine scoliosis follow up." |
| 2. Reproducibility and accuracy of measurements: The image quality was assessed by "assessing the reproducibility and the accuracy of the measurements of clinically relevant scoliosis angles." | |
| Conclusion: "Micro Dose feature enables the analysis of global skeletal deformity in the context of radiographic examinations which do not require fine bone structure analysis, such as follow-up exams of the spine or lower limb." |
Note: The document does not explicitly state numerical acceptance criteria for image quality (e.g., minimum landmark visibility score, specific accuracy/reproducibility metrics). The reported performance is a qualitative statement of efficacy based on the assessments performed.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details on the sample size used for the clinical test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It only mentions "clinical testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts used to establish the ground truth or their qualifications. It mentions "rating the visibility of the anatomical landmarks" and "assessing the reproducibility and the accuracy of the measurements of clinically relevant scoliosis angles," which implies expert review, but no further details are given.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without. The study described focuses on the standalone performance and image quality of the Micro Dose feature.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The "Performance Data" section describes testing designed to "confirm the ability of the EOS System's Micro Dose acquisition feature to generate very low X-ray dose images allowing for the follow-up assessment of global skeletal deformities in pediatric patients." This indicates an evaluation of the device's output (images) directly, independent of a human-in-the-loop scenario. The assessment focused on the quality of these images for diagnostic purposes.
7. Type of Ground Truth Used
The ground truth appears to be based on expert assessment/consensus related to:
- Visibility of anatomical landmarks: This would involve experts evaluating whether critical anatomical points are clearly discernible in the low-dose images.
- Reproducibility and accuracy of measurements: This suggests that measurements (e.g., scoliosis angles) were taken from the Micro Dose images and compared against either a gold standard measurement (though not explicitly stated what that standard was) or assessed for consistency by experts. The "clinically relevant scoliosis angles" imply that expert clinical judgment was involved in defining and assessing these.
8. Sample Size for the Training Set
The document does not mention any sample size for a training set. Given that the EOS System is a digital radiography system with a new acquisition feature (Micro Dose), and not explicitly an AI/ML algorithm that requires a dedicated training set beyond its physics-based image processing, a "training set" in the context of supervised machine learning might not be applicable here. The focus is on the performance of the image acquisition and processing pipeline at a reduced dose.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of an AI/ML algorithm, the method for establishing its ground truth is not applicable or described. The performance evaluation is related to the image quality produced by the system for specific diagnostic tasks.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.