(25 days)
The DR 100s system is a mobile X-ray imaging system used in hospitals, clinics and medical practices by radiographers and radiologists 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 adult, pediatric or neonatal patients.
Applications can be performed with the patient in the sitting, standing or lying position.
This device is not intended for mammography applications.
Agfa's DR 100s is a mobile x-ray system, a direct radiography system (product code ILL) intended to capture images of the human body. The device is an integrated mobile digital radiography x-ray system. The complete DR 100s systems consists of the mobile x-ray unit with integrated x-ray generator and NX software and one or more DR detectors. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital image capture. It is compatible with Agfa's computed radiography systems as well.
This submission is to add another mobile unit to Agfa's direct radiography portfolio.
The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are identical to those previously cleared in the DX-D 100 (K103597) and other devices in Agfa's radiography portfolio today, which includes DR 600 (K152639), DR 400 (K141192) and DR 800 (K183275).
Significant dose reduction can be achieved using the DR 100s with patented Agfa's MUSICA imaging processing and CsI flat-panel detectors. Testing with board certified radiologists determined that Cesium Bromide (CR) and Cesium Iodine (DR) detectors when used with MUSICA imaging processing can provide dose reduction between 50-60% for adult patients and up to 60% for pediatric and neonatal patients when compared to traditional Barium Fluoro Bromide CR systems (K141602).
Principles of operation and technological characteristics of the new and predicate device are the same. The new device is virtually identical to Agfa's DX-D 100(K103597) with the exception that it has a telescopic column and ergonomic design. It uses the same flat panel detectors to capture and digitize the image. Differences in devices do not alter the intended diagnostic effect.
The provided text describes the DR 100s mobile X-ray system and its substantial equivalence to a predicate device, the DX-D 100. However, it does not contain specific acceptance criteria or a detailed clinical study proving the device meets these criteria in the manner requested.
The document states that the DR 100s uses the same image processing algorithms and flat-panel detectors as previously cleared devices, and that "Clinical image validation was conducted during testing in support for the 510(k) clearances for the flat-panel detectors (K161368 and K172784) and MUSICA software (K183275) in a previous submission." It also mentions that "Image quality bench tests were conducted in support of this 510(k) submission in which anthropomorphic adult and pediatric images taken with the DR 100s and the predicate device, DX-D 100 (K103597) were compared to ensure substantial equivalency. The test results indicated the image processing of the DR 100s passed the acceptance criteria."
This means the primary method for demonstrating equivalence and meeting acceptance criteria was through bench testing and referencing prior clearances for components. There's no detailed mention of a specific, standalone clinical study with human patients for the DR 100s itself, nor a multi-reader multi-case (MRMC) study.
Therefore, many of the requested details about a clinical study's methodology (sample size, data provenance, expert numbers, adjudication, MRMC results, ground truth types) cannot be extracted from this document directly for the DR 100s.
Here's an attempt to answer the questions based only on the provided text, acknowledging where information is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria in a table format for image quality or specific diagnostic performance metrics (e.g., sensitivity, specificity). Instead, it states:
- "The test results indicated the image processing of the DR 100s passed the acceptance criteria." (for image quality bench tests)
- "All design input requirements have been tested and passed." (for technical and acceptance testing)
- "The results of these tests fell within the acceptance criteria for the DR 100s X-ray system therefore, the DR 100s supports a General radiographic workflow including adult and pediatric patients." (for usability and functionality)
Without specific numerical criteria, a performance table cannot be constructed. The main "performance" metrics provided are technical specifications of the flat-panel detectors (DQE, MTF, pixel size, etc.) which are compared to predicate devices but don't represent acceptance criteria for a clinical study proving diagnostic performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the image quality bench tests. The document only mentions "anthropomorphic adult and pediatric images."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are described as "bench tests" using anthropomorphic phantoms, not real patient data directly for the DR 100s itself. The "clinical image validation" mentioned refers to prior 510(k) clearances for components (detectors and software), not this specific device submission.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: It vaguely mentions "internal experts" for usability and functionality evaluations. For the "clinical image validation" of previously cleared components, it references validation conducted with "board certified radiologists" for dose reduction testing (K141602), but this is for a different aspect (dose reduction with MUSICA and CsI detectors) and potentially not the core image quality comparison for equivalence of the total system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No MRMC study is explicitly mentioned for the DR 100s. The document states "No clinical trials were performed in the development of the device. No animal or clinical studies were performed in the development of the new device."
- Effect Size: Not applicable, as no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a mobile X-ray system and image processor, not an AI algorithm for diagnosis. Its performance is inherent in the image acquisition and processing. The "image processing of the DR 100s passed the acceptance criteria" refers to the system's ability to produce images comparable to the predicate. Therefore, the "standalone" performance is the image quality produced directly by the system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the image quality bench tests, the "ground truth" was likely established through objective phantom measurements and comparison to the predicate device, rather than clinical ground truth (expert consensus, pathology, or outcomes data). The document refers to "anthropomorphic adult and pediatric images" meaning images of phantoms designed to mimic human anatomy.
8. The sample size for the training set
- Training Set for DR 100s: The DR 100s system itself is a hardware device with integrated software for image processing (MUSICA). It's not an AI model that undergoes a "training" phase in the conventional sense (e.g., deep learning). The MUSICA image processing algorithms are stated to be "identical to those previously cleared" in other Agfa devices (K103597, K152639, K141192, K183275). Therefore, any "training" (algorithm development/tuning) would have occurred for these prior versions/devices, and no specific training set for the DR 100s is mentioned.
9. How the ground truth for the training set was established
- Not applicable/Not specified as the DR 100s itself does not undergo a "training" phase like a new AI algorithm. The MUSICA algorithms were previously developed and cleared.
§ 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.