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 - Sscan K121650 - 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:

1. Upgrading of the electronics
1. Patient bed unlocking function
1. A new software version

AI/ML Overview

This document is a 510(k) summary for the S-scan Magnetic Resonance (MR) system from Esaote S.p.A. It describes a modified version of the S-scan device compared to its cleared predicate (K121650).

Here's an analysis of the provided text regarding acceptance criteria and the study:

Important Note: The provided 510(k) summary is for a modified device, and the changes are described as "improvement of the system performance" due to "Upgrading of the electronics," "Patient bed unlocking function," and "A new software version." Crucially, it states that these modifications "do not affect the intended use or alter the fundamental scientific technology of the device." As a result, this 510(k) relies on the substantial equivalence to the predicate device (K121650) and does not describe a new study with explicit acceptance criteria for a novel AI/software feature with reported device performance results.

Therefore, I cannot directly extract "acceptance criteria and the study that proves the device meets the acceptance criteria" in the typical sense of a new AI algorithm's performance study from this particular document. The document essentially states that because the fundamental scientific technology and intended use are unchanged, a new major performance study against specific acceptance criteria for the new components is not required to demonstrate substantial equivalence for the overall device.

However, I can still extract information related to the device and its intended function, which would implicitly encompass its performance requirements.

1. Table of acceptance criteria and the reported device performance

Based on the provided text, there are no explicit acceptance criteria or reported device performance metrics stated for the modified S-scan's new software/electronics within this 510(k) summary. This is because the submission is a "Special 510(k)" relying on the fundamental equivalence to the predicate, K121650, where performance was presumably established. The modifications are described as improvements that do not alter the fundamental scientific technology or intended use.

The intended function of the device is to produce diagnostic MR images. Therefore, the implicit acceptance criterion is that the modified device must continue to produce diagnostically useful images of equivalent or improved quality compared to the predicate device, as determined by a medical expert.

Acceptance Criteria (Implicit for MRI Systems)	Reported Device Performance (Not explicitly stated in this 510(k) for the modifications)
Produce transversal, sagittal, coronal, and oblique cross-section images of specified body parts (limbs, joints, spinal column).	The device continues to perform its intended function of producing these image types.
Images correspond to spatial distribution of protons, determining MR properties (T1, T2, nuclei density, flow velocity, chemical shift).	The device's fundamental scientific technology in producing these images remains unchanged.
Images provide diagnostically useful information when interpreted by a medical expert trained in MR.	Implied: The diagnostic utility is maintained or improved due to performance upgrades, but no specific metrics are provided in this summary.
Maintain or improve image quality characteristics (e.g., signal-to-noise ratio, spatial resolution, contrast) previously established for the predicate device.	Implied: The "improvement of the system performance" via electronics and software upgrades aims to enhance these aspects, but no quantitative results are given.
Device functions safely and effectively.	Implied: The modifications are cleared as substantially equivalent, suggesting safety and effectiveness are maintained.

Regarding the study proving the device meets acceptance criteria:

The document doesn't describe a specific clinical study for the modified S-scan to prove it meets new or modified acceptance criteria as if it were a novel AI algorithm. Instead, the "proof" is based on the argument of substantial equivalence to the predicate device (K121650). The modifications are considered "improvements" that do not alter the fundamental scientific technology. This type of submission (a Special 510(k)) typically relies on verification and validation of the engineering changes to ensure the device continues to meet its established performance specifications, rather than a full-scale clinical trial to re-establish diagnostic accuracy.

Therefore, for aspects 2-9, the answer is largely that this information is not applicable to this specific 510(k) summary because it doesn't describe a new performance study to establish primary diagnostic performance of a new algorithm but rather an upgrade to an existing MR imaging system.

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

Not applicable. This 510(k) does not describe a new performance study with a test set of images for diagnostic evaluation by a new algorithm. The "test set" for the system itself would be part of the predicate device's original clearance (K121650) and internal engineering verification and validation testing for the upgrades.

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)

Not applicable. See point 2.

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

Not applicable. See point 2.

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 510(k) is for a conventional MR imaging system, not an AI-assisted diagnostic tool.

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

Not applicable. This 510(k) is for an MR imaging system; it does not involve a standalone algorithm for diagnostic interpretation. The device's output (images) requires interpretation by a medical expert. ("When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.")

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

Not applicable for this 510(k) submission. For the original predicate device (K121650), the ground truth for validating MR image quality would typically involve various phantoms, physical measurements, and potentially clinical correlation with other imaging modalities or pathologies if clinical validation was performed.

8. The sample size for the training set

Not applicable. This device is an MR imaging system; it is not described as involving a machine learning algorithm with a "training set" in this context. The "new software version" likely refers to operational software for the MRI, not an AI diagnostic algorithm.

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

Not applicable. See point 8.

Summary

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510(k) Summary S-Scan Esaote S.p.A.

510(k) Summary

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

807.92(a)(1)

Submitter Information

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

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

June 26, 2013 Date:

807.92(a)(2)

Devices

Trade Name: S-scan Common Name: System, Nuclear Magnetic Resonance Imaging Classification Name(s): Magnetic Resonance Diagnostic Device Classification Number: аогин

807.92(a)(3)

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.	K121650

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510(k) Summary S-Scan Esaote S.p.A.

807.92(a)(4)

Device Description

1. Upgrading of the electronics
1. Patient bed unlocking function
1. A new software version

807.92(a)(5)

Intended Use(s)

807.92(a)(6)

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 K121650.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble a human figure.

Public Health Service

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

December 13, 2013

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

Re: K131996

Trade/Device Name: S-scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 14, 2013 Received: November 15, 2013

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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Page 2-Ms. Scott

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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michal D. O. O. D.

Janine M. Morris 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) KI31996

Device Name S-scan MR System

Indications for Use (Describe)

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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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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)

FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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.