(53 days)
These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, interventional, or fluoroscopy use.
The Amrad Systems are permanently-installed diagnostic x-ray systems for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. They are intended to produce diagnostic x-ray images of human anatomy. The Amrad Systems enable radiographic exposures of the whole body including: skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The resultant images are evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan. It is not intended for fluoroscopy, angiography, or mammography. The Amrad Systems typically include a tube support, x-ray generator, x-ray tube, radiographic wall stand, and collimator. An FDA cleared digital imaging system is included.
The provided text describes a 510(k) premarket notification for Amrad Medical Digital Radiography Systems, asserting their substantial equivalence to a legally marketed predicate device. This submission does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML medical device would.
Instead, the submission focuses on demonstrating that the new devices are functionally equivalent and technologically similar to a previously cleared predicate device, and that their individual components (like the digital panels) have already received FDA clearance. Therefore, the following information, typically found in AI/ML performance studies, is largely not applicable or not provided in this document.
However, I can extract the acceptance criteria (or rather, the basis for substantial equivalence) and what performance was reported in relation to the submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Basis for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use: Same as predicate device. | Identical: "These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use." |
| Technological Characteristics: Functionally identical and technologically similar in design and composition. | Similar Functionality: |
- Tube crane/stand: Similar Functionality (Predicate has overhead, new devices have U-Arm, Floor Stand, or Wall/Floor Stand).
- Wall stand: Same (manual or motorized).
- Table: Same or Similar Functionality.
- X-ray tube: Similar Functionality (150 kVp 0.6/1.2mm focal spots).
- Collimator: Similar Functionality (Ralco R221 or R225 vs. Collimare).
- X-ray Generator: Identical Functionality (40, 50, 65, or 80 kW models).
- Wireless detector: Greater convenience (new device includes Cleared Wi-Fi, predicate does not explicitly mention).
- Fixed detector: Similar Functionality (new device uses THALES/CMT K162224 ArtPix Mobile EZ2GO using Pixium Portable 3543 EZ and 2430 EZ Wireless Detectors; predicate uses Varian PaxScan 4343R and 4336R panels cleared in K093066 and K130318).
- Conventional film/screen systems or CR cassettes: Similar Functionality (both can still be used).
- Operator console: Similar Functionality ("Same").
- Power Source: Same (AC LINE). |
| Safety: Device must adhere to recognized safety standards (EMC, mechanical, electrical). | Mitigated Risks: EMC, mechanical safety, and electrical safety were evaluated according to various FDA-recognized consensus standards. Identified risks were mitigated. All components bear UL or ETL certification labels. |
| Imaging Performance: Imaging components previously cleared by FDA. | Phantoms Used: "We did collect and evaluate digital images using standardized phantoms." Clinical study not required because imaging components already received FDA clearance. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This submission doesn't describe a performance study with a test set in the context of AI/ML evaluation. It uses phantoms for image evaluation.
- 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. Ground truth establishment for a diagnostic study is not described.
4. Adjudication method for the test set:
- Not applicable.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a general radiography system, not an AI-powered diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a radiographic system, not an algorithm. The software and digital panels are part of the system and were previously cleared by FDA.
7. The type of ground truth used:
- Not explicitly defined in the context of a diagnostic dataset. The "ground truth" for the submission's purpose is related to compliance with safety standards and the performance of previously cleared imaging components, evaluated via:
- Comparison to a predicate device's established performance.
- Evaluation of digital images using standardized phantoms.
8. The sample size for the training set:
- Not applicable. This document does not describe the development or training of an AI/ML algorithm.
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.