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510(k) Data Aggregation
(113 days)
Apelem-DMS Group
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 radiology and diagnostic fluoroscopy examinations, conventional linear tomography and pediatrics 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, cranial, skeletal, thoracic, lung and urogenital tract examinations.
It may also be used in: lymphography, endoscopy, myelography, venography and arthrography.
The Platinum dRF may also be used for outpatient or emergency services, as well as for mobile transport examinations (wheelchair and bed).
The Platinum dRF is not indicated for use in interventional radiology.
The subject of this Special 510(k) application is the change to the imaging software system to the ADAM Imaging System. As the resources are now available, Apelem-DMS Group was able to develop their own Imaging System called the ADAM Imaging System. The ADAM Imaging System will now be developed by Apelem-DMS Group. The predicate device (K160301) had an Off the Shelf Software Imaging System called DUET DRF Imaging System which was developed by Thales.
The ADAM Imaging System is a digital image acquisition system to be used in conjunction with a detector during radiography or fluoroscopy X-ray examinations to acquire, display, process and export images according to DICOM protocol via a network connection.
The ADAM Imaging System software interfaces with an X-Ray detector to acquire raw pixel data and image processing algorithms which transform raw pixel data into images and image sequences to help medical professionals with viewing images to for patient diagnosis.
The Duet DRF requires the use of the THALES RF4343 FL detectors, whereas ADAM Imaging System requires the use of the VIEWORKS VIVIX-D 1717G detector. Both detectors employ the same state-of-the-art indirect conversion technology based on CsI scintillator and photo-diodes. The detector Vivix-D 1717G is connected to the x-ray system by cable. The integration with the PLATINUM dRF system has been established and appears adequate. The VIEWWORKS VIVIX-D 1717G detector is only compatible with the ADAM Imaging System.
The Duet DRF and ADAM Imaging System are designed to support general radiography (excluding mammography) and fluoroscopy imaging procedures.
The Apelem-DMS Group ADAM Imaging System is not a stand-alone device. It is integrated into the Platinum dRF Imaging System and 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 Group 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.
The provided document is a 510(k) summary for the Platinum dRF Imaging System and does not contain detailed information about acceptance criteria or a study proving that the device meets those criteria. The document states that the new ADAM Imaging System component changes the internal imaging software and detector, but it does not include performance data or explicit acceptance criteria for image quality, diagnostic accuracy, or clinical effectiveness.
The submission focuses primarily on demonstrating substantial equivalence to a predicate device (K160301) by comparing technical specifications and highlighting that the proposed changes do not raise new questions of safety or effectiveness. It mentions compliance with various IEC and ISO standards related to medical electrical equipment, software, and risk management, which are general safety and performance standards rather than specific acceptance criteria for a diagnostic imaging study.
Therefore, most of the requested information regarding acceptance criteria and performance study details cannot be extracted from this document.
However, based on the available information, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics for a diagnostic study. The document primarily focuses on demonstrating that the performance of the new detector (VIEWORKS VIVIX-D 1717G) is "similar enough" or "sufficient" compared to the predicate's detector.
- Reported Device Performance: The document provides technical specifications of the new detector and compares them to the predicate's detector, implying these are the performance characteristics considered.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (ADAM Imaging System Detector) | Reported Predicate Performance (DUET Imaging System Detector) | Comment |
|---|---|---|---|---|
| Scintillator | Same as predicate | CsI | CsI | Same |
| Pixel Pitch | Similar to predicate; smaller is generally better | 140µm | 148µm | ADAM Imaging System's detector has a smaller pixel pitch which means better detail detectability. |
| Pixel Matrix | Similar to predicate; larger is generally better | 3072 x 3072 pixels | 2874 x 2840 pixels | Adam Imaging System's detector has a larger pixel matrix which means a larger detection field. |
| Image Size | Same as predicate | 17" x 17" | 17" x 17" | Same |
| Grayscale | Same as predicate | 16 bits | 16 bit | Same |
| Resolution | Performance similar enough (>3%) for indicated procedures | 3.5 linepairs/mm | 3.4 linepairs/mm | The performance of both detectors are similar enough (>3%) for the procedures indicated. |
| Modulation Transfer Function (MTF) | Performance of both detectors sufficient for general radiographic procedures | MTF IEC 0.5 lp/mm: Minimal 78%, Typical 83% | ||
| MTF IEC 1 lp/mm: Minimal 50%, Typical 55% | ||||
| MTF IEC 2 lp/mm: Minimal 20%, Typical 25% | ||||
| MTF IEC 3 lp/mm: Minimal 5%, Typical 10% | MTF IEC 0.5 lp/mm: Minimal 79%, Typical N/A | |||
| MTF IEC 1 lp/mm: Minimal 55%, Typical 66% | ||||
| MTF IEC 2 lp/mm: Minimal 25%, Typical 35% | ||||
| MTF IEC 3 lp/mm: Minimal 10%, Typical 19% | Performance of both detectors are sufficient for general radiographic procedures. (Predicate listed MTF IEC Nyquist as 7% Minimal, 15% Typical) | |||
| Detective Quantum Efficiency (DQE) | DQE difference |
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(29 days)
Apelem-DMS Group
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.
The subject of this Special 510(k) application is the additional offering of the Platinum with a different flat panel detector (RF4343 FL) that does not include some less regularly used options (of the FDA cleared Platinum with RF4343 flat panel detector), has lower frames/sec and does not include a lead shield for use with the RF4343 FL is manufactured and installed by DMS. This additional offering is less expensive and will fit the needs of most customers.
The provided document is a 510(k) premarket notification for a medical device (Platinum dRF Imaging System) seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that a new component (a different flat panel detector) does not alter the device's safety or effectiveness.
Therefore, this document does not contain the information requested regarding specific acceptance criteria for device performance, a study proving the device meets these criteria, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies.
The document states:
- The subject of this Special 510(k) application is the additional offering of the Platinum with a different flat panel detector (RF4343 FL) that does not include some less regularly used options (of the FDA cleared Platinum with RF4343 flat panel detector), has lower frames/sec and does not include a lead shield for use with the RF4343 FL is manufactured and installed by DMS.
- There is no change in the Indications for Use.
- The change in frame rate has no impact on image quality as the image specifications are not changes.
- The results of assessment under Design Controls supports that the Apelem-DMS Platinum dRF Imaging System with RF434FL flat panel detector is substantially equivalent to the predicate device. The differences between the RF4343 FL flat panel detector do not raise different issues of safety or effectiveness.
- The Platinum with RF4343 FL has no impact on the image quality or safety of the device, and does not raise different issues of safety or effectiveness.
This indicates that the submission relies on the previous clearance of the predicate device (K131766) and argues that the minor changes to the flat panel detector do not necessitate new performance studies or acceptance criteria beyond demonstrating continued compliance with general safety and performance standards for X-ray equipment.
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(178 days)
APELEM-DMS GROUP
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 |
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