The E-Scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The system preliminarily named "Artoscan S" is going to be commercialized under the trade name "E-Scan". The changes performed, with respect to the cleared version, are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort. The intended use of the modified device has not changed as a result of the modifications nor such modifications alter its fundamental scientific technology.

Device Description

The E-Scan is a Magnetic resonance diagnostic device. It is a System, Nuclear Magnetic Resonance Imaging. The changes performed, with respect to the cleared version (Artoscan S), are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort.

AI/ML Overview

Here's an analysis of the provided K990968 document, focusing on acceptance criteria and supporting studies.

It's important to note that this document is a 510(k) summary for a Magnetic Resonance Diagnostic Device (E-Scan) from 1999. The submission focuses on demonstrating substantial equivalence to a predicate device (Artoscan S), rather than presenting a performance study with detailed acceptance criteria as one might expect for a modern AI/software device. Therefore, many of the requested categories for AI device studies will not be directly applicable or present in this type of submission.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria here are implicitly based on demonstrating that the E-Scan device is substantially equivalent to its predicate device, the Artoscan S. The performance metrics are relative to the predicate, showing that the E-Scan maintains or improves upon the predicate's capabilities.

Acceptance Criteria Category	E-Scan Performance (relative to Artoscan S)
Imaging Parameters
Slices per Echo	1 - 96 (vs. 1 - 128 for Artoscan S). Comment: This is a reduction, but likely deemed acceptable as it still covers a wide range and does not negatively impact safety or effectiveness for the intended use.
Homogeneity	< + 50 ppm (pk pk) on 140 mm DSV (vs. < + 30 ppm on 120 mm DSV for Artoscan S). Comment: Slight increase in ppm but on a larger DSV, allowing for a larger Field of View. Deemed an improvement.
Fringe Field (0.5 mT line)	X-axis: 150 cm front, 120 rear; Y-axis: 130 cm right/left; Z-axis: 150 cm top/bottom (vs. 140 cm front, 90 cm rear; 120 cm right/left; 90 cm top/bottom for Artoscan S). Comment: Increased, indicating a larger safe zone, due to industrialization.
RF Shielding	Integrated RF shielding (up to 30 dBμV/m), Shielding Box (up to 60 dBμV/m), External shielding (up to 100 dBμV/m) (vs. Self contained (up to 30 dBμV/m), External (up to 100 dBμV/m) for Artoscan S). Comment: Improved/clarified shielding options.
Gradients' Rise Time	0.8 ms from 0 to 20 mT/m from 0 to 99% (vs. 0.5 ms from 0 to 20 mT or from -20 to 0 mT for Artoscan S). Comment: More precise characterization; presumed acceptable.
Functional/Anatomical Coverage
Sequences	GEFS renamed to GE-STIR. Comment: Renaming, not a change in fundamental function.
Anatomical Regions Covered	Includes Arm (vs. selected as "Other" in Artoscan S). Comment: Arm is now a standard, making it more convenient.
Physical/Installation
Installation Area (Integrated shielding)	3.7 x 4 m (vs. 3.7 x 3.7 sq. m for Artoscan S). Comment: Slight increase in one dimension but within similar scale.
Installation Area (Shielding Box)	4 x 4.5 sq. m. (min height 2.4 m) (new option, not directly comparable to Artoscan S). Comment: Provides a new intermediate shielding solution.
Patient Comfort/Accessibility	Improved accessibility inside the gantry toward greater patient comfort. (Implicit acceptance criteria, not quantified, but stated as an improvement).
Intended Use	Unchanged from predicate.
Fundamental Scientific Technology	Unchanged from predicate.

Study Information (Based on the K990968 Submission):

The provided document is a 510(k) summary, which for a device like an MRI, primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device. It typically does not include a detailed, prospective clinical performance study with the types of metrics and specific methodologies you'd find for a novel AI diagnostic device.

Here's an attempt to answer the questions based on what can be inferred from this type of submission, or noting what is not applicable:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided. This 510(k) submission does not describe a clinical test set or study in the way an AI/software device would. The "study" here is essentially a technical comparison demonstrating that the modifications to the Artoscan S (to become E-Scan) do not alter the fundamental safety or effectiveness and that the new specifications are within acceptable ranges or represent improvements.
- There is no mention of patient data, retrospective or prospective studies, or country of origin for such data.
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. Since no specific test set and ground truthing process for diagnostic performance are described, this information is not provided. The intended use states that images, "If interpreted by a medical expert, these images can provide diagnostically useful information," implying that medical experts (like radiologists) would interpret the output, but this is not part of a performance study setup in this document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or related adjudication is described.
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 was not done. This is a 1999 submission for an MRI hardware device, not an AI-powered diagnostic tool. The concept of "human readers improve with AI" is not relevant here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is an MRI scanner, not an algorithm. Its performance is inherent in the image quality and physical specifications.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No explicit ground truth for diagnostic performance is mentioned. The implicit "ground truth" for the substantial equivalence claim is the performance and specifications of the predicate device (Artoscan S).
The sample size for the training set:
- Not Applicable. This device is an MRI machine; it does not utilize a "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for a machine learning model, this question does not apply.

