(45 days)
DIAMOND-5A/6A/8A, is a stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammography, bone density, fluoroscopy and angiography applications.
DIAMOND-5A/6A/8A, system is a digital radiographic system. There are 3 power output configurations which are reflected in the model designation "5A/6A/8A". The models have 3 different output power ratings: 52kW, 68kW, 82kW. DIAMOND 5A/6A/8A, incorporates digital flat panel detector technology, along with an automatic motorized U-arm radiographic stand and mobile patient table that can fit into smaller rooms without the need of ceiling support structures for X-Ray tube suspensions. The subject device comes in 2 hardware configurations; a Radiographic Stand configuration for a wired detector and a Radiographic Stand for removable detectors. The main components of the subject device are the same as the predicate. Components of the x-ray source are the tube assembly, motorized x-ray collimator, HV cable assembly and high frequency x-ray generator. A touch screen LCD based x-ray control console provides a user interface and technique selection. The automatic collimator supports high accuracy for selected x-ray field size over SID. Selection of an anatomical study on the imaging software automatically sets up the x-ray generator's pre-programmed exposure technique setting, motorized radiographic stand positioning, x-ray collimation and post image processing for selected study. Also, removable high-resolution grids which have 100 and 180cm (40 and 72 inch) focal distance. The integrated touch screen console located on the tube side, operator can easily control the radiographic techniques and stand positioning. Furthermore, the operator can verify the digital x-ray image on this screen. The GUI, automatically rotates corresponds to rotation angle of U-arm.
The provided text is a 510(k) summary for the DRGEM Corporation's DIAMOND-5A/6A/8A stationary digital diagnostic x-ray system. This summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's diagnostic performance for measuring accuracy against a ground truth.
Therefore, much of the requested information (e.g., acceptance criteria for diagnostic capability, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and ground truth types for diagnostic accuracy) is not available in this document. The document primarily addresses the safety and performance of the hardware components and software in comparison to a previously cleared device.
Here's the information that can be extracted from the provided text:
Acceptance Criteria and Reported Device Performance (as pertains to safety and technical function):
| Acceptance Criteria (General Safety and Performance) | Reported Device Performance |
|---|---|
| Follows international standards for medical electrical equipment, radiation protection, usability, X-ray source assemblies, X-ray equipment for radiography, software lifecycle, and risk management (e.g., IEC 60601 series, IEC 62366, ISO 14971). | The DIAMOND-5A/6A/8A device has met all the requirements listed in the cited International Standards (except for inapplicable requirements). Validation testing demonstrated that predetermined acceptance criteria were met. |
| The system's complete functionality (hardware and software, including new detectors) must have no negative impact on safety or efficacy. | The system has been tested, and there is no negative impact on safety or efficacy. No new potential or increased safety risks concerning the differences (e.g., added detectors, updated RADMAX software). |
| Performance profile similar to the predicate device. | The subject device was found to have a safe and effectiveness profile similar to the predicate device. |
| Compliant with DICOM standards for digital imaging. | NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set DICOM Standard. |
| Compliant with JPEG standards for image compression. | JPEG Standard IEC/ISO10918-1 First edition 1994-02-15. |
| Compliant with standards for exposure index of digital X-ray systems. | IEC 62494-1 Edition 1.0 (2008-08), Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography. |
Detailed Study Information (as requested, with notes on unavailability):
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Sample size used for the test set and the data provenance: Not applicable/available. The document describes non-clinical testing for safety and functionality, not a clinical study on diagnostic accuracy.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available. No clinical test set requiring expert ground truth for diagnostic accuracy is described.
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Adjudication method for the test set: Not applicable/available.
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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: Not applicable/available. This device is a digital X-ray system, not an AI-powered diagnostic aide for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/available. This refers to the performance of the X-ray system itself. The document states "The complete system has been assessed and tested at the factory and by Standards testing facilities. DIAMOND-5A/6A/8A, has passed all predetermined testing criteria." This indicates standalone testing for the system's technical function and safety.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/available for diagnostic accuracy. For safety and performance testing, the "ground truth" would be adherence to the cited international standards and predetermined testing criteria.
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The sample size for the training set: Not applicable/available. The device is not an AI algorithm that requires a training set in the conventional sense for diagnostic tasks. Its software (RADMAX) is for image management and system control.
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How the ground truth for the training set was established: Not applicable/available.
Summary of the Study (as described in the document):
The "study" described in the 510(k) summary is a non-clinical performance and safety assessment comparing the DIAMOND-5A/6A/8A system to its predicate device (also DIAMOND-5A/6A/8A, K192453). The primary purpose was to demonstrate that adding new digital flat panel detectors (Fujifilm, Varex, i-Ray models) and an updated version of the RADMAX image management software (version 1.01) did not negatively impact safety or efficacy and did not raise new safety risks.
The testing involved assessing the complete system's adherence to various international standards for medical electrical equipment, radiation protection, usability, software lifecycle processes, and risk management. The conclusion was that the device met all predetermined testing criteria and demonstrated a safe and effective profile similar to the predicate device. No clinical (diagnostic accuracy) studies are reported in this summary.
§ 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.