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The SYMBIS Surgical System is a computer-controlled electromechanical arm. The arm is performed by the neurosurgeon. It is intended to be used in the spatial positioning and orientation of a biopsy instrument guide.

Guidance is based on a pre-operative plan developed using the Medtronic StealthStation® along with fiducial marker or optical registration. The system is intended for use by neurosurgeons to guide a biopsy needle.

It is intended for use by trained physicians for needle based biopsy.

The SYMBIS Surgical System is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument guide. The system is intended for use by trained physicians for needle based biopsy.

The SYMBIS Surgical System consists of the a Surgeon Console, Surgical Cart, Manipulator, Robot Control Cabinet (RCC), Vision System, Platform Room Integration Kit and System Software.

The Manipulator is a master/slave robot configured with either a left arm or a right arm is mounted to the Surgical Cart. The Surgical Cart is used to transport the Manipulator to and from the operating room, as well as serve as a stationary platform for robotic surgery. The Surgical Cart has an onboard immobilization system to prevent horizontal movement when positioned for surgery. The Instrument Guide is attached to the draped Manipulator and is used by the surgeon to guide the trajectory of a stereotactic instrument (e.g. Biopsy Needle). The Manipulator has six (6) degrees of freedom (DOF). The SYMBIS System provides tremor filtering and motion scaling while the surgeon positions the Manipulator and Instrument Guide to the target position. A Vision System mounted to the Surgical Cart provides the surgeon with a high definition, three-dimensional view of the patient, surgical site, and Manipulator.

The Surgeon Console provides the surgeon with workstation console from which the surgeon controls the Manipulator. The Surgeon Console is located in the operating room. The surgeon, seated at the Surgeon Console, controls all movements of the Manipulator with a hand controller and foot pedal. The upper and middle displays on the Surgeon Console are medical grade, high definition monitors, and the middle monitor is capable of displaying 3 dimensional (3D) images The upper display provides the video output from a third-party navigation system (i.e. Medtronic Stealth station s7/i7). The middle display provides the 3D video output from the field camera, to provide situational awareness to the surgeon when moving the robot near the patient, surgical site, and OR staff. The video from the Vision System, along with the video from the third-party navigation system, is used by the surgeon to manipulate the Instrument Guide to the entry position.

The Robot Control Cabinet (RCC) is an electronics rack and contains to operate the Surgical Cart, Manipulator and Surgeon Console. It is situated in the hospital's equipment room, adjacent to the surgical suite. The RCC includes the supporting electronic, power supply, and computers for the system.

The platform room integration kit includes motor drivers to run the Manipulator, an OR Pendant with an E-Stop, cable interface mounting plates and system integration cables.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for SYMBIS Surgical System

1. Table of Acceptance Criteria and Reported Device Performance

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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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The iMRI 1.5T A and 3T S are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that displays the internal structure and / or function of the head, body or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The iMRI 1.5T A and 3T S systems may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.

The iMRI 1.5T A and 3T S MRI systems may also be used for imaging in a multi-room suite.

The IMRIS Intraoperative MRI systems (iMRI 1.5T A and iMRI 3T S) are a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside an RF shielded room to facilitate intra-operative and multi-room use. The magnet is normally situated in a diagnostic room until imaging is requested. For Diagnostic room purposes, the system retains the standard diagnostic features of an MRI system. The diagnostic room is separated from the intra-operative suite by sliding doors that are part of the facility structure.

The iMRI system (1.5T A/3T S) is a tool for radiologists and surgeons, used to acquire images for diagnostic, intra-operative or interventional procedures. For OR purposes, high-resolution images can be obtained immediately prior to surgical incision, intraoperative and after wound closure. The iMRI 1.5T A is based on the IMRIS Neuro II-SE predicate cleared under 510(k) K071099 and the Siemens MAGNETOM Aera/Skyra MRI system cleared under 510(k) K101347. The iMRI 3T S is based on the IMRIS Neuro III-SV cleared under 510(k) K083137 and the Siemens MAGNETOM Aera/Skyra MRI system cleared under 510(k) K101347. The major components of the iMRI systems are: the Siemens MAGNETOM MRI system with minor modifications; IMRIS Magnet Mover System, OR Table, RF coils and 3-pin head fixation device.

