(29 days)
The AQUARIUS 8600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the AQUARIUS 8600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only.
The AQUARIUS 8600 is not intended for mammography.
The Aquarius 8600 is a digital radiography sensor which automatically collects x-ray images from an x-ray source. The Aquarius 8600 sensor (flat panel type) collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor includes with a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.
This is a 510(k) premarket notification for the AQUARIUS 8600 Digital Radiography Sensor. The core of this submission is to demonstrate the substantial equivalence of the modified device to a previously cleared predicate device.
Based on the provided text, the acceptance criteria and the study proving the device meets those criteria are established through a non-clinical performance evaluation and image comparison rather than a human-in-the-loop clinical trial or a detailed algorithm performance study with predefined metrics like sensitivity/specificity. This is typical for certain types of device modifications or new devices where the primary claim is equivalence in image quality or basic functionality to an existing device.
Here's the breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical performance thresholds (e.g., specific sensitivity, specificity, or image quality scores). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices in terms of:
| Acceptance Criteria Category | Reported Device Performance and Justification |
|---|---|
| Image Quality and Characteristics | "The Aquarius 8600 produces images of similar quality and characteristics that are equivalent to those of the both the Aquarius 8600 and BIOK4600 predicate devices." |
| Hardware Performance | "Because the sensor hardware is the same as the Aquarius 8600 predicate device hardware, the sensor has the same performance, biocompatibility, effectiveness, thermal, electrical and mechanical safety and is substantially equivalent to the predicate device." |
| Software Functionality | "The Aquarius 8600 software functionality is equivalent to the original BIOK4600 predicate device, except for the Sensor Driver interface application which reads the images from the Aquarius 8600 flat panel instead of the BIOK 4600 sensor." |
| Conformity to Standards | "The design, development and production of the sensor conforms to 892.1680 and ISO 13485 quality systems." |
| Technical Specifications (Physical/Operational) | Spatial resolution: 3.9 lp/mm |
| Optical resolution: 3.9 lp/mm | |
| Acquisition to display time: |
§ 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.