(28 days)
Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used.
Agfa's DX-D Imaging Package is not indicated for use in mammography.
Agfa's DX-D Imaging Package is a solid state flat panel x-ray system, a direct radiography (DR) system (product code MQB) intended to capture general radiography images of the human body. It is a combination of Agfa's NX workstation and one or more flat-panel detectors.
This submission is to add the DR14e and DR17e Flat Panel Detectors to Agfa's DX-D Imaging Package portfolio. Agfa's DR 14e and DR 17e wireless panels are currently marketed by Innolux as RIC 35C/G and RIC 43C/G, which is one of the predicates for this submission.
Principles of operation and technological characteristics of the new and predicate devices are the same. There are no changes to the intended use/indications of the device. The new device is physically and electronically identical to both predicates, K161368 and K162344. It uses the same workstation as predicate K161368 and the same flat panel detectors to capture and digitize the images as predicate K162344.
1. A table of acceptance criteria and the reported device performance
| Performance Characteristics | Acceptance Criteria (Implicit: Equivalence to Predicates) | Reported Device Performance (DR 14e & DR 17e) |
|---|---|---|
| Image Quality | At least equivalent to other Agfa flat-panel detectors currently on the market (DX-D 10 and DX-D 20), including the predicate K161368. | At least the same if not better image quality than other flat-panel detectors currently on the market (DX-D 10 and DX-D 20). |
| Usability/Functionality | Supports a radiographic workflow including calibration, compatibility, linear dose, and dynamic ranges. | Results fell within the acceptance criteria for all flat-panel detectors, supporting a radiographic workflow. |
| Grid Evaluation | Consistent with other Agfa HealthCare flat-panel detectors currently on the market, including the predicate K161368, and fulfills intended use. | Results remained consistent with other Agfa HealthCare flat-panel detectors, including the predicate K161368. Intended use fulfilled. |
| Software Validation | No risks identified in the "Not Acceptable Region" after mitigation for XRDi18 and NX9000. Benefits of the device outweigh residual risks. | For XRDi18: Zero risks identified in the Not Acceptable Region. For NX9000: No identified residual risks in the ALARP region, only three in the Broadly Acceptable Region. Device assumed safe, benefits outweigh residual risks. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated with a specific number of images or cases. The document mentions "anthropomorphic phantoms" for Image Quality Validation and that "When patient images were utilized, they were first anonymized." This suggests a mix of phantom images and anonymized retrospective patient images, but no specific count is provided for either.
- Data Provenance: Not specified. The document does not mention the country of origin for any patient data. The studies appear to be internal laboratory tests.
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)
- Image Quality Validation: Evaluated by "qualified independent radiographers." No specific number of experts or their years of experience are provided.
- Usability and Functionality Evaluations: Conducted with a "qualified internal radiographer." No specific number of experts or their years of experience are provided.
- Grid Evaluation: Conducted with a "qualified internal radiographer." No specific number of experts or their years of experience are provided.
- Software Validation (Risk Analysis): Performed by a "risk management team." No specific number or qualifications are given for this team.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No formal adjudication method (like 2+1 or 3+1 consensus) is described for any of the evaluations. The image quality and usability/functionality tests were evaluated by "qualified independent radiographers" or "qualified internal radiographer," suggesting individual assessment rather than a multi-reader consensus process.
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 conducted. The study performed was for substantial equivalence with predicate devices, focusing on technical performance and image quality compared to existing devices, not on human reader improvement with or without AI assistance. The device is a digital radiography imaging package, not explicitly described as an AI-powered diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary evaluation was a standalone assessment of the device's image acquisition and processing capabilities. The studies focused on the performance of the DX-D Imaging Package (DR 14e & DR 17e detectors in combination with the NX workstation) itself, confirming its image quality, usability, and functionality against established internal benchmarks and predicate devices. While radiographers were involved in evaluating image quality, their role was to assess the output of the device, not to measure their own diagnostic performance with or without the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Image Quality Validation: The ground truth for image quality was based on expert assessment by "qualified independent radiographers" comparing images from the new device to established quality standards and images from existing Agfa flat-panel detectors (DX-D 10 and DX-D 20, and predicate K161368). The phrasing "at least the same if not better image quality" implies a subjective expert evaluation against a benchmark.
- Usability and Functionality: Ground truth was adherence to predefined acceptance criteria for workflow, calibration, compatibility, linear dose, and dynamic ranges, assessed by a "qualified internal radiographer."
- Grid Evaluation: Ground truth was consistency with other Agfa HealthCare flat-panel detectors and fulfillment of intended use, assessed by a "qualified internal radiographer."
- Software Validation: Ground truth for software safety and risk was established against internal risk management frameworks and relevant product/quality management standards (IEC 60601-1, ISO 14971, ISO 13485, ISO 62366, ISO 62304).
8. The sample size for the training set
The document states, "No animal or clinical studies were performed in the development of the new device." This implies that there wasn't a separate training set of clinical images in the context of developing a new algorithm or AI model for diagnostic purposes. The device is hardware (detectors) and associated software, and development would involve engineering and performance testing rather than machine learning training sets.
9. How the ground truth for the training set was established
Not applicable, as no specific training set for an AI algorithm appears to have been used or described for this device submission. The device is described as an imaging package with new detectors integrating into an existing workstation, not a novel AI diagnostic tool requiring extensive clinical training data.
§ 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.