(28 days)
The AeroDR SYSTEM 2 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpse diagnostic procedures.
The AeroDR SYSTEM 2 is not in mammography. fluoroscopy, tomography and angiography applications.
The AeroDR SYSTEM 2 including AeroDR P-51 and AeroDR P-52 is intended 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 2 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.
The AeroDR P-51 and AeroDR P-52 (hereinafter AeroDR detector) are lightweight, mobile FPD those are that is compatible with the size of ISO standard.
The AeroDR SYSTEM 2 performs X-ray imaging of the human body using an X-ray planar detector (FPD) that outputs a digital signal, which is then input into an image processing device, and the acquired image is then transmitted to a filing system, printer, and image display device as diagnostic image data. The image processing device displays the image on the screen after applying image processing to the raw data of image provided by FPD. The AeroDR detector can communicate with the image processing device through the wired Ethernet and/or the Wireless LAN (IEEE802.11a/n and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.
The operator console software, Console CS-7, is a software program for installation on a PC. It performs image processing of X-ray images received from an AeroDR FPDs. The modified post processing function named 'Intelligent Grid' (IG Processing) is introduced as a part of the Image post processing function of console CS-7 software. The IG processing are fundamentally the same as those functions of other post processing of the Image Processing module of Console CS-7. The IG Processing is NOT a function for substitution of Grid's effects. It's a post processing of image adjustment to reduce the effects of scatter radiation. The user can adjusts to improve contrast by reducing effects of scatter radiation, and then the user MUST confirm the effects of the processing prior to determining the final images as well.
The provided text does not contain detailed information regarding the acceptance criteria of device performance and the study that proves the device meets those criteria for the AeroDR System 2.
The document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study with specific acceptance criteria.
Here's what can be extracted based on the request and the provided text:
- No detailed acceptance criteria or reported device performance for specific metrics are provided. The document states that the image performance specification of the proposed device (AeroDR P-52) is the same as the AeroDR P-12 (a component of the predicate AeroDR SYSTEM 2, K141271, and originally cleared as K102349).
- Non-clinical tests were conducted where "qualified persons have affirmed and have concluded that both nonclinical images of proposed AeroDR P-52 and predicate AeroDR P-12 are equivalent and have sufficient capabilities for the intended purpose of the device." However, no specific metrics or quantitative acceptance criteria for image quality are given.
- Risk analysis was performed for the modifications (addition of AeroDR P-52 and modification of 'Intelligent Grid' function), and the conclusion was that these changes "don't pose any significant risk to device safety or effectiveness." It also states that "All of the verification activities, as required by the risk analysis, for the modification to AeroDR SYSTEM 2 were performed and the results demonstrated that the predetermined acceptance criteria were met." However, these acceptance criteria are not detailed in the document.
Therefore, most of the specific information requested cannot be provided from this document.
Missing Information:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document explicitly states: "The clinical studies as a performance testing are not required to support substantial equivalence for the proposed device." This further indicates that a comprehensive, independent study with detailed acceptance criteria and performance metrics (as typically looked for in an AI/ML context for diagnostic accuracy) was not conducted or reported in this 510(k) summary. The demonstration was largely based on the equivalence of technological characteristics and non-clinical image evaluations.
§ 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.