(23 days)
The X3C 1100 motorized patient table with digital radiographic detector (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 head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, lying in the prone or supine positions.
The X3C 1100 (510k submission device) is not intended for mammography.
The X3C 1100 is a modification to Xplorer 1100 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1100 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1100 system is manufactured by Imaging Dynamics.
This submission (K071408) is for a X3C 1100 motorized patient table with digital radiographic detector. This device is a modification of an existing device, where the digital radiographic detector component has been updated.
The key takeaway is that no clinical studies were conducted for this 510(k) submission. The manufacturer relied on non-clinical tests and demonstrating substantial equivalence to a predicate device (Xplorer 1100, K062417) to meet acceptance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Performance | The device's operational capabilities (e.g., image quality, functionality) | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Biocompatibility | Assessment of potential biological risks associated with material contact. | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Effectiveness | The device's ability to achieve its intended diagnostic purpose. | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Thermal Safety | Evaluation of potential thermal hazards. | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Electrical Safety | Evaluation of potential electrical hazards. | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Mechanical Safety | Evaluation of potential mechanical hazards. | Evaluated through non-clinical tests; found to be substantially equivalent to the predicate device. |
| Quality Systems | Compliance with regulatory standards for design and manufacturing. | Conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set was used for this submission. The evaluation was based on non-clinical tests and comparison to a predicate device.
- Data Provenance: Not applicable for clinical data. Non-clinical test data provenance is not specified beyond being generated by Imaging Dynamics Company Ltd.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set requiring expert ground truth establishment was conducted for this submission.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was conducted for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical tests: No clinical tests conducted."
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a digital radiographic detector integrated into an X-ray system, not a standalone algorithm. Also, no clinical studies were performed.
7. Type of Ground Truth Used
- Not applicable for clinical studies. For the non-clinical tests, the "ground truth" would be established by engineering specifications, regulatory standards, and performance against the predicate device through direct comparison testing.
8. Sample Size for the Training Set
- Not applicable. This device does not appear to involve AI/ML requiring a training set in the context of this submission. The evaluation was primarily engineering-based and comparison to a predicate device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as 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.