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G-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.

G-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

G-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.

The changes performed on the modified G-scan device, with respect to the cleared version – G-scan K042236 –, are due to the improvement of the system safety and performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. A modified version of the magnet poles and of the gradient coils.
• 2. New receiving coils.
• 3. Modified pulse sequences.
• 4. A new Emergency button procedure.
• 5. A new safety device named sensitive edge.
• 6. A new safety switch named "Bed in"
• 7. A hand protection for patient table.
• 8. A head protection for patient table.
• 9. An exam positioning indicator kit for patient table.
• 10. A new step for patient positioning.
• 11. Contraindications have been added in the user manual due to the possibility of patient syncope caused by protracted orthostatic positions required for the examination.
• 12. A new software release.

The provided 510(k) summary for the G-Scan MR system does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria. This summary focuses on demonstrating substantial equivalence to a predicate device based on modifications to an existing and cleared MR system.

Here's why and what information is missing:

• Focus on Substantial Equivalence: The document is a 510(k) summary, which aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics and intended use, rather than presenting de novo performance studies against specific acceptance criteria.
• Modifications, Not New Device: The G-Scan discussed is a modified version of an already cleared device (G-scan K042236). The modifications listed (magnet poles, coils, pulse sequences, safety features, software) are presented as improvements to safety and performance that "do not affect the intended use or alter the fundamental scientific technology of the device." This context suggests that extensive new performance studies (like those for a novel AI device) against acceptance criteria were likely not deemed necessary for this type of submission.
• Interpretation by Medical Expert: The "Indications for Use" section states: "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." This implies that the diagnostic performance is ultimately dependent on a human expert, not solely on an algorithmic output against predefined metrics.

Therefore, I cannot provide the requested table and details as they are not present in the provided text. The document is concerned with the safety and technological equivalence of an updated magnetic resonance imaging system, not the analytical or clinical performance of an AI algorithm against specific acceptance criteria.

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The G-scan Cervical Spine Coil is to be used in MR imaging of the cervical section of the spine column.

G-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections.

G-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The Cervical Spine Coil is to be used with the MRI system G-scan, cleared via K042236.

This is a solenoidal linear receiving coil, shaped for suitability to the areas under examination and designed to be matched to the patient's cervical vertebrae; the coil is also morphologically adapted to the examined area to obtain a good Signal-to-Noise Ratio.

The patient's neck is inserted into the coil after the coil itself has been opened by means of nonmagnetic contacts inserted in the coil loops.

The height of the patient's head can be regulated by a suitable mechanism with a lever command. A special cushion is attached to the coil assuring that the patient maintains comfortably his position during the examination.

The mechanical connection between the coil and the patient table is provided through a mechanism that positions the coil at the proper position for a cervical examination.

The coil is equipped with a connecting cable, which must be fitted to the connector on the patient table for proper electrical wiring and for automatic coil model recognition.

The coil resonator is composed of 3 copper tubes each one with two couples of non-magnetic contacts, the three tubes are arranged in a circular path and connected in series and with 3 tuning capacitors groups.

De-coupling between the transmitting and the receiving coil is accomplished via a couple of PIN diodes in a passive circuit. During the RF transmitting pulse, the diodes placed in the receiving coil decoupling circuit are switched on by the pulse and enable a LC parallel resonating circuit, at the working frequency, so that the overall impedance of the coil becomes very high and the parasitic current is minimised.

The provided text is a 510(k) summary for a medical device (G-scan Cervical Spine Coil) seeking clearance from the FDA. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics in the way a diagnostic AI device might.

Therefore, the document does not contain the kind of information typically found in a study proving a device meets acceptance criteria, especially for software-based diagnostic aids. Specifically, it lacks:

• A table of acceptance criteria and reported device performance (beyond general similarity to predicate device).
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or specific standalone performance metrics.
• Details on ground truth establishment for training or test sets.

Instead, the document focuses on:

• Device Description: What the G-scan Cervical Spine Coil is, how it works, and its physical characteristics.
• Intended Use: The medical application for which the device is designed (MR imaging of the cervical spine column).
• Technological Characteristics Comparison: A side-by-side table comparing the new device's coil characteristics (primarily dimensions) to those of the predicate device. This is the closest the document comes to performance comparison, but it's a comparison of physical specs, not diagnostic accuracy.
• Substantial Equivalence Argument: The core of a 510(k) is to argue that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or if different, the differences do not raise new questions of safety and effectiveness.

Based on the provided text, I cannot fill out the requested table and answer many of the specific questions because the document does not contain that information. The G-scan Cervical Spine Coil is a physical component of an MRI system, not a diagnostic AI algorithm, and therefore its clearance process relies on demonstrating physical and functional similarity to an already cleared device, rather than a clinical trial demonstrating diagnostic performance against specific benchmarks.

If this were a submission for a diagnostic AI device, the information you requested would be critical. However, for a physically similar device like a new coil for an existing MRI system, the FDA's focus is on safety and effective integration with the existing system, and ensuring its technical parameters are comparable to predicate devices.

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