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 hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine 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 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.

Device Description

The changes performed on the modified S-scan device, with respect to the cleared version – S-scan K110802 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

A new step for patient positioning.
A kit for patient positioning during hip examination using 4-channels lumbar spine coil 17 and 18.
Geometric distortion correction.
FSE parameters optimization
FSE acceleration and improving.
FSE sampling frequency management.
Streaming acquisition performance increasing.
Configurable send and export of XBONE echoes.
Environment for the management of the virtual film.
Data matching for patient coming from a worklist server.
SpeedUp technique introduction, cleared via K120748.
A new software version.

AI/ML Overview

This 510(k) submission (K121650) for the S-Scan MR system describes modifications to an already cleared device (K110802), rather than a new device that requires extensive clinical validation to demonstrate its performance against acceptance criteria. Therefore, the information typically associated with acceptance criteria and a detailed study proving performance (e.g., specific metrics, ground truth establishment, sample sizes for training/testing datasets, expert qualifications, adjudication methods, or MRMC studies) is not explicitly provided in the document.

The submission focuses on demonstrating that the modifications to the S-Scan device do not affect its intended use or alter its fundamental scientific technology, and thus the device remains substantially equivalent to its predicate. The "acceptance criteria" here are implied to be that the improved system performance from the modifications does not negatively impact image quality or diagnostic utility against the baseline established by the predicate device.

However, based on the provided text, we can infer some aspects related to the device performance implicitly.

Here's an analysis based on the document, addressing as many of your points as possible:

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

Since this is a Special 510(k) for device modifications, explicit "acceptance criteria" for a new device's performance are not detailed in the provided text. The implicit acceptance criterion is that the modified device's performance is at least equivalent to, or improved compared to, the predicate device (K110802), specifically in areas where modifications were made, without compromising the overall diagnostic utility.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit from modifications)
No degradation of image quality for diagnostic interpretation.	System performance improvements via: - Geometric distortion correction. - FSE parameters optimization. - FSE acceleration and improving. - FSE sampling frequency management. - Streaming acquisition performance increasing. - SpeedUp technique introduction. These modifications aim to enhance image quality and acquisition efficiency.
Maintenance of intended use and fundamental scientific technology.	Stated: "These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device." The images "can provide diagnostically useful information" when interpreted by a medical expert.
Compliance with general controls and relevant regulations.	Reviewed by FDA for substantial equivalence and allowed to market.

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

The document does not specify a separate "test set" sample size or data provenance for a performance study. Since the modifications are for an already cleared device, it's likely that internal verification and validation activities were performed by the manufacturer, rather than a new clinical study with a distinct test set described in the 510(k). No information is provided regarding the country of origin or whether data was retrospective or prospective.

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

This information is not provided. Given the nature of a Special 510(k) for modifications to an established MR system, it's improbable that a new, extensive ground truth establishment process for a clinical test set was required and detailed in this submission. The "ground truth" for the diagnostic utility of MR images, in general, is implicitly established by the experience and training of "a medical expert trained in the use of MR equipment."

4. Adjudication method for the test set

Not specified in the document.

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

An MRMC study is not mentioned. The device described is an MR system, not an AI-assisted diagnostic tool, so the concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.

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

Not applicable. The S-Scan is an MR imaging system, not a standalone algorithm. Its output, images, requires interpretation by a human expert.

7. The type of ground truth used

The ground truth is implied to be expert interpretation of MR images. The document states: "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." There is no mention of pathology or outcomes data as direct ground truth for this submission, as the submission focuses on system modifications.

8. The sample size for the training set

Not applicable. This document describes modifications to an MR imaging system. It is not an AI/algorithm-based device that would typically have a "training set" in the context of machine learning.

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

Not applicable, as there is no mention of a training set for an AI/algorithm.

Summary

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K121650

9 2012 JUL

510(k) Summary

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

Submitter Information

Donatella Ragghianti Esaote, S.p.A. Via Siffredi 58 Genova 16153 Italy

Contact Person: Allison Scott, RAC P: 317.569.9500 x106 F: 317.569.9520 ascott@ansongroup.com

June 1, 2012 Date:

Trade Name: S-Scan

Common Name: System, Nuclear Magnetic Resonance Imaging

Classification Name(s): Magnetic Resonance Diagnostic Device

Classification Number: 90LNH

Predicate Device(s)

Trade Name	Common name	Class	Product code	Manufacturer	K number
S-scan	System, nuclear magneticresonance imaging	II	LNH	ESAOTE S.P.A.	K110802

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Device Description

1. A new step for patient positioning.
1. A kit for patient positioning during hip examination using 4-channels lumbar spine coil 17 and 18.
1. Geometric distortion correction.
1. FSE parameters optimization

1. FSE acceleration and improving.
1. FSE sampling frequency management.
1. Streaming acquisition performance increasing.
1. Configurable send and export of XBONE echoes.
1. Environment for the management of the virtual film.
1. Data matching for patient coming from a worklist server.

SpeedUp technique introduction, cleared via K120748.

1. A new software version.

Intended Use(s)

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 hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.

Technological Characteristics

The changes to the S-scan system, reflected in this Special 510(k), do not alter the fundamental scientific technology of the S-scan system, the predicate device, cleared via K110802.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an abstract eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Esaote S.p.A % Ms. Allison Scott, RAC Regulatory Associate · Anson Group, LLC 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K121650

Trade/Device Name: S-Scan MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 1, 2012 Received: June 5, 2012

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of t

9 2012 JUL

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: S-Scan MR System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

(Division Sign-C

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

919K K121650

S-Scan E-MRI Brio 2.0 510(k)

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.