(26 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 X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. An acquisition feature named Micro Dose allows image acquisition with a patient entrance dose of 10 to 90 uGv 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.
The provided text describes the EOS System, a stationary x-ray system, and states that it has been determined to be substantially equivalent to a legally marketed predicate device. However, this document does not contain details about specific acceptance criteria or an explicit study proving device performance against those criteria in the way you've outlined for clinical performance.
Instead, the document focuses on demonstrating substantial equivalence to an existing cleared device (K142773) based on:
- Same Intended Use/Indications for Use: Both the modified and predicate EOS systems share the same intended use for general radiographic examinations, excluding lung nodules, fluoroscopy, angiography, and mammography. They both also offer the "Micro Dose" feature for assessing global skeletal deformities in follow-up pediatric examinations (with specific dose and BMI limitations).
- Similar Technological Characteristics/Principles of Operation: The fundamental technological characteristics of the modified EOS are unchanged from the cleared EOS. Minor modifications (hardware component supplier changes, electrical component changes due to obsolescence, mirror sticker accessory, software modification related to a recall, optimization of default acquisition protocols, improvement of image processing, and addition of new features like Dose Structured Report and Reject and Repeat Analysis) are described as not altering the core function or safety.
- Performance Data (Bench Testing): The document mentions "Performance data demonstrates that the modified EOS is as safe and effective as the cleared predicate device." This includes "bench testing to confirm appropriate dosing and image quality." It also states, "Performance testing has demonstrated that this modification allows reducing the entrance dose for the changed protocols, with maintaining equivalent or better image quality than the cleared EOS" (referring to the optimization of default acquisition protocols).
Therefore, I cannot fill in your requested table and many of the study details because the provided text does not describe a clinical performance study with defined acceptance criteria and results for the device itself, but rather an argument for substantial equivalence of a modified device to a predicate device based on technical performance and safety.
Here's what I can extract and state based on the provided text, while also noting what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Doc) | Reported Device Performance (from Doc) |
|---|---|
| Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy for a clinical task). | "Performance and functional testing has confirmed the equivalent performance of the modified EOS compared to the cleared predicate EOS." |
| "appropriate dosing" | "bench testing to confirm appropriate dosing" |
| "image quality" | "bench testing... to confirm image quality." "maintaining equivalent or better image quality than the cleared EOS" (for optimized acquisition protocols). |
| "reducing the entrance dose" (for modified protocols) | "Performance testing has demonstrated that this modification allows reducing the entrance dose for the changed protocols." |
| No new questions of safety or effectiveness. | "The minor differences... do not raise any new questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly mentioned. The document refers to "bench testing" and "performance and functional testing," which typically involves phantoms or test objects, not patient datasets with "test sets" in the clinical sense.
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)
- Not applicable/Not mentioned. Since this was a substantial equivalence submission based on technical modifications and bench testing, there's no indication of expert review for clinical ground truth on a 'test set.'
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned.
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
- No. This document describes an X-ray system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As the device is an X-ray imaging system, "standalone" performance refers to its ability to acquire images, which is addressed by the "bench testing" and "performance and functional testing" mentioned. There is no algorithm performance discussed in the context of diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not mentioned for clinical ground truth. The "ground truth" for the performance claims appears to be based on physical measurements of dose and objective assessments of image quality (e.g., spatial resolution, contrast-to-noise ratio) from bench testing, rather than clinical outcomes or pathology.
8. The sample size for the training set
- Not applicable/Not mentioned. This is not an AI/machine learning device that would require a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned.
§ 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.