(87 days)
The DR 600 is a GenRad X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adults and pediatric patients. Applications can be performed with the patient in sitting, standing or lying position.
The DR 600 is not intended for use in Mammography applications.
Agfa's DR 600 is a solid state x-ray system, a direct radiography (DR) system (product code MOB) intended to capture images of the human body. The device is a combination of a conventional x-ray system with digital image capture. The DR 600 is a ceiling mounted tube and operator console with a motorized patient table and/or wall stand. The DR 600 uses Agfa's NX workstation with MUSICA2 ™ image processing and flat-panel detectors of the scintillatorphotodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). It is compatible with Agfa's computed radoigraphy systems as well.
The provided document is a 510(k) premarket notification for the Agfa DR 600, a stationary X-ray system. The core of this submission is to demonstrate substantial equivalence to previously cleared devices, not to demonstrate clinical efficacy or a specific performance benchmark for an AI model.
Therefore, the acceptance criteria and study proving an AI device meets those criteria, as typically understood in Machine Learning or AI product development, are not explicitly present in this document. The document focuses on demonstrating that the DR 600, as an imaging system, performs equivalently to its predicates based on physical and technological characteristics, and that its image quality is comparable.
However, I can extract the closest analogous information to the requested points, interpreting "acceptance criteria" through the lens of demonstrating "substantial equivalence" and "device performance" in terms of physical and image quality comparisons.
Here's how the document addresses the spirit of your request, adapted for a medical imaging device without a specific AI component being evaluated for a diagnostic task:
Acceptance Criteria and Study for Agfa DR 600 (Interpreted for a Standard X-Ray System)
The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to legally marketed predicate devices. This means proving that the DR 600 is as safe and effective as the predicate devices and does not raise different questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim for an X-ray system, the "acceptance criteria" are implied by comparing the new device's technical specifications and image quality to well-established predicates. No numerical "performance metrics" in the typical AI sense (e.g., AUC, sensitivity, specificity) for a diagnostic task are provided, as the device itself is the imaging system, not a diagnostic algorithm.
| Parameter/Characteristic | Acceptance Criteria (Implied by Predicates) | Reported DR 600 Performance |
|---|---|---|
| Image Quality | Equivalent to or better than predicate devices (DR 400 & DX-M) based on visual assessment by qualified radiologists. No artifacts influencing image quality. | Laboratory image quality comparison of DR 600 (with flat-panel & CR cassettes) and DR 400 (predicate K141192) and DX-M (CR System) anthropomorphic phantoms were performed. "The study confirmed that the Agfa DR 600 system... was equivalent to or better in performance than the DR 400 and DX-M." No artifacts detected using DR 600 that could influence image quality. |
| Usability & Functionality | Supports radiographic workflow, design, functionality, and usability within a hospital environment. FLFS workflow rated positive. Fulfilled intended use. | Usability and functionality evaluations conducted. "The results of the usability test fell within the acceptance criteria for all components; therefore, the DR 600 supports a radiographic workflow. The usability and functionality of Full Leg Full Spine (FLFS) workflow for DR was rated positive as well. The intended use is fulfilled using different flat-panel detectors." |
| Grid Tests Consistency | Consistent with predicate DR 400 results. Varian (DX-D 10) and Vieworks (DX-D 40) detectors work well. | Flat field, chest, and skull phantoms created using all grids for DR 600. "The results of the grid tests remained consistent with the DR 400 (predicate K141192) results. The Varian (DX-D 10) and Vieworks (DX-D 40) detectors worked well and had positive results. The intended use is fulfilled using different flat-panel detectors and/or CR cassettes and plates." |
| Technological Characteristics | "Same" or "similar" to predicates for key components (e.g., communication, detector material, pixel size, dynamic range, workstation, image processing). | "Principles of operation and technological characteristics of the new and predicate devices are the same." (Detailed comparisons in pages 6-7). Minor differences like ceiling vs. floor mounted tube, and specific generator/tube models, are deemed not to alter intended diagnostic effect. |
| Regulatory Compliance | Meets relevant safety and performance standards (e.g., IEC 60601 series, ISO 14971, ISO 13485). | Compliance demonstrated through laboratory testing and software verification/validation against standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ACR/NEMA PS3.1-3.20 (DICOM), ISO 14971, ISO 13485 (Page 8). |
| Risk Assessment | Risks are broadly acceptable or ALARP (As Low As Reasonably Practicable), with zero in the "Not Acceptable Region." | "For the DR 600 there are a total of 97 risks in the broadly acceptable region and eight risks in the ALARP region. Zero risks were identified in the Not Acceptable Region." (Page 8). |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document mentions "anthropomorphic phantoms" for image quality comparison and "all grids" for grid tests. It does not specify a specific number of phantom images or actual patient data. For usability, "qualified independent radiographers" and "qualified internal radiographer" participated.
- Data Provenance: The data appears to be prospective laboratory testing using phantoms rather than retrospective patient data. The country of origin for the data is not specified but would presumably be Agfa's testing facilities (likely in Belgium or the US, given the submission details).
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts:
- Image Quality: "Qualified independent radiologists" (plural, so at least two).
- Usability & Functionality: "Qualified independent radiographers" (plural, so at least two).
- Grid Tests: "Qualified internal radiographer" (singular, presumably one).
- Qualifications: "Qualified" is a general term. Specific years of experience or board certifications are not provided in this document.
4. Adjudication Method for the Test Set
- Image Quality: "Performed in pairs by the qualified independent radiologists." This suggests a consensus or comparison method, possibly side-by-side. The specific adjudication rule (e.g., majority vote, forced consensus) is not detailed.
- Usability & Functionality / Grid Tests: No specific adjudication method is mentioned beyond the conduct of the studies by qualified individuals.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This document describes an X-ray imaging system, not an AI software intended for diagnostic assistance. The "image quality evaluations conducted with independent radiologists" were for demonstrating primary image quality equivalence, not for evaluating radiologist performance with or without an AI.
6. Standalone Performance (Algorithm Only)
- Not applicable in the context of an AI algorithm. This device is a complete X-ray imaging system. Its performance (image quality, technical specifications) is evaluated as a standalone product. The "laboratory image quality comparison" can be considered as the "algorithm only" type of evaluation in the sense that the system's output (images) were assessed directly.
7. Type of Ground Truth Used
- For image quality, the ground truth appears to be expert visual consensus/comparison on anthropomorphic phantom images.
- For usability and functionality, the ground truth is based on user feedback and assessment against predefined usability criteria.
- For grid tests, the ground truth is the consistency of the results with predicate device expectations and visual assessment by an expert.
- No pathology or outcomes data were used as ground truth, as this is a technical equivalence submission for an imaging device, not a diagnostic AI.
8. Sample Size for the Training Set
- Not applicable. This document describes a medical device, not a machine learning model. There is no concept of a "training set" for the DR 600 system itself. Its internal image processing (MUSICA2™) is mentioned as being identical to that used in the predicate devices, implying it's a pre-existing, validated algorithm rather than one trained specifically for this submission.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for the DR 600 as a whole, this question is not addressed. The MUSICA2™ image processing is a pre-existing component validated with prior devices.
Summary: This 510(k) submission successfully demonstrates substantial equivalence of the DR 600 to its predicate devices through rigorous bench testing, including technical specifications comparison, image quality evaluation with phantoms by qualified radiologists, usability studies, and compliance with relevant safety and performance standards. The evaluations performed align with the requirements for showing that a new hardware medical imaging device is functionally and safely comparable to existing ones, rather than testing a novel AI diagnostic algorithm.
§ 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.