The provided text is a 510(k) Premarket Notification for the IMRIS iMRI 1.5T A and 3T S systems, which are Magnetic Resonance Diagnostic Devices (MRDD). This document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards. It does not describe a study involving specific acceptance criteria for diagnostic performance outcomes (like sensitivity, specificity, accuracy) using a clinical dataset and expert review, as would be typical for an AI-powered diagnostic device.

Instead, the "study" described is a verification and validation process primarily focused on demonstrating safety, effectiveness, and substantial equivalence to existing MRI systems.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a "test set" in the context of clinical image data for diagnostic performance evaluation, nor does it mention data provenance (country of origin, retrospective/prospective). The "Sample clinical images" mentioned under "Design Verification and Validation Test (Bench Testing)" are likely for qualitative visual assessment and system validation, not for quantitative diagnostic performance metrics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The filing does not detail a study involving expert-established ground truth for a test set of patient cases. The evaluation is focused on engineering and system performance standards, and comparison to predicate devices, rather than the diagnostic interpretive accuracy of the images by human readers.

4. Adjudication Method for the Test Set

Not applicable, as there is no specific test set requiring expert adjudication for establishing ground truth on diagnostic findings.

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 510(k) pertains to an MRI system itself, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted or reported.

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

Not applicable. This device is a diagnostic imaging system, not an algorithm.

7. The Type of Ground Truth Used

For the safety and performance evaluations, the "ground truth" used is adherence to established engineering and medical device standards (IEC 60601 series, IEC 62304), and comparison against the technical specifications and performance characteristics of predicate and reference MRI devices for substantial equivalence. "Sample clinical images" were part of the V&V, implying visual assessment against expected image quality, but not a formally established clinical ground truth from pathology or outcomes.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable.

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The iCT device with sliding gantry is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

(*spiral plane: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the sliding gantry).

iCT is a whole body x-ray computed tomography (CT) scanner. It combines a standard CT gantry with a ceiling mounted suspension and drive mechanism to move the gantry horizontally during image acquisition. The standard CT gantry features a continuously rotating tub-detector system and functions according to the fan beam principle. The ceiling mounted suspension and drive mechanism allows iCT to be moved along rails for storage or to share the iCT between multiple rooms. The ceiling mounted system also provides precise horizontal movement that is integrated with the CT scan control. During image acquisition, the iCT drive mechanism translates the CT gantry while the patient table remains stationary. Moving the gantry allows the patient to remain stationary instead of translating the patient relative to the gantry as is required with fixed gantry systems. iCT may be used with commercially available patient tables, including surgical tables, that meet the appropriate size and x-ray transmission characteristic requirements.

iCT leverages the previously cleared SOMATOM Definition, Model AS/AS+ (K081022) gantry, power supply and operator console components, including the syngo software platform and compatible syngo applications. iCT produces CT images in DICOM format. The syngo platform is able to run optional postprocessing applications.

Here's a breakdown of the acceptance criteria and study information for the iCT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document explicitly states that "sample clinical images are unnecessary to support substantial equivalence in this case and instead testing relied on laboratory studies." This implies that clinical images were NOT used as a test set. The testing was done using "high precision phantoms." The specific number of phantoms or scans performed is not provided.
• Data Provenance: Not applicable, as clinical data was not used for the test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable as the testing was conducted using "high precision phantoms" and laboratory studies, not clinical data and expert interpretation.

4. Adjudication Method for the Test Set

• Not applicable, as the testing was conducted using "high precision phantoms" and laboratory studies, not human evaluation of clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states that "sample clinical images are unnecessary to support substantial equivalence in this case and instead testing relied on laboratory studies." This indicates the evaluation was technical and mechanical, not clinical or involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes, the primary evaluation was a standalone technical/mechanical evaluation of the iCT system's performance metrics (image quality, z-axis accuracy, gantry stability) against the specifications of the predicate device using phantoms. This is effectively a "standalone" assessment of the device's physical and image acquisition capabilities without human interpretation of clinical images.

