(137 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 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 Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems are intended for general diagnostic x-rays and compared for substantial equivalence to the Siemens Multix Fusion (K121513). The document does not provide a table of acceptance criteria or a detailed study proving the device meets specific performance criteria. Instead, it relies on substantial equivalence to a predicate device and adherence to recognized industry standards for safety and effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria with corresponding device performance metrics (e.g., sensitivity, specificity, resolution, dose). Instead, it states that "EMC, mechanical safety, and electrical safety were evaluated according to various FDA recognized consensus standards," and "the identified risk of EMC, mechanical, and electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance:
No specific test set or sample size for evaluating clinical performance is mentioned. The document states: "Clinical testing is not required for a determination of substantial equivalence because the imaging components supplied have already received FDA clearance. Furthermore, the intended operators of the Amrad Medical OTS, DFMTS, or FRS Digital Radiography Systems are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, and radiation hazards, Summit Industries LLC adheres to recognized and established industry practice, and all equipment is subject to final performance testing. All components bear the UL or ETL certification labels."
The document also mentions: "We did collect and evaluate digital images using standardized phantoms." However, details on the sample size of these phantom images, their provenance, or how they relate to a "test set" are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical test set requiring expert-established ground truth is described. The device's substantial equivalence is based on physical and technological characteristics compared to a predicate device.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The document focuses on substantial equivalence based on technical specifications and safety standards, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a digital radiography system, not an AI algorithm for image interpretation. Its performance is inherent in its ability to produce diagnostic x-ray images.
7. Type of Ground Truth Used:
The primary "ground truth" for the clearance is indirect:
- Substantial equivalence to the predicate device (Siemens Multix Fusion K121513): This implies that the predicate device's established safety and effectiveness serve as the ground truth for the new device.
- FDA-cleared imaging components: The digital panels and software (PaxScan 4343R and 4336R) used in the Amrad Systems were previously cleared by the FDA in K093066 and K130318. Their prior clearance acts as a form of ground truth for their performance.
- Standardized phantoms: The document mentions evaluating "digital images using standardized phantoms." This type of testing uses known physical properties of the phantoms as ground truth for image quality measurements (e.g., spatial resolution, contrast-to-noise ratio), but no details of such measurements or acceptance criteria are provided.
8. Sample Size for the Training Set:
Not applicable. This device is a hardware system, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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.