(58 days)
uDR 380i Pro is a mobile digital radiography device intended to acquire X-ray images of the human anatomy for medical diagnosis. uDR 380i Pro can be used on both adult and pediatric patient by a qualified and trained operator. This device is not intended for mammography.
uDR 380i Pro is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. It can be moved to different environments for an examination, like emergency room. ICU and ward. It mainly consists of a lifting column - telescopic cantilever frame system, system motion assembly, X-ray System (high voltage generator, x-ray tube, collimator and wireless flat panel detectors which have been cleared in K170332 and K192632), power supply system and software for acquiring and processing the clinical images.
uDR 380i Pro is intended to acquire X-ray images for both adult and pediatric, especially for person who may not be able to be moved to a traditional RAD room. The system offers:
- A 14"×17" or 14"×14" flat panel detector
- . A high-power, 32 kW or 50kW generator
- A maneuverable drive system
- X-ray tube-collimator assembly with flexible movement
- Storage for detectors and supplies
- Image Acquisition Workstation with touchscreen user interface
I am sorry, but the provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined with performance metrics, sample sizes, expert qualifications, and adjudication methods.
The document is a 510(k) premarket notification for a medical device (uDR 380i Pro) and focuses on demonstrating substantial equivalence to a predicate device (Carestream DRX-Revolution). While it lists some technical specifications and claims that these differences do not raise new safety and effectiveness concerns, it does not present a formal study with acceptance criteria and reported device performance in the format you requested.
Here's a breakdown of what is available in the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
- The document provides a "Comparison of Technological Characteristics with the Predicate Devices" table (pages 4-7) which lists various specifications for both the proposed device (uDR 380i Pro) and the predicate device (DRX-Revolution).
- Instead of acceptance criteria, it provides the specifications of both devices and uses "Remark" notes (Note 1 to Note 13) to discuss any differences and justify why these differences do not raise new safety and effectiveness concerns.
- For example, for "Maximum Output Power," the proposed device lists "32kW/ 50kW" compared to the predicate's "32kW." The remark states that the larger output power represents better capability and does not raise new safety and effectiveness concerns.
- For "DQE" (Detective Quantum Efficiency), it states "Typical: 58% @3uGy,0.5lp/mm" for the proposed device and "Typical: 63% @2.5uGy,0.5lp/mm" for the predicate, noting that "Performance is similar" and "it did not raise new safety and effectiveness concerns."
- This is a comparison for substantial equivalence, not a standalone performance study against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
- The document mentions a "Clinical Image Evaluation" on page 10. It states: "Sample image of Head, chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided with a board certified radiologist to evaluate the image quality in this submission."
- However, it does not specify the sample size (number of images or cases) used for this evaluation.
- The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- It states that "a board certified radiologist" was used.
- It refers to "a board certified radiologist" (singular), implying one expert.
- No specific experience level (e.g., 10 years of experience) is mentioned beyond "board certified."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document states that "Each image was reviewed with a statement indicating that image quality are sufficient for clinical diagnosis."
- This description points to a subjective review rather than a formal adjudication process (like 2+1 or 3+1 consensus). It sounds like a single radiologist's assessment.
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 is mentioned. The device is a mobile X-ray system, not an AI-based diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a hardware system (mobile X-ray) with accompanying software for image acquisition and processing. It is not an algorithm for standalone diagnostic performance. Therefore, this question is not directly applicable in the context of this device. The "Clinical Image Evaluation" was about the image quality produced by the system for visual assessment by a radiologist.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Clinical Image Evaluation," the "ground truth" was the assessment of image quality by "a board certified radiologist" who determined if the images were "sufficient for clinical diagnosis." This falls under expert opinion/assessment of image quality rather than a definitive diagnosis established by other means like pathology or outcomes data.
8. The sample size for the training set:
- The document does not mention any training set size because the submission is for a medical imaging device (hardware and software for image acquisition), not a machine learning or AI algorithm that requires a training set for its core function of interpretation or diagnosis.
9. How the ground truth for the training set was established:
- As no training set is discussed or implied for the device's primary function, this information is not available.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence based on technical specifications and a general assessment of clinical image quality by a radiologist, rather than a detailed performance study against specific acceptance criteria for an AI-enabled diagnostic device.
§ 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.