E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique images of the limbs and joints. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip.

E-scan XQ MR 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 DPA Shoulder Coil is to be used with the E-scan XQ magnetic resonance imaging system. It is a receiving coil and is the result of the combination of two different coils. The first is a coil designed to be "worn" by the patient and connected in a series with 4 tuning capacitors positioned under the primary coil and is composed of 3 turns designed to improve the image homogeneity and having spatially complementary sensitivity with respect to the primary coil. The coil allows for imaging of both the left and right shoulder, due to the symmetrical mechanical connection between its base and the magnet.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for the E-scan XQ MRI System, specifically addressing the addition of a DPA Shoulder Coil. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is largely absent from this document.

Here's an analysis based on the provided text, highlighting the information that is and is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not specify quantitative acceptance criteria or provide performance metrics such as sensitivity, specificity, or accuracy of the device for diagnostic tasks. The focus is on the "technological characteristics" of the new shoulder coil being "similar" to the predicate, and producing diagnostically useful images when interpreted by a medical expert.

2. Sample Size for the Test Set and Data Provenance

Not available. The document describes the device and its intended use but does not mention any specific test set of cases, their size, or their origin (country, retrospective/prospective). This is typical for a 510(k) submission where substantial equivalence is demonstrated through engineering and functional comparisons, not necessarily new clinical performance data for diagnostic accuracy.

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

Not applicable/Not available. Since no specific test set or diagnostic performance study is described, there's no mention of experts establishing ground truth for such a study. The document generally states that images provide "diagnostically useful information" when "interpreted by a medical expert trained in the use of MR equipment." This is a general statement about the expected use of an MR system, not a specific study methodology.

4. Adjudication Method for the Test Set

Not applicable/Not available. As no test set for diagnostic performance is detailed, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device itself is an MRI system and coil, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

No. The device is an MRI system. By its nature, it requires a human expert ("a medical expert trained in the use of MR equipment") to interpret the images. There is no mention of an algorithm-only standalone performance study.

7. Type of Ground Truth Used

Not available. Since no specific performance study with a test set is detailed, the type of ground truth used to evaluate diagnostic accuracy is not mentioned. The document focuses on the physical properties of the MR images (spatial distribution of protons, relaxation times, etc.) rather than diagnostic outcomes.

8. Sample Size for the Training Set

Not applicable. The E-scan XQ MRI System is a hardware device; it does not appear to employ machine learning or AI that would require a "training set" in the computational sense.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no description of how ground truth would be established for it.

Summary of what is present in the document:

Device Description: The DPA Shoulder Coil for the E-scan XQ MRI system is a receiving coil connected in series with tuning capacitors. It's designed to be "worn" by the patient and improve image homogeneity and Signal-to-Noise Ratio (SNR).
Intended Use: The E-scan XQ MR system, with the DPA Shoulder Coil, is intended for imaging portions of the upper and lower limbs, specifically mentioning the shoulder. It produces transversal, sagittal, coronal, and oblique images corresponding to the spatial distribution of protons.
Technological Characteristics (Comparison to Predicate): The document affirms that the "technological characteristics of the DPA 7 Shoulder coil are similar to the characterisitics of the predicate device DPA receiving coils." It lists physical dimensions for various coils (Knee, Hand, Foot/Ankle) for both the predicate and the modified E-scan XQ, highlighting the addition of the Shoulder coil.
Predicate Device: Esaote E-Scan (K990968, K001894), Esaote Hip Coil (K012728), Esaote E-Scan XQ (K020164, K032121).
Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls.

This 510(k) largely relies on demonstrating that the new shoulder coil does not raise new questions of safety and effectiveness compared to existing, cleared MRI coils and systems, rather than presenting new clinical performance data for diagnostic accuracy.