7. The Type of Ground Truth Used

• The ground truth was established by the specifications and performance characteristics of the predicate device, specifically the SOMATOM Definition, Model AS/AS+ with the sliding gantry package. The iCT's performance was measured against these established technical benchmarks using "high precision phantoms."

8. The Sample Size for the Training Set

• Not applicable. The iCT is leveraging a previously cleared CT gantry, power supply and operator console components (SOMATOM Definition, Model AS/AS+), including its syngo software platform and compatible syngo applications. The iCT itself is primarily a modification concerning the physical mounting and movement of this existing CT technology (ceiling rails vs. floor rails). Therefore, it doesn't appear to involve its own separate "training set" in the context of an AI/algorithm. The core imaging algorithms are assumed to be from the predicate device.

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

• Not applicable, as a separate training set for the iCT's distinct features (ceiling mounted gantry movement) is not described, and the core imaging software/algorithms are inherited from the cleared predicate device. The information provided focuses on the physical and technical performance of the modified gantry system.

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VISIUS Wireless Coils 1.5T and 3T are intended for use with IMRIS (Siemens MAGNETOM) 1.5T and 3T MRI Systems as an imaging device for clinical procedures.

VISIUS Wireless Coils produce images of the head and upper C-spine internal structures.

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

The IMRIS VISIUS Wireless Coil 1.5T is a receive-only three channel flexible phased array coil. The 1.5T upper coil has two elements and the lower coil has one element. The 1.5T VISIUS Wireless Coils is a pair of receive-only phased array coils designed for use with the IMRIS/Siemens MAGNETOM 1.5T MRI system.

The IMRIS VISIUS Wireless Coils, 3T is a receive-only three channel flexible phased array coil. The 3T upper coil is has two elements and the lower coil has one element. The 3T VISIUS Wireless Coils is a pair of receive-only phased array coils designed for use with the IMRIS/Siemens MAGNETOM 3T MRI system.

The IMRIS 1.5T/3T VISIUS Wireless Coils balance surgical requirements with the MRI requirements to provide MR imaging in intra-operative and interventional procedures. The coils are used to acquire MR images of the head and upper C-spine during intra-operative finterventional procedures. The IMRIS 1.5T/3T Disposable Coils can also be used as standard diagnostic head coils for diagnostic examinations.

This document is a 510(k) summary for MRI coils, not an AI/ML device submission. Therefore, it does not contain the information requested about acceptance criteria and study designs typically associated with AI/ML device performance evaluation, such as:

• A table of acceptance criteria and reported device performance for an algorithm. Instead, it lists various engineering and safety tests for the hardware.
• Sample sizes for AI algorithm test sets.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC studies for human reader improvement with AI assistance.
• Standalone algorithm performance.
• Ground truth types for AI models.
• Training set sample sizes or how their ground truth was established.

The document describes the VISIUS Wireless Coils, 1.5T/3T, which are hardware components (receive-only phased array coils) for MRI systems. The 510(k) submission establishes their substantial equivalence to predicate devices (IMRIS HC150/HC300 coils) based on their intended use, technological characteristics, and safety and performance testing.

Here's an analysis of the provided text, focusing on what is present in terms of acceptance criteria and the study (testing) conducted for this hardware device:

Acceptance Criteria and Device Performance (Bench Testing/Verification & Validation)

The document lists several tests performed to demonstrate the safety and effectiveness of the device. These tests serve as the "acceptance criteria" for a hardware component, ensuring it meets specified engineering and safety standards.

1. Table of "Acceptance Criteria" (Tests) and "Reported Device Performance" (Outcome):

Study Information (for a Medical Device Hardware Component):

This document describes a series of non-clinical data (bench testing) and some clinical image comparison as the "study" proving the device meets its criteria for safety and effectiveness.

