(56 days)
This Portable Diagnostic Radiographic System 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, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
The Sedecal SPL-HF-4.0 portable x-ray generator consists of: X-ray Unit with: Control Panel with controls and displays for radiographic operations; Power Module containing control and power components; HV Tank that comprises the High Voltage Transformer, the Filament Transformer and the X-ray Tube; and a Collimator with controls to limit the X-ray beam; a Handswitch and a Mobile Column with an Articulated Arm and a Cassette Basket.
This 510(k) submission describes a new mobile X-ray system, the Sedecal SPL-HF-4.0 (and SPL-HF-2.0), which is intended for diagnostic radiographic exposures. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the Sedecal Models SP-HF-2.8 and SP-HF-4.0 (K020436).
Based on the provided information, the focus is on demonstrating safety and effectiveness through non-clinical testing rather than a clinical study involving human subjects and diagnostic performance metrics. Therefore, many of the requested elements pertaining to clinical study design, such as sample size, ground truth establishment for a test set, expert qualifications, and comparative effectiveness, are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Tested to IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Tested to IEC 60601-1-2 |
| Software Validation | Software validation testing performed |
| Radiation Safety/Performance | Tested to IEC 60601-1-3 and IEC 60601-2-7 (These standards relate to general requirements for radiation protection in diagnostic X-ray equipment and particular requirements for the safety of medical electron accelerators, respectively. While IEC 60601-1-3 is directly relevant to diagnostic X-ray, the inclusion of IEC 60601-2-7 seems slightly out of place for a mobile diagnostic X-ray system and might be a typo or refer to a general safety assessment for components). Implicitly, the device's technological characteristics are "nearly identical" to the predicate, suggesting similar performance. |
| Substantial Equivalence | Based on results of nonclinical tests, the device is "as safe, as effective, and performs as well as or better than the legally marketed devices." Materials and construction methods are "nearly identical" to the predicate. |
2. Sample size used for the test set and the data provenance
Not applicable. The submission describes non-clinical testing (electrical safety, EMC, software, and radiation safety standards) rather than a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth for image interpretation or diagnostic accuracy was established as this was not a clinical performance study.
4. Adjudication method 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. No MRMC study was performed as this is a new X-ray generator, not an AI-based interpretation device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (X-ray generator), not an algorithm or AI system.
7. The type of ground truth used
Not applicable for a clinical performance study. For the non-clinical testing, the "ground truth" would be the specifications and requirements defined by the referenced IEC standards and internal design specifications.
8. The sample size for the training set
Not applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is primarily a series of non-clinical tests mandated by international standards for medical electrical equipment and X-ray devices. These include:
- Electrical Safety Testing (IEC 60601-1): This standard ensures the device does not pose electrical hazards to patients or operators.
- Electromagnetic Compatibility (EMC) Testing (IEC 60601-1-2): This verifies that the device functions correctly in its electromagnetic environment and does not interfere with other equipment.
- Software Validation Testing: Ensures the software controlling the device functions as intended and is reliable.
- Radiation Safety/Performance Testing (IEC 60601-1-3 and IEC 60601-2-7): IEC 60601-1-3 specifies general requirements for radiation protection in diagnostic X-ray equipment, ensuring appropriate X-ray emission and safety features. As mentioned, IEC 60601-2-7's relevance here is somewhat ambiguous; it typically applies to medical electron accelerators. However, its inclusion suggests a comprehensive approach to safety standards where applicable.
The submission asserts that based on the results of these non-clinical tests, the device is "as safe, as effective, and performs as well as or better than the legally marketed devices" (specifically, the predicate device K020436). The core argument for acceptance and substantial equivalence relies on the fact that the new device shares "nearly identical" technological characteristics, design, materials, chemical composition, and energy source with the predicate device, with this submission representing an "updated design" of the previous model. The conclusion is that because the updated model passes the relevant safety and performance standards, and its technical characteristics are so similar to an already cleared device, it is substantially equivalent.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.