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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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