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The intended use of the AtamA™ System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-operative room, while stabilizing the patient's head during neurosurgical procedures and imaging.

The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed.

The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

The AtamA"" System is comprised of two subsystems:

• (i) MR Head Coil
• (ii) Patient Stabilization System

These two subsystems have been designed to work independently and in unison to meet the varied needs of neurosurgical procedures utilizing MRI. In addition, the patient head fixation ring subsystem and patient board can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed. Also, the head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.

Specifically, the AtamA System allows a streamlined workflow for procedures requiring the patient to undergo MRI examination before, during, or after neurosurgical procedures. The AtamA System maintains patient head fixation while providing a patient board for convenient, safe and effective method of moving the patient from an OR table to transport gurney to MRI couch without the need to unpin and re-pin the patient.

This submission clears the use of the additional 3.0 Telsa AtamA Head Coil for use with specific Siemens and Imris 3.0 Telsa MRI Systems, and the expanded labeling of the components of the Patient Stabilization System for their compatibility with both 1.5 Tesla and 3.0 Telsa systems.

This document is a 510(k) Pre-market Notification (K132444) for the Monteris Medical AtamA™ System, seeking to expand its compatibility to 3.0 Tesla MRI systems. This notification is not for an AI device, therefore, the requested information regarding acceptance criteria and studies for AI/algorithm performance is not applicable.

The submission focuses on demonstrating the substantial equivalence of the modified AtamA™ System (specifically, the addition of a 3.0 Tesla MR head coil and expanded labeling for the patient stabilization system) to its predicate device (K110411), which was cleared for 1.5 Tesla MR Systems. The primary form of evidence presented is bench testing for MR compatibility.

Here's an analysis of the information provided, tailored to what is relevant to the 510(k) submission's purpose:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state acceptance criteria in a quantitative table format for performance. Instead, it aims for "substantial equivalence" to the predicate device, particularly concerning safety and efficacy in the 3.0T MRI environment. The "acceptance criteria" here are qualitative for MR compatibility, meaning the device must not introduce new safety concerns or compromise image quality when used with 3.0T MRI.

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

The document does not detail a "test set" in the context of subject-based performance evaluation as it would for an AI algorithm. The testing described is bench testing (laboratory-based) with the physical device. Therefore, there is no human subject sample size or data provenance in terms of country of origin or retrospective/prospective clinical data for this submission.

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 applicable. There is no "ground truth" to be established by experts in the context of an AI algorithm for this device. The evaluation is based on engineering principles and NEMA standards for MR compatibility.

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

Not applicable. As this is not a clinical study involving human assessment of results, there is no adjudication method.

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 is not an AI device submission.

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

Not applicable. This is not an AI device submission.

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

The "ground truth" equivalent for this type of device is established engineering standards and specifications (e.g., NEMA Standards for MRI compatibility). The device is evaluated against these physical and electrical compatibility requirements, not against clinical outcomes or expert diagnoses.

8. The sample size for the training set:

Not applicable. This is not an AI device; therefore, there is no training set.

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

Not applicable. As there is no training set for an AI algorithm, this question does not apply.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the (implied) acceptance criteria of 3.0 Tesla MR Conditional compatibility for both the head coil and the patient stabilization subsystem is summarized as follows:

• Study Type: Bench testing.
• Methodology: The 3.0 Tesla MR Head Coil underwent bench testing "in accordance with NEMA Standards" to demonstrate compatibility with 3.0 Tesla MRI systems. For the Patient Stabilization Subsystem, an "analysis of materials has shown" compatibility with 3.0 Tesla MR environments.
• Conclusion: The bench testing and material analysis concluded that the Monteris Medical AtamA System is safe and effective for use in both 1.5T and 3.0T MRI environments and can be labeled with both 1.5T and 3.0T MR Conditional Compatibility. The submission argues that these tests demonstrate the new device does not raise new issues of safety or efficacy compared to the predicate device.

