(75 days)
The AeroDR SYSTEM with P-21 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM with P-21 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
The AeroDR SYSTEM, K102349 is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Defector (flat panel digital detector), Console CS-7 (operator console), AeroDR Interface Unit, AeroDR Generator Interface Unit, AeroDR Access Point and AeroDR Battery Charger. Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice. The modification was made to the AeroDR SYSTEM with P-21 to add the different panel size. The panel size of 17 x 17 inches (P-21) is added to 17 x 14 inches. The materials of the panel remain unchanged and no other changes were made other than the panel size from 17 x 14 inches to 17 x 17 inches.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document describes a 510(k) submission for a medical device (AeroDR SYSTEM with P-21), but it primarily focuses on its substantial equivalence to a predicate device, its indications for use, and regulatory compliance.
Specifically, the "Performance Testing" section states: "Performance data from non-clinical testing of the AeroDR SYSTEM with P-21 is compared with data from the predicate device, AeroDR SYSTEM (P-11). This comparison showed that the AeroDR SYSTEM with P-21 performed as well as the predicate device."
This statement indicates a comparison was made, but it does not provide details on:
- Specific acceptance criteria.
- The results of the performance data in terms of specific metrics.
- The type of study conducted (e.g., sample size, data provenance, ground truth, expert involvement, MRMC, standalone performance).
Therefore, I cannot populate the table or answer the specific questions about the study from the given text.
§ 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.