(30 days)
The Xplorer 2200 is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediation patients and other, performed with patient sitting, standing or lying in the prone or supine positions.
The Xplorer 2200 (510k submission device) is not intended for mammography.
The Xplorer 2200 is a combination of two Xplorer 1000 CCD imagers, a previously marketed device covered by 510k K992955. One imager is in the Xplorer 1100 radiographic table, a previously marketed device covered by 510k K062417 and the other imager is on a vertical stand, a previously marketed device covered by 510k K062405. The system is operated in conjunction with a celling mounted X-ray tube/collimator assembly. The Xplorer 2200 system is manufactured by Imaging Dynamics. The CCD Imagers are unchanged from that which is marketed under K992955.
The provided text does not contain acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, the document is a 510(k) summary for the Imaging Dynamics Xplorer 2200 Digital Radiographic System. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (the predicate device) rather than presenting new performance data against acceptance criteria.
The key points from the provided text are:
- Device Description: The Xplorer 2200 is a combination of existing components (two Xplorer 1000 CCD imagers, an Xplorer 1100 radiographic table, and a vertical stand) with a ceiling-mounted X-ray tube/collimator assembly. The core imager technology is unchanged from a previously cleared device (K992955).
- Predicate Device: The Xplorer 1600 Digital Radiographic System (K042041).
- Comparison with Predicate Device: The manufacturer states that "The Xplorer 2200 is substantially equivalent to the currently marketed Xplorer 1600. Xplorer 2200 device does not alter the fundamental scientific technology from Xplorer 1600 predicate device." The only modification is the integration of existing components.
- Non-clinical tests: Evaluated for performance, biocompatibility, thermal, electrical, and mechanical safety, and found substantially equivalent to the predicate device.
- Clinical tests: "No clinical tests conducted."
- Conclusion: The device was evaluated against the predicate device for all performance, safety & effectiveness requirements and found to be substantially equivalent.
Therefore, I cannot provide the requested information because the provided text explicitly states that no clinical tests were conducted to establish new performance data against specific acceptance criteria for the Xplorer 2200. The regulatory approval was based on the substantial equivalence to a predicate device, leveraging the performance data and established safety/effectiveness of its constituent components.
To answer your specific points:
- A table of acceptance criteria and the reported device performance: Not available. The submission relies on the substantial equivalence to the predicate device's performance, not new performance data for this specific combined system.
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set was used.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set was used.
- 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 system, not an AI-powered diagnostic tool, and no clinical study was conducted.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical study was performed.
- The sample size for the training set: Not applicable. The device is not an AI algorithm requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details a Special 510(k) submission based on substantial equivalence and the integration of previously cleared components. It explicitly states that no new clinical tests were conducted for this specific permutation of the device.
§ 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.