(59 days)
Allengers Wireless / Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is used to acquire/ Process/ Display/ Store/ Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screen or CR system is used
Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is substantially equivalent product of its predicate device, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG are portable (wireless) and G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG, G4343RG, G4343RC (wired) Digital are non-portable detectors. The Wireless/ Wired X-Ray Flat Panel Detectors is designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for nongrid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.
This Device is currently indicated for general projection radiographic applications and the scintillator material is using cesium iodide (Csl) or gadolinium oxy sulfide (GOS).
The Wireless/ Wired X-Ray Flat Panel Detectors sensor can automatically collect x-ray from an x-ray source. It collects the x-ray and converts it into digital image and transfers it to Desktop computer / Laptop/ Tablet for image display. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images, the personal computer is not part of this submission.
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR, runs on a Windows based Desktop computer/ Laptop/ Tablet as a user interface for radiologist to perform a general radiography exam. The function includes:
-
- User Login
-
- Display Connectivity status of hardware devices like detector
-
- Patient entry (Manual, Emergency and Worklist)
-
- Exam entry
-
- Image processing
-
- Search patient Data
-
- Print DICOM Image
-
- Exit
The provided text outlines the performance data for the "Wireless/Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR." However, it does not specifically present a table of acceptance criteria and reported device performance in a quantitative manner (e.g., sensitivity, specificity, accuracy). Instead, it primarily focuses on compliance with recognized standards and guidance documents, emphasizing non-clinical tests.
Here's an analysis of the information provided, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not provide a quantitative table of acceptance criteria (e.g., specific metrics like DQE values, spatial resolution, or SNR targets) with corresponding reported device performance values. Instead, it states that the device "confirms to the voluntary standards" and that "the image quality evaluation confirmed that the image quality of the Wireless/ Wired X-Ray Flat Panel Detectors is substantially equivalent to that of the predicate device."
The acceptance criteria are implicitly tied to the successful demonstration of compliance with a long list of international and FDA-recognized consensus standards and guidance documents. The reported performance is that the device "Met all requirements" for each of these standards.
Implicit Acceptance Criteria and Reported Performance (based on document content):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with AAMI / ANSI ES60601-1 (Basic Safety & Performance) | Met all requirements |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | Met all requirements; results were satisfactory |
| Compliance with IEC 62304 (Software Life Cycle Processes) | Met all requirements |
| Compliance with IEC 60601-1-6 (Usability) | Met all requirements |
| Compliance with ANSI AAMI IEC 62366-1 (Usability Engineering) | Met all requirements |
| Compliance with ISO 10993-1 (Biological Evaluation) | Met all requirements; material safe and effective |
| Compliance with ISO 10993-10 (Irritation & Skin Sensitization) | Met all requirements |
| Compliance with ISO 14971 (Risk Management) | Met all requirements |
| Compliance with ISO 15223-1 (Symbols for Information) | Met all requirements |
| Compliance with ANSI AAMI HE75 (Human Factors Engineering) | Met all requirements |
| Compliance with ISO 10993-5 (Cytotoxicity) | Met all requirements |
| Compliance with IEC 62220-1-1 (Detective Quantum Efficiency) | Met all requirements |
| Compliance with IEC 62133-2 (Safety of Lithium Systems) | Met all requirements |
| Compliance with ISO 20417 (Information by Manufacturer) | Met all requirements |
| Compliance with FDA Guidance for Solid State X-ray Imaging Devices | Met all requirements |
| Compliance with FDA Guidance for Cybersecurity in Medical Devices | Met all requirements; no new/increased cybersecurity risks |
| Compliance with FDA Guidance for Content of Premarket Submissions for Software | Met all requirements |
| Image quality comparable to predicate devices | Image quality confirmed substantially equivalent |
| Load-bearing characteristics | Tested and passed |
| Protection against ingress of water | Tested and passed |
| EMC emission testing (IEC 60601-1-2) | Demonstrated through testing; results satisfactory |
| Biocompatibility | Demonstrated through ISO 10993 series |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance data (bench testing). There is no mention of a specific "test set" with a sample size of patient data. The provenance of testing (e.g., country of origin, retrospective/prospective) for these non-clinical tests is not detailed, beyond being conducted by Allengers Medical Systems Limited and likely by accredited testing labs for compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or not provided since no clinical study with a "test set" requiring expert ground truth establishment for diagnostic performance is described. The evaluation focuses on engineering and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided as there was no clinical test set requiring expert adjudication.
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
No MRMC comparative effectiveness study was done or reported. The document explicitly states: "Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies." Furthermore, this device is an X-ray flat panel detector and associated acquisition software, not an AI-powered diagnostic algorithm designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of an X-ray detector. The device itself is a component for acquiring images. Its "standalone performance" is assessed through engineering metrics and compliance with imaging standards (e.g., DQE, MTF, noise characteristics), which are part of the non-clinical testing. It's not an "algorithm" in the sense of a standalone diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is typically defined by the technical specifications of the standards and test methodologies themselves. For example:
- For IEC 62220-1-1 (DQE), the ground truth is the physical properties of the detector under specific X-ray conditions, measured according to the standard's protocol.
- For biocompatibility (ISO 10993), the ground truth is the absence of adverse biological reactions as determined by standardized in vitro and in vivo tests.
- For safety (IEC 60601-1), the ground truth is meeting the safety limits and design requirements outlined in the standard.
There is no mention of clinical ground truth (expert consensus, pathology, outcomes data) as no clinical studies were performed.
8. The sample size for the training set
Not applicable. This device is a hardware component (X-ray detector) and its associated acquisition software. It is not described as involving a machine learning algorithm that requires a "training set" of data for diagnostic purposes. The software mentioned ([AWS] Synergy DR FDX/ Synergy DR) is for image acquisition, processing, display, and storage, not for AI-driven detection or diagnosis.
9. How the ground truth for the training set was established
Not applicable for the reasons stated in point 8.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.