(28 days)
The proposed Zenition 70 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 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 is a 510(k) summary for the Philips Zenition 70, a fluoroscopic X-ray system. The submission focuses on demonstrating substantial equivalence to a predicate device (previous Zenition 70 model K183040) and a reference device (Digiscan FDX K200218) by adding a new flat panel detector (FD17) and some software/UI updates.
The document states that no clinical studies were required as substantial equivalence was demonstrated through non-clinical performance testing and similarity in indications for use and technological characteristics. Therefore, the device's acceptance criteria are primarily met through compliance with recognized standards and verification of technical performance, rather than a clinical study involving human readers or a set of clinical cases with ground truth.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of specific clinical acceptance criteria and corresponding performance metrics from a study involving clinical cases. Instead, the acceptance criteria are largely defined by adherence to a comprehensive list of international and FDA-recognized consensus standards and FDA guidance documents. The "reported device performance" is the statement that the device complies with these standards.
| Acceptance Criteria Category | Specific Criteria (as derived from the text) | Reported Device Performance |
|---|---|---|
| Basic Safety & Essential Performance | Compliance with ES60601-1:2005/(R)2012 and A1:2012 | Complies |
| Electromagnetic Disturbances | Compliance with IEC 60601-1-2 (Edition 4.0 2014-02) | Complies |
| Radiation Protection (Diagnostic X-Ray) | Compliance with IEC 60601-1-3 (Edition 2.1 2013-04) | Complies |
| Usability | Compliance with IEC 60601-1-6 (Edition 3.1 2013-10) and IEC 62366-1 (Edition 1.0 2015-02) | Complies |
| Safety & Performance (Interventional X-Ray) | Compliance with IEC 60601-2-43 (Edition 2.1 2017-05) | Complies |
| Safety & Performance (Radiography and Radioscopy) | Compliance with IEC 60601-2-54 (Edition 1.2 2018-06) | Complies |
| X-Ray Tube Assemblies | Compliance with IEC 60601-2-28 (Edition 2.0 2010-03) | Complies |
| Software Life Cycle Processes | Compliance with IEC 62304 (Edition 1.1 2015-06) | Complies |
| Risk Management | Compliance with ISO 14971 (Edition 2.0 2007-03) | Complies |
| Medical Device Symbols | Compliance with ISO 15223-1 (Edition 3.0 2016-11) | Complies |
| Solid State X-ray Imaging Devices | Adherence to "FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" | Assessed and Verified |
| Pediatric Information | Adherence to "Pediatric Information for X-ray Imaging Device Premarket Notifications" | (Not explicitly stated as "complies" but is a guidance document followed) |
| Software in Medical Devices (Content of Submissions) | Adherence to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | (Not explicitly stated as "complies" but is a guidance document followed) |
| Cybersecurity Management | Adherence to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" | (Not explicitly stated as "complies" but is a guidance document followed) |
| Image Quality Performance | Image quality performance of FD17 (PX3030S) compared to FD15 (PX2630Sv) and FD12 (PX2121CV/S) detectors. | Found to be equal. |
| Safety and Effectiveness | No new questions regarding safety or effectiveness raised by differences. | Demonstrated for substantial equivalence. |
| Intended Use & Technical Claims | Non-clinical V&V tests performed with regards to intended use, technical claims, requirement specifications, and risk management results. | All tests used to support substantial equivalence and demonstrate the device meets acceptance criteria and is adequate for 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 explicitly states: "The proposed Zenition 70 did not require clinical study since substantial equivalence to the currently marketed and predicate device Zenition 70 was demonstrated with the following attributes: Indications for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness."
Therefore, there was no test set of clinical cases that a sample size would apply to. The testing involved non-clinical performance evaluations against standards.
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 test set requiring expert ground truth was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was performed.
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
Not applicable. This is a submission for an X-ray imaging system, not an AI-powered diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable, as this is an imaging system, not a standalone algorithm. Its performance is evaluated through technical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission comes from the established and recognized international and FDA standards for medical electrical equipment and X-ray imaging devices. The performance of the new FD17 detector was compared to the predicate detectors, where "image quality performance...is compared and found to be equal." This comparison is technical/physical, not clinical.
8. The sample size for the training set
Not applicable, as this is an X-ray system. The "training" for such a device involves engineering, design, and manufacturing processes compliant with quality systems, not machine learning training on a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of machine learning for this device.
§ 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.