(70 days)
The Wireless DR Imaging Option -WDR1, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems maybe used.
The device is not intended for mammography or fluoroscopy applications.
The Wireless DR Imaging Option - WDR1 consists of a wireless detector, system interface box, computer, display, keyboard and mouse. It is designed to acquire digital radiographic images when used with existing radiographic x-ray systems. Images captured can be communicated to the system via wireless signal, tethered cable or direct connection (docked). The Wireless detector is very similar to the digital detector currently in use as the GE Digital Radiographic Detector (K982196), and the Philips Medical Systems Wireless Portable Detector FD-W17 (K090625) comprised of amorphous silicon with a cesium iodide scintillator.
It is used on radiographic X-ray systems as a substitute for film/screen systems or CR systems. The Radiographic X-ray system remains unchanged except for the replacement of the systems receptor with the Wireless WDR 1 detector.
The provided text describes a 510(k) premarket notification for the GE Wireless DR Imaging Option - WDR1. This is largely a declaration of substantial equivalence to existing devices rather than a detailed study demonstrating acceptance criteria for the device's diagnostic performance. Therefore, many of the requested points related to a diagnostic performance study are not explicitly present in the provided document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for diagnostic accuracy or clinical performance in terms of disease detection. Instead, the acceptance criteria are focused on safety and technological equivalence to predicate devices. The "reported device performance" is essentially that it meets these safety and equivalence standards.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Technological Equivalence | - No fundamental change in X-ray detection technology or image creation. |
- Uses virtually identical operating principles to predicate device (GE Digital Radiographic Detector K982196).
- Same technological characteristics related to safety and effectiveness as predicate devices. | - The Wireless DR Imaging Option - WDR1 is an enhanced wireless version of and substantially equivalent to the GE Digital Radiographic Detector (K982196) and Philips Medical Systems wireless detector FD-W17 (K090625).
- Changes involve wireless functionality, reduced weight, power, and design modifications (hardware, software, firmware), but not fundamental X-ray detection technology. |
| Safety | - No new potential safety risks compared to predicate devices. - Complies with X-ray requirements of 21 CFR.
- Complies with safety requirements of IEC 60601-1 and associated collateral and particular standards.
- Device evaluated for electrical, mechanical, and radiation safety.
- Controlled potential hazards through risk management (hazard analysis), system verification/validation, adherence to industry/international standards, and compliance to CDRH 21 CFR subchapter J.
- Designed and manufactured under 21 CFR 820 Quality System Regulations. | - "No new safety concerns and is as safe an effective as the predicate devices."
- Certified to comply with 21 CFR X-ray requirements and IEC 60601-1 standards.
- Evaluated for electrical, mechanical, and radiation safety.
- Conforms to applicable medical device safety standards. |
| Performance (Bench) | - Performs as well as devices currently on the market. | - "Performs as well as the devices currently on the market." (Based on standards testing and bench data). |
| Indications for Use | - Similar indications for use as predicate devices. | - Indicated for use "in generating radiographic images of human anatomy" and "all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma." - Not intended for mammography or fluoroscopy. (Consistent with general radiography detectors). |
2. Sample size used for the test set and the data provenance
The document refers to "bench and standards testing" and "bench data," but does not specify a sample size for a clinical test set or images. It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective) for any image-based testing. This is typical for a 510(k) focused on technological equivalence rather than new clinical claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. As no clinical performance study with image interpretation is detailed, there's no mention of experts or ground truth establishment in that context.
4. Adjudication method for the test set
This information is not provided in the document, as no clinical performance study involving multiple readers or complex diagnostic interpretation requiring adjudication is described.
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 MRMC comparative effectiveness study is described. This device is a digital radiography detector, not an AI-powered diagnostic tool. Therefore, questions about human reader improvement with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is hardware (a detector), not a standalone algorithm. Therefore, "standalone" algorithm performance is not applicable in this context. The document refers to its performance in acquiring digital radiographic images.
7. The type of ground truth used
For the safety and technological equivalence claims, the "ground truth" implicitly refers to:
- Predicate device characteristics and performance: The known technological aspects, safety profile, and output of the GE Digital Radiographic Detector (K982196) and Philips FD-W17 (K090625).
- Industry and regulatory standards: IEC 60601-1, 21 CFR X-ray requirements, and 21 CFR 820 Quality System Regulations.
- Bench test results: Outputs from various technical tests that confirm the device's electrical, mechanical, and radiation safety properties, and its ability to produce digital images.
There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for a clinical diagnostic performance study.
8. The sample size for the training set
This is not applicable as the device is hardware and not an AI algorithm that undergoes training.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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.