(178 days)
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, diagnostic fluoroscopy, conventional linear tomography, angiography and pediatric examinations.
The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, digital angiography and digital subtraction angiography (DSA).
The Platinum dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The Platinum dRF is not indicated for use in interventional radiology.
The Apelem-DMS Platinum dRF Imaging System (Platinum) is not a stand-alone device, but functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator. X-ray tube and software imaging packages), that are installed with a Apelem-DMS manufactured radiological examination table, control panel with system controller software. and electrical panel.
The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography. This device allows for treatment on the whole body, using all angles. It allows the user dynamic acquisition for the whole body, to target the zones to analyze, and to be able to track contrast media.
Here's a breakdown of the acceptance criteria and the study information for the Apelem-DMS Platinum dRF Imaging System, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. This type of submission often focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than performing extensive novel clinical trials as might be seen for entirely new technologies. Therefore, some detailed information about performance comparisons or AI assistance might not be present as it's not typically required for this type of submission.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with specific thresholds. Instead, it relies on demonstrating substantial equivalence to a predicate device (Siemens AXIOM Luminos dRF). The performance is discussed in terms of similarities and improvements compared to the predicate, with the underlying assumption that if it's equivalent or better in relevant aspects, it meets necessary performance standards.
The table below summarizes the comparison:
| Feature / Acceptance Criteria (Implied) | Platinum dRF Imaging System (Reported Performance) | Siemens AXIOM Luminos dRF (Predicate) | Notes / Implicit Acceptance |
|---|---|---|---|
| Product Code | JAA | JAA, OWB, OXO | Equivalent primary product code. |
| Flat Detector | Trixell Pixium RF 4343 (K080859) | Trixell Pixium RF 4343 | Identical component, implying equivalent image quality at the detector level. |
| Collimator | RALCO R225 ACS (K091517) | Self manufactured | Different manufacturer, but accepted as equivalent. |
| Collimator Type | Motorized, remote controlled, with ± 45° manual rotation, automatic lighting, positioning camera | Motorized up to a maximum of ± 45°, detent at 0° | Platinum dRF offers more rotational flexibility and features than the predicate. |
| Field Coverage | min 4x4 and max 48x48 at 100 cm SID | min/max not reported | Platinum dRF provides specific field coverage details. |
| Generator Power | 50-80 kW | 65 kW or 80 kW (optional) | Overlaps with and potentially exceeds predicate's power output. |
| AEC Interface | 4 ionization chambers max (solid state ionization 3 fields) | Not available | Platinum dRF offers an AEC interface not explicitly available on the predicate, an enhancement. |
| X-ray tube | Varian 600 kHU tubes RAD92 and G292: 400 kHU tube RAD60 | Self manufactured | Different manufacturer, but accepted as equivalent. |
| Use with X-ray ceiling tube | Yes | Yes | Equivalent functionality. |
| X-ray Grid | Smit Röntgen | Self manufactured | Different manufacturer, but accepted as equivalent. |
| Tube motorized rotation | +180°/-180° | +180°/-90° | Platinum dRF offers greater rotational range. |
| Oblique projections (Rotational Angle) | 45°/-45° motorized adjustment, height 10-450mm | 40°/-40° motorized adjustment, height 10-300mm | Platinum dRF offers slightly larger angle and greater height adjustment range, implying enhanced patient positioning. |
| Distance between table-top and detector | 6.2 cm | 7 cm | Slightly smaller distance for Platinum dRF. |
| Anti-diffusion grid | Oscillating: ratio 10:1, 12:1 / 40 l:cm - 60 l:cm / Multifocus 140 cm, easy ejection | Fixed: ratio 15:1, 80 lignes/cm, f0 = 125 cm, easy ejection | Different specifications, but implies equivalent or improved anti-diffusion capabilities. |
| Movement of the AB selector | Max 158 cm (remotely), increments up to 6 cm/sec | Max 113 cm (remotely), increments up to 7 cm/sec, PERISTEPPING | Platinum dRF offers greater remote movement range. |
| Compression cone | 0-160 N with indication above 3 kg | 5-155 N | Platinum dRF offers a wider compression range, implying broader applicability. |
| Imaging Software | CMT Thales Duet (K103028) | Flurospot COMPACT digital imaging system | Different software, but both are standalone cleared/registered components. |
| Image Resolution | 3.4 lp/mm | 3.4 lp/mm | Identical, demonstrating equivalent image quality. This is a key technical specification for image performance. |
| Speed (Radiography) | 12 f/s (RAD) | 8 f/s (RAD) | Platinum dRF is faster, indicating an improvement. |
| Speed (Fluoroscopy) | 18 f/sec (large field) | 15 f/s | Platinum dRF is faster, indicating an improvement. |
| Dose Reduction | Yes | Yes | Equivalent functionality. |
| DICOM | Yes | Yes | Equivalent functionality. |
| DAP measuring range | 0.1 - 99,999,999 µGy.m2 | Not available | Platinum dRF includes DAP measurement, an enhancement for patient dose management. |
| Pulse frequency | 15, 7.5 and 3 pulsed per sec | 15, 10, 7.5 and 3 pulsed per sec | Slightly different options, but within acceptable range for fluoroscopy. |
| Table Tilting | +90°/-90°, variable tilting up to 10°/sec | +90°/-45° or +90°/-90° (optional), two speeds | Equivalent or improved tilting. |
| Table top height | 50 cm to 130 cm continuously adjustable | 50 cm to 100 cm continuously adjustable | Platinum dRF offers a greater adjustable height range, accommodating more patient types. |
| Table top dimensions | 240 x 85 cm / radio transparent field: 283 x 65 cm | 210 x 80 cm / radio transparent field: 193 x 53.5 cm | Platinum dRF has a larger table top and radio-transparent field, accommodating larger patients. |
| Table top attenuation value |
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.