(261 days)
The Brivo XR385 Digital X-Ray System is intended for use on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
The Brivo XR385 Digital Diagnostic Radiographic system provides state of the art image quality, image manipulation, operator control, dose reporting and system maintenance. These features make this system easy to use and reliable while providing high quality radiographic images in a digital environment. The Brivo XR385 system configuration includes an integrated tube stand and patient support table with a floating table top, under-the-table high-voltage generator and power distribution unit, an X-ray tube assembly with dual focal spot X-ray tube, a manual beam limiting device, and a wall stand and a digital detector that captures radiographic images in digital form. The system also includes an acquisition and review workstation for image post-processing, short-term storage, and quick in-room viewing of images. Images may be transferred manually or automatically via a DICOM network for printing, long-term storage archive, and detailed review.
This submission for the Brivo XR385 Digital Diagnostic Radiographic system explicitly states that clinical studies were not required to support substantial equivalence (ref. page 3). Therefore, much of the requested information about acceptance criteria, device performance from a test set, and detailed study parameters for proving performance against acceptance criteria is not present in the provided text.
The submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons, adherence to voluntary standards, and bench testing, rather than a clinical performance study.
However, based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly defined in terms of quantitative performance metrics from a clinical study within the provided text. The "acceptance criteria" are implied to be conformance with voluntary standards and related FDA guidance, and the successful completion of various engineering and quality assurance tests.
- Reported Device Performance: Not reported in terms of specific clinical accuracy, sensitivity, or specificity from a study. The general statement is that the device provides "state of the art image quality, image manipulation, operator control, dose reporting and system maintenance" (ref. page 1), and "high quality radiographic images in a digital environment".
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Compliance with voluntary standards and related FDA guidance | "High quality radiographic images in a digital environment" |
| Successful completion of Quality Assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit testing, Integration testing, Performance testing, Safety testing, Simulated use testing | Device functions as intended and provides "state of the art image quality, image manipulation, operator control, dose reporting and system maintenance" |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable, as no clinical test set was used for a performance study.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set with expert-established ground truth was used.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set with adjudicated ground truth was used.
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 was done. The submission explicitly states "The subject of this premarket submission, Brivo XR385, did not require clinical studies to support substantial equivalence" (ref. page 3). The device described is an X-ray system, not specifically an AI-powered diagnostic tool, so an MRMC study with AI assistance would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was done. This device is an X-ray system, not a standalone algorithm.
7. The type of ground truth used:
- Not applicable for a clinical performance study. The "ground truth" for the non-clinical testing would be the engineering specifications and test results, ensuring the device met its design and safety requirements.
8. The sample size for the training set:
- Not applicable, as this is an X-ray system and not an AI/algorithm-based device that would typically have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.