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.

Device Description

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

AI/ML Overview

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:

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."

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.
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."
Adjudication Method for the Test Set
- Not applicable, as no clinical test set requiring expert adjudication for performance metrics (like diagnostic accuracy) was performed.
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."
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.
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.
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.
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:

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.
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.
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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2016

Esaote S.p.A. % Ms. Allison Scott Senior Regulatory Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K153039

Trade/Device Name: S-scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 15, 2015 Received: December 16, 2015

Dear Ms. Scott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

UNKNOWN

Device Name

S-scan

Indications for Use (Describe)

can provide diagnostically useful information.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Submission S-scan Esaote, S.p.A.

Special 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.

Submitter Information

Esaote S.p.A. Via Siffredi 58 16153 Genova - Italy

Contact Person:

Allison Scott, RAC Managing Regulatory Consultant Tel. 317.228.8719 Fax 317.228.8701 allison.scott@navigant.com

Date:	October 15, 2015
Tradename:	S-scan
Common name:	System, Nuclear Magnetic Resonance Imaging
Classification Name:	Radiology
Classification Number:	90LNH

Predicate Devices

Trade name	Common name	Class	Product code	Manufacturer	K number
S-scan	System, nuclear magnetic resonance imaging	II	LNH	ESAOTE S.P.A	K151668
S-scan	System, nuclear magnetic resonance imaging	II	LNH	ESAOTE S.P.A	K080968

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Device Description

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

Intended Use

Technological Characteristics

The technological characteristics of the S-scan systems with the addition of the MRI Dynamic Analysis Plus software option, reflected in this Special 510(k), do not alter the scientific technology of the S-scan system and are substantially equivalent to those of the predicate devices.

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Summary of Non-Clinical Tests

The devices have been evaluated for biocompatibility, electrical, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.

. IEC 60601-1
IEC 60601-1-2 ●
IEC 60601-1-6 ●
IEC 60601-2-33 ●
IEC62304
IEC62366 ●
ISO10993-1
NEMA MS-1 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic ● Resonance Imaging
NEMA MS-3 Determination of Image Uniformity in Diagnostic Resonance ● Images

Summary of Clinical Tests

No clinical tests were performed.

Conclusion

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.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.