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510(k) Data Aggregation
(605 days)
This equipment is used for generating X-ray to get the X-ray image for the purpose of diagnosis of patient.
This equipment is possible to move the place for patient because it is designed for portable type.
This equipment is possible to combine with the mobile stand unit for convenience for patient positioning according to user's needs.
The AJEX 1200H/ AJEX 240H Mobile X-ray Generator is designed for the following applications :
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Physician with general practice
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Bedside exposures in hospital ward
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Surgery and Orthopedics
The AJEX 1200H and AJEX 240H are portable x-ray units which operate at 110V or 220V, 50/60 HZ. The units have an LED display with up and down soft keys to control KvP. In addition the unit has preset memory keys to store and select KvP. The units can be installed on a mobile stand, a support arm or can be hand held. The unit should be used only by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts. The usual safety precautions regarding the use of x-ray units must be observed by the operator.
The provided text describes a 510(k) premarket notification for two portable X-ray units, the AJEX 1200H and AJEX 240H. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through clinical studies or standalone algorithm performance.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided document, as it falls outside the scope of a typical 510(k) submission for this type of device.
Below is a breakdown of what can be extracted and what information is not available:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to legally marketed predicate devices. This means that the new devices are considered safe and effective if they have the same intended use and similar technological characteristics to the predicate devices, or if any differences do not raise new questions of safety or effectiveness.
The "device performance" in this context is primarily a comparison of technical specifications and performance parameters against the predicate devices.
| Characteristic | Acceptance Criterion (Substantially Equivalent to Predicate) | Reported Device Performance (AJEX-1200H) | Reported Device Performance (AJEX-240H) |
|---|---|---|---|
| Intended Use | SAME as Predicate | SAME | SAME |
| mA | Comparable to Predicate (14-60 mA or 20,25,30 mA) | 15-80 | 15-40 |
| kVp | Comparable to Predicate (40-100 kVp or 40-120 kVp) | 40-120 | 40-120 |
| mAs | Comparable to Predicate (0.6-100 mAs or 0.6-212 mAs) | 0.6-168 | 0.4-140 |
| Focal Spot | Comparable to Predicate (1.2mm) | 1.8mm | 1.2mm |
| Power Requirement | Comparable to Predicate | 110 or 220V, 50/60Hz | 110 or 220V, 50/60Hz |
| User Interface | SAME as Predicate | Exposure Switch and Console | Exposure Switch and Console |
| Collimator | SAME (manual) | manual | manual |
| Size | Comparable to Predicate | 13.4" x 9.9" x 9.8" | 13.4" x 7.6" x 6.4" |
| Weight | Comparable to Predicate | 44lbs | 32lbs |
The conclusion states: "After analyzing all the data it is the conclusion of JPI that the AJEX-1200H and 240H are as safe and effective as the predicate devise. The systems have few technological differences, and have no new indication for use. thus rendering them substantially equivalent to the predicate devices."
Study Information Not Applicable/Available:
The provided document is a 510(k) summary for X-ray units, not an AI/algorithm-driven device. Therefore, a "study" in the sense of a clinical trial proving diagnostic performance against specific metrics with human readers or standalone AI performance is not detailed. The "study" here is primarily a technical comparison to predicate devices, supported by the engineering and design choices.
- Sample size used for the test set and the data provenance: Not applicable. This is a submission for a hardware device (X-ray unit), not an algorithm or diagnostic imaging study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic image interpretation is not relevant for the substantial equivalence of an X-ray generator.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. The device is an X-ray generator, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. There is no "training set" in the context of an X-ray generator's substantial equivalence demonstration.
- How the ground truth for the training set was established: Not applicable.
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