Search Results

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.

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device