(36 days)
These Digital 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.
Easy Moving Plus is a mobile x-ray unit that covers, with a wide range of models, all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. The cordless Easy Moving "B" (battery powered version) combines stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging.
The provided text is a 510(k) summary for the Sedecal Easy Moving Plus Mobile X-Ray System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, many of the requested categories about specific performance metrics, ground truth, and expert studies are not applicable or explicitly stated in this type of submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for substantial equivalence to predicate devices, there isn't a table of specific acceptance criteria in the sense of quantitative performance targets for a new therapeutic or diagnostic algorithm. Instead, the "acceptance criteria" are implied by demonstrating that the new device's characteristics are either identical to or non-inferior to the predicate devices, particularly regarding safety and effectiveness.
The document directly compares the Sedecal Easy Moving Plus to its predicate devices, K012663 (Easy Moving film) and K043002 (Easy Moving Digital). The performance is effectively assessed by establishing that the new device shares the same intended use, configuration, relevant performance standards, and similar technical specifications (e.g., generator type, collimator, electrical safety).
| Characteristic | Predicate Device K012663 (Easy Moving film) | Predicate Device K043002 (Easy Moving Digital) | Sedecal Easy Moving Plus (K090322) |
|---|---|---|---|
| Intended Use | Same as indicated below | Same as indicated below | 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. |
| Configuration | Battery operated mobile | Battery operated mobile | Battery operated mobile |
| Performance Standard | 21 CFR 1020.30 | 21 CFR 1020.30 | 21 CFR 1020.30 |
| Generator | High frequency made by Sedecal | High frequency made by Sedecal | High frequency made by Sedecal |
| Generator Power | 20 or 30 kw (2 models) | 16 to 50 kw (4 models) | 20 to 50 kw (4 models) |
| Collimator | Ralco R221 DHHS | Ralco R221 DHHS | Ralco R221 DHHS |
| Image Acquisition | Film | Digital CANON 50G | CANON 50G (Film or digital models available) |
| Electrical Safety | Electrical Safety per IEC-60601. UL listed | Electrical Safety per IEC-60601. UL listed | Electrical Safety per IEC-60601. UL listed |
2. Sample Size Used for the Test Set and Data Provenance
This is not a study involving a "test set" in the context of an AI algorithm or a diagnostic test with patient data. The submission relies on bench and external laboratory testing to applicable standards, as stated in Section 5 and 7. The data provenance is not specified beyond "bench and external laboratory results," implying controlled engineering and electrical testing rather than clinical data from specific countries or patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study is not assessing a diagnostic or predictive device requiring expert-established ground truth from clinical cases. It's about the safety and performance of an X-ray system itself.
4. Adjudication Method for the Test Set
Not applicable, as there is no clinical "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
Not applicable. This is a medical device clearance for an X-ray system, not a clinical study evaluating the effectiveness of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an X-ray system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the applicable performance standards (e.g., 21 CFR 1020.30 for performance standards for diagnostic X-ray systems and their major components; IEC-60601 for electrical safety). The device's compliance with these standards (through bench and laboratory testing) serves as the "ground truth" for its safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.