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The AnatoMark Noninvasive Head Reference System is an accessory for routine head MR that is designed to provide reproducible anatomical markers. The Head Reference System is designed to aid in patient positioning to achieve consistent anatomical images over multiple imaging sessions. The head localizer produces a set of six fiduciary marks on axial images that are positioned reproducibly with reference to stable anatomical structures internal to the patient's cranium. The fiduciary marks are also visible in CT images, making possible the co-registration of CT and MR images.

The AnatoMark Noninvasive Head Reference System is a simple device, worn externally on the head, designed for use in routine head or brain MRI to provide reference markers that are visible on magnetic resonance (MR) images. The AnatoMark Noninvasive Head Reference System is intended to provide fiduciary marks that are visible on magnetic resonance (MR) images. The device may also be used to provide MRI/CT co-registration of fiduciary marks. The device is worn externally on the head, is simple and non-invasive, and wearing it is somewhat similar to the wearing of eyeglasses. The device is intended to be used with the "scout" or localization image sequence to establish a reproducible reference plane within the MR system's imaging coordinate system for the subsequent imaging session. At each of three reference locations on the device there is a reference block that contains two reference tubes that appear on MR images. The reference marks are physically implemented as cylinders set in the reference block such that they are orthogonal to each other and cross at their midpoints. When imaged slightly out of plane of the midpoints, the cross-sections of the small cylinders appear as two fiduciary marks that are not side by side. When imaged in the plane of the midpoints, however, the fiduciary marks are side by side. By adjusting the plane of the images such that all three pairs of reference marks show side by side, a reproducible reference plane may be established.

The provided document is a 510(k) summary for the AnatoMark™ Noninvasive Head Reference System, seeking Substantial Equivalence to predicate devices. It describes the device's function and intended use but does not provide detailed acceptance criteria or a study report with specific performance metrics and statistical analyses. The submission focuses on demonstrating substantial equivalence rather than proving device performance against pre-defined acceptance criteria in a quantitative manner.

Therefore, much of the requested information cannot be extracted directly from this document. However, based on the provided text, here's what can be inferred or explicitly stated:

AnatoMark™ Noninvasive Head Reference System Study Information

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. The nature of the device (a physical marker system) would likely involve physical measurements of marker reproducibility rather than expert ground truth establishment for a diagnostic output.

4. Adjudication method for the test set

Not applicable/Not specified.

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 applicable. This device is a passive reference system, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This is a physical device, not an algorithm. The testing would have focused on the physical accuracy and reproducibility of the markers themselves.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) is not directly applicable here. The "ground truth" in this context would likely be physical measurements of the position and reproducibility of the fiduciary marks relative to a known reference or across multiple imaging sessions.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable.

Summary of Device Performance Claim:

The document states: "Interneuron Pharmaceuticals has carried out testing of the device to demonstrate that it provides reproducible reference markers. This testing indicated that the accuracy is substantially equivalent to the accuracy of the predicate device."

This claim of "substantial equivalence" is the central finding presented in the 510(k) summary, rather than a detailed report of reaching specific, quantitative acceptance criteria for the new device's performance. The "study" mentioned refers to this internal testing to support the substantial equivalence claim.

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