(92 days)
The BV Pulsera system is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients except babies, within the limits of the systems. The system is to be used in health care facilities both inside the operating room, sterile as well as non-sterile environments, with a variety of procedures.
The 3D-RX functionality on the BV Pulsera provides 3D imaging and intended to be used whenever the physician benefits from intra-operatively-generated 3D information of high-contrast objects and anatomical structures.
The 3D application areas for the BV Pulsera are:
- Skull (Ear Nose and Throat, Maxillo Facial)
- . Cervical spine
- . Fore arm
- Elbow .
- Hand /Wrist ●
- . Knee
- Lower leg ●
- Foot / Ankle .
The 3D-RX Option on the BV Pulsera provides 3D imaging functionality and is intended to be used whenever the physician benefits from intra-operated 3D information of high contrast objects and anatomical structures.
The Philips 3D-RX Option for BV Pulsera is a mobile C-Arm X-Ray System offering Radiographic and Fluoroscopic techniques, which extends the functionality of the BV Pulsera Release 2.2 with 3D imaging. Using the 3D-RX Option on the BV Pulsera, an operator another a rotation run to acquire images. These images are used by an integrated 3D workstation which creates a 3D reconstruction, and which provides tools for further processing and analysis. Both hardware and software additions are added to the BV Pulsera C-Arm X-Ray System to produce the 3D-RX Option.
This submission K061685 describes the 3D-RX Option for BV Pulsera, Release 2.2, a mobile C-Arm X-Ray System with 3D imaging capabilities. The
review indicates this is a traditional 510(k), and therefore this device was found substantially equivalent to predicate devices via performance testing. However:
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A table of acceptance criteria and the reported device performance: No specific acceptance criteria or quantitative performance metrics are provided within the document. The submission focuses on substantial equivalence to the predicate device (Siemens ArcadisOrbic 3D, K042646) based on general safety and effectiveness, and compliance with applicable standards.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information is provided regarding the sample size of a test set, data provenance, or study design (retrospective or prospective). The submission primarily discusses compliance with safety standards and substantial equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No information is provided about experts establishing ground truth, as no specific performance study with a test set is detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information is provided about an adjudication method for a test set, as no specific performance study is detailed.
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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 study or AI assistance is mentioned in the document. The device is a 3D imaging option for an X-ray system, not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an imaging system providing 3D reconstructions, not a standalone algorithm for diagnosis without human-in-the-loop performance. Its functionality is to provide 3D information for physicians during procedures.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): No specific ground truth type is mentioned, as no performance study is detailed. The assessment is based on the system's ability to create 3D reconstructions of high-contrast objects and anatomical structures, implying visual assessment by physicians would be the primary verification method in clinical use.
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The sample size for the training set: Not applicable. The submission does not describe a machine learning or AI algorithm development that would require a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.
§ 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.