(18 days)
The X3C 1590 is intended for use by a qualified/trained doctor or lechnologist 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. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1590 (510k submission device) is not intended for mammography.
The 1590 Digital Radiographic System is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained day 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 the patient sitting, standing or lying in the prone or supine positions.
The X3C 1590 is a modification to Xplorer 1590 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1590 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1590 system is manufactured by Imaging Dynamics.
The provided text is a 510(k) summary for the X3C 1590 Digital Radiographic System. It details a special 510(k) submission where a component (digital radiographic detector) of an existing device (Xplorer 1590) is replaced with a previously marketed device (X3C digital radiographic detector).
Based on the provided information, the device does not have specific acceptance criteria or a study demonstrating performance against those criteria in the typical sense of an AI/ML device or a device requiring new clinical performance data.
Here's a breakdown of why and what information is (or isn't) present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The submission focuses on substantial equivalence to a predicate device.
- Reported Device Performance: The document states that the device has been evaluated for "performance, biocompatibility and effectiveness as well as thermal, electrical and mechanical safety" and found to be "substantially equivalent to predicate device." No specific quantitative performance metrics are provided for the X3C 1590 system itself in this summary. The performance of the individual components (Xplorer 1590 system and X3C digital radiographic detector) must have been established in their respective prior 510(k) submissions (K062405 and K070079).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The submission explicitly states "Clinical tests: No clinical tests conducted." The evaluation relied on non-clinical tests and a comparison to a 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. No clinical studies were conducted, so no ground truth was established by experts for a test set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical studies were conducted.
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 submission is for a digital radiographic system, not an AI/ML algorithm. No MRMC study was performed, nor is AI assistance mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established for this submission. The "ground truth" here is the established safety and effectiveness of the predicate device and the approved components.
8. The sample size for the training set
- Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML algorithm.
Summary of Acceptance:
The acceptance of the X3C 1590 Digital Radiographic System is based on demonstrating substantial equivalence to a legally marketed predicate device (Xplorer 1590 - K062405). The key "study" proving this is a non-clinical evaluation comparing the modified device to the predicate device, focusing on:
- Non-clinical tests: Performance, biocompatibility, effectiveness, thermal, electrical, and mechanical safety.
- Fundamental scientific technology: The submission asserts that replacing the detector does not alter the fundamental scientific technology.
- Intended Use: The intended use remains the same as the predicate device.
- Quality Systems: The manufacturer conforms to 21 CFR part 820, ISO 9001, and ISO 13485 quality systems.
The FDA's decision to grant 510(k) clearance (as evidenced by the letter in the document) indicates they agreed that the device is substantially equivalent and does not require new clinical data for market entry.
§ 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.