(104 days)
DF-211H Radiographic X-Ray system is designed to be used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images of the skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The DF-211H Radiographic X-Ray system is complete, consisting of a 50kW X-Ray generator, control console, X-Ray tube assembly, collimator, and radiographic table. This product is applicable to clinical diagnostic radiography in all hospitals whether large or small. It has functions such as general radiography, anatomic program radiography (APR), etc. It has option of ionization chamber automatic exposure control (AEC). It is applicable to the radiography of various parts of human body. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380V, 50Hz; single phase: 120V, 60 Hz; fluctuation range for voltage: 10%; the power source capacity: 50kW.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DF-211H Radiographic X-Ray system:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the DF-211H Radiographic X-Ray system is cleared as "substantially equivalent" to a predicate device (HF-50R Computer Controlled X-Ray System, K052541) primarily through demonstrating adherence to safety and performance standards. There are no specific quantitative clinical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) provided in the summary.
The "acceptance criteria" are effectively the requirements outlined in the safety and performance standards listed, and the "reported device performance" is that the device met these standards.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (1988, Amd. 1&2) | Device complies with this standard. |
| EN 60601-1-2:2007: Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic | Device complies with this standard. |
| IEC 60601-2-7:1998 (GB 9706.3-2000 idt): Medical electrical equipment -Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators | Device complies with this standard. |
| IEC 60601-2-28:1993 (GB 9706.11-1997 idt): Medical electrical equipment Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | Device complies with this standard. |
| IEC 60601-1-3:1994 (GB 9706.12-1997 idt): Medical electrical equipment Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment | Device complies with this standard. |
| IEC 60601-2-32:1994 (GB 9706.14-1997 idt): Medical electrical equipment Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment | Device complies with this standard. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a clinical test set involving patients or images for evaluating diagnostic performance. The "testing data" mentioned are "bench and external laboratory testing data." Therefore, there is no sample size for a "test set" in the context of diagnostic performance (e.g., number of images, patients).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As noted above, there is no described clinical test set requiring ground truth established by experts for diagnostic performance.
4. Adjudication Method for the Test Set
Not applicable. There is no described clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The provided text indicates that "bench and external laboratory testing data" were used to establish substantial equivalence based on safety and performance standards, not a comparative effectiveness study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Not applicable. This device is an X-ray system, not an AI algorithm. Its performance is evaluated based on its ability to generate X-ray images safely and effectively according to established standards, not on an algorithm's diagnostic interpretation.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is its conformance to established international and national standards for medical electrical equipment, including general safety, electromagnetic compatibility, and specific requirements for X-ray generators and tube assemblies. This is determined through objective measurements and tests performed in bench and external laboratories against the specifications of these standards, rather than a clinical "ground truth" like pathology or expert consensus on images.
8. The Sample Size for the Training Set
Not applicable. An X-ray system is not an AI algorithm that requires a "training set" of data for machine learning. Its design and manufacturing adhere to engineering principles and standards.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is involved.
§ 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.