G-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 the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.

G-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

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

The changes performed on the modified G-scan device, with respect to the cleared version – G-scan K110238 –, are due to the improvement of the system safety and performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

1. Temporomandibular receiving coil.
1. New sensor for magnet patient table system rotation.
1. Import/export, in DICOM format, images/patient data on USB pen drive.
1. Streaming acquisition.
1. Modified pulse sequences.
1. A new software release.

AI/ML Overview

This 510(k) summary for the Esaote G-Scan MR system (K111803) indicates that it is a modification of a previously cleared device (K110238). This type of submission, often a Special 510(k), focuses on demonstrating that the modified device is as safe and effective as the predicate device, not necessarily on a novel clinical performance study for diagnosing conditions.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and performance studies for diagnostic accuracy. Instead, it focuses on demonstrating that modifications to the device (new coil, sensor, DICOM export, streaming acquisition, pulse sequences, and software) do not alter the fundamental scientific technology or intended use and that non-clinical testing confirmed it meets performance requirements and is as safe and effective as the predicate.

Here's a breakdown of why many of your requested points cannot be extracted from this document, and what is mentioned:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated for diagnostic performance in this document. The focus is on demonstrating that the modified device "met performance requirements" generally, implying equivalence to the predicate.
Reported Device Performance: No specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) are reported. The document states that "non-clinical testing... demonstrated that it met performance requirements and is as safe and effective as the predicate device."

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

Not Applicable/Not Provided: This document describes a Special 510(k) for device modifications, not a new clinical performance study for diagnostic accuracy. No information on a test set (e.g., patient cases used for diagnostic evaluation) is present.

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

Not Applicable/Not Provided: As no diagnostic performance study involving a test set is described, there's no mention of experts establishing ground truth for such a set.

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

Not Applicable/Not Provided: For the same reasons as above.

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:

No: This document is for an MR system, not an AI-powered diagnostic tool. No MRMC study is mentioned, nor is any AI component.

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

Not Applicable/No: This is a diagnostic imaging device, not an algorithm. Standalone performance as you describe is not relevant here.

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

Not Applicable/Not Provided: No diagnostic performance study is described. The "ground truth" for the non-clinical testing referenced would likely relate to engineering specifications, image quality metrics, and safety standards, rather than clinical diagnostic ground truth.

8. The sample size for the training set:

Not Applicable/Not Provided: No machine learning or AI component is mentioned, so there is no training set for an algorithm.

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

Not Applicable/Not Provided: For the same reasons as above.

Summary of what the document does state about performance:

Type of Study: Non-clinical testing.
Purpose: To demonstrate that the modified G-scan system met performance requirements and is as safe and effective as the predicate device (K110238).
Nature of Performance: Related to the improvements in system safety and performance due to the specific modifications listed (e.g., new coil, software, pulse sequences). This would likely involve technical image quality assessments, safety checks, and functional tests to ensure the device operates as intended and produces diagnostically useful images when interpreted by a medical expert.
Intended Use: The device produces images of internal structures (limbs, joints, spinal column) that, when interpreted by a medical expert trained in the use of MR equipment, can provide diagnostically useful information. This emphasizes the human-in-the-loop nature of its use.

Summary

{0}------------------------------------------------

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

JUL 15 2011

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

Date:	June 24, 2011
Trade Name:	G-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
G-scan	System, nuclear magneticresonance imaging	II	LNH	ESAOTE S.P.A	K110238

{1}------------------------------------------------

Device Description

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

1. Temporomandibular receiving coil.
1. New sensor for magnet patient table system rotation.
1. Import/export, in DICOM format, images/patient data on USB pen drive.
1. Streaming acquisition.
1. Modified pulse sequences.
1. A new software release.

Intended Use(s)

Technological Characteristics

The changes to the G-scan system, reflected in this Special 510(k), do not alter the fundamental scientific technology of the G-scan system, the predicate device, cleared via K110238.

Performance Testing

Non-clinical testing of the G-scan system with the modifications reflected in this Special 510(k) demonstrated that it met performance requirements and is as safe and effective as the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The logo is black and white.

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 Regulatory Associate Anson Group, LLC 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

JUL 1 5 2011

Re: K111803

Trade/Device Name: G-Scan MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 24, 2011 Received: June 27, 2011

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

{3}------------------------------------------------

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,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: G-Scan MR System

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patil
Division Chief Officer

Division Sig Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K111803

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.