(22 days)
The X3C (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of headto-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system.
The X3C (510k submission device) is not intended for mammography.
The X3C Digital Radiographic Detector (510k submission device) is substantially equivalent to the Xaminer (predicate device). The CCD imagers in both the X3C Digital Radiographic Detector (510k submission device) and the Xaminer (predicate device) are identical. Traditionally the Xaminer (predicate device) has been fitted into existing radiography systems. The X3C Digital Radiographic Detector (510k submission device) is a modified imager will also be fitted into existing radiography systems.
The replacement of the submission device is the only significant change between the two imagers. Both submission and predicate devices have technological aspects, methods of operation, power sources, controls, user interfaces, and product configuration - with the exception of the scintillator on the X3C Digital Radiographic Detector (510k submission device)
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets those criteria. Instead, it is a 510(k) summary for a substantial equivalence determination for the X3C Digital Radiographic Detector, emphasizing its equivalence to a predicate device, the Xaminer.
Here's an analysis based on the provided text, addressing your questions to the extent possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria or report device performance in a quantitative manner for the X3C Digital Radiographic Detector. The claim is based on substantial equivalence to the Xaminer.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated for X3C (implied to be equivalent to predicate) | The X3C Digital Radiographic Detector and the Xaminer are substantially equivalent. The CCD imagers are identical. Differences involve the scintillator, which are deemed "not significant and do not raise 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)
- Sample Size for Test Set: Not applicable/not provided. This submission relies on equivalence to a predicate device that has "five years of clinical data/field experience involving millions of examinations on human patients." No specific new test set data for the X3C is presented.
- Data Provenance: The predicate device, Xaminer, has "millions of examinations on human patients," but the country of origin of this data is not specified, nor is it indicated if it was retrospective or prospective.
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 provided. The document focuses on substantial equivalence based on technical specifications and prior performance of the predicate device, not on a new clinical study requiring ground truth by experts for the X3C.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/not provided. No new clinical test set requiring adjudication is described for the X3C.
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 applicable. This device is a digital radiographic detector, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is hardware (an imager), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for the X3C directly. The predicate device (Xaminer) had "five years of clinical data/field experience involving millions of examinations on human patients," which implies real-world diagnostic outcomes, but the specific type of ground truth used in those examinations is not detailed.
8. The sample size for the training set
Not applicable. This device is a hardware component. There is no mention of a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 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.