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The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

The Philips OmniDiagnost Eleva is a multifunctional, universal, overtable X-ray system offering radiographic, fluoroscopic, angiographic, and interventional techniques in a wide variety of applications. The Philips OmniDiagnost Eleva consisting of a floor mounted stand with an integrated tilting patient support table is supported at only one end, allowing patient access from both sides.

As a fully integrated system, the Philips OmniDiagnost Eleva stand can be configured with X-ray generators from the Philips generator family and Philips digital spot film device. The system comes with a 38 cm multimode Image Intensifier, XTV imaging system, collimator for patient positioning without X-rays, Philips glass or metal X-ray tubes, and TV monitors.

This document is a 510(k) premarket notification for the Philips OmniDiagnost Eleva X-ray system. It establishes substantial equivalence to a predicate device and declares compliance with various safety and regulatory standards. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML or diagnostic performance evaluation.

The document focuses on:

• Identifying the device and its manufacturer.
• Declaring the device's intended use (radiographic, fluoroscopic, angiographic, and interventional applications).
• Stating its substantial equivalence to a predicate device (Philips OmniDiagnost).
• Outlining the general safety and effectiveness requirements the device and its labeling will comply with (e.g., 21 CFR, UL Standard, DICOM).
• The FDA's letter of clearance, granting permission to market the device based on substantial equivalence.

Therefore, for the information requested in your prompt regarding acceptance criteria and performance studies, the provided text does not contain any of that information.

Specifically, I cannot extract:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory compliance and substantial equivalence, not specific performance metrics against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance: Not present. No performance study data is included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
4. Adjudication method: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not present. The device is an X-ray machine, not an AI/ML algorithm requiring such comparison for its own performance. The document does not discuss AI assistance.
6. If a standalone performance (algorithm only) was done: Not applicable and not present, as this is an X-ray system, not an AI algorithm.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not applicable and not present.
9. How the ground truth for the training set was established: Not applicable and not present.

This document serves as a regulatory submission for a medical device, not a scientific publication detailing performance evaluation against specific clinical metrics.

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