(83 days)
These Portable Diagnostic Radiographic Systems are 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 Dragon LW 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 portable column with an Articulated Arm, a Cassette Basket, and any of the following (previously cleared) Canon Digital X-Ray Receptor Panels: CXDI-501, CXDI-70C, or CXDI-80C. Each of these panels has their own 510(k) clearance. The two generator units are capable of either 4 or 8 kW depending on the model. They are AC line operated. The user interface is the same touchscreen control that was introduced in the K042361 SP-HF-4.0 D Portable.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Conforms to IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 |
| Software Validation | Validated |
| X-ray System Performance | Conforms to IEC 60601-1-3 and IEC 60601-2-7 |
| Clinical Image Evaluation | Clinical images acquired and evaluated based on FDA Guidance for Solid State X-ray Imaging Devices. Device concluded to be as safe, effective, and perform as well as or better than legally marketed predicate devices. |
Note: The document states that the device is "as safe, as effective, and performs as well as or better than the legally marketed devices" (predicates K103522 and K042361). Specific quantifiable metrics for clinical performance (e.g., sensitivity, specificity, image quality scores) are not provided in this summary. The acceptance criteria for clinical performance are implied by the comparison to predicate devices and adherence to FDA guidance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical images were acquired and evaluated," but does not provide the number of images or patients.
- Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The document only mentions that "Clinical images were acquired and evaluated."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study focused on demonstrating substantial equivalence to existing predicate devices through non-clinical and clinical image evaluations, not on comparing performance with and without AI assistance or quantifying improvements in human readers. This device is an X-ray unit, not an AI-powered diagnostic tool in the typical sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable/not explicitly stated. This device is an X-ray unit, which generates images. It is not an algorithm designed for standalone diagnostic interpretation. Its performance is as an imaging device.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. For "clinical images," the ground truth implicitly refers to the diagnostic findings determined by the evaluating professionals (likely radiologists or other trained clinicians), but the specific methodology for establishing this ground truth (e.g., expert consensus, pathology, follow-up outcomes) is not provided.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes an X-ray imaging device, not an AI/machine learning model that typically requires a separate training set. The "testing" mentioned refers to engineering and clinical performance validation of the hardware and associated software.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable (see point 8).
§ 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.