(104 days)
The DR 600 system is a General Radiography 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 adult, pediatric or neonatal patients.
In addition, the system provides the Agfa tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
Applications can be performed with the patient in the sitting, standing or lying position.
This system is not intended for mammography applications.
The DR 600 with Tomosynthesis is a tomographic and solid state x-ray system (product codes IZF and MQB) intended to capture tomographic slices and static images of the human body. The DR 600 with Tomosynthesis is a ceiling mounted tomographic and general radiographic system that consists of a tube and operator console with a motorized patient table and/or wall stand. The DR 600 with Tomosynthesis uses Agfa's NX workstation with MUSICA2 ™ image processing and flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.
The provided text describes the Agfa DR 600 with Tomosynthesis device and its K193262 510(k) submission. However, it does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's meeting of these criteria. The document focuses on showing substantial equivalence to predicate devices primarily through technological characteristics and bench testing, not through comparative clinical effectiveness studies with explicit acceptance criteria for diagnostic performance.
Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in the provided text. The document explicitly states: "No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device."
Based on the available information, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance (as inferred from the document's approach to substantial equivalence):
Since no specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) are presented, the "acceptance criteria" for this 510(k) appear to be primarily focused on demonstrating substantial equivalence to predicate devices through technical specifications, image quality evaluations (bench testing), and compliance with various electrical safety, EMC, and software standards.
| Acceptance Criteria (Inferred from Document) | Reported Device Performance |
|---|---|
| 1. Technological Characteristics are Identical/Equivalent to Predicates: |
- Communications (DICOM)
- Flat Panel Detectors (type, material, sizes, pixel size, dynamic range)
- Operator Workstation (Agfa NX)
- Image Processing (MUSICA DTS, MUSICA2, MUSICA3/3+)
- Operating System (Windows 7, 8, 8.1, 10)
- Display System (Separately cleared medical display)
- Power Supply
- Generators
2. Indication for Use statement is consistent/identical to predicates.
3. Performance/Functionality as Intended:
- Confirmed functions and performs as intended.
- Supports a tomographic workflow and Smart Dr visualization (including adult and pediatric patients).
4. Image Quality Equivalent to Predicate:
- For both adult and pediatric patients.
5. Software Validation:
- Verification and validation plans confirmed.
- Risk assessment shows no unacceptable risks.
6. Electrical Safety and EMC Compliance:
- Adherence to specified IEC standards (60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-54).
- Compliance with FDA Subchapter J mandated performance standard 21 CFR 1020.30 and 1020.31.
7. Quality Management System Compliance:
- Adherence to ISO 13485:2015, ISO 14971:2012, ACR/NEMA PS3.1-3.20 (DICOM). | 1. Technological Characteristics:
- Communications: Same as both predicates (DICOM).
- Flat Panel Detectors: Same as both predicates (Flat Panel Detectors, GOS/CsI Scintillator, various sizes 17x17, 14x17, 10x10 in., 148 µm pixel size in primary predicate, 139 µm in other, 16 bit dynamic range in primary predicate, 14 bit in other). The new device shares characteristics with both, indicating equivalence.
- Operator Workstation: Same as both predicates (Agfa NX).
- Image Processing: MUSICA DTS, MUSICA2, MUSICA3/3+. The addition of tomographic image processing is identical to the DR 800 (K183275) primary predicate device.
- Operating System: Same as predicate K183275 (Windows 7, 8, 8.1, 10).
- Display System: Same as both predicates (Separately cleared medical display K051901).
- Power Supply: Same as predicate K152639 (50-60 Hz, 380/400/415/440/480V + 10%).
- Generators: Same as predicate K183275 (Choice of three models: 50, 65KW, 80 KW).
- Overall: "Principles of operation and technological characteristics of the new and predicate devices are the same."
2. Indication for Use: "The DR 600 system is a General Radiography X-ray imaging system... In addition, the system provides the Agfa tomosynthesis option... Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep." This is stated to be "virtually identical" to K152639 with the tomosynthesis addition from K183275.
