(21 days)
The X3C 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pediatic patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatri patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1600 (510k submission device) is not intended for mammography.
The X3C 1600 is a modification to Xplorer 1600 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1600 system is replaced with X3C digital radiographic detector, previously marketed device under 1000 The X3C 1600 system is manufactured by Imaging Dynamics.
The provided text describes a 510(k) submission for the X3C 1600 Digital Radiographic System. This is a submission for a modification to an existing device (Xplorer 1600), where the detector is replaced. The key takeaway from the provided information is that no clinical tests were conducted for this device. Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.
Instead, the submission relies on the concept of "substantial equivalence" to a predicate device (Xplorer 1600, K042041). This means the manufacturer demonstrated that the new device (X3C 1600) is as safe and effective as a legally marketed device without needing to perform new clinical trials.
Given that no clinical study was conducted, I cannot provide information on acceptance criteria related to device performance in a clinical setting, sample sizes, expert ground truth, MRMC studies, or standalone performance.
However, I can extract the information provided regarding the non-clinical tests and the basis for substantial equivalence.
Based on the provided text, here is what can be inferred about the acceptance criteria and the "study" (non-clinical evaluations) proving the device meets them:
1. A table of acceptance criteria and the reported device performance
Since no clinical study was performed, there are no reported clinical performance metrics in terms of sensitivity, specificity, accuracy, etc. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence through non-clinical evaluations.
| Acceptance Criteria Category | Reported Device Performance (Non-Clinical) |
|---|---|
| Performance | Evaluated and found to be "substantially equivalent" to predicate device (Xplorer 1600, K042041). |
| Biocompatibility | Evaluated and found to be "substantially equivalent" to predicate device. |
| Effectiveness | Evaluated and found to be "substantially equivalent" to predicate device. |
| Thermal Safety | Evaluated and found to be "substantially equivalent" to predicate device. |
| Electrical Safety | Evaluated and found to be "substantially equivalent" to predicate device. |
| Mechanical Safety | Evaluated and found to be "substantially equivalent" to predicate device. |
| Quality Systems | Design and development process conforms to 21 CFR part 820, ISO 9001, and ISO 13485 quality systems. |
| Intended Use | Has the same intended use as the predicate devices: diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts on adult and pediatric patients (not mammography). |
| Fundamental Technology | Does not alter the fundamental scientific technology from Xplorer 1600 predicate device. The only significant change is the replacement of the digital radiographic detector. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical test set was used. The evaluation was based on non-clinical tests for an engineering modification and comparison to a predicate device.
- Data provenance: Not applicable as no clinical data was generated for this specific 510(k) submission.
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. No clinical test set requiring expert ground truth was used.
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
- No MRMC study was done. This is not an AI-assisted device, and no clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a digital radiographic system, not an algorithm, and no standalone clinical performance was assessed for this 510(k) submission. The evaluation was non-clinical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established as no clinical study was conducted. The "ground truth" for the non-clinical evaluations would be established engineering and quality standards for device performance, safety, and effectiveness.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device, and no training set was used in the context of this 510(k) submission.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.