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510(k) Data Aggregation
(131 days)
LUMINOS Q.namix T and LUMINOS Q.namix R are devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics.
LUMINOS Q.namix T and LUMINOS Q.namix R are not intended to be used for mammography examinations.
The LUMINOS Q.namix T is an under-table fluoroscopy system and the LUMINOS Q.namix R is an over-table fluoroscopy system. Both systems are multifunctional, general R/F systems, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics. They are designed as modular systems with components such as main fluoro table including fixed fluoroscopy detector and X-ray tube, a ceiling suspension with X-ray tube, Bucky wall stand, X-ray generator, monitors, a bucky tray in the table as well as portable wireless and fixed integrated detectors that may be combined into different configurations to meet specific customer needs.
This FDA 510(k) clearance letter and summary discuss the LUMINOS Q.namix T and LUMINOS Q.namix R X-ray systems. The provided documentation does not include specific acceptance criteria (e.g., numerical thresholds for image quality, diagnostic accuracy, or performance metrics) in the same way an AI/ML device often would. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to recognized standards.
The study presented focuses primarily on image quality evaluation for the new detectors (X.fluoro and X.wi-D24) for diagnostic acceptability, rather than establishing acceptance criteria for the entire system's overall performance.
Here's an attempt to extract and present the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria for the overall device performance are not stated in the provided 510(k) summary, this section will reflect the available qualitative performance assessment for the new detectors. The primary "acceptance criterion" implied for the overall device is substantial equivalence to predicate devices and acceptability for diagnostic use.
| Feature/Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance (LUMINOS Q.namix T/R with new detectors) |
|---|---|---|
| Overall Device Equivalence | Substantially equivalent to predicate devices (Luminos Agile Max, Luminos dRF Max) in indications for use, design, material, functionality, technology, and energy source. | Systems are comparable and substantially equivalent to predicate devices. Test results show comparability. |
| New Detector Image Quality (X.fluoro, X.wi-D24) | Acceptable for diagnostic use in radiography & fluoroscopy. | Evaluated images and fluorography studies from different body regions were qualified for proper diagnosis by a US board-certified radiologist and by expert evaluations. |
| Compliance with Standards | Compliance with relevant medical electrical safety, performance, and software standards (e.g., IEC 60601 series, ISO 14971, IEC 62304, DICOM). | The LUMINOS Q.namix T/LUMINOS Q.namix R systems were tested and comply with the listed voluntary standards. |
| Risk Management | Application of risk management process (per ISO 14971). | Risk Analysis was applied. |
| Software Life Cycle | Application of software life cycle processes (per IEC 62304). | IEC 62304 (Medical device software - Software life cycle processes) was applied. |
| Usability | Compliance with usability engineering standards (per IEC 60601-1-6, IEC 62366-1). | IEC 60601-1-6 and IEC 62366-1 were applied. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: "expert evaluations" for the new detectors X.fluoro and X.wi-D24.
- Sample Size: The exact number of images or fluorography studies evaluated is not specified. The document mentions "multiple images and fluorography studies from different body regions" for the US board-certified radiologist's evaluation.
- Data Provenance:
- Countries of Origin: Germany (University Hospital Augsburg, Klinikum rechts der Isar Munich, Herz-Jesu-Krankenhaus Münster/Hiltrup) and Belgium (ZAS Jan Palfijn Hospital of Merksem).
- Retrospective or Prospective: Not explicitly stated, but clinical image quality evaluations often involve prospective data collection or a mix with retrospective cases. Given they are evaluating "new detectors" and "clinical image quality evaluation", it implies real or simulated clinical scenarios.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts:
- Initial Evaluations: Multiple "expert evaluations" (implies more than one) were conducted across the listed hospitals. The exact number of individual experts is not specified.
- Specific Evaluation: One "US board-certified radiologist" performed a dedicated clinical image quality evaluation.
- Qualifications of Experts:
- For the general "expert evaluations": Not specified beyond being "experts."
- For the specific evaluation: "US board-certified radiologist." No mention of years of experience is provided.
4. Adjudication Method for the Test Set
The document does not specify any formal adjudication method (e.g., 2+1, 3+1 consensus voting) for establishing ground truth or evaluating the image quality. The evaluations appear to be individual or group assessments leading to a conclusion of "acceptability for diagnostic use."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? The document does not describe a formal MRMC comparative effectiveness study designed to quantify the improvement of human readers with AI vs. without AI assistance.
- Effect Size of Human Reader Improvement: Therefore, no effect size is reported.
- Note: While the device includes "AI-based Auto Cropping" and "AI based Automatic collimation," the study described is an evaluation of the detectors' image quality and the overall system's substantial equivalence, not the clinical impact of these specific AI features on human reader performance.
6. Standalone Performance Study (Algorithm Only)
- The document primarily describes an evaluation of the new detectors within the LUMINOS Q.namix T/R systems and the overall system's substantial equivalence.
- While the device includes "AI-based Auto Cropping" and "AI based Automatic collimation," the document does not report on a standalone performance study specifically for these AI algorithms in isolation from the human-in-the-loop system. The AI features are listed as technological characteristics that contribute to the device's overall updated design.
7. Type of Ground Truth Used
For the detector image quality evaluation, the ground truth was based on expert assessment ("qualified for proper diagnosis"). This falls under expert consensus or expert judgment regarding diagnostic acceptability.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set for any AI components. The focus of this 510(k) summary is on substantiating equivalence and safety/effectiveness of the entire X-ray system, not on the development of individual AI algorithms within it.
9. How the Ground Truth for the Training Set Was Established
Since no information is provided about a training set, the method for establishing its ground truth is not mentioned in the document.
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