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S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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, the thoracic and the lumbosacral sections as portions of the spinal column. S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spinlattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The changes performed to S-scan, with respect to the cleared version – S-scan K131996 – are due to the improvement of the system performance. These modifications, which do not alter the fundamental scientific technology of the device, are the following and all have been cleared with G-scan Brio via K142421:

• 1. A new Bilateral TMJ Coil
• 2. Introduction of the thoracic spine section examination
• 3. A new software version including the following features:
  • Customization of Image Enhancement ●
  • Overlay sending to PACS
  • Isotropic 3D acquisition ●

This document describes a 510(k) submission for the Esaote S-Scan Magnetic Resonance (MR) system. The submission, K151668, pertains to improvements made to the S-Scan, specifically the introduction of a new Bilateral TMJ Coil, thoracic spine section examination, and new software features (Customization of Image Enhancement, Overlay sending to PACS, Isotropic 3D acquisition).

However, the provided text explicitly states that no clinical tests were performed to prove that the device meets acceptance criteria. Instead, the submission relies on the substantial equivalence to a previously cleared device, the G-Scan Brio (K142421), which already incorporated these changes.

Therefore, many of the requested details regarding acceptance criteria and a study proving their fulfillment cannot be extracted directly from this document.

Here's the information that can be gleaned and a table summarizing the explicitly requested points, with "N/A" where the information is not provided because no specific clinical study was conducted for this submission:

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

Since no new clinical tests were performed for this 510(k) submission, specific acceptance criteria and performance metrics for the S-Scan (K151668) are not detailed in the provided text. The submission argues that the changes do not alter the fundamental scientific technology and that the image quality performance has already been cleared via K142421 (G-Scan Brio).

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

N/A - No clinical tests were performed for this submission.

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)

N/A - No clinical tests were performed for this submission.

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

N/A - No clinical tests were performed for this submission.

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

N/A - This document describes an MR system, not an AI-assisted device. No MRMC study was mentioned.

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

N/A - This document describes an MR system, not an algorithm, and no standalone performance study was mentioned.

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

N/A - No clinical tests were performed for this submission.

8. The sample size for the training set

N/A - No clinical tests or machine learning training were described for this submission.

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

N/A - No clinical tests or machine learning training were described for this submission.

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