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The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray Sus on for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.

The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray Sus on for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.

This document is a 510(k) summary for the Mayfield® ScanMate™ Mobile CT System, primarily focused on establishing substantial equivalence to a predicate device rather than detailing specific performance studies against acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this document.

Here's an attempt to extract the relevant information based on the provided text, with explicit notes where the information is not available:

Acceptance Criteria and Device Performance

Study Details

1. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not available.
• Data Provenance: Not available. The document is a 510(k) summary for substantial equivalence and does not describe a clinical performance study with a distinct test set.

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

• Number of Experts: Not applicable, as no specific test set ground truth establishment is described.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable, as no specific test set or adjudication process is described.

4. 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:

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described. The device is a CT system, not an AI-assisted diagnostic tool in the context of this document.
• Effect Size of Human Readers with/without AI: Not applicable, as it's not an AI-assisted device for diagnostic improvement, but a standalone imaging system.

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

• Standalone Performance: The device itself is a standalone CT system. However, the document does not describe a performance study for the algorithm only (as it's a medical device, not solely an algorithm). It's a system to produce images for human interpretation. The 510(k) process focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device.

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

• Type of Ground Truth: Not applicable, as no specific performance study requiring ground truth establishment is detailed. The 510(k) relies on comparison to a predicate device.

7. The sample size for the training set:

• Sample Size for Training Set: Not applicable. The document describes a CT system, not a machine learning algorithm that requires a training set in the conventional sense.

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

• Ground Truth Establishment for Training Set: Not applicable, as it's not a machine learning algorithm.

Summary of Document's Focus:

The provided 510(k) summary primarily asserts that the Mayfield® ScanMate™ Mobile CT System is substantially equivalent to the Analogic Corporation's ANATOM 2000. It states that the ScanMate Mobile CT System shares "the same uses, indications for use, technological characteristics, and principles of operation" as its predicate device. This implies that the device's acceptable performance is demonstrated by its similarity to an already approved device, rather than through a detailed independent performance study with specific acceptance criteria, test sets, and ground truths as typically associated with new algorithmic or AI-based devices.

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MAYFIELD® ACCISS™ II IMAGE GUIDED SURGERY SYSTEM is indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure such as the skull, a long bone, or vertebra can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.

The Mayfield® ACCISS™ II Image Guided Surgery System comprises a cart, power supplies and tracking devices. The tracking devices track the position and orientation of surgical probes and other instruments. The computer is loaded with the software. The images are correlated to the patient by physically matching points, such as scanned fiducial markers and anatomical landmarks.

In the optical tracking method, the configuration of infrared light points is detected by two cameras to calculate the spatial position of the point configuration. With this method, the cameras must constantly maintain a line of sight with the configuration. This inconvenience can be eliminated by the use of measuring electromagnetic fields. This means the transmitter can be placed underneath the operating table and covered.

An image guidance procedure can be performed based on pre-operative (CT/MRI) or intraoperative acquired diagnostic images, like intra-operative MRI, CT or Fluoroscopy. The Mayfield® ACCISS™ II Image Guided Surgery System must first establish a correlation between the "real world" of the operating room so that the position of special surgical instruments, such as a pointer or surgical tool, can be portrayed within the scanned image data. This is called image data registration. Clearly and easily identified scanned markers in both the "real world" and the "image world" are used. These markers can be artificial markers (fiducials) which will be attached to the patient before image acquisition. The artificial markers (fiducials) have a defined shape and contrast medium appropriate for the imaging procedures. The Mayfield® ACCISS™ II Image Guided Surgery System uses a two-component marker system. The markers with contrast medium are attached to a self-adhesive pad before they are affixed to the prepared skin of the patient. These markers must remain on the patient during most of the scanning procedure, but the adhesive pads must remain on the patient with or without the markers removed and the counting process will be automatically identified and located within the image data by the Mayfield® ACCISS™ II Image Guided Surgery System during the data preparation.

The images from the scanner are archived in a specific data format and stored in a specific data medium, or transmitted directly to the Mayfield® ACCISS™ II Image Guided Surgery System workstation. The Mayfield® ACCISS™ II Image Guided Surgery System supports the DICOM data format and the DICOM data transfer. Other formats and transfer protocols are supported by customer specifications.

After successful review the transferred data for quality and consistency, the images slices are there combined in a three-dimensional volume and viewed on the monitor screen as axial, sagittal then coronal orthogonal images. The user can now manually check for image quality, image orientation and patient identification. Artifacts can be sliced off (at least at the screen border) without changing the image content. The brain, lesions or special access paths and landmarks can be segmented and displayed as three-dimensional objects which can be useful during planning and navigation process.

In the operating room, measuring aids (i.e., registration markers) will be attached to the adhesive pads. After selection of the tracking system (optical/electromagnetic), the markers positions (or bone marks) are repeatedly measured by pressing the function button on the pointer. This measurement routine creates a correlation between the data and the "real world." During this procedure, the number of measured points and the number of clusters found are displayed. A cluster describes the position of one unique marker point. The Mayfield® ACCISS™ II Image Guided Surgery System assigns a cluster to a correct image point automatically. At least four cluster pairs are required to establish an image registration. The system shows the fiducial registration error (FRE) and presents a prediction of the target registration error (TRE) to provide the surgeon with a rough quality gauge of the image accuracy. However, even a good error prediction cannot replace surgeon expertise. That's why the surgeon is responsible to verify the given information by proofing the markers position as well as well-defined anatomical landmarks close to the region of interest.

Once the registration is completed, the pointer's position to the patient's head is displayed in the scanned images. The marker pads can be removed once the registration quality satisfies the surgical needs and requirements. The surgical area can be cleaned and draped.

The pointer used for image registration is replaced with a sterile instrument and cranial navigation can begin. The system automatically recognizes this new instrument. In case of using surgical tools with an intra-operatively mounted position sensor an instrument calibration has to be performed first.

The surgeon can define a reachable area near the operating field, in which he or she is able to control the Mayfield® ACCISS™ II Image Guided Surgery System via the pointer device. If the instrument reaches this defined area, the system switches from navigation mode to control mode. Through spatial movement within the defined area, the surgeon can control all essential guidance functions by pressing the function key on the instrument.

The provided text does not contain specific acceptance criteria or a study detailing device performance against such criteria for the Mayfield® ACCISS™ II Image Guided Surgery System. The document is a 510(k) premarket notification summary, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results that would typically include acceptance criteria.

The information provided outlines:

• Intended Use and Device Description: Explains what the device does and for what medical conditions it is used (cranial, spinal, ENT procedures, referencing CT/MR based models or fluoroscopy for image guidance during open and percutaneous procedures). It also details the tracking methods (optical and electromagnetic) and the process of image registration using fiducial markers.
• Summary of Substantial Equivalence: This section explicitly states that the device is considered substantially equivalent to predicate devices (Mayfield® ACCISS™ Operating Arm System and Mayfield® Optical ACCISS™ System (K013428) and Nicolet Biomedical Electromagnetic Navigational System (K013419)) based on indications, design, materials, manufacturing, and specifications. It concludes that "The indications, design, materials, manufacturing, and specifications of the Mayfield® ACCISS™ II Image Guided Surgery System do not raise any new unresolved issues relating to safety and effectiveness."

Therefore, I cannot extract the information requested as it is not present in the provided text. The document focuses on regulatory approval through substantial equivalence, which often means direct performance studies against numerical acceptance criteria are not required or detailed in the public summary if the device's function is already well-established and similar to existing predicate devices.

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