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The SIEMENS MAGNETOM Project 024 is a 1Tesla whole body magnetic resonance imaging (MRI) system intended for general diagnostic use. This MRI system will present images which reflect the spatial distribution and/or magnetic resonance spectra which are a function of the frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging.

The SIEMENS MAGNETOM Project 024 is a 1.0T vhole body magnetic The SIEMILING MITONETON tern. The MAGNETOM Project 024 is the first resonalice innaging (MRL) byotic resonance imaging (MRI) systems. The meatber of a family of mag-e Project 024 is being introduced as a new system and as an upgrade to the commercially available MAGNETOM Impact system.

The provided document, K970852, is a 510(k) premarket notification for the SIEMENS MAGNETOM Project 024, a 1.0T whole-body magnetic resonance imaging (MRI) system, submitted in 1997. The document aims to demonstrate substantial equivalence to previously cleared devices (MAGNETOM Vision and MAGNETOM Impact systems) rather than explicitly detailing acceptance criteria and performance data from a specific study for this new device.

Therefore, based on the provided text, the document primarily focuses on establishing "substantial equivalence" and does not contain detailed information regarding:

• Specific acceptance criteria (numerical thresholds for sensitivity, specificity, accuracy, etc.)
• A standalone study proving the device meets those specific criteria.
• Sample sizes for test sets, data provenance, ground truth establishment methods for a specific study on this device.
• Expert involvement for ground truth, adjudication methods, or MRMC comparative effectiveness studies.
• Standalone algorithm performance or training set details.

The document states that the "safety and performance characteristics for this system are within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems. No additional safety concerns have been raised." This implies that the new device is expected to perform similarly to its predicates, and a direct comparative effectiveness study with human readers or standalone performance metrics are not presented for the MAGNETOM Project 024 itself.

Consequently, I cannot generate the requested table and detailed study information as it is not present in the provided 510(k) submission.

What can be inferred from the document regarding the "study" or justification for acceptance:

• Acceptance Criteria/Performance: Not explicitly defined with quantitative metrics for the MAGNETOM Project 024. The implicit acceptance criterion is "substantial equivalence" to previously cleared MRI systems (MAGNETOM Vision and MAGNETOM Impact). This means its performance is assumed to be comparable to those devices, which would have had their own validation data at the time of their clearance.
• Study: There isn't a specific study detailed in this document that proves the MAGNETOM Project 024 meets explicit acceptance criteria. Instead, the submission relies on the assertion that its "safety and performance characteristics...are within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems."
• Ground Truth: The general diagnostic use of an MRI system inherently relies on medical consensus and clinical outcomes as the ultimate ground truth for its images and derived parameters. However, how this was specifically evaluated for the MAGNETOM Project 024 (or its predicates in this specific submission) is not detailed.

In summary, the provided 510(k) is a declaration of substantial equivalence, not a detailed report of a new clinical study with specific acceptance criteria and performance data for the MAGNETOM Project 024.

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