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

• Test Set Sample Size: Not explicitly stated for each test. For "Clinical image comparison," the number of images or patients is not provided. For NEMA testing, specific phantom data would be used, but the quantity is not detailed.
• Data Provenance: Not explicitly stated. Given IMRIS is a Canadian company and the device is intended for use with Siemens MAGNETOM MRI systems, it's likely testing was conducted in a controlled lab or clinical environment associated with the manufacturer or partner. It's retrospective in the sense that these are pre-market tests, but not "retrospective data" in the AI/ML context of analyzing a pre-existing dataset.

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

• Not Applicable in the AI/ML sense. Ground truth for this hardware device involves engineering specifications, safety standards, and image quality metrics (like SNR, non-uniformity) which are objectively measured. For the "Clinical image comparison," performance would be assessed by trained physicians, as stated in the indications for use. Their number and specific qualifications are not detailed, but they would be radiologists or other physicians interpreting MRI images.

4. Adjudication Method for the Test Set:

• Not Applicable for hardware testing. This concept applies to human interpretation of data, typically in AI/ML performance evaluation. The "clinical image comparison" would rely on a physician's ability to interpret the images effectively, but no formal adjudication process for a test set is described.

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

• No evidence of an MRMC study. This type of study assesses how AI assistance affects human reader performance. As this is a hardware device (MRI coil) and not an AI algorithm, such a study would not be relevant or described in the 510(k) for this product aspect. The focus is on the coil's ability to produce diagnostically usable images.

6. Standalone Performance:

• Standalone (algorithm only) performance is not applicable. This device is a passive hardware component (a receive-only coil). Its "performance" is inherently tied to being used with an MRI system. The NEMA standard measurements (SNR, non-uniformity) are a form of standalone technical performance for the coil's imaging capabilities, but not an "algorithm-only" performance as in AI.

7. Type of Ground Truth Used:

• Engineering Specifications / Objective Measurements: For the majority of tests (IEC standards, heating, electrical, flammability, NEMA image quality metrics), the "ground truth" is defined by compliance to established engineering standards, physical measurements, and performance benchmarks.
• Clinical Efficacy (Implicit): For "clinical image comparison," the ground truth is implicitly the ability of the images produced by the new coils to be diagnostically equivalent or superior to those from the predicate coils, as assessed by trained physicians. This is not "pathology" or "outcomes data" in the typical sense for a diagnostic device, but rather the diagnostic quality of the images themselves.

8. Sample Size for the Training Set:

• Not Applicable. This is a hardware device. It does not involve a training set as an AI/ML model would. The design and manufacturing processes are refined through engineering, prototyping, and testing (V&V), not "training."

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

• Not Applicable. As there is no AI/ML training set, this question is irrelevant to the described device.

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The IMRIS Oncology package uses the IMRISneuro family of Intra-operative MRI systems/Siemens MAGNETOM MR systems indicated for use as a diagnostic imaging device that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the entire body, including, but not limited to head, neck, and pelvis regions. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The IMRIS Oncology Package provides an additional patient tabletop for IMRIS MR systems /Siemens MAGNETOM that allows patients to be imaged on a flat surface. The flat patient surface enables IMRIS MR system/Siemens MAGNETOM to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-ray, CT, PET and radiation therapy.

The IMRIS MR systems/Siemens MAGNETOM MR Systems with IMRIS Oncology Package may also be used with MR safe/MR conditional patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.

The IMRIS Oncology Package provides an additional patient tabletop (MR SIMS table top) that can be used with IMRIS Neuro 1.5T / Siemens MAGNETOM 1.5T MRI scanners for radiation therapy planning. The MR SIMS table top allows patients to be imaged on a flat surface that matches the imaging patient position. The oncology package includes Head and Neck coil (HNC150) and Pelvic coil (PCC 150). Used in the IMRISneuro 1.5Tsystem/Siemens MAGNETOM 1.5 Tesla, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal, and oblique images of the internal structures of the head, neck and pelvic regions. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The IMRIS HNC150 and PCC150 coils can also be used as standard diagnostic head coils and pelvic coil respectively for diagnostic examinations. The Oncology package may be used with MR-conditional/ MR safe patient immobilization accessories to assist in consistent positions throughout multiple imaging sessions.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: IMRIS Oncology Package (K121997)

This submission is for an IMRIS Oncology Package, which includes an additional patient tabletop (MR SIMS table top), Head and Neck coil (HNC150), and Pelvic coil (PCC150) for use with IMRIS Neuro 1.5T / Siemens MAGNETOM 1.5T MRI scanners. Its primary intended use is for radiation therapy planning, allowing patients to be imaged on a flat surface similar to other modalities like X-ray, CT, and PET.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes design verification and validation tests (bench testing) rather than specific quantitative "acceptance criteria" against which a statistical performance metric is measured (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on compliance with standards and successful completion of various engineering and clinical image comparison tests.