3. Performance/Functionality:
- "Technical and acceptance testing was completed on the DR 600 in order to confirm the medical device functions and performs as intended. All deviations or variances are documented... All design input requirements have been tested and passed."
- "Functionality evaluations were conducted with three qualified radiographers. Usability and TBD. The results of these tests fell within the acceptance criteria for the DR 600; therefore, the DR 600 supports a tomographic workflow and Smart Dr visualization including adult and pediatric patients."
4. Image Quality: "Image quality bench tests were conducted in support of this 510(k) submission in which anthropomorphic adult and pediatric images taken with the DR 600 and the primary predicate device, DR 800 (K183275) were compared to ensure substantial equivalency. The test results indicated the image processing of the DR 600 passed the acceptance criteria and was equal to the image processing for the primary predicate, DR 800 (K183275) device for both adult and pediatric patients."
5. Software Validation: "Verification and validation testing confirmed the device meets performance, safety, usability and security requirements... For the NX22 (NX Nomad) software there are a total of 342 risks in the broadly acceptable region and 27 risks in the ALARP region with only one of these risks identified. Zero risks were identified in the Not Acceptable Region."
6. Electrical Safety and EMC Compliance: Document states compliance with all listed IEC standards and FDA performance standards.
7. Quality Management System Compliance: Document states adherence to all listed ISO and other standards. |
Study Details (Based on the provided text):
-
Sample sizes used for the test set and the data provenance:
- Test Set: No specific numerical sample size is mentioned for image quality evaluations beyond "anthropomorphic adult and pediatric images." The document mentions "functionality evaluations were conducted with three qualified radiographers," but this refers to human user testing of workflow and usability, not diagnostic image performance.
- Data Provenance: Not explicitly stated, but likely retrospective as it refers to comparisons of images taken with the new device and a predicate device. The comparison of anthropomorphic phantom images suggests a controlled laboratory setting.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "Laboratory data and image quality evaluations conducted with internal and independent specialists confirm that performance is equivalent to the predicates." It also mentions "clinical image quality evaluations for adults and pediatric patients" and "functionality evaluations were conducted with three qualified radiographers."
- Number of Experts: At least "three qualified radiographers" for functionality, and "internal and independent specialists" for image quality, but exact numbers or specific qualifications (e.g., years of experience, board certification) are not detailed.
- Qualifications: "Qualified radiographers" and "internal and independent specialists."
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is described for the image quality evaluations or other performance tests. The comparison to predicates implies direct visual or quantitative comparison by specialists.
-
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. The document explicitly states: "No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device."
- Therefore, no effect size of human readers improving with AI assistance is provided as this type of study was not conducted. The device in question is an imaging system, not an AI-based diagnostic assistance tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "performance data including clinical image quality evaluations for adults and pediatric patients" involved the system's output. The "image processing of the DR 600 passed the acceptance criteria and was equal to the image processing for the primary predicate, DR 800 (K183275) device for both adult and pediatric patients." This implies an evaluation of the algorithm's output (image quality) without necessarily focusing on a human-in-the-loop diagnostic task. So, in essence, standalone image quality performance was evaluated against a predicate.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for image quality evaluation appears to be comparison to a cleared predicate device's image quality, as judged by "internal and independent specialists," using anthropomorphic phantoms. There is no mention of pathological confirmation or patient outcomes for establishing ground truth, as it was not a clinical trial.
-
The sample size for the training set:
- This device is an X-ray system with image processing, not a machine learning/AI algorithm that requires a "training set" in the traditional sense of AI development. The software capabilities (MUSICA DTS, MUSICA2, MUSICA3/3+) are described as being identical to previously cleared versions in predicate devices. Therefore, a "training set" for a new AI model is not applicable here.
-
How the ground truth for the training set was established:
- Not applicable, as no new AI model training set is described. The image processing algorithms are identical to those previously cleared.
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.