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For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of sterotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure can be identified relative to a CT or MR-based model of the anatomy.

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This 510(k) summary does not contain the detailed study information required to fill out the table and answer all questions. It primarily focuses on the FDA's determination of substantial equivalence for the Spherz™ stereotaxic instrument based on its indications for use and comparison to a predicate device.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test sets or training sets.
• Details on ground truth establishment (number/qualifications of experts, adjudication method, type of ground truth).
• Whether a standalone or MRMC comparative effectiveness study was done, or any associated effect sizes.
• Data provenance.

Therefore, most of the requested information cannot be extracted from the provided text.

Based on the information given, here's what can be inferred or stated:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in this document. Substantial equivalence for 510(k) usually implies performance similar to a predicate device, but specific quantitative criteria are not provided here.
   • Reported Device Performance: Not detailed in this document. The FDA's letter only states that the device is substantially equivalent to a legally marketed predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided in the document.

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 provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not provided in the document.

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 provided in the document. This device (Spherz™) is described as a "stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures." It's not an AI-driven diagnostic reader, so an MRMC study comparing human readers with and without AI assistance is unlikely to be relevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not provided in the document. Given it's an "accessory to aid in auto-registration and localization," it functions with human intervention as part of an image-guided surgery system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not provided in the document.

8. The sample size for the training set:

   • Not provided in the document.

9. How the ground truth for the training set was established:

   • Not provided in the document.

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For use as permanently-filled and -sealed artificial fiduciary markers with the head rings and localizer I brass as permanently and systems in order to facilitate localizing and documenting the precise superimposition of CT and MRI imaging data.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "MRI Line Marker Non-invasive Radiographic Skin Marker." This document approves the device for market based on substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) clearance process in the U.S. generally focuses on demonstrating substantial equivalence to pre-existing legally marketed devices, rather than requiring new clinical trials to establish independent safety and effectiveness metrics through specific acceptance criteria and detailed study designs as might be required for a Premarket Approval (PMA).

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

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MR Enhancer is designed for use as a MRI accessory to improve image homogeneity by reducing skin-air interfaces, thereby images from such pulsing parameters as chemical shift fat saturation and gradient echo. MR Enhancer also serves as a stabilizing device to reduce vascular and tissue pulsation artifacts.

MR Enhancer

The provided document is a 510(k) premarket notification letter from the FDA to I.Z.I. Corporation for their device "MR Enhancer". This letter confirms substantial equivalence of the device to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on FDA's regulatory decision regarding substantial equivalence. It describes the device's intended use as an MRI accessory to improve image homogeneity and reduce artifacts by reducing skin-air interfaces and stabilizing the patient.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the information provided.

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For use in high energy radiation therapy to correct for anatomical irregularities and deliver the prescribed dose to the skin surface and underlying tissue.

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I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a device called "Super Tissue". It confirms that the device is substantially equivalent to a predicate device and can be marketed. However, it does not contain any information about acceptance criteria, study details, performance data, sample sizes, expert ground truth, or any of the other specific study-related information you requested.

The document is purely a regulatory clearance and does not include the technical study results that would typically accompany such a submission.

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