(199 days)
The Diagnostic X-ray System is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
The Diagnostic X-ray System is a mobile (within an imaging facility) general-purpose diagnostic fluoroscopic X-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities.
The Diagnostic X-ray System is consists of X-ray source assembly (combined type), collimator, flat-panel detector, image processing workstation, C-arm and mobile rack, Medical Image Workstation Software.
It appears that the provided FDA 510(k) clearance letter and associated summary pertain to a Diagnostic X-ray System (Trade Name: Diagnostic X-ray System, Model: PLX119C) manufactured by Nanjing Perlove Medical Equipment Co., Ltd.
Crucially, the document explicitly states: "No clinical study is included in this submission."
Therefore, I cannot provide details about acceptance criteria derived from a clinical study, as no such study was presented for this device's 510(k) clearance.
However, I can extract the information provided regarding the non-clinical performance and testing. It's important to understand that for a general-purpose diagnostic X-ray system, substantial equivalence is often demonstrated through comparisons of technical specifications and non-clinical performance to a legally marketed predicate device, rather than a full-scale clinical trial proving "improved" diagnostic accuracy in a specific clinical context.
Here's a breakdown of the available information based on your request, with a clear note about the absence of a clinical study for demonstrating performance against acceptance criteria in a clinical setting:
1. A table of acceptance criteria and the reported device performance
Since no clinical study was performed to establish clinical performance acceptance criteria and then demonstrate the device meets them, I can only present the reported non-clinical performance and compliance with relevant standards. The "acceptance criteria" here are implied by meeting recognized standards and demonstrating comparable technical characteristics to the predicate device.
| Category | Acceptance Criteria / Standard Compliance | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1-2: 2014+AMD1:2020 / EN 60601-1-2: 2015+A1: 2021 | The system complies with IEC 60601-1-2: 2014+AMD1:2020 / EN 60601-1-2: 2015+A1: 2021. |
| EMC Testing | Compliance with IEC 60601-1-2: 2014+AMD1:2020 / EN 60601-1-2: 2015+A1: 2021 | The system complies with IEC 60601-1-2: 2014+AMD1:2020 / EN 60601-1-2: 2015+A1: 2021. |
| X-ray Equipment | Compliance with IEC 60601-2-54: 2009+AMD2:2018 / EN 60601-2-54: 2009+A2:2019 (For X-ray equipment for radiography and radioscopy) | The system complies with IEC 60601-2-54: 2009+AMD2:2018 / EN 60601-2-54: 2009+A2:2019. |
| Radiation Protection | Compliance with IEC 60601-1-3:2008+A1:2013+A2:2021 / EN 60601-1-3:2008+A1:2013+A2:2021 (For radiation protection in diagnostic X-ray equipment) | The system complies with IEC 60601-1-3:2008+A1:2013+A2:2021 / EN 60601-1-3:2008+A1:2013+A2:2021. |
| Interventional X-ray | Compliance with IEC 60601-2-43:2010+A1:2017+A2:2019 / EN 60601-2-43:2010+A1:2018+A2:2020 (For X-ray equipment for interventional procedures) | The system complies with IEC 60601-2-43:2010+A1:2017+A2:2019 / EN 60601-2-43:2010+A1:2018+A2:2020. |
| Detector Performance | Bench testing of imaging metrics (MTF, DQE comparable to predicate). Expected to meet industry standards for diagnostic image quality. | MTF @ 1.0 LP/mm: Typical 59% (Predicate: Typical 64%) |
| DQE @ 0 LP/min: Typical 77% (Predicate: Typical 77%) | ||
| Note: While MTF is slightly lower than predicate, it's implied to be within acceptable diagnostic limits for the intended use and often compensated by other factors in real-world imaging. | ||
| Software V&V | Compliance with FDA's "Content of Premarket Submissions for Software Contained in Medical Devices" guidance; basic level documentation sufficient as failure not expected to lead to death or serious injury. | Software verification and validation testing were conducted and documentation was provided as recommended. The embedded and workstation software for this device required basic level documentation, as a failure of software function(s) would not present a hazardous situation with a probable risk of death or serious injury. |
| Cybersecurity | Compliance with FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" | Cybersecurity documentation was provided according to FDA guidance. |
| Usability | Compliance with IEC 60601-1-6 and IEC 62366-1 | Usability validation was performed and documentation was provided, complying with IEC 60601-1-6 and IEC 62366-1. |
| Biocompatibility | Compliance with ISO 10993-1:2018 "Biological Evaluation of Medical Devices − Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. | Biocompatibility evaluation for the proposed device was conducted in accordance with ISO 10993-1:2018. |
| Clinical Image Quality | Implied acceptance criteria: acceptable imaging performance for diagnostic/interventional guidance, comparability to predicate. | Clinical images of multiple body parts were taken using radiography and fluoroscopy, with motion, to demonstrate acceptable imaging performance of the Diagnostic X-ray System. These images were reviewed and assessed by a qualified radiologist. (Specificity of "acceptable" is not defined, but the assessment implies it met expectations for its intended use.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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Clinical Images: "Clinical images of multiple body parts were taken using radiography and fluoroscopy, with motion".
- Sample Size: Not specified (described as "multiple body parts").
- Data Provenance: Not specified, but generally, for 510(k) submissions from foreign manufacturers, testing would occur at a site capable of generating such data, potentially in the country of origin (China, in this case, for the manufacturer). The images would be prospective as they were "taken" for the purpose of demonstrating performance.
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Bench Testing (Detector Imaging Metrics):
- Sample Size: Not specified.
- Data Provenance: Not specified, but typically conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Clinical Images: "reviewed and assessed by a qualified radiologist."
- Number of Experts: One ("a qualified radiologist").
- Qualifications: "qualified radiologist" – further specific experience or board certification is not detailed in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Clinical Images: The document states the images were "reviewed and assessed by a qualified radiologist." This implies a single-reader assessment, with no mention of an adjudication process (e.g., if multiple readers disagreed). Therefore, the adjudication method was none.
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 MRMC study was done. The device is a diagnostic X-ray system, not an AI-powered diagnostic aide. The submission explicitly states: "No clinical study is included in this submission." Therefore, there is no information about human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a diagnostic X-ray system and does not appear to contain an AI algorithm for standalone diagnostic performance. The primary focus is on the image acquisition, processing, and display capabilities for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "clinical images," the "ground truth" or standard of reference for "acceptable imaging performance" was the assessment by a qualified radiologist. This is a form of expert assessment/consensus (though by a single expert in this case for the review of performance). There is no mention of pathology or outcomes data being used as ground truth for performance evaluation of the imager itself.
8. The sample size for the training set
- Not applicable / Not specified. This device is hardware with associated software for image acquisition and processing. There is no mention of machine learning or deep learning algorithms requiring a distinct "training set" in the context of AI. The software verification and validation are standard procedures for medical device software, not AI training.
9. How the ground truth for the training set was established
- Not applicable. As there is no mention of a traditional "training set" for an AI algorithm, the concept of establishing ground truth for it does not apply here. The software development follows general software engineering principles and V&V, not AI model training.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.