(310 days)
Digital X-ray Imaging System, DRC-1000, is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, extremities, and other body parts. Not to be used for fluoroscopy, angiography, or screening mammography. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
DRC-1000 is a digital diagnostic x-ray system which consists of Solid State Xray Imager (Flat Panel), tube-collimator assembly mounted on a U-Arm, generator and operation control unit. DRC-1000 is designed for adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The provided 510(k) summary for the DRC-1000 Digital X-ray Imaging System does not contain information about specific acceptance criteria or a dedicated study proving the device meets particular clinical performance criteria.
This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Sedecal X-Plus LP Plus Digital) primarily based on technical specifications and adherence to electrical, mechanical, environmental safety, and EMC standards.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a summary of what can be inferred or explicitly stated from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- No specific clinical acceptance criteria (e.g., sensitivity, specificity, image quality metrics) are provided in the document.
- The device performance is described in terms of its ability to meet safety and electrical standards rather than clinical diagnostic performance.
| Acceptance Criterion (Inferred from document) | Reported Device Performance (Inferred from document) |
|---|---|
| Electrical Safety (IEC 60601-1) | All test results were satisfactory. |
| Mechanical Safety | All test results were satisfactory. |
| Environmental Safety | All test results were satisfactory. |
| Performance (IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32) | All test results were satisfactory. |
| EMC (IEC 60601-1-2) | All test results were satisfactory. |
| Substantial Equivalence to Predicate Device | Concluded to be safe, effective, and substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not specified. The document does not describe a clinical test set or data involving patient images for performance evaluation. The "test results" mentioned pertain to engineering and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical ground truth establishment is described.
4. Adjudication method for the test set:
- Not applicable. No clinical test set or adjudication process is described.
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. This is a traditional X-ray system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device; "standalone algorithm performance" is not relevant here.
7. The type of ground truth used:
- Not applicable for clinical performance. The "ground truth" for the reported tests would be adherence to the specifications of the mentioned IEC standards (e.g., electrical parameters, radiation output, mechanical stability).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant.
In summary: The provided 510(k) summary demonstrates substantial equivalence for the DRC-1000 by
- Comparing its general description and indications for use to a legally marketed predicate device.
- Stating successful completion of various electrical, mechanical, environmental safety, performance, and EMC standard tests (IEC 60601 series).
It does not include any information regarding clinical performance studies, such as those involving image analysis, diagnostic accuracy, or reader performance, which would typically involve specific acceptance criteria, test sets, expert readers, and ground truth establishment. This is common for traditional imaging hardware where regulatory clearance hinges on safety, basic performance, and equivalence to existing technology, rather than novel clinical diagnostic claims.
§ 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.