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The Philips MultiDiagnost Eleva is intended for the same applications as the previous MultiDiagnost 4 and MultiDiagnost 3 systems. As a multi-functional/universal system. general R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialised interventional applications. This includes the following general areas. Digestive System, Skeletal System, Urinary System, Reproductive System, Various lodine, Respiratory System, Circulatory System.

The MultiDiagnost Eleva is indicated for use in Radiographic/Fluoroscopic, Angiographic, and Interventional diagnostic imaging examinations.

The Philips MultiDiagnost Eleva is a multi-functional, tilting C-arm system consisting of a floor-mounted stand with an integrated tilting patient support table. The table is supported at only one end, allowing patient access from both sides. As a fully integrated system, it can be configured with generators from the Philips Optimus family and Digital Imaging systems. The system comes with a 38 cm multi mode Intensifier, XTV imaging system, collimator with laser cross for patient positioning without x-rays, Philips glass or metal x-ray tubed, and TV monitors.

This Philips Medical Systems 510(k) summary (K023441) describes the Philips MultiDiagnost Eleva, a multi-functional x-ray system. However, the document provided does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document focuses on establishing substantial equivalence to a predicate device (Philips MultiDiagnost 4, K961374) based on similar indications for use, device description, and compliance with general safety and effectiveness standards for X-ray systems (21 CFR, UL 2601-1, DICOM).

Therefore, I cannot provide the requested information from the given text.

Summary of missing information:

1. Acceptance criteria and reported device performance: Not mentioned.
2. Sample size for test set and data provenance: Not mentioned.
3. Number of experts and qualifications for ground truth: Not mentioned, as no study results are presented.
4. Adjudication method: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
6. Standalone (algorithm only) performance study: Not mentioned.
7. Type of ground truth used: Not mentioned.
8. Sample size for training set: Not mentioned.
9. How ground truth for training set was established: Not mentioned.

This document is a regulatory submission for a traditional x-ray system, not a software-driven AI device, which explains the absence of the detailed performance study information typically required for AI software.

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