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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, imaging the temporomandibular joint 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 K110238 –, 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. Temporomandibular receiving coil.
• 2. New sensor for magnet patient table system rotation.
• 3. Import/export, in DICOM format, images/patient data on USB pen drive.
• 4. Streaming acquisition.
• 5. Modified pulse sequences.
• 6. A new software release.

This 510(k) summary for the Esaote G-Scan MR system (K111803) indicates that it is a modification of a previously cleared device (K110238). This type of submission, often a Special 510(k), focuses on demonstrating that the modified device is as safe and effective as the predicate device, not necessarily on a novel clinical performance study for diagnosing conditions.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and performance studies for diagnostic accuracy. Instead, it focuses on demonstrating that modifications to the device (new coil, sensor, DICOM export, streaming acquisition, pulse sequences, and software) do not alter the fundamental scientific technology or intended use and that non-clinical testing confirmed it meets performance requirements and is as safe and effective as the predicate.

Here's a breakdown of why many of your requested points cannot be extracted from this document, and what is mentioned:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated for diagnostic performance in this document. The focus is on demonstrating that the modified device "met performance requirements" generally, implying equivalence to the predicate.
• Reported Device Performance: No specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) are reported. The document states that "non-clinical testing... demonstrated that it met performance requirements and is as safe and effective as the predicate device."

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

• Not Applicable/Not Provided: This document describes a Special 510(k) for device modifications, not a new clinical performance study for diagnostic accuracy. No information on a test set (e.g., patient cases used for diagnostic evaluation) is present.

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

• Not Applicable/Not Provided: As no diagnostic performance study involving a test set is described, there's no mention of experts establishing ground truth for such a set.

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

• Not Applicable/Not Provided: For the same reasons as above.

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:

• No: This document is for an MR system, not an AI-powered diagnostic tool. No MRMC study is mentioned, nor is any AI component.

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

• Not Applicable/No: This is a diagnostic imaging device, not an algorithm. Standalone performance as you describe is not relevant here.

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

• Not Applicable/Not Provided: No diagnostic performance study is described. The "ground truth" for the non-clinical testing referenced would likely relate to engineering specifications, image quality metrics, and safety standards, rather than clinical diagnostic ground truth.

8. The sample size for the training set:

• Not Applicable/Not Provided: No machine learning or AI component is mentioned, so there is no training set for an algorithm.

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

• Not Applicable/Not Provided: For the same reasons as above.

Summary of what the document does state about performance:

• Type of Study: Non-clinical testing.
• Purpose: To demonstrate that the modified G-scan system met performance requirements and is as safe and effective as the predicate device (K110238).
• Nature of Performance: Related to the improvements in system safety and performance due to the specific modifications listed (e.g., new coil, software, pulse sequences). This would likely involve technical image quality assessments, safety checks, and functional tests to ensure the device operates as intended and produces diagnostically useful images when interpreted by a medical expert.
• Intended Use: The device produces images of internal structures (limbs, joints, spinal column) that, when interpreted by a medical expert trained in the use of MR equipment, can provide diagnostically useful information. This emphasizes the human-in-the-loop nature of its use.

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