(69 days)
This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.
This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Toshiba Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Toshiba flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate device is the supplier of the digital x-ray receptor panel. The previous supplier was Varian. The two model numbers differ only in the configuration and weight of the mounting hardware.
The provided document is a 510(k) premarket notification for a digital portable X-ray system. The aim of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove the device meets specific performance criteria through a study with acceptance criteria in the way a novel therapeutic or diagnostic device would.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert qualifications, and ground truth establishment, which are typical for studies validating the performance of a new diagnostic algorithm or device feature, are not applicable here. This document focuses on demonstrating that a modified device (changing the digital panel supplier) performs equivalently to an already cleared device.
Here's an attempt to extract relevant information given the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: While specific numerical acceptance criteria for image quality aren't explicitly stated in a table format, the underlying criterion is that the diagnostic image quality of the new device (with the Toshiba panel) must be comparable to that of the predicate device (with the Varian panel).
- Reported Device Performance: "The images were evaluated by a board certified radiologist and found to be of comparable diagnostic quality."
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Diagnostic Image Quality | Comparable to predicate device | Images found to be of comparable diagnostic quality |
| Safety and Effectiveness | As safe and effective as predicate device | Results of bench testing indicates new device is as safe and effective |
| Proper System Operation | Fully verified upon installation | Verified to work properly and produce diagnostic quality images as good as predicate |
| Compliance with Radiation Safety Standards | DHHS radiation safety standards (21 CFR 1020.30 & 1020.31) | Complies with DHHS radiation safety standards |
| Electrical Medical Device Safety | UL 60601-1 | Undergone testing for compliance with UL 60601-1 |
| Electromagnetic Compatibility | IEC 60601-1-2 | Undergone testing for compliance with IEC 60601-1-2 |
| Software Compliance | NEMA PS 3.1-3.20 (DICOM) | Software tested to and complies with DICOM standard |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: "Several test exposures" were performed using "Supertech" lung/chest phantom and other phantoms. A precise number is not given.
- Data Provenance: Not applicable as phantom images were used, not patient data with specific country of origin. This was a prospective test in the sense that the new system was assembled and then tested with phantoms.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: One
- Qualifications of Experts: "A board certified radiologist." Specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: "None" for comparison, as only one radiologist evaluated the images. The radiologist made a direct comparison to images from the predicate device.
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
- MRMC Study: No, an MRMC study was NOT done. This device is an X-ray system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an X-ray imaging device. The device's "performance" is its ability to produce diagnostic images. The evaluation described involves a human (radiologist) interpreting these images.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for the comparison was the diagnostic quality of images produced by the predicate device (MinXray CMDR-2S with Varian 4336R panel). This is a comparison of diagnostic image quality as assessed by an expert, rather than reference to pathology, outcomes data, or a different "ground truth" standard. The phantoms represent known anatomical structures.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes a 510(k) submission for a medical device (X-ray system), not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as this is not an AI/machine learning algorithm with a training set.
§ 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.