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

• The document does not specify a numerical sample size for the "clinical image comparison" or other tests.
• Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are described as "Design Verification and Validation Test (Bench Testing)" which suggests these were conducted in a controlled, engineering test environment rather than a large-scale clinical study with real patient data from specific geographical locations. The "clinical image comparison" would likely have involved imaging a small number of volunteers or phantoms, or a small selection of patient cases.

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

• This information is not provided in the summary. For "clinical image comparison," it is implied that a "trained physician" would interpret the images, but the number or specific qualifications for establishing ground truth are not detailed.

4. Adjudication method for the test set

• An adjudication method is not mentioned in the summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study is not described or implied in the provided text. The submission focuses on device safety, performance, and substantial equivalence to a predicate device through bench testing and image quality assessments, not comparative effectiveness with or without AI assistance.

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

• This device is an MRI accessory package (tabletop and coils), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable to this submission. The device produces images that are then interpreted by a trained physician.

7. The type of ground truth used

• For the "clinical image comparison," the ground truth is implicitly expert interpretation by "a trained physician" (as stated in the Indications for Use). For the technical tests (SNR, non-uniformity, artifacts), the "ground truth" would be the NEMA standards themselves and engineering specifications. Pathology or outcomes data are not indicated as ground truth types for this submission.

8. The sample size for the training set

• This device is an MRI accessory package and does not describe an AI algorithm or a "training set" in the context of machine learning. Therefore, this question is not applicable.

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

• As the device is an MRI accessory package and not an AI algorithm, there is no training set and thus no ground truth established for a training set.

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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 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) is an MR compatible mechanical support system intended to be used 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 the patient in the prone, supine or lateral positions. The HFD100 system can be use with either the operating room table or the angiography room table. The IMRIS HFD100 consists of the Table Adapter, Linkage System. Skull Clamp and Skull Pins. The linkage system is used to mount the Skull Clamp (including 3 skull pins) to the table Adaptor is used to mount HFD100 on the table. The 3-point rigid cranial fixation device, skull clamp, provides multifunctional options for cranial stabilization and provides maximum immobilization of the patient's skull during the procedure. The HFD100 provides rigid skeletal fixation within the optimal imaging envelope during intraoperative procedure with minimal artifacts in the acquired images.

The provided document is a 510(k) summary for the IMRIS Head Fixation Device (HFD100). This type of submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It does not provide information about clinical studies or acceptance criteria typical for AI/ML devices, such as performance metrics (sensitivity, specificity, AUC), sample sizes for test and training sets, expert consensus for ground truth, or MRMC studies.

Therefore, many of the requested elements for describing acceptance criteria and study details cannot be extracted from this document, as they are not relevant to a 510(k) for a mechanical support system.

However, I can extract the information related to the device's functional and safety performance as demonstrated through non-clinical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests passed by the HFD100 system, indicating that it meets product specifications. While specific numerical acceptance criteria (e.g., minimum load in Newtons) are not detailed in the summary, the fact that the tests were "passed" implies that the device met pre-defined criteria for each test.

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

This information is not applicable to this 510(k) summary. The testing described is non-clinical bench testing of a mechanical device, not clinical performance evaluation using patient data. Therefore, there's no "test set" in the context of clinical data, no data provenance (country of origin), and no retrospective or prospective study design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. Ground truth, in the context of expert consensus, is typically for evaluating diagnostic or predictive algorithms, not for mechanical device performance in non-clinical bench tests.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert assessments, which is not relevant for bench testing of a mechanical device.

