(121 days)
The TR90BH is a portable X-ray system with following limitations of use:
The device may be used for handheld diagnostic imaging of body extremities
The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities.
The device may be used for stand mounted imaging of the chest when used without a grid.
- Not to be used on bariatric patients, unless imaging body extremities
- Not for mammography use
- The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
We have developed compact, lightweight, battery powered easy-carry TR90BH based on the technology of HF1202H. This device can be used with a stand or hand-held. A detailed comparison table with an equivalent device is provided below. The MinXray TR90BH consists of a battery powered X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, battery charger, AC adaptor and AC power cord, and those are provided in a portable carry case with wheels. If a stand is purchased with the TR90BH, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the TR90BH are included with the stand. The device works with a dedicated secondary Lithiumion battery, therefore it can be operated at no power supply places such as disaster sites. A few number of shots can be taken in short chanks to the newly designed and superior patent licensed battery. The x-ray tube is Toshiba Electron Tubes & Devices D-0814 0.8mm, 9.86kHU which is designed for diagnostic x-ray applications. 2-stage exposure switch: The exposure switch has 2-stage button. The first stage preheats the filament of the x-ray tube and lights collimator enabling operator to confirm exposure area. After keeping the button position at the first stage end for approximately 1 second, exposure preparation will be done and the STAND BY indicator will light. The second stage initiates the x-ray exposure for the sec display in advance. When the second stage is fully pressed, x-ray will be emitted, the X-RAY indicator will light, and an audible signal will be heard. One must PRESS AND HOLD THE SECOND STAGE END POSITION UNTIL THE EXPOSURE HAS TERMINATED. The switch operates in a "dead man" mode in that x-ray exposure will terminate immediately as a safety feature when the button is released.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic imaging AI would. Instead, this document is a 510(k) summary for an X-ray system (TR90BH), focusing on demonstrating substantial equivalence to a predicate device based on technical specifications, safety standards compliance, and intended use.
However, I can extract the information that is present concerning testing and validation.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) or image quality metrics. Instead, it relies on demonstrating compliance with recognized safety and performance standards for X-ray equipment and a general assessment of its functionality and image output.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with Safety Standards | The device complies with numerous IEC standards including IEC 60601-1 (General Requirements for Safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (Radiation Protection), IEC 60601-1-6 (Usability), IEC 60601-2-28 (X-ray source assemblies), IEC 60601-2-54 (Radiography/Radioscopy), IEC 62304 (Software life-cycle), and IEC 62366 (Usability Engineering). |
| Battery Safety & Performance | Battery performance testing performed according to UN "Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria." Successfully passed: Altitude simulation, Thermal test, Vibration, Shock, External short circuit, Impact, Overcharge, and Forced discharge. |
| Image Quality / Functionality | "Overall operation by taking and reviewing test images" confirmed. (No specific quantitative metrics for image quality are provided beyond this general statement.) |
| Ability to image non-extremities | "A limited clinical test was performed to demonstrate that the device could image anatomy other than extremities." This test was "successful." |
| Software Performance | Software is "unchanged" from predicate, with a "moderate level of concern" and risk analysis performed. A power-on password routine added for cybersecurity. |
| Safety for Hand-Held Use | Took into account FDA Guidance: "Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use; Document issued on December 24, 2008." Involved extra shielding and cautionary labeling. Meets US Performance standard on leakage. |
| Substantial Equivalence | Concluded to be as safe and effective as the predicate device (HF1202H PowerPlus™ K153059), with few technological differences and similar indications for use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for clinical test: The document states "A limited clinical test was performed." No specific number of patients or images is provided.
- Data provenance: Not specified. It's likely an internal test conducted by MinXray Inc. or a contracted entity, given the nature of a 510(k) submission for an X-ray system rather than a diagnostic AI. The test was clinical in nature, implying prospective data collection, but details are absent.
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)
- Number of experts: One expert.
- Qualifications of experts: "A Board Certified Radiologist performed a successful review." No details on years of experience or specialization beyond being Board Certified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. Only one expert was involved in the review.
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 comparative effectiveness study was not done. This device is an X-ray system, not an AI-powered diagnostic tool for interpretation. Its evaluation focuses on hardware performance, safety, and image generation, not reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable in the context of diagnostic AI. This device is an X-ray machine. The "clinical test" assessed its ability to image anatomy, not its performance as a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground truth for clinical test: The "successful review" by a Board Certified Radiologist served as the ground truth, confirming the device's ability to image anatomy. This is essentially expert review/opinion on imaging capability rather than a ground truth for a specific disease diagnosis.
8. The sample size for the training set
- Training set sample size: Not applicable. This document describes an X-ray hardware system, not a 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 there is no training set for this type of 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.