(104 days)
The GM60A Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
The GM60A Digital Mobile X-ray imaging system consists of High voltage generator (HVG), X-ray tube, Collimator, Detector, DAP and Barcode scanner. This system is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the operation software and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.
The provided text describes the 510(k) summary for the GM60A Digital Mobile X-ray Imaging System. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in comprehensive clinical study reports. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.
Here's an analysis of the information that is present and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing: The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for sensitivity, specificity, accuracy, or image quality metrics) that the device was required to meet for regulatory approval.
- Present (Implicit Performance Comparison): The "Summary of Technological characteristic of the proposed device compared with the predicate device" table ({5}-{6}) provides a comparison of technical specifications (e.g., Max. Power, kVp Range, mA Range, Exposure Time, Tube Moving Range, Rotation Range, Detector Area, Number of pixels, Pixel Pitch, High Contrast Limiting Resolution, Communication, Grid Lines/cm). For many of these, the proposed device's performance is stated as "Same as" or "Same or better" than the predicate device. This indirectly suggests that the performance observed for the predicate device forms an implicit benchmark for acceptance.
- Present (Non-clinical Data): "MTF and DQE were tested and measured by IEC 62220-1. The proposed device shows same curves and measurements of MTF and DQE than the predicate device (K140334) at all spatial frequencies tested." This indicates that the MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) performance of the proposed device were found to be equivalent to the predicate device, serving as a non-clinical performance benchmark.
- Present (Clinical Data): "clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. They were evaluated by professional radiologists and found to be equivalent to the predicate device." This indicates a clinical performance outcome of "equivalence" to the predicate.
2. Sample size used for the test set and the data provenance:
- Missing: The sample size for the clinical test set (i.e., number of images or patients) is not specified.
- Missing: The data provenance (e.g., country of origin, retrospective or prospective) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Present (Partial): "They were evaluated by professional radiologists".
- Missing: The exact number of radiologists is not specified.
- Missing: The qualifications of the radiologists (e.g., years of experience, subspecialty) are not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Missing: The adjudication method used for the radiologists' evaluation is not specified.
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:
- Missing: This document describes an X-ray imaging system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and not mentioned. The clinical data section only states that images were "evaluated by professional radiologists and found to be equivalent to the predicate device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing: This is an X-ray imaging system, not a standalone AI algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The performance reported relates to the imaging system's ability to produce images comparable to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Present (Implicit, for clinical evaluation): The "ground truth" for the clinical evaluation seems to be the interpretations by professional radiologists, who assessed the "equivalence" of the images from the proposed device to those of the predicate device. This suggests a form of expert consensus or comparison against an established benchmark (the predicate device's image quality).
- Missing (Definitive Ground Truth): The document does not describe a definitive "ground truth" derived from pathology, long-term outcomes, or a strict consensus process, which would be more typical for diagnostic accuracy studies of an AI algorithm. For this type of imaging device, the focus is on image quality and its diagnostic adequacy.
8. The sample size for the training set:
- Missing: This document pertains to the regulatory submission for an X-ray imaging system itself, not an AI algorithm that requires a training set. Therefore, a training set and its sample size are not applicable and not mentioned.
9. How the ground truth for the training set was established:
- Missing: As no training set for an AI algorithm is mentioned, this information is not applicable.
In summary:
The provided text focuses on demonstrating the substantial equivalence of the GM60A X-ray system to legally marketed predicate devices based on technical specifications and a general statement of clinical image equivalence as assessed by radiologists. It does not provide the detailed parameters of a study (like sample size, specific acceptance criteria, expert qualifications, or adjudication methods) that would be expected for a comprehensive performance study of an AI diagnostic device.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.