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S-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 imaging portions of the spinal column, including the cervical and lumbo-sacral sections.

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 spin-lattice relaxation time (Ti), 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.

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

This 510(k) is to add the DPA cervical coil. This is a dual phased array receiving coil, shaped for suitability to the areas under examination and designed to the patient's cervical vertebrae.

This 510(k) summary is for the addition of a DPA cervical coil to the Esaote S-Scan MR System, not for a new device requiring a comprehensive study to prove its acceptance criteria. Therefore, the document primarily focuses on demonstrating substantial equivalence to a predicate device (K080968) rather than providing extensive details about a performance study with acceptance criteria in the manner requested.

Based on the provided text, a detailed table of acceptance criteria and reported device performance, or a standalone study as typically seen for new AI/CADe devices, is not present. The submission focuses on demonstrating that the addition of a new coil does not alter the fundamental scientific technology or intended use of the already cleared S-Scan system.

Here's an attempt to address your requests based only on the provided text, acknowledging that many points cannot be fully answered due to the nature of this particular 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table detailing "acceptance criteria" for the device's diagnostic performance and "reported device performance" against those criteria. This 510(k) submission is for an accessory (DPA cervical coil) to an already cleared MR system (S-Scan, K080968). The primary "acceptance" is demonstrating that the new coil does not materially change the safety and effectiveness of the existing device.

The "performance" described is in the context of the overall S-Scan MR system, which "produces transverse, sagittal and oblique cross-section images of the limbs, joints and spinal column." The images "can provide diagnostically useful information when interpreted by a medical expert trained in the use of MR equipment." This implies that the image quality with the new coil is expected to be sufficient for expert interpretation, consistent with the predicate device.

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

Not applicable/Not provided. The document does not describe a clinical performance study with a distinct "test set" in the context of diagnostic accuracy for the addition of the DPA cervical coil. This 510(k) focuses on the technological characteristics and substantial equivalence to an existing device.

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

Not applicable/Not provided. No test set requiring expert ground truth establishment is described for this 510(k) submission.

4. Adjudication method for the test set

Not applicable/Not provided. No test set requiring adjudication is described.

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

Not applicable. This device is a Magnetic Resonance (MR) system with an added coil, not an AI or CADe device. Therefore, no MRMC study or AI-related comparative effectiveness is mentioned.

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

Not applicable. This is an MR imaging system, not an algorithm.

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

Not applicable/Not provided. As no specific clinical performance study with ground truth is described, this information is not available in the document. The general implication for the S-Scan system is that "diagnostically useful information" comes from images "interpreted by a medical expert trained in the use of MR equipment," suggesting clinical diagnosis as the ultimate truth.

8. The sample size for the training set

Not applicable/Not provided. This submission does not describe an algorithm requiring a training set.

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

Not applicable/Not provided.

Summary of the Study (or lack thereof) Proving Acceptance Criteria:

The document states: "The addition of the DPA Cervical Spine Coil to the S-scan system... does not alter the fundamental scientific technology of the S-scan system, the predicate device, cleared via K080968."

This statement is the core of the "proof" for this particular 510(k). The regulatory acceptance criteria for this submission are primarily met by demonstrating:

• Substantial Equivalence: The new DPA cervical coil, when added to the S-Scan system, is substantially equivalent to the predicate S-Scan system (K080968) in terms of its technological characteristics and intended use.
• No new questions of safety or effectiveness: The addition of the coil does not raise new questions of safety or effectiveness that were not addressed by the predicate device.

The study proving this involved a comparison of "Technological Characteristics" between the modified device (S-Scan with DPA cervical coil) and its predicate. This is typically achieved through engineering design verification and validation, ensuring that the new component integrates safely and produces images of comparable quality and diagnostic utility to what the original system was cleared for. No specific clinical trial or performance study with detailed metrics against acceptance criteria is described in this summary because the change is limited to an accessory and its impact on the fundamental technology.

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