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The CTF Systems Inc. "Whole-Cortex MEG System" non-invasively measures the magnetoencephalographic (MEG) signals (and, now optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These signals are recorded by the data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. MEG locations may then be correlated with anatomical information of the brain. MEG is also used to non-invasively locate the visual, auditory, somatosensory, and motor cortex in the brain. * MEG is also used to non-invasively locate regions of epileptic activity within the brain. * The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning. *when routinely used in conjunction with evoked response averaging devices

The CTF "Whole-Cortex MEG System" integrates up to 200 dc-SQUID axial gradiometer detectors, a patient bed, a magnetic shielded room, workstation computers and data acquisition software in order to measure the magnetic signals generated by the intracellular and dendritic currents. These detectors are positioned in a helmet shaped array which gives the user the ability to record signals from the entire surface of the brain simultaneously without having to move the position of the probe.

The provided text describes the 510(k) summary for the CTF "Whole-Cortex MEG System." It asserts the device's substantial equivalence to two predicate devices (Neuromag-122 and Biomagnetic Technologies Magnes Single) based on a comparison of technical parameters and intended use. However, the text does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about sample sizes, data provenance, expert qualifications, or adjudication methods for any test or training sets.

The document is a regulatory submission focused on demonstrating substantial equivalence, not a performance study. It lists specifications of the new device and compares them to predicate devices, but there is no mention of performance metrics (sensitivity, specificity, accuracy, etc.) or a study designed to evaluate them against predefined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based only on the provided text:

Acceptance Criteria and Device Performance Study Details

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

• Acceptance Criteria: Not provided in the text.
• Reported Device Performance: Not provided in the text. The document focuses on demonstrating substantial equivalence in design and intended use, not on presenting performance metrics like sensitivity, specificity, or accuracy compared to a ground truth. The table presented compares technical specifications of the device to predicate devices.

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

• Sample Size (Test Set): Not mentioned.
• Data Provenance: Not mentioned.

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)

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Adjudication Method: Not mentioned.

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

• MRMC Study: Not mentioned as having been done.
• Effect Size: Not applicable, as no MRMC study or AI assistance is described. The device itself is a MEG system, not an AI-powered diagnostic tool for human readers.

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

• Standalone Performance: Not described. The device is a measurement system; its performance is related to its technical specifications for capturing biomagnetic signals, not an "algorithm only" performance as might be seen with AI. The document states "When interpreted by a trained clinician, the data enhances the diagnostic capability..." implying human interpretation is integral.

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

• Type of Ground Truth: Not mentioned. The document describes the device's function (measuring MEG signals) and its intended use (data interpreted by a trained clinician to help localize active areas), but not how its accuracy in localization would be verified against a ground truth.

8. The sample size for the training set

• Sample Size (Training Set): Not mentioned.

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

• Ground Truth Establishment (Training Set): Not mentioned.

Summary of available information from the text:

The document is a 510(k) summary (K971329) for the CTF "Whole-Cortex MEG System," a Class II Magnetoencephalograph. It demonstrates substantial equivalence to predicate devices (Neuromag-122 and Biomagnetic Technologies Magnes Single) by comparing technical specifications such as:

• Number of SQUID detectors/channels (64 to 200)
• Operating Principle (superconducting flux transformer coupled with dc-SQUID controlled by digital flux-locked loop)
• Number of auxiliary channels (88)
• Gradiometer type (1 axial first order gradiometer per location)
• Intersensor spacing (32 mm for 150 sensor configuration)
• Gradiometer placement (64 to 200 locations across a helmet-shaped dewar)
• Cryogen used (Liquid Helium)
• Coverage (One acquisition to cover the entire head)
• Gantry type (Floor mounted, standard fixed; optional tilts to 90°)
• Patient Position (Seated, or lying on back with optional bed)
• Head position indicator (Included)
• Computer (HP workstation with UNIX environment)
• Networking capabilities (Ethernet connections)
• Magnetic shielded room accessories (Interior DC lights, video camera and monitor, two-way intercom)

The intended use is to non-invasively measure MEG (and optionally EEG) signals produced by electrically active tissue of the brain. These signals are displayed and interpreted by trained physicians to help localize active areas, which can then be correlated with anatomical information. The system is also used to non-invasively locate motor, sensory, auditory, and somatosensory cortex and regions of epileptic activity, and for neurosurgical planning in conjunction with other diagnostic data.

Crucially, the provided text is a regulatory submission for device clearance based on substantial equivalence, not a scientific study reporting detailed performance metrics against a defined standard or ground truth.

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