(26 days)
EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, and mammography. EOSedge 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 assessing global skeletal deformities in follow-up pediatric exams.
The EOSedge system is a digital radiography system comprised of an acquisition workstation, a gantry including an electrical cabinet housing the system power and communication controls, and an acquisition software to obtain diagnostic images. Two identical sets of detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. If desired, the Micro Dose feature enables image acquisition for assessing global skeletal deformities in follow-up pediatric exams. The two sets of detectors and X-ray tubes are identical between the predicate device and the subject device. The image acquisition can be performed with a MANUAL mode or an AUTO mode of patient examination. To select the area of interest (acquisition area), a vertical collimation is set using green lasers and to correctly position the patient in the EOSedge, a centering system is used based on red lasers. The diagnostic images are stored in a local database and are displayed on a high-resolution medical-quality non-diagnostic monitor. The diagnostic image can be transmitted through a DICOM compatible digital network for printing and archiving.
The provided text describes a 510(k) premarket notification for the EOSedge™ system, an updated digital radiography system. The document focuses on demonstrating that the updated device is substantially equivalent to a previously cleared predicate device (EOS imaging's EOSedge System K192079).
Based on the provided text, the acceptance criteria and study proving the device meets these criteria are primarily based on bench testing and comparative analysis with a predicate device, rather than a clinical study evaluating diagnostic performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device, implying that the updated device must perform at least as safely and effectively. The performance data section refers to conformity to various IEC standards and internal functional testing.
| Feature / Standard | Acceptance Criteria (Implicit: Equivalence to Predicate, Conformity to Standards) | Reported Device Performance |
|---|---|---|
| Safety (Electrical, Radiation, Usability) | Conformity to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54, IEC 60825-1 | "EOSedge is designed and has been certified to conform to IEC 60601-1 and collateral standards." |
| Image Quality | No explicit quantitative criteria mentioned, but implied to be equivalent to predicate. Bench testing conducted. | "Bench testing to confirm appropriate dosing and image quality." "Bench performance testing were conducted based on FDA's Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices (September 1, 2016), to verify that EOSedge performs according to specifications and is as safe and effective as the predicate device." |
| Dosing | No explicit quantitative criteria mentioned, but implied to be appropriate and equivalent to predicate. | "Bench testing to confirm appropriate dosing..." |
| Software Functionality | Verified and validated software performance. | "Software verification and validation testing was also conducted." |
| Technical Specifications (Detectors) | As per predicate (K192079) | From Table 1 and Table 3 (for both current and predicate): |
- Quantity: 2
- Type: Hybrid CdTe-CMOS dual energy photons counting X-ray detector
- Dimensions: Width 585 mm x 98 mm, Thickness 131 mm
- Weight: 131 000 gray levels)
- Nominal input voltage: 12 VDC – 20 A
- Temperature control: Internal check, Peltier + PWM, Ventilator system checked
- DQE type: RQA5 spectrum ~ 80%
- MTF type: ~70% @ 2lp / mm, ~25% @ 5lp / mm
- Pixel Depth: 17 bits (> 131 000 grey levels)
- Pixel Size: 100 µm
- Resolution: 3.7 lp/mm
- Typical Dynamic Range: > 100 dB |
| Average Acquisition Time | Must be comparable or improved compared to predicate. | Current Device (EOSedge™): 7 seconds for a spine and 13 seconds for an entire body
Predicate Device (EOSedge System K192079): 8 seconds for a spine and 15 seconds for an entire body (Improved performance stated for current device) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set with patient data for evaluating diagnostic performance. The testing described is primarily bench testing and software verification/validation. Therefore, there are no details on sample size for a test set of patient images or their provenance (country of origin, retrospective/prospective). The assessment is based on technical specifications and comparison to the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
As there is no clinical test set for diagnostic performance described, there is no information on experts establishing ground truth for such a set. The ground truth for the engineering/technical tests would be the established specifications and accepted performance metrics for medical imaging devices, as defined by relevant IEC and FDA guidance.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication is described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not explicitly done or described in the provided text. The submission focuses on demonstrating substantial equivalence through technical performance data and comparison to a predicate device, not on improved human reader performance with AI assistance. The device itself is an X-ray imaging system, not an AI diagnostic assistant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not explicitly applicable in the context of an X-ray imaging system. The performance evaluated here is the image acquisition and processing capabilities of the X-ray device itself, which operates as a standalone system to produce images for human interpretation.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on established engineering and performance standards for X-ray imaging devices (e.g., IEC standards, FDA guidance for solid-state X-ray imaging devices). For comparative purposes, the predicate device's cleared performance serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical imaging device (hardware and software for image acquisition), not a machine learning algorithm that requires a training set of data for inference.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a machine learning algorithm described.
§ 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.