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

This information is not applicable. The device is a mechanical head fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and effects on human reader performance are irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a mechanical head fixation system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on engineering specifications, safety standards, and validated testing protocols (e.g., ISO standards for biocompatibility, specified load limits for mechanical strength, established methods for MR compatibility testing). For example, the biocompatibility "ground truth" relies on adherence to ISO 10993 standards and prior verification by the predicate device manufacturer.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a mechanical device, not a machine learning model.

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

This information is not applicable, as there is no training set.

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IMRIS Flex coils HC150 (1.5T Head coil) and HC300 (3T Head coil) are used in conjunction with respective MR Systems IMRIS 1.5T MAGNETOM and IMRIS 3T MAGNETOM as an imaging device for clinical procedures.

IMRIS Flex coils produce images of the human head and upper C-spine internal structures.

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

The IMRIS 1.5T Head Coil (HC150) is a receive-only eight channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. The HC150 is a pair of receive-only phased array coils designed for use with the IMRIS 1.5T system. The IMRIS 1.5T (Neuro II-SE) uses the Siemens MAGNETOM 1.5T MRI system (MAGNETOM Espree).

The IMRIS 3T Head Coil (HC300) is a receive-only eight channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. The HC300 is a pair of receive-only phased array coils designed for use with the IMRIS 3T system. The IMRIS 3T (Neuro III-SV) uses the Siemens MAGNETOM 3T MRI system (MAGNETOM Verio).

The IMRIS HC150/HC300 head coils balance surgical requirements with the MRI reguirements to provide MR imaging in intra-operative and interventional procedures. Coils are used to acquire MR images of the head and upper C-spine during intra-operative /interventional procedures. The IMRIS HC150/HC300 head coils can also be used as standard diagnostic head coils for diagnostic examinations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IMRIS HC150/HC300 head coils:

Summary of Device and Regulatory Context:

The submission concerns the IMRIS HC150 (1.5T Head Coil) and HC300 (3T Head Coil), which are receive-only eight-channel phased array coils designed for use with IMRIS 1.5T and 3T MRI systems, respectively. Their intended use is to produce images of the human head and upper C-spine for clinical procedures, providing information useful for diagnosis and therapy options when interpreted by a trained physician. The device is classified as a Class II medical device (21 CFR 892.1000, Product Code: MOS). The submission is a 510(k) premarket notification, seeking substantial equivalence to previously cleared IMRIS 1.5T/3T Split Array Head (SAH) coils.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify the sample size used for the test set (number of images, scans, or subjects). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the image acquisition). It only states that tests were performed according to NEMA standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The provided document does not mention the use of experts or the establishment of ground truth for any test set in the context of image interpretation or diagnostic accuracy. The study described focuses on technical performance metrics (SNR, uniformity) and equivalence to predicate devices, not on human interpretation of images for diagnosis.

4. Adjudication Method for the Test Set:

Since the study described focuses on technical performance metrics (SNR, uniformity) as opposed to diagnostic accuracy evaluated by human readers, there is no mention of an adjudication method for a test set. This type of study would typically not involve adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The provided text describes a study focused on technical performance metrics (SNR, uniformity) of the new coils compared to predicate coils, not on human reader performance with or without AI assistance. Therefore, no effect size for human reader improvement with AI is mentioned.

6. Standalone Performance Study (Algorithm Only):

No, a standalone performance study of an algorithm without human-in-the-loop performance was not done. The device in question (HC150/HC300) is a physical MRI coil, not an AI algorithm. The performance evaluation focuses on the coil's ability to acquire good quality images, which are then intended to be interpreted by a physician.

7. Type of Ground Truth Used:

For the technical performance tests (SNR and image uniformity), the "ground truth" is established by the NEMA standard itself and objective measurements. There is no mention of expert consensus, pathology, or outcomes data used to establish ground truth for these metrics. The performance is compared against the performance of the predicate devices.

8. Sample Size for the Training Set:

The provided document does not mention a training set as this is not a study involving an AI algorithm or machine learning model that would require a training set. The device is a physical MRI coil.

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

As there is no training set, there is no mention of how ground truth for a training set was established.

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