(35 days)
The Zenition 70 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 is to be used in health care facilities both inside and outside the operating room, sterile environment in a variety of procedures.
Applications:
- Orthopedic .
- · Neuro
- · Abdominal
- . Vascular
- · Thoracic
- · Cardiac
The proposed Zenition 70 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 two main components: the C-arm stand and a mobile view station
The provided text describes the regulatory clearance for the Philips Zenition 70, an image-intensified fluoroscopic x-ray system, based on substantial equivalence to a predicate device (Veradius Unity).
Here's an analysis of the acceptance criteria and supporting study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a table of specific quantitative acceptance criteria for device performance in the traditional sense (e.g., sensitivity, specificity, accuracy for a diagnostic task). Instead, the acceptance criteria are framed in terms of compliance with recognized standards and guidance documents. The "reported device performance" is primarily that it meets these standards and is comparable to the predicate device.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with International and FDA-recognized consensus standards and FDA guidance documents. | The Zenition 70 demonstrates compliance with a comprehensive list of standards including IEC 62304, ISO 14971, IEC 60601 series (2-43, 2-54, 2-28, 1, 1-2, 1-3, 1-6), IEC 62366, and several FDA guidance documents (e.g., Solid State X-ray Imaging Devices, Software in Medical Devices, Human Factors, Cybersecurity, Radiofrequency Wireless Technology). |
| Adequate for its intended use. | Non-clinical validation testing covered intended use, commercial claims, service needs, user needs, effectiveness of safety measures, instructions for use, and usability testing. The device "meets the acceptance criteria and is adequate for its intended use." |
| No new questions regarding safety or effectiveness compared to the predicate device. | Risk management activities show all risks are sufficiently mitigated, and residual risks are acceptable. Differences do not raise new safety or effectiveness concerns. |
| Substantial equivalence to the predicate device (Veradius Unity) in terms of: | Demonstrated substantial equivalence based on: |
| a. Indication for use | Identical indications for use. |
| b. Technological characteristics | Employs the same basic construction and fundamental scientific technology (X-ray generator, X-ray tube, image detection, beam-limiting device) as the predicate. Modifications (e.g., improved architecture, optional detector, DICOM connectivity, security features) do not alter fundamental technology. |
| c. Non-clinical performance testing | Demonstrated robust non-clinical performance testing against recognized standards as listed above. The optional 12-inch detector's technical characteristics were assessed and verified according to FDA guidance for Solid State X-ray Imaging Devices. |
| d. Safety and effectiveness | Demonstrated through compliance with standards and non-clinical testing; no new safety/effectiveness concerns. |
2. Sample size used for the test set and the data provenance:
- Test Set (Non-clinical Performance Data): The document refers to "Non-clinical performance testing" and "Non-clinical validation testing." It states that these tests demonstrate compliance with standards and that the device meets acceptance criteria.
- Sample Size: The document does not specify a sample size for the non-clinical tests. This type of testing typically involves engineering and bench testing, not patient-based data, so a "sample size" in the clinical sense is not applicable.
- Data Provenance: The data comes from internal non-clinical verification and validation testing conducted by the manufacturer, Philips Medical Systems Nederland B.V. The nature of the studies implies prospective testing against engineering specifications and regulatory standards. No patient data or country of origin for such data is mentioned as this device clearance did not involve clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document explicitly states: "The Zenition 70 did not require clinical study since substantial equivalence... was demonstrated." Therefore, there was no clinical test set requiring expert ground truth establishment. The ground truth for the non-clinical tests would be the design specifications and the requirements of the standards themselves, assessed by engineers and regulatory experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable for the same reason as point 3. There was no clinical test set requiring image interpretation or expert adjudication.
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 is not applicable. The device is an image-intensified fluoroscopic x-ray system, which is a hardware device for imaging. It is not an AI-driven diagnostic assistance tool that would typically undergo an MRMC study to compare human reader performance with and without AI assistance. The clearance is based on substantial equivalence to another fluoroscopy system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. As mentioned above, the Zenition 70 is a medical imaging hardware system, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance and validation tests, the "ground truth" was derived from:
- Engineering specifications and design requirements of the device.
- Requirements stipulated by the international and FDA-recognized consensus standards (e.g., IEC 60601 series for electrical safety, radiation protection; ISO 14971 for risk management; IEC 62304 for software lifecycle processes).
- FDA guidance documents relevant to X-ray imaging devices.
8. The sample size for the training set:
This is not applicable. The Zenition 70 is a hardware imaging device, not a machine learning or AI model that requires a "training set." The development process would involve traditional engineering design, manufacturing, and testing.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.