In essence, this 510(k) submission relies on standard engineering tests for MR safety and compatibility, rather than clinical performance studies typically required for AI or new therapeutic devices.

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The intended use of the AtamA™ System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-operative room, while stabilizing the patient's head during neurosurgical procedures and imaging. The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed. The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

The Monteris medical AtamA™ System is comprised of two major subsystems: (i) a MR head coil functionality, and (ii) a patient stabilization functionality. These two subsystems have been designed to work independently and in unison to meet the varied needs of neurosurgical procedures utilizing MRI. The Head Coil Subsystem is comprised of a novel design of a standard split-array multichannel (8 channel) receive coil in the form of a common Lower Coil and two interchangeable Upper Coils (only one used at any time) and the appropriate coil configuration data, known as "coil files", for the selected MR system to be used. The design of the two-part Head Coil system is such that, in conjunction with the rest of the AtamA System, openings in the two-part coil can be rotated around the patient's head to allow surgical access to essentially any supratentorial aspect of the patient's head, and still allow for the collection of MR data without repositioning the patient or moving the coils within the MR system. This will allow for more expedient collection of high quality MR data, minimize moving the patient, and maintenance of spatial registration (required for or supporting stereotactic procedures). The Stabilization subsystem is comprised of three major components and their accessories. The major components are: A Head Fixation Ring (HFR) apparatus, A Cradle that fixates the HFR and the two-part Coil relative to each other and the MRI system bore, and A patient Board that allows for the effective transport of the patient to and from various procedures and procedure locations while maintaining the stability and spatial registration of the patient.

The provided document describes a medical device, the Monteris Medical AtamA™ System, and its substantial equivalence to predicate devices, rather than a study proving the device meets a specific set of acceptance criteria based on clinical performance metrics. The document explicitly states: "This application does not rely on any clinical investigations or clinical performance testing in support of substantial equivalence to the stated predicate devices."

Therefore, I cannot provide information for many of the requested categories related to clinical performance studies. However, I can extract information regarding non-clinical performance and the device's characteristics.

Here’s a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

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

The document does not provide a specific table of acceptance criteria with corresponding reported device performance metrics in the way one would expect for a clinical performance study (e.g., sensitivity, specificity, accuracy). Instead, it states:

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

Not applicable, as no clinical performance study with a test set was mentioned or conducted. The non-clinical performance data appears to be from bench testing and biocompatibility assessments, not human subject data.

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 applicable, as no clinical performance study with a test set was mentioned or conducted.

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

Not applicable, as no clinical performance study with a test set was mentioned or conducted.

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 head coil and stabilization system, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

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

Not applicable, as this is a hardware device, not an algorithm.

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

For the non-clinical performance, the "ground truth" or reference points were:

• ISO 10993 for biocompatibility.
• Product specifications, expectations of the medical community, and product labeling for bench testing.
• Recognized standards (NEMA Magnetic Resonance Imaging standards) and actual/reported values of predicate devices for coil functionality.

8. The sample size for the training set

Not applicable, as no training set for an algorithm was mentioned or used.

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

Not applicable, as no training set for an algorithm was mentioned or used.

Summary of the study conducted (as per the document):

The document explicitly states that the application for the Monteris Medical AtamA™ System does not rely on any clinical investigations or clinical performance testing in support of substantial equivalence. Instead, the substantial equivalence to predicate devices is supported by:

• Non-Clinical Performance Data:
  • Biocompatibility analysis: Demonstrated compliance with ISO 10993.
  • Bench testing: Demonstrated compliance with product specifications, the expectations of the medical community, and product labeling.
  • Performance testing for Coil functionality: Conducted according to recognized standards (NEMA Magnetic Resonance Imaging standards, where appropriate) and by comparing to actual or reported values of predicate devices.
• Technological Characteristics: The device's technical modes of action and technical principles are materially the same as the predicate devices, including split array 8-channel MR head coil design, construction, functionally similar materials, and the same principles of head stabilization/immobilization. The design differences are in integration and utilization for expediency and convenience.

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