Summary of this 510(k) Submission:

This 510(k) for the E-Scan MRI machine is a request for clearance based on substantial equivalence to a previous version of the device (Artoscan S). The "study" involves a side-by-side technical comparison of specifications and features, demonstrating that the E-Scan either maintains the same capabilities as the predicate, offers minor improvements (like patient comfort or ease of use for certain anatomical regions), or has minor technical differences (e.g., slices per echo, homogeneity figures) that don't negatively impact safety or effectiveness for the stated intended use. A formal clinical study with patient data, ground truth establishment, or reader performance metrics, as would be expected for a modern AI medical device, is not part of this type of submission.

Summary

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K990968

MAY 2 7 1999

510(k) Summary E-Scan Biosound Esaote

510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

Submitter Information

Colleen Hittle, Official Correspondent
8000 Castleway Drive
Indianapolis, IN 46250
Phone:	(317) 849-1916
Facsimile:	(317) 577-9070
Contact Person:	Colleen Hittle
Date:	March 10, 1999

807.92(a)(2)

Trade Name:	E-Scan
Common Name:	Magnetic resonance diagnostic device
Classification Name(s):	System, Nuclear Magnetic Resonance Imaging
Classification Number:

807.92(a)(3)

Predicate Device(s)

Esaote	Artoscan S	K981358
--------	------------	---------

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

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510(k) Summary E-Scan Biosound Esaote

807.92(a)(5)

Intended Use(s)

The E-Scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spinspin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

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510(k) Summary E-Scan Biosound Esaote

Item	Artoscan S	E-SCAN	Comments
# slices perecho	1 - 128	1 – 96
Homogeneity	< + 30 ppm on 120 mmDSV	< + 50 ppm (pk pk) on 140mm DSV	Final result allows toenlarge the Field of View
Fringe field(0,5 mT line)	0,5 mT line: 140 cmfrom the center of themagnetX axis: 140 cm front; 90 cm rear;Y axis: 120 cmright/left;Z axis: 90 cmtop/bottom	0,5 mT line: 150 cm fromthe center of the magnetX axis: 150 cm front, 120rear;Y axis: 130 cm right/leftZ axis: 150 cm top/bottom	Variations due to theindustrialization of themagnet
RF Shielding	Self contained RFshielding (up to 30dBμV/m)External shielding (up to100 dBμV/m)	Integrated RF shielding(up to 30 dBμV/m)Shielding Box (up to 60dBμV/m)External shielding (up to100 dBμV/m)	The term "integrated"represents better theconcept than "self-contained"A shielding box has beenadded as intermediatesolution, in terms of bothperformances and costs,between the integrated RFshielding and thetraditional RF cage (as this
			latter is always possiblebut more expensive).
Gradients' risetime	0.5 ms from 0 to 20 mTor from -20 to 0 mT	0.8 ms from 0 to 20 mT/mfrom 0 to 99%	More precisecharacterization of thedata
Sequences		The sequence preliminaryindicated as GEFS hasbeen renamed into GE-STIR
Item	Artoscan S	E-SCAN	Comments
Anatomicalregions	Limbs: in particular Hip,Knee, Leg, Ankle, Foot,Hand, Wrist, Forearm,Elbow and Shoulder	Limbs: in particular Hip,Knee, Leg, Ankle, Foot,Hand, Wrist, Forearm,Elbow, Arm and Shoulder	It was possible to examinearms also before but it wasnecessary to select Otherand to introduce the Armdata. Now arm is includedin the standard and mostcommon districts to beexamined with E-scan
Installationarea	3.7 x 3.7 sq. m.	Integrated shielding: 3.7 x4 mtShielding box: 4 x 4.5 sq.m. (min height 2.4 m)	Variation due to theindustrialization of thesystem.

Comparison Chart for Substantial Equivalence

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510(k) Summary E-Scan Biosound Esaote

Comparison Chart for Substantial Equivalence Continued

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 1099

Colleen Hittle Official Correspondent Biosound Esaote, Inc. 8000 Castleway Drive Indianapolis, Indiana 46250 RE:

K990968 E-Scan Magnetic Resonance Diagnostic Device Dated: March 19, 1999 Received: March 23, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Hittle:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known):

K 99 0968

Device Name:

E-Scan

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
✓

Over-The-Counter Use

David U. Bergman

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

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.