(88 days)
The product is intended as an X-Ray source for diagnosis. Operators of the Hand Diagnostic Radiography Imaging System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed.
Indication for use – The device is stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of hands of adults and children.
Limitations for use – This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, bone density, fluoroscopy and angiography applications.
The major functions of the Hand Diagnostic Radiography Imaging System is including:
- Hand and Wrist radiography
- · Hand PA, AP, Oblique, Lateral
The Hand Diagnostic Radiography Imaging System is a stationary digital diagnostic X-ray system designed to use in generating radiographic images of hands or wrist.
The Hand Diagnostic Radiography Imaging System consists of a system enclosure (with shielding to protect users from exposure to radiation); an X-ray module consists of the X-ray tube (consists of the X-ray tube, cooling fluid, electronics, and casing), generator, and beam limiter; a CCD camera assists the hand position; and the LCD which provides a imagine to make sure the hand on the right position.
The Hand Diagnostic Radiography Imaging System is designed to operate with a Flat Panel Digital X-ray Detector Model Yushan 1417C (K201528), manufactured by InnoCare Inc.
The intended operators of the Hand Diagnostic Radiography Imaging System are healthcare professionals familiar with and responsible for the X-ray examinations being performed.
To minimize electrical, mechanical, and radiation hazards, the Hand Diagnostic Radiography Imaging System adheres to recognized and established industry practices and standards.
The provided text describes the Hand Diagnostic Radiography Imaging System (K220271) and its comparison to a predicate device (DIAMOND-5A/6A/8A, K202156) for 510(k) clearance. However, it does not contain specific acceptance criteria, reported device performance data, details of a clinical study, or information related to AI/algorithm performance (standalone or human-in-the-loop). It focuses on non-clinical testing, standards compliance, and a comparison of technical specifications to a predicate device.
Therefore, I cannot fully answer your request based only on the provided text. The document primarily addresses the substantial equivalence determination for a stationary X-ray system, which typically involves demonstrating that the new device is as safe and as effective as a legally marketed predicate device. This often relies on engineering and performance specifications, and compliance with recognized standards, rather than full-scale clinical trials with acceptance criteria for diagnostic accuracy metrics.
Here's what can be inferred or stated based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "predetermined acceptance criteria were met" for non-clinical testing, but it does not provide a specific table of acceptance criteria or corresponding reported device performance metrics in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) that would typically be associated with AI/algorithm performance.
The "Performance Data" section primarily lists internal validation and verification (V&V) test plans and reports, which relate to:
- Hardware Architecture Development
- Software Development
- Production Process Development
- Validation of I/O Back Board Assembly
- Validation of Distribution Board Assembly
- Validation of Mini Console Assembly
- Validation of the Assembly of the Light Strip Control Module
- Communication Test Validation of the Final Product
- Validation of the Functionality of the Final Product
These are engineering and system validation tests, not clinical performance studies measuring diagnostic accuracy against a ground truth.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable/Not mentioned. The document focuses on non-clinical testing (V&V) rather than a clinical "test set" in the context of diagnostic accuracy. There's no mention of patient data, images, or a test set used for performance evaluation against acceptance criteria related to diagnostic performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable/Not mentioned. Since no clinical test set for diagnostic performance is described, there's no mention of experts or ground truth establishment in that context.
4. Adjudication Method for the Test Set:
Not applicable/Not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document does not describe an MRMC study. The device is an X-ray imaging system, not an AI or CAD (Computer-Aided Detection/Diagnosis) algorithm designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to the described device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. The device is an X-ray system, not a standalone algorithm. Its performance is related to image generation and system functionality, not algorithmic interpretation of images.
7. The Type of Ground Truth Used:
Not applicable/Not mentioned for diagnostic accuracy. The "ground truth" implied for this device would be its adherence to engineering specifications and safety standards during the non-clinical V&V testing. For example, "Validation of the Functionality of the Final Product" would imply testing whether the system performs its intended functions correctly, with internal benchmarks serving as the "ground truth." This is different from ground truth for clinical diagnostic accuracy (e.g., pathology, expert consensus).
8. The Sample Size for the Training Set:
Not applicable/Not mentioned. The device is an X-ray system, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable/Not mentioned.
Summary of what the document does provide:
- Device Type: Stationary Digital Diagnostic X-ray System for hands or wrists.
- Purpose of Study/Testing: To demonstrate substantial equivalence to a predicate device (DIAMOND-5A/6A/8A, K202156) through non-clinical testing and comparison of specifications.
- Non-Clinical Testing: A list of internal Validation and Verification (V&V) test plans and reports related to hardware, software, production, and functional validation of the system components.
- Standards Compliance: The device has met requirements of various IEC and ISO standards related to medical electrical equipment, radiation protection, software lifecycle, usability, and risk management (e.g., IEC 60601 series, IEC 62304, ISO 14971).
- Safety and Effectiveness Conclusion: Based on V&V testing, the device was found to have a safe and effective profile similar to the predicate device and is substantially equivalent.
In conclusion, the provided text describes the regulatory clearance process for an X-ray imaging system, focusing on engineering validation and adherence to recognized standards for safety and performance, rather than a clinical study evaluating the diagnostic accuracy of a software algorithm against specific acceptance criteria.
§ 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.