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510(k) Data Aggregation
(54 days)
The Zenition 50 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Applications:
Orthopedic
Neuro
Abdominal
Vascular
Thoracic
Cardiac
The proposed Zenition 50 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises of two main components: the C-arm stand and a Mobile View Station(MVS)
The provided text describes the Philips Medical Systems Nederland BV Zenition 50, an image-intensified fluoroscopic X-ray system. The document is a 510(k) summary indicating substantial equivalence to a predicate device, the BV Pulsera.
Based on the provided document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission demonstrates substantial equivalence by showing compliance with various recognized standards and guidance documents. This largely forms the acceptance criteria for safety and performance.
| Acceptance Criteria (from International and FDA Recognized Standards & Guidance) | Reported Device Performance (Zenition 50) |
|---|---|
| Safety and Essential Performance Specific Standards: | |
| IEC 60601-2-43 (X-Ray equipment for interventional procedures) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-2-54 (X-Ray Equipment for Radiography and Radioscopy) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-2-28 (X-ray tube assemblies for medical diagnosis) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-1 (General requirements for basic safety and essential performance) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-1-3 (Radiation Protection in Diagnostic X-Ray Equipment) | Complies (stated in "Non-clinical verification and validation test results") |
| Software and Usability Specific Standards/Guidance: | |
| IEC 62304 (Medical device software Software life cycle processes) | Complies (stated in "Non-clinical verification and validation test results") |
| ISO 14971 (Application of risk management to medical devices) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-1-6 (Usability) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 62366 (Application of Usability Engineering to Medical Devices) | Complies (stated in "Non-clinical verification and validation test results") |
| Guidance for Content of Premarket Submissions for Software | Complies (stated in "Non-clinical verification and validation test results") |
| Guidance for Applying Human Factors and Usability Engineering | Complies (stated in "Non-clinical verification and validation test results") |
| Guidance for Management of Cybersecurity in Medical Devices | Complies (stated in "Non-clinical verification and validation test results") (Note: "Introduction of the security features" is described as not impacting clinical functionality and demonstrating substantial equivalence.) |
| Other: | |
| FDA Performance Standard for Diagnostic X-Ray Systems (21 CFR 1020.30 & 1020.32) | Complies ("Image processing performance is compared by means of an image quality performance comparison with the predicate device and found equal or improved, see Appendix A38. This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence.") |
| Pediatric information for x-ray imaging device premarket notifications | Complies (stated as a guidance document the device complies with) |
| Radio frequency wireless technology in medical devices guidance | Complies (for wireless footswitch, stated that "The change does not introduce new risks, but only minor update to existing risks compared to the predicate device. This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence.") |
| Effectiveness of Safety Measures & Intended Use | Non-clinical validation testing performed to cover intended use, commercial claims, service, user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users. Results demonstrate the device "Meets the acceptance criteria and is adequate for its intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical performance testing (verification and validation) against recognized standards. There is no mention of a clinical study or a specific "test set" of patient data for the Zenition 50 itself. The performance comparison is done against a predicate device, and improvements are assessed through non-clinical means.
3. 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)
Not applicable. As no clinical study or specific "test set" with a ground truth established by experts is described for the Zenition 50, this information is not provided. The evaluation relies on compliance with technical standards and comparison to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set or adjudication process for image interpretation (which would be typical for AI/algorithm performance) is described.
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
No MRMC comparative effectiveness study is mentioned. The device is a fluoroscopic X-ray system, and the submission focuses on its safety and performance equivalence to a predicate device through non-clinical testing, not on AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe the Zenition 50 as an AI/algorithm-only device or an algorithm with standalone performance. It is a medical imaging system. Its image processing performance was compared to the predicate device and found "equal or improved" through non-clinical means (Appendix A38, not provided here).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the Zenition 50, the "ground truth" for demonstrating safety and effectiveness relies on compliance with established international and FDA-recognized consensus standards and guidance documents, and by demonstrating substantial equivalence to a legally marketed predicate device (BV Pulsera). This primarily involves technical specifications, risk management, and performance testing against defined engineering and regulatory requirements, rather than clinical ground truth like pathology or outcomes data for a novel diagnostic claim.
8. The sample size for the training set
Not applicable. The document does not describe the Zenition 50 as being developed using a training set of data in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for machine learning/AI.
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