(126 days)
The DIAMOND-5A,6A,8A Digital Diagnostic X-ray System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
The digital X-ray imaging system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, a wall stand unit, a bucky table unit, a detector, operating software, and a tube, operates on a high-frequency inverter method, and is primarily used in a hospital for diagnosis of diseases in skeletal. respiratory and urinary systems.
The provided 510(k) summary (K102408) for the DRGEM Corporation's DIAMOND-5A, 6A, 8A Digital Diagnostic X-ray System does not contain information related to specific acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Sedecal X-Plus LP Plus Digital, K090238) by showing compliance with electrical, mechanical, environmental safety, and EMC standards, which are considered sufficient for this type of device in the 510(k) pathway.
Therefore, many of the requested details about acceptance criteria, clinical studies, ground truth, and expert involvement are not present in the provided document.
Here's a breakdown of what can be extracted based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Performance Standards Compliance: |
- EN/IEC 60601-1 (General medical electrical equipment safety)
- EN/IEC 60601-1-1 (Safety requirements for medical electrical systems)
- EN/IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment)
- EN/IEC 60601-2-7 (Safety of high-voltage generators for diagnostic X-ray equipment)
- EN/IEC 60601-2-28 (Safety for X-ray source assemblies and X-ray tube assemblies for medical diagnosis)
- EN/IEC 60601-2-32 (Safety of associated equipment for diagnostic X-ray equipment)
- EN/IEC 60601-1-2(2001) (Electromagnetic compatibility - Requirements and tests) | All test results were satisfactory for compliance with the listed electrical, mechanical, environmental safety, and EMC standards. (This is a general statement and specific performance metrics against these standards are not provided in the summary.) |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. The submission details compliance with engineering and safety standards, not a clinical performance study with a test set of images or patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. No clinical performance study requiring ground truth establishment is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No clinical performance study requiring adjudication is mentioned.
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. This is a traditional X-ray imaging system, not an AI-assisted diagnostic device. A MRMC study was not conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a traditional X-ray imaging system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided. No clinical performance study requiring ground truth is mentioned.
8. The sample size for the training set
- Not Applicable / Not Provided. This is not an AI/machine learning device that would typically have a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. This is not an AI/machine learning device.
Summary of the Study (as described in the 510(k) summary):
The "study" described in this 510(k) summary is primarily a technical verification and validation (V&V) against recognized electrical, mechanical, environmental, and EMC safety and performance standards (EN/IEC 60601 series). The manufacturer performed these tests to demonstrate that the DIAMOND-5A,6A,8A system operates safely and effectively as an X-ray imaging system, and is substantially equivalent to the predicate device. The results of these tests were deemed "satisfactory," indicating compliance with the standards, which serves as the basis for the safety and effectiveness conclusion. There is no mention of clinical trials or studies related to diagnostic accuracy or clinical outcomes.
§ 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.