(42 days)
The AJEX 9015/135H Portable X-rays are intended for use in general radiographic medical applications, by qualified/trained doctors or technicians on Tactographic incored. applications, and ing diagnostic radiographic exposures of body parts.
-The AJEX 9015H is used by foot and hand care clinics and portable orthopedic needs by sports medicine groups at sports arenas for general radiographic exposures.
-The AJEX 135H is used in general radiographic mobile applications with stand, by qualified/trained doctors, technicians or nurses, for on -site and off-site patients that are not mobile .
The AJEX 9015H and AJEX 135H are portable x-ray units which operate at 110V 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.
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for the AJEX 9015H and AJEX 135H Portable X-Ray units in the traditional sense of performance metrics with specific thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly evaluated through a comparison of technical characteristics and intended use.
Characteristic Predicate Devices (PXP-HF15, PXP-HF20, PXP-HF40) Range AJEX 9015H Performance AJEX 135H Performance Acceptance (Substantially Equivalent) Intended Use Portable general radiographic applications SAME SAME Met MA (mA) 15 - 35 15 35 Met kVp (kV peak) 80 - 100 90 100 Met Max. Output (kW) 1.2 - 2.4 1.35 2.25 Met Focal Spot (mm) 1.2 1.2 1.2 Met Power Requirement 120/220 Vol., 50/60 Hz 110 Vol., 50/60 Hz 110 Vol., 50/60 Hz Minor difference, but considered equivalent for function User Interface LED display, Up-Down push buttons for kVp selection, With memory key storage SAME SAME Met Collimator Manual Halogen 4 Blade (50W - 150W) Manual 50W Halogen 4 Blade Manual 100W Halogen 4 Blade Met Size (cm) approx. 17.78x20.32x22.86 to 25x20x35 23.8x34x19.4 16.5x29x21.5 Within comparable range Weight (lb) 21 - 28 17 32 Within comparable range (AJEX 135H slightly heavier than PXP range, but the comparison emphasizes overall equivalence, not strict numerical matching of min/max across all predicates.) -
Sample Size Used for the Test Set and Data Provenance:
The document describes a comparison to predicate devices rather than a formal clinical study with a "test set" of patient data. The evaluation is based on technical specifications and intended use of the device itself, not on imaging performance on a set of clinical cases. Therefore, there is no specified sample size, data provenance, or retrospective/prospective nature for a "test set" in the context of clinical images. -
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical "test set" requiring expert ground truth establishment is described. The evaluation is based on technical specifications and substantial equivalence to existing devices. -
Adjudication Method for the Test Set:
Not applicable, as no clinical "test set" requiring adjudication is described. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This submission is for an X-ray unit, not an AI or image analysis software, so such a study would not be relevant. -
Standalone Performance Study (Algorithm only without human-in-the-loop):
Not applicable. This device is a portable X-ray unit, a hardware device that produces images. It is not an algorithm for image processing or interpretation. The performance evaluation is based on the device's technical specifications and functionality, not an algorithm's standalone capability. -
Type of Ground Truth Used:
The "ground truth" in this context is the established technical specifications and performance characteristics of the legally marketed predicate devices (PXP-HF15, PXP-HF20, PXP-HF40). The new devices (AJEX 9015H and AJEX 135H) are compared against these known, accepted standards to demonstrate "substantial equivalence." -
Sample Size for the Training Set:
Not applicable. This device is a hardware X-ray unit and does not involve machine learning algorithms that require a "training set." -
How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is used.
§ 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.