(32 days)
The X3C 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 pediatric patients can be performed with patient sitting, standing or lying in the prone or supine positions.
The X3C 2200 (510k submission device) is not intended for mammography.
The X3C 2200 is a modification to Xplorer 2200 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 2200 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 2200 system is manufactured by Imaging Dynamics.
This 510(k) submission, K071401, for the X3C 2200 Digital Radiographic System, explicitly states: "No clinical tests conducted." This means that there is no study described in the provided text that proves the device meets specific acceptance criteria based on clinical performance.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Xplorer 2200, K063039) through non-clinical tests. The acceptance criteria and "device performance" in this context refer to the device's ability to meet safety, effectiveness, and performance requirements comparable to the predicate device through non-clinical evaluations.
Therefore, the requested information elements related to clinical studies, such as sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details, are not applicable or not available from the provided text for this specific submission because no clinical studies were performed.
Here's an attempt to answer the questions based on the available information regarding substantial equivalence and non-clinical testing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (based on substantial equivalence to predicate) | Reported Device Performance (via non-clinical tests) |
|---|---|
| Performance: Device functions as intended without adverse impact due to detector change from predicate. | Evaluated for performance and found substantially equivalent to predicate device. |
| Biocompatibility: Materials in contact with patient are biocompatible. | Evaluated for biocompatibility and found substantially equivalent to predicate device. |
| Effectiveness: Device effectively captures diagnostic radiographic exposures similar to predicate. | Evaluated for effectiveness and found substantially equivalent to predicate device. |
| Thermal Safety: Operates within safe temperature limits. | Evaluated for thermal safety and found substantially equivalent to predicate device. |
| Electrical Safety: Meets electrical safety standards. | Evaluated for electrical safety and found substantially equivalent to predicate device. |
| Mechanical Safety: Mechanically sound and safe for operation. | Evaluated for mechanical safety and found substantially equivalent to predicate device. |
| Intended Use: Matches the predicate device's intended use (diagnostic radiography excluding mammography for adult and pediatric patients). | Device has the same intended use as the predicate device. |
| Manufacturing Quality Systems: Conforms to relevant quality standards. | Manufacturer conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set or patient data was used as "No clinical tests conducted." The evaluation was based on non-clinical performance, safety, and effectiveness testing of the device itself, likely comparing its specifications and outputs to the predicate device.
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. As no clinical tests were conducted, there was no "test set" requiring ground truth established by medical experts in this submission. The "ground truth" for substantial equivalence was based on meeting engineering and safety standards, and performance specifications benchmarked against the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was used.
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 system, not an AI-assisted diagnostic tool. Furthermore, no clinical studies (including MRMC) were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This submission is for a digital radiographic system hardware, not a standalone algorithm. Also, no clinical studies were performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for evaluating this device's substantial equivalence in non-clinical testing would have been based on engineering specifications, performance metrics (e.g., image quality parameters, dose measurements), safety standards (electrical, thermal, mechanical), and biocompatibility testing results, all compared against the established characteristics of the predicate device. It represents verification against technical and regulatory benchmarks, not clinical disease states.
8. The sample size for the training set
- Not applicable. As this device is a hardware system and "No clinical tests conducted," there was no "training set" of data in the context of an AI/ML algorithm being developed or assessed.
9. How the ground truth for the training set was established
- Not applicable. There was no training set for this 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.