(54 days)
This is a digital mobile diagnostic x-ray system 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.
This is a new type of our previous predicate mobile PhoeniX. The predicate PhoeniX mobile is interfaced with Canon Digital X-ray panels and Canon control software CXDI-NE. The new PhoeniX mobile is interfaced with Konica – Minolta Digital X-ray panels and CS-7 or Ultra software image acquisition. Phoenix mobile systems will be marketed in the USA by KONICA MINOLTA. Models with the CS-7 Software will be marketed as AeroDR Tran-X Models with the Ultra Software will be marketed as mKDR II. The compatible digital receptor panels are the same for either model. The CS-7 software was cleared under K151465/K172793, while the Ultra software is new. The CS-7 is a DIRECT DIGITIZER used with an image diagnosis device, medical imaging device and image storage device connected via the network. This device digitally processes patient images collected by the medical imaging device to provide image and patient information. By contrast the Ultra-DR software is designed as an exam-based modality image acquisition tool. Ultra-DR software and its accompanying Universal Acquisition Interface (UAI) were developed to be acquisition device independent. Basic Features of the software include Modality Worklist Management (MWM) / Modality Worklist (MWL) support, DICOM Send, CD Burn, DICOM Print, and Exam Procedure Mapping. Ultra Software is designed to increase patient throughput while minimizing data input errors. Ultra is made up of multiple components that increase efficiency while minimizing errors. The main components of Ultra are the Worklist, Acquisition Interface and Configuration Utility. These components combine to create a Stable, Powerful, and Customizable Image capture system. The intuitive graphical user interface is designed to improve Radiology, Technologist accuracy, and image quality. Worklist and Exam screens were developed to allow site specific customizations to seamlessly integrate into existing practice workflows.
Here's an analysis of the acceptance criteria and study information for the PHOENIX Digital Mobile Diagnostic X-Ray System, based on the provided text.
Based on the provided document, the PHOENIX device is a digital mobile diagnostic x-ray system, and the submission is for a modification to an existing cleared device (K192011 PHOENIX). The "study" described is primarily non-clinical bench testing to demonstrate that the modified system, with new digital flat-panel detectors (AeroDR series) and new acquisition software (Ultra), is as safe and effective as the predicate device. No clinical study information is provided in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the overall device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The comparison is primarily in the form of feature similarity and compliance with international standards for safety and electrical performance.
| Characteristic | Predicate (K192011 PHOENIX) | PHOENIX (Proposed) | Comparison of Performance |
|---|---|---|---|
| Indications for Use | 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. | SAME (includes device description as requested by FDA) | Met: Indications for use are identical, signifying no change in intended clinical application. |
| Configuration | Mobile System with digital x-ray panel and image acquisition computer | SAME | Met: Basic physical configuration remains unchanged. |
| X-ray Generator(s) | kW rating: 20 kW, 32 kW, 40 kW and 50 kW. kV range: from 40 kV to 150 kV in 1 kV steps. mA range: from 10 mA to 630 mA / 640 mA / 650 mA. | SAME | Met: The X-ray generator specifications are identical, ensuring consistent radiation output characteristics. |
| Collimator | Ralco R108F | Ralco R108F | Met: The collimator model is identical, ensuring consistent radiation field shaping. |
| Meets US Performance Standard | YES 21 CFR 1020.30 | SAME | Met: Compliance with the US Performance Standard for diagnostic X-ray systems is maintained. |
| Power Source | Universal power supply, from 100 V~ to 240 V~. 1 phase, 1.2 kVA | SAME | Met: Power supply specifications are identical. |
| Software | Canon control software CXDI-NE | Konica-Minolta control software CS-7 (K151465 or K172793) OR Konica-Minolta control software Ultra. | Met (by validation): New software (Ultra) validated according to FDA Guidance. CS-7 was previously reviewed. This is a key change, and compliance is asserted through specific software validation. |
| Panel Interface | Ethernet or Wi-Fi wireless | SAME | Met: Interface method is unchanged. |
| Image Area Sizes (Detectors) | CANON CXDI-401C 16"x 17", CXDI-701C 14" x 17", CXDI-801C 11" x 14", CXDI-710C 14" x 17", CXDI-810C 14" x 11", CXDI-410C 17" x 17" | AeroDR P-51 14" x 17", AeroDR P-52 14" x 17", AeroDR P-61 14" x 17", AeroDR P-71 17" x 17", AeroDR P-81 10" x 12". (Similar range of sizes, all previously cleared) | Met (by equivalence): The new detectors offer a "similar range of sizes" and are all "previously cleared" by FDA. This implies their performance characteristics within those sizes are acceptable. |
