(21 days)
The MinXray IIF120/60H PowerPlus™ is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60~ AC. The unit utilizes a newly designed 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.
This appears to be a 510(k) summary for a medical device, the MinXray HF120/60H PowerPlus™ High Frequency Diagnostic X-Ray Unit. The purpose of this document is to establish substantial equivalence to a predicate device, not necessarily to detail comprehensive acceptance criteria and a deep study proving its performance against those criteria in the way one might expect for a novel AI algorithm.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable in this context, as they pertain to the evaluation of algorithms or AI systems, not a new iteration of a diagnostic X-ray unit being compared to a pre-amendments device based on its physical and performance characteristics.
Here's the information that can be extracted relevant to your request, with the understanding that the "acceptance criteria" here are largely about demonstrating equivalence to an existing device rather than novel performance benchmarks:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, "acceptance criteria" are typically met by demonstrating that the new device's performance characteristics are equivalent to or better than those of the predicate device, especially regarding safety and effectiveness for the stated intended use. The table below summarizes the comparison provided:
| Characteristic | Acceptance Criteria (based on Predicate Device: MinXray HF100H) | Reported Device Performance (MinXray HF120/60H PowerPlus™) |
|---|---|---|
| Intended Use | For diagnostic x-rays by qualified physician/technician on adult & pediatric subjects. | SAME |
| Physical Characteristics | ||
| Size/Weight | 406 x 222 x 241 mm, 18.6 kg | 406 x 221 x 240 mm, 20 kg. (Slight increase in weight) |
| Energy Source | 120 V 50-60~ AC | SAME |
| User Interface | Up-Down pushbuttons for three kVp selections and exposure time selections with LED indicators. | Up-Down pushbuttons for kVp selections and exposure time selections with LED indicators, mAs indicator. (Added mAs indicator) |
| Exposure times | 199 (in 0.01 sec. Steps) 0.08 - 4.00 sec. | (0.01 - 0.2 sec in 0.01 sec. Step), (0.2 - 0.4 sec in 0.02 sec. Step), (0.4 - 1.0 sec in 0.05 sec. Step), (1.0 - 5.0 sec in 0.1 sec. Step). (More granular and extended range) |
| mA | 20 mA constant | 30 mA (40-60kV), 25mA (62-80kV), 20mA (82-100kV). (Variable mA based on kV, higher peak mA) |
| kVp | 40-100 kVp | Max. 120 kVp. (Higher maximum kVp) |
| Standards & Safety | ||
| Performance Standard | 21 CFR 1020.30 | SAME |
| Electrical Safety | UL 2601, IEC 60601-1 | SAME, plus UL listed. (Additional certification) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench and user testing" but does not specify sample sizes for any test set or the provenance of any data. The evaluation is primarily a comparison of technical specifications against a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. This submission does not describe a study involving expert-established ground truth for a test set in the context of diagnostic accuracy, as it is for an X-ray unit itself, not an interpretive algorithm. The "user testing" mentioned would likely involve engineers or technicians verifying functionality, not radiologists establishing ground truth.
4. Adjudication Method for the Test Set
Not Applicable. No ground truth establishment or adjudication method is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not mentioned or implied. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the scope of this device's submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No. This device is an X-ray unit, which is a hardware device for image acquisition, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance and safety profile of the predicate device (MinXray HF100H) and adherence to relevant performance and electrical safety standards (21 CFR 1020.30, UL 2601, IEC 60601-1). The new device is deemed "substantially equivalent" if it meets or exceeds these characteristics and standards.
8. The Sample Size for the Training Set
Not Applicable. This is an X-ray unit, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. This is an X-ray unit, not an AI algorithm.
§ 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.