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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.

MRI Dynamic Analysis Plus is the Esaote commercial name of a software option intended for use on S-scan Esaote MRI systems; this option allows the extension of the functionalities of the option MRI Dynamic Analysis (cleared for S-scan K080968). MRI Dynamic Analysis enables the acquisition of a set of dynamic images and subsequent display of the time varying signals that is due to absorption of the contrast agent over time in the image series acquired. The software described above provides values of signal intensity over time and calculates the interpolation curve of these values, the maximum slope and the asymptotic value. The MRI Dynamic Analysis Plus software option has been implemented to enhance the performance of the MRJ Dynamic Analysis in terms of ease of use, reliability (operator independence) of the uptake-curves calculation, productivity and robustness. The MRI Dynamic Analysis Plus software option enhances performance of the existing MRI Dynamic Analysis (K080968) software in the following regard:

• Evolution of the available and consolidated Uptake Curve
• . Enabled by the options «MRI Dynamic Analysis» + «MRI Dynamic Analysis Plus»
• . Reliability (Operator independence) - Curve is automatically evaluated pixel on the whole image, instead of on an averaged ROI
• . Productivity - An intensity reference on images (vial placed alongside the wrist) is no more required
• . Robustness - Image data in extended scale is used, that is before "intensity normalization", in order to eliminate RF perturbations effects and to ensure that the pixel intensities along different series of dynamic examination are homogenous

Here's an analysis based on the provided document, addressing your request. It's important to note that this document is a 510(k) summary for a software option (MRI Dynamic Analysis Plus) for an existing MRI system (S-scan), rather than a new standalone device. This significantly impacts the type of studies and acceptance criteria presented.

Based on the provided text, a comprehensive study proving the device meets acceptance criteria in the traditional sense of diagnostic AI performance (e.g., sensitivity, specificity for a specific condition) was not conducted or reported. The submission is for a software enhancement to an existing device, focusing on equivalence and safety.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criterion (Implicit)	Reported Device Performance
   Safety Standards Compliance:
   - IEC 60601-1 (General Safety)	Device found to conform.
   - IEC 60601-1-2 (Electromagnetic Compatibility)	Device found to conform.
   - IEC 60601-1-6 (Usability)	Device found to conform (implied for software enhancement). The software aims to improve "ease of use" and "operator independence."
   - IEC 60601-2-33 (Specific Requirements for MRI)	Device found to conform.
   - IEC 62304 (Software Life Cycle Processes)	Device found to conform.
   - IEC 62366 (Usability Engineering for Medical Devices)	Device found to conform (implied for software enhancement).
   - ISO 10993-1 (Biocompatibility)	Device evaluated for biocompatibility and found to conform (likely referring to hardware components, as this is a software update).
   Imaging Performance (NEMA Standards for MRI):
   - NEMA MS-1 (Signal-to-Noise Ratio)	Device evaluated and found to conform.
   - NEMA MS-3 (Image Uniformity)	Device evaluated and found to conform.
   Functional Equivalence/Improvements:	The MRI Dynamic Analysis Plus software option enhances performance of the existing MRI Dynamic Analysis (K080968) software in terms of:
   - Reliability (Operator Independence)	Curve is automatically evaluated pixel on the whole image, instead of on an averaged ROI. This implies improved reliability and reduced operator-dependent variability.
   - Productivity	An intensity reference on images (vial placed alongside the wrist) is no longer required. This streamlines the workflow.
   - Robustness	Image data in extended scale is used (before "intensity normalization") to eliminate RF perturbations effects and ensure homogenous pixel intensities along different series of dynamic examinations. This suggests the software is less susceptible to noise and variability.
   Substantial Equivalence to Predicate Device (K080968/K151668)	"The changes proposed to the S-scan System are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards." The technological characteristics "do not alter the scientific technology of the S-scan system and are substantially equivalent to those of the predicate devices." Implies the updated software maintains the safety and effectiveness of the original system while offering functional improvements without introducing new risks or altering the fundamental imaging capabilities. "MRI Dynamic Analysis enables the acquisition of a set of dynamic images and subsequent display of the time varying signals that is due to absorption of the contrast agent over time in the image series acquired."

2. Sample Size Used for the Test Set and Data Provenance

   • Sample Size: Not specified for any specific clinical test or validation. The document states, "No clinical tests were performed." The testing appears to have focused on non-clinical aspects (safety, electrical, electromagnetic, mechanical, software validation against standards).
   • Data Provenance: Not applicable, as no external clinical dataset for performance evaluation (e.g., diagnostic accuracy) is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

   • Not applicable. No "ground truth" for diagnostic evaluation by experts is described, as the submission relies on adherence to technical standards and demonstrated functional improvements. The device's output (images) is expected to be "interpreted by a medical expert trained in use of MR equipment."

4. Adjudication Method for the Test Set

   • Not applicable, as no clinical test set requiring expert adjudication for performance metrics (like diagnostic accuracy) was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

   • No MRMC comparative effectiveness study was done. The document explicitly states, "No clinical tests were performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

   • The "MRI Dynamic Analysis Plus" is a software option that enhances the processing and display of MRI data. While it automates curve evaluation ("curve is automatically evaluated pixel on the whole image"), an expert is still required to interpret the images and the diagnostically useful information derived from them. Therefore, it's not a standalone diagnostic algorithm in the sense of providing a final diagnosis without human input. Its performance was assessed against technical and functional criteria, not standalone diagnostic accuracy.

7. The Type of Ground Truth Used

   • For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the relevant international and national standards (e.g., IEC, NEMA). The device's performance was compared against these predefined technical criteria.
   • For the functional improvements (reliability, productivity, robustness), the "ground truth" would be the documented benefits and features of the new software compared to the previous version (K080968), as described in the "Device Description" section.

8. The Sample Size for the Training Set

   • Not applicable. This document pertains to a software feature for an existing MRI system. The software processes existing MRI signals; it's not an AI model that requires a "training set" in the machine learning sense for diagnostic purposes.

9. How the Ground Truth for the Training Set Was Established

   • Not applicable, as no medical "training set" (e.g., for an AI algorithm learning to identify disease) is mentioned or implied. The software's capabilities are based on physics and engineering principles for processing MR signals.

Summary of Acceptance Criteria and Evidence for This Specific Device:

This 510(k) submission for the "MRI Dynamic Analysis Plus" software option for the S-scan MRI system is focused on demonstrating:

1. Safety and Compliance with Standards: The core acceptance criteria revolve around conforming to established international and national medical device safety and performance standards (e.g., IEC 60601 series, NEMA MS-1, MS-3). This is a standard requirement for medical devices and was confirmed through non-clinical testing.
2. Substantial Equivalence: The primary regulatory acceptance criterion for a 510(k) is proving substantial equivalence to a legally marketed predicate device (K151668 and K080968). The claim is that the software update does not alter the fundamental scientific technology or intended use, and that any changes (improvements in usability, reliability, robustness) do not introduce new safety concerns or diminish effectiveness.
3. Functional Improvements: The acceptance relies on the description of how the software enhances the performance of dynamic MRI analysis, making it easier to use, more reliable (less operator-dependent), more productive (no vial reference needed), and more robust (better handling of RF perturbations). These benefits are described qualitatively as design objectives and achieved features, rather than being quantified through a formal clinical comparative study with specific diagnostic endpoints.

In essence, this submission is not about proving the diagnostic accuracy of a new diagnostic algorithm or device, but rather about demonstrating that a software enhancement to an already cleared imaging system maintains its safety and effectiveness while offering described functional benefits.

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