| Pixel Sizes (Detectors) | CANON CXDI (all 125 µm) | AeroDR P-51 175 µm, AeroDR P-52 175 µm, AeroDR P-61 100/200 µm, AeroDR P-71 100/200 µm. | Met (by equivalence): The new pixel sizes are different but are associated with previously cleared detectors, implying their diagnostic utility is acceptable. Specific performance comparison (e.g., to predicate's pixel size) isn't given for diagnostic equivalence, but rather for detector equivalence. |
| Resolutions (Detectors) | CANON CXDI (various, e.g., CXDI-401C 3320 × 3408 pixels) | AeroDR P-51 1994 × 2430 pixels, AeroDR P-52 1994 × 2430 pixels, AeroDR P-61 3488 × 4256 pixels, AeroDR P-71 4248 × 4248 pixels, AeroDR P-81 2456 × 2968 pixels. | Met (by equivalence): Similar to pixel size, specific resolutions differ but are for previously cleared detectors. Diagnostic equivalence is asserted by the prior clearance of the detectors themselves. |
| MTF (Detectors) | CANON CXDI (all 0.35 @ 2cy/mm) | AeroDR P-51 0.30 @ 2cy/mm, AeroDR P-52 0.30 @ 2cy/mm, AeroDR P-61 0.30 @ 2cy/mm, AeroDR P-71 0.30 @ 2cy/mm, AeroDR P-81 0.30 @ 2cy/mm. | Met (by equivalence): The new detectors have slightly lower MTF values at 2cy/mm, but these are for previously cleared detectors, implying acceptable image quality for diagnostic use. |
| DQE (Detectors) | CANON CXDI (all 0.6 @ 0 lp/mm) | AeroDR P-51 0.62 @ 0 lp/mm, AeroDR P-52 0.62 @ 0 lp/mm, AeroDR P-61 0.56 @ 1 lp/mm, AeroDR P-71 0.56 @ 1 lp/mm, AeroDR P-81 0.56 @ 1 lp/mm. | Met (by equivalence): DQE values differ but are for previously cleared detectors, suggesting acceptable performance. Some are higher, some are slightly lower (e.g., P61/P71/P81 at 1 lp/mm vs. predicate at 0 lp/mm). The key is the "previously cleared" status. |
| Compliance with Standards | N/A (implied by predicate clearance) | IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, IEC 60601-1-3:2008+A1:2013, IEC 60601-2-54:2009+A1:2015, IEC 60601-2-28:2010, IEC 60601-1-6:2010 + A1:2013, IEC 62304:2006 + A1:2016. | Met: Device tested and found compliant with these international standards for safety and essential performance. |
Summary of the "Study" Proving Acceptance Criteria
The study described is a non-clinical, bench testing-based assessment for demonstrating substantial equivalence rather than a clinical study measuring diagnostic performance outcomes.
The core argument for substantial equivalence is based on:
- Identical Indications for Use.
- Identical platform (mobile system, generator, collimator, power source).
- Replacement of components (detectors and acquisition software) with components that are either:
- Previously FDA cleared (AeroDR detectors, CS-7 software).
- Validated according to FDA guidance (Ultra software).
- Compliance with recognized international standards for medical electrical equipment.
Here are the specific details requested:
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No patient-level test set data is mentioned for testing diagnostic performance. The "test set" consisted of physical devices (systems covering all generator/panel combinations) for bench testing and software for validation.
- Data Provenance: Not applicable for a clinical test set. The testing was non-clinical bench testing. The detectors themselves (AeroDR) are stated to have been "previously cleared" by the FDA, implying their performance was established via other submissions, likely including data from various countries consistent with regulatory submissions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. There was no clinical test set requiring expert ground truth establishment for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance."
- Effect size of human readers improvement: Not applicable, as no such study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, for the software component. The new image acquisition software (Ultra) was validated according to the "FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This validation assesses the software's functionality and performance as a standalone component within the system, ensuring it correctly manages workflow, acquires images, and processes them. However, this is software validation, not a standalone diagnostic performance study in the context of an AI algorithm producing diagnostic outputs.
7. The Type of Ground Truth Used
- For the overall device: Substantial equivalence to a legally marketed predicate device (K192011 PHOENIX), which itself would have demonstrated safety and effectiveness.
- For the components (detectors): Prior FDA clearance of the Konica-Minolta AeroDR panels served as the "ground truth" for their imaging characteristics (MTF, DQE, pixel size, etc.) being diagnostically acceptable.
- For the software (Ultra): Validation against specified functional and performance requirements outlined in the FDA software guidance, which serves as the ground truth for software quality and safety.
- For the PHOENIX system itself: Compliance with international safety and performance standards (IEC series) served as the ground truth for its electrical, mechanical, and radiation safety.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense of image analysis. It is an imaging acquisition device. The software validation is based on engineering principles and testing, not statistical training on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set for an AI/ML algorithm was used.
§ 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.