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The IMRIS MR/X-ray Head Fixation Device System is an MR safe mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The MR/X-ray HFD is indicated for use during utilization of imaging modalities such as intraoperative MRI, CT imaging, and C-Arm X-ray angiography.

The IMRIS MR/X-ray Head Fixation Device System (HFD) is an MR safe mechanical support system intended to be used in head, neck and spine surgery when rigid fixation is recruined for cranial stabilization. The IMRIS MR/X-ray HFD has been designed for use with intra-perative MR imaging, Xray Fluoroscopy and CT imaging modality.

The IMRIS MR/X-ray HFD and its accessories are designed to immobilize the head during surgical procedures and support patient in the prone, supine or lateral positions. The IMRIS MR/A Province ട് പ്രേം കേ ray HFD system can be used with either the operating room table or the angigraphy room table. The table adaptor is used to mount IMRIS MR/X-ray HFD on the table. The linkage system is used to mont the Skull Clamp to the table Adapter. The skull clamp (including 3 skull pins) is used to hold head and neck in a particular position during surgical procedures.

The provided 510(k) summary for the IMRIS MR/X-ray HFD describes the device's substantial equivalence to predicate devices, focusing on its intended use, indications for use, and technological characteristics. Crucially, this document does not detail specific acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) for an AI/algorithm-based device, nor does it describe a study proving the device meets such criteria in the context of AI. This is because the device being reviewed is a physical neurosurgical head holder, not an AI or algorithm.

Therefore, I cannot provide information regarding AI-specific acceptance criteria, reported performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

However, I can extract the relevant non-clinical data and testing performed for this physical device.

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

The document does not explicitly state numerical acceptance criteria with corresponding performance values in a table. Instead, it states that the device "passed the following tests and meets product specifications." The "reported device performance" is essentially that it successfully passed these tests.

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

The document describes bench testing, meaning the "test set" would refer to the physical device prototypes undergoing various engineering tests. The sample size of devices tested is not specified, but it would typically be a small number of units for such mechanical verification. There is no data provenance in terms of country of origin or retrospective/prospective as this applies to clinical data, not materials testing.

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. "Ground truth" in this context would refer to established engineering standards, material properties, and safety requirements. The "experts" would be the engineers and quality assurance personnel conducting and reviewing the tests, rather than medical experts establishing diagnostic ground truth. No specific number or qualifications are mentioned for this type of non-clinical testing.

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

Not applicable. This concept is relevant for interpreting ambiguous clinical data, not for objective engineering tests (e.g., a loading test either passes or fails based on predefined thresholds).

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 a physical device, not an AI system.

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 AI system.

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

For the biocompatibility of pins, the "ground truth" or verification was established by previous FDA clearances (K021604 and K072208) obtained by Integra LifeSciences Corporation, which manufactured the pins. For the design verification and validation (bench testing), the "ground truth" would be established engineering specifications, mechanical safety standards, MR compatibility standards, and usability requirements.

8. The sample size for the training set

Not applicable. This is a physical device.

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

Not applicable. This is a physical device.

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The MAYFIELD® Radiolucent Skull Pins A-2020 are intended for use with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MR imaging is used.

The MAYFIELD® Radiolucent Skull Pins A-2020 are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative CT or MR imaging of the patient is used.

The Mayfield® Radiolucent Skull Pins are single use devices which are used with Mayfield® Skull Clamps for approaches that require rigid skeletal fixation. In preparation for surgery three Radiolucent Skull Pins are installed in a Mayfield® Skull Clamp. Two Radiolucent Skull Pins are inserted in the Rocker Arm side of the Clamp and a single Radiolucent Skull Pins is inserted on the opposite side. The Mayfield® Radiolucent Skull Pins may be used in surgical procedures when rigid fixation is desired and Intra-Operative CT or MR imaging is used.

This document is a 510(k) summary for the Mayfield® Radiolucent Skull Pins, detailing their substantial equivalence to a previously cleared device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity, which are typically associated with artificial intelligence or diagnostic devices.

The submission is for a device modification of existing skull pins, and the conclusion states: "The modified Mayfield® Radiolucent Skull Pins is substantially equivalent to the unmodified Mayfield® Radiolucent Skull Pins. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness."

Therefore, the requested information about acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone performance), ground truth, and training set information is not applicable to this 510(k) submission.

This is a regulatory submission for a physical medical device (skull pins), not an AI/ML-driven diagnostic or prognostic device that would typically undergo studies to demonstrate performance metrics against a defined ground truth. The "proof" in this context is the demonstration of substantial equivalence to a predicate device, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness.

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