(29 days)
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
This device is simply the combination of two cleared devices, the Wireless Portable Detector FD-W17 (K090625) marketed by Philips Medical Systems and the Easy Moving Plus, Mobile Diagnostic X-Ray (K090322) made by Sedecal. The x-ray source is a motor driven mobile x-ray and the x-ray receptor panel is a digital wireless unit. The Wireless Portable Detector FD-W17 consists of three main parts: Portable radiography detector (x-ray sensitive part), docking station which is directly connected to the radiographic workstation, backup cable which can connect the detector to the docking station if the wireless connection cannot be used. Detector size: 35 x 43 cm (14 x 17") Image matrix size: 3000 pixels x 2400 pixels. Pixel size 144 um、Image resolution up to 3.5 LP/mm
Here's an analysis of the provided text regarding the acceptance criteria and study for the MobileDiagnost wDR device:
This 510(k) summary focuses on demonstrating substantial equivalence for the MobileDiagnost wDR as a combination of two already cleared predicate devices. It does not contain a traditional clinical study with detailed performance metrics against specific acceptance criteria for a novel algorithm. Instead, the "study" is a comparison to predicate devices, focusing on the absence of significant differences.
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly define acceptance criteria as quantitative performance metrics for the MobileDiagnost wDR itself (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to its predicate devices, implying that if it performs comparably to already cleared devices, it meets the required safety and effectiveness.
| Characteristic | Acceptance Criteria (implied by predicate) | Reported Device Performance (MobileDiagnost wDR) |
|---|---|---|
| Intended Use | Same as Sedecal Easy Moving Digital (K090322) | SAME |
| Configuration | Battery or line operated mobile | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by Sedecal | SAME |
| Generator power levels | 20 to 50 kw (4 models) | 20 to 50 kw (4 models) |
| Collimator | Ralco R221 DHHS | Ralco 108F DHHS (equivalent) |
| Image acquisition | Digital CANON CDXI-50G (K031447) | Philips Wireless Portable Detector FD-W17 (K090625) |
| Electrical safety | Electrical Safety per IEC-60601, UL listed | SAME |
| Clinical Images | No significant differences compared to predicate | No significant differences |
| Software Validation | All tests passed | Tests performed, results indicate safety and effectiveness |
| Risk Analysis | Acceptable risk profile | Analysis performed |
| Hardware Compliance | US Performance Standards, CSA Certified | Conforms to US Performance Standards, CSA Certified |
2. Sample size used for the test set and the data provenance
- Sample Size: The document states "Clinical images were acquired and compared to our predicate images." It does not specify the number of clinical images acquired.
- Data Provenance: Not explicitly stated (e.g., retrospective/prospective, country of origin). It's implied that the images were taken for the purpose of this comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a direct comparison of images from the new device to those from predicate devices, likely for visual assessment of image quality, not for diagnostic accuracy against a ground truth diagnosis established by experts. The comparison involved assessing clinical images for "significant differences," which would typically be done by qualified personnel familiar with diagnostic image quality, but no specific number or qualification of experts is mentioned for this task.
4. Adjudication method for the test set
Not applicable. There's no mention of an adjudication process, as the goal was a direct comparison of image quality between two systems, not a diagnostic accuracy assessment requiring consensus on diagnoses.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. A MRMC study was not performed. The study described is a comparison of "Clinical images... acquired and compared to our predicate images." This indicates a technical comparison rather than a human reader performance study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a way. The "algorithm" here refers to the overall device's image acquisition and processing. The comparison of clinical images and software validation are assessments of the device's standalone performance in producing images and functioning correctly, without explicit human assistance in the "performance" measurement.
7. The type of ground truth used
Not explicitly stated. For the "clinical images were acquired and compared to our predicate images" statement, the "ground truth" would be the expected image quality and diagnostic information provided by the predicate device. The comparison aimed to show that the new device produced images of essentially the same quality and diagnostic utility as the predicate. It did not involve comparing readings against a histopathological diagnosis or clinical outcomes.
8. The sample size for the training set
Not applicable. The device is a combination of existing cleared devices (a mobile X-ray unit and a digital detector). This is not an AI/ML algorithm that requires a separate "training set." The software validation refers to functional testing, not model training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm mentioned in this submission.
§ 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.