Summary

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

510(k) Summary E-scan XQ Biosound Esaote

MAY 1 4 2004

K041145
Page 1 of 3

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

Carri Graham, Official Correspondent8000 Castleway DriveIndianapolis, IN 46250(317) 849-1916Phone:(317) 577-9070Facsimile:
Carri GrahamContact Person:
Date:	April 30, 2004
807.92(a)(2)
Trade Name:	E-Scan XQ
Common Name:	Magnetic resonance diagnostic device
Classification Name(s):	System, Nuclear Magnetic Resonance Imaging
Classification Number:	90LNI-I
807.92(a)(3)	Predicate Device(s)
Esaote	E-Scan	K990968
Esaote	E-Scan	K001894
Esaote	Hip Coil	K012728
Esaote	E - Scan XQ	K020164
Esaote	E-Scan XQ	K032121

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

510(k) Summary E-scan XQ Biosound Esaote

K041145
Pengelup

01.92(a)(4)

Device Description

The DPA Shoulder Coil is to be used with the E-scan XQ magnetic resonance imaging system. It is a receiving THE DF A Shoulder Con is to be asou with and is the result of the combination of two different coils. The first is con designed to be "wom" by are patient and lonected in a series with 4 tuning capacitors positioned under the the printary con and is composed of - cans ocists of 3 turns designed to improve the image homogenery and having spatially complementary sensitivity with respect to the primary coil. The coil allows for imaging of both the left and right shoulder, due to the symmetrical mechanical connection between its base and the magnet.

807.92(a)(5)

Intended Use(s)

E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique L-scall AQ is a maginent resumbled for imaging the upper limb, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging the lower limb, including the foot, ankle, calf, knee, thigh and hip.

E-scan XQ MR 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 magine resolutios proportion (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a I II, Spin Telandien and ( of MR equipment, the images can provide diagnostically useful information.

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

Image /page/2/Picture/0 description: The image contains text that appears to be from a document. The text includes "510(k) Summary", "E-scan XQ", and "Biosound Esaote". There is also some illegible handwriting on the right side of the image.

807.92(a)(6)

Technological Characteristics

Comparison to the cleared device E-scan XQ K032121

Characteristics	E-scan XQK032121	ModifiedE-scan XQ	Comments
DPA receivingcoils	2 Knee coil: 22.5 x21.0 x 18.3 cm (h x w x d) external; 14.3 x16.0 x 18.3 cm (h x w x d) internal3 Hand coil: 17.8 x17.5 x 20 cm (h x w xd) external; 11.9 x 7.2x 20 cm (h x w x d)internal4 Foot/Ankle coil: 22.0x 19.2 x 28.5 cm (h xw x d) external; 14.6 x10.0 x 28.5 cm (h x wx d) internal	2 Knee coil: 22.5 x21.0 x 18.3 cm (h x w x d) external; 14.3 x16.0 x 18.3 cm (h x w x d) internal3 Hand coil: 17.8 x17.5 x 20 cm (h x w xd) external; 11.9 x 7.2x 20 cm (h x w x d)internal4 Foot/Ankle coil: 22.0x 19.2 x 28.5 cm (h xw x d) external; 14.6 x10.0 x 28.5 cm (h x wx d) internal7 Shoulder coil: 25.5 x18.5 cm (largeropening)13.3 x 13.3 cm(smaller opening)	The technologicalcharacteristics of theDPA 7 Shoulder coilare similar to thecharacterisitics of thepredicate device DPAreceiving coils.The coil is designed tobe morphologicallyadapted to theexamined area forincreasing the Signal-to-Noise Ratio.See section "DPAShoulder CoilDescription".

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

MAY 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Esaote S.p.A. % Ms. Carri Graham Official Correspondent The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K041145

Trade/Device Name: E-scan XQ MRI System Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II Product Code: 90 MOS Dated: April 30, 2004 Received: May 3, 2004

Dear Ms. Graham:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050

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

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogden

Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): ΚοΨ 114)

Device Name: E-scan XQ MR System

Indications for Use:

E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and L-scan AQ is a inaginene resources of the limbs and joints. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and maging portions of the apper will the lower limb, including the foot, ankle, calf, knee, thigh and hip.

Prescription Use X (Part 21 CFR 801 Subpart D) AP/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Lyonn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Page 1 of 1

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.