SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the k-space, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

Device Description

SpeedUp is a software option intended for use on G-scan and O-scan Esaote MRI svstems. SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the kspace, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "SpeedUp," which is a software option for MRI systems designed to increase scan speed. It states that the device is "substantially equivalent" to predicate devices, but it does not contain specific acceptance criteria or details of a study with performance metrics in a format that would allow for the direct creation of the requested table and detailed study information.

Here's a breakdown of what is and is not available in the provided text, and how it relates to your request:

1. Table of acceptance criteria and reported device performance:

Not Available. The document states that "non-clinical verification and validation testing" and "clinical images... demonstrated that the systems met performance requirements and are as safe and effective as the predicate devices." However, it does not provide any specific quantitative (e.g., sensitivity, specificity, accuracy, dice score) or qualitative performance metrics, nor does it define what those "performance requirements" actually were.

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

Not Available. The document mentions "clinical images" were used, but does not specify the number of cases or patients included in any test set, nor does it provide information about the country of origin or whether the 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:

Not Available. The document does not describe how ground truth was established, nor does it mention the number or qualifications of any experts involved in such a process.

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

Not Available. There is no mention of any adjudication method.

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 Available. The document does not mention an MRMC study or any AI component. SpeedUp is described as an "imaging technique" and "software option" for MRI to reduce acquisition time through k-space undersampling and non-linear reconstruction, which is a signal processing technique, not necessarily an AI algorithm in the contemporary sense. It focuses on the image acquisition and reconstruction quality compared to standard methods, not on human interpretation improvement with or without AI assistance.

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

Partially Available (Implied Standalone). SpeedUp is described as a "software option" that "reconstructs" images. The statement "Clinical images... demonstrated that the systems met performance requirements" implies a standalone assessment of the generated images, likely for image quality and diagnostic utility, but specific standalone performance metrics (e.g., SNR, contrast, resolution) are not provided. The function itself is image reconstruction, which is inherently "algorithm only" in its output.

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

Not Available. The document refers to "clinical images" and meeting "performance requirements" but does not specify the ground truth used to evaluate these images or the output of the SpeedUp software.

8. The sample size for the training set:

Not Applicable/Not Available. Given that SpeedUp is described as exploiting "sparsity" and using a "non-linear reconstruction method" rather than a deep learning AI model requiring a training set in the modern sense, a "training set" as typically understood for AI algorithms may not be relevant. Even if there were parameters optimized, the document does not mention any specific training data or its size.

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

Not Applicable/Not Available. (See point 8).

In summary, the provided 510(k) summary for SpeedUp attests to substantial equivalence based on meeting performance requirements through non-clinical and clinical testing, but it does not disclose the specific criteria, study designs, sample sizes, expert involvement, or quantitative results that would fulfill your request for detailed acceptance criteria and study proving device performance. The document is high-level and focused on regulatory compliance through substantial equivalence, not detailed technical performance disclosure.

Summary

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Esaote, S.p.A. 510(k) Summary SpeedUp

MAY - 1 2012

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K120 748

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.928(a).

Submitter Information

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

Contact Person:

Allison Scott, RAC Phone: (317) 569-9500 x 106 Facsimile:(317) 569-9520 ascott@ansongroup.com

Date:

March 9, 2012

Trade Name: SpeedUp

Common Name:

System, Nuclear Magnetic Resonance Imaging

Classification Name(s): Magnetic resonance diagnostic device

Classification Number: 90LNH

Predicate Device(s)

Tradename	Common name	Class	Product code	Manufacturer	K number
G-scan	System, nuclear magneticresonance imaging	II	LNH	ESAOTE S.P.A.	K111803
S-scan	System, nuclear magneticresonance imaging	II	LNH	ESAOTE S.P.A.	K080968
O-scan	System, nuclear magneticresonance imaging	II	LNH	ESAOTE S.P.A.	K092469
Achieva	System, nuclear magneticresonance imaging	II	LNH	PHILIPS	K043147

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Esaote, S.p.A. 510(k) Summary SpeedUp

Device Description

SpeedUp is a software option intended for use on G-scan and O-scan Esaote MRI svstems.

SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the kspace, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

Intended Use(s)

SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the kspace, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

Technological Characteristics

The technological characteristics of the G-scan, S-scan systems with the addition of the SpeedUp software option, reflected in this Traditional 510(k), are substantially equivalent to those of the predicate devices.

Non-Clinical Summary

Non-clinical verification and validation testing of the G-scan and O-scan systems. with the addition of the SpeedUp software option, was conducted according to design controls per CFR820.30. Testing demonstrated that the systems met performance requirements and are as safe and effective as the predicate devices.

Clinical Summary

Clinical images of the G-scan and O-scan systems with the addition of the SpeedUp software option demonstrated that the systems met performance requirements and are as safe and effective as the predicate devices.

Conclusion

The G-scan. S-scan and O-scan systems with the addition of the Speed Up software are safe and effective, and perform substantially equivalent to the legally marketed devices.

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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 eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

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

Re: K120748

Trade/Device Name: SpeedUp Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 8, 2012 Received: March 12, 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

MAY - 1 2012

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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 Form

510(k) Number (if known):

Device Name: SpeedUp

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

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

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

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

Andrew D. Ohm

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120748

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.