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The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

The IMRIS Head Fixation Device System (HFD100) Rocker Arm Accessory is an MR compatible mechanical support system intended to use in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

The HFD100 and its accessories are designed to immobilize the head during surgical procedures and support patient in the prone, supine or lateral positions. The HFD100 system is comprised of the table adapter, linkage system, one or two rocker arm skull clamps, and skull pins. The HFD100 system can be used with either the operating room table or the angiography room table. The table adaptor is used to mount HFD100 on the table. The linkage system is used to mount the Skull Clamp (including 3 or 4 skull pins) to the table Adapter.

The Skull Clamp requires the use of three (3) or four (4) Skull Pins. IMRIS is using MAYFIELD® Disposable and Reusable Titanium Skull Pins manufactured by Integra LifeSciences Corporation and cleared by FDA K072208. The MAYFIELD® Disposable and Reusable Titanium Skull Pins are used in surgical procedures when rigid fixation is desired and Intra-Operative MR imaging is used.

IMRIS 3-pin and 4-pin HFD100 attached to the OR table assembly is part of the IMRISneuro system. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. The HFD100 can be used individually or with the IMRIS Flexible Intra-operative Head Coils and third party accessories, such as retractor systems and navigation mounts. The HFD100 provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images.

The IMRISneuro 1.5T/3T Systems (Neuro III-SV) are traditional MRI units that have been suspended on an overhead rail system to facilitate intra-operative, interventional and diagnostic use. The main components of the IMRISneuro systems are the MRI system, the magnet mover system, the OR Table assembly, the Intra-operative Coil and the Head Fixation Device. The IMRISneuro intraoperative imaging systems are tools for radiologists and surgeons, used to acquire images for diagnosis and surgical planning and monitoring during surgery. When images are requested by the surgeon, the magnet is brought into the operating room or Angiography room moving on a pair of overhead rails. The patient remains stationary throughout the procedure and the magnet moves into the room and over the patient for imaging. The magnet can be moved into and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. The surgeon has access to updated MR images in the surgical field, but does not have to change the surgery would typically be performed. Obtaining images intra-operatively allows surgeons to verify the absence of surgical complications before releasing the patient from the operating room.

The provided text describes a 510(k) premarket notification for a medical device, the IMRIS Head Fixation Device (HFD100) Rocker Arm Accessory. This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to a previously cleared predicate device.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific quantitative acceptance criteria (e.g., "withstanding X N of force," "maintaining Y mm of displacement"). Instead, the main "acceptance criterion" for this 510(k) submission is that the HFD100 Rocker Arm Accessory, which enables a 4-pin configuration, maintains the performance and safety equivalency of the previously cleared 3-pin HFD100 system.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set in terms of patients or independent cases. The "study" mentioned is described as "verification and validation testing." For a mechanical device like this, verification and validation typically involve engineering tests on the device itself, rather than clinical data from a "test set" of patients.

• Sample Size: Not applicable in the context of clinical data. It would refer to the number of devices or components tested, which is not specified.
• Data Provenance: Not applicable in the context of clinical data (e.g., country of origin, retrospective/prospective). The data would be from engineering tests conducted by IMRIS.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and submission. The ground truth for a mechanical fixation device's performance would be established through engineering specifications, standards adherence (though none are referenced in this submission), and physical testing, not expert clinical consensus on images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a "test set" in the context of clinical data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is typically done for diagnostic imaging or AI algorithms where human interpretation is involved. This submission is for a mechanical fixation device, not an imaging or AI interpretation product.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not an algorithm or AI product.

7. Type of Ground Truth Used

The "ground truth" for this device's performance would be based on engineering specifications, physical measurements, and mechanical testing results (e.g., stability under load, material properties, MRI compatibility through phantom testing). The document does not detail these specific technical ground truths but implies they were met through "verification and validation testing."

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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