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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.

2. Sample size used for the test set and the data provenance

• This information is not provided in the document. The submission focuses on technical specifications of the components rather than a clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the document. No clinical or diagnostic performance study with expert adjudication is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided in the document. No adjudication method is described as no clinical performance study is detailed.

5. 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

• This information is not applicable/not provided. The device is an imaging system (hardware and software for image acquisition and display), not an AI-assisted diagnostic tool. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• This information is not applicable/not provided. The device is a complete imaging system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• This information is not provided. The submission relies on technical specifications and compliance with standards, not on a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

• This information is not provided. As no AI/machine learning component for diagnosis is indicated, a 'training set' in that context is not relevant to this submission. The software changes are for image acquisition, display, and processing.

9. How the ground truth for the training set was established

• This information is not provided. See point 8.

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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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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:

The study is primarily a substantial equivalence assessment against a predicate device, as detailed in the "Substantial Equivalence Discussion" and "Performance" sections.

1. Sample size used for the test set and the data provenance:

   • The document does not describe a specific "test set" of images or patient cases for direct performance evaluation of the integrated Platinum dRF system.
   • Since the system is a platform for already-cleared or registered components, the performance data referenced for these individual components would likely have been generated by their respective manufacturers. The provenance of that data is not specified in this document.
   • The submission focuses on the integration of these components and the overall system's physical and technical specifications compared to a predicate.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable, as a dedicated clinical test set with ground truth established by experts is not described for this 510(k) submission. Performance is inferred through substantial equivalence and compliance with standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable, as a dedicated clinical test set requiring expert adjudication is not described.

4. 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:

   • No MRMC comparative effectiveness study is mentioned.
   • This device is an X-ray imaging system, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This device is an X-ray imaging system. Its "standalone" performance means its ability to produce images and operate according to its specifications.
   • The document states: "The Platinum is manufactured with FDA cleared/registered commercially available imaging components. Data as required in the appropriate sections of 21 CFR 1020 have been generated by the appropriate component manufacturer, and included in their manuals. Data generated by Apelem-DMS is limited to that required in CFR 1020.31(e)(1). No additional special imaging performance testing was conducted."
   • This indicates that the performance of the individual imaging components (like the Trixell detector, RALCO collimator, Varian X-ray tube, and CMT Thales Duet imaging software) had been established stand-alone by their respective manufacturers and cleared by the FDA prior to their integration into the Platinum dRF system. The current submission is for the integrated system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the integrated system, the "ground truth" for showing safety and effectiveness relies on:
     • Technical specifications comparison: Demonstrating that key imaging parameters (e.g., image resolution, image speed, dose reduction) are equivalent to or better than the predicate.
     • Compliance with recognized standards: Adherence to IEC (International Electrotechnical Commission) and NEMA (National Electrical Manufacturers Association) standards, as well as FDA regulations (21 CFR 1020, 21 CFR 807.92). These standards ensure basic safety, electrical performance, radiation protection, and electromagnetic compatibility.
     • Prior FDA clearance/registration of components: The individual FDA-cleared components (detector, software) imply their own established performance and "ground truth" from their specific submissions.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning model requiring a training set. The device is a hardware imaging system integrating existing cleared components.

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as above.

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