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The Hitachi Model Altaire MR Interventional Package aids in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user.

The Hitachi Model Altaire Interventional MR Package is an optional enhancement designed for use with the Hitachi Model Altaire Magnetic Resonance Diagnostic Device (K050620). It's intended function and use is to aid to aid in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. (Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user).

The package consists of an open head coil, an open body coil and an MR compatible in room color monitor. The head and body coils are used for obtaining diagnostic images of the head and body regions, while the display monitor is used for in room review of the images during the interventional procedure(s). The head and body coils are compatible with existing Altaire hardware and software. Therefore no hardware or software modifications are needed to use these coils.

Based on the provided text, the device described is the Hitachi Model Altaire MR Interventional Package. This submission ([K053309](https://510k.innolitics.com/search/K053309)) is a 510(k) premarket notification for an optional enhancement to an existing MRI system. The text indicates that the device is substantially equivalent to a predicate device and addresses its intended use and description, but it does not contain any information about acceptance criteria or a study proving that specific performance criteria are met.

The document is a 510(k) summary and the FDA's acceptance letter. These types of documents typically focus on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, especially for accessories or enhancements to well-established technology like an MRI system.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone performance study.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for the training set was established.

The 510(k) summary indicates that the device "aids in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures...that may be facilitated by real-time MR guidance." It further states that "Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user." This implies that the device's functionality is to enhance existing MRI procedures by providing real-time guidance, and its performance is inherently tied to the overall MRI system (Hitachi Model Altaire Magnetic Resonance Diagnostic Device, K050620) and the user's clinical expertise and choice of MRI-compatible instrumentation.

In summary, the provided text does not contain the detailed performance study information requested.

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