K Number

Device Name

Manufacturer

GE MEDICAL SYSTEMS CHINA CO., LTD.

Date Cleared

2013-02-25

(132 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Achilles OsteoReportN is software used with the Achilles family of ultrasonometers to provide a patient database, customized reporting, and communication with Health Information Systems. Achilles OsteoReportN together with the Achilles ultrasonometers measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index.

The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorptiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician. in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

Device Description

Achilles OsteoReportN is a software program running on PC to enter patient information, remote control and retrieve measurement results of GE ultrasonometer to help physicians to analysis the osteoporotic fracture risk and communicate with hospital information system.

Achilles ultrasonometers measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index.

The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorpiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorpiometry, which makes it suitable for monitoring bone changes.

Achilles OsteoReportN is a windows based application running on PC and will provide the following capabilities for Achilles series device:

1. A patient database
1. Customizable reporting
1. Operation of the Achilles unit from the PC to provide ergonomic relief to the operator
1. Communication to the hospital/clinic information system

The objectives of this program including:

Support Windows 7 (64 bit)/Windows XP(32bit) . operating system
. Support merging the database with older version of Achilles product with the database used with the newer Achilles ultrasonometers, which is stored on the device.
. Support remote control of EXPII's measurement and retrieve measurement results
Support customized report printing .
. Support DICOM

AI/ML Overview

The provided text describes a 510(k) premarket notification submission for the "Achilles OsteoReportN" software. This software is intended to be used with Achilles ultrasonometers to provide a patient database, customized reporting, and communication with Health Information Systems, ultimately assisting in the diagnosis of osteoporosis.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

The submission documentation does not explicitly state specific quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the device's performance in diagnosing osteoporosis. Instead, it focuses on the device's functional equivalence and technical characteristics relative to its predicate device.

The reported device performance emphasizes that:

"The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip."
"Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry."
"The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes."
"Achilles OsteoReportN employs the same fundamental scientific technology as its predicate devices."

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

The document explicitly states: "The subject of this premarket submission, Achilles OsteoReportN, did not require clinical studies to support substantial equivalence."

This indicates that there was no specific test set or clinical study conducted for this particular 510(k) submission. The device's substantial equivalence was based on its functional and technological similarity to a predicate device, Achilles EXP II.

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)

Since no clinical studies were conducted for this submission, there were no experts specifically utilized to establish ground truth for a test set related to Achilles OsteoReportN.

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

Not applicable, as no clinical studies were conducted.

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. The device is a software program designed to assist in analysis and reporting, not explicitly an "AI" for image interpretation, and no MRMC studies are mentioned.

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

Not applicable, as no clinical studies were conducted. The software itself is an analytical and reporting tool that operates "with the Achilles family of ultrasonometers."

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

For this specific submission, the "ground truth" for proving substantial equivalence was primarily the established performance and indications for use of the predicate device (Achilles EXP II), rather than a new clinical ground truth established for the Achilles OsteoReportN. The underlying scientific principle (Stiffness Index from os calcis ultrasound) had previously been shown to be comparable to BMD from X-ray absorptiometry.

8. The sample size for the training set

The document does not mention any training sets or machine learning model development for the Achilles OsteoReportN software itself. Its development focused on functionalities like database management, customizable reporting, remote control, and DICOM support, rather than learning from a dataset.

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

Not applicable, as no training set is mentioned in the provided text for the Achilles OsteoReportN software.

Summary of Device Acceptance and Study Detail:

The acceptance of Achilles OsteoReportN was based on a demonstration of substantial equivalence to a predicate device (Achilles EXP II), rather than new clinical performance trials for the software itself. The submission highlighted the software's functional capabilities (patient database, reporting, communication) and its reliance on the same fundamental scientific technology as the predicate device for generating the Stiffness Index measurements.

The submission specifically states: "The subject of this premarket submission, Achilles OsteoReportN, did not require clinical studies to support substantial equivalence."

Instead, the following quality assurance measures were applied to the development of the system:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Performance testing (Verification)
Safety testing (Verification)
Simulated use testing (Validation)

The provided information focuses on the software's functionality, compatibility, and its intended use in conjunction with existing Achilles ultrasonometers, assuming the clinical efficacy of the Stiffness Index measurements themselves, which were presumably established and accepted for the predicate devices.

Summary

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K 123238

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are decorative swirls or flourishes around the outer edge of the circle, giving it a vintage or classic appearance.

FEB 2 5 2013

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: October 12, 2012 Date: Submitter: GE Healthcare, (GE Medical Systems (China) Co., Ltd) No.19, Changjiang Road, Wuxi National Hi-Tech Development Zone, Jiangsu, China Primary Contact Person: Liu Zhao Regulatory Affairs Leader GE Healthcare, (GE Medical Systems (China) Co., Ltd) (+86 510) 85278028 (+86 510) 85226891 Trishia Dwyer Secondary Contact Person: Regulatory Affairs Leader GE Healthcare Telephone: (608) 221-1551 x 500-3074 Fax: (608) 646-6488 Trade Name: Achilles Device: Common/Usual Name: Achilles OsteoReportN Classification Names: 21CFR892.1180, Class II Product Code: MUA Regulation Description: A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal. Secondary Product Code: LLZ Secondary Regulation A picture archiving and communications system is a device that Description: provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide

functions for performing operations related to image

manipulation, enhancement, compression or quantification.

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular shape. There are decorative swirls or flourishes around the letters, adding to the logo's distinctive appearance. The logo is black and white.

GE Healthcare 510(k) Premarket Notification Submission

Predicate Device(s): Achilles EXP II

Device Description:

Achilles ultrasonometers measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index.

The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

Achilles OsteoReportN is a windows based application running on PC and will provide the following capabilities for Achilles series device:

1. A patient database
1. Customizable reporting
1. Operation of the Achilles unit from the PC to provide ergonomic relief to the operator
1. Communication to the hospital/clinic information system

The objectives of this program including:

Support Windows 7 (64 bit)/Windows XP(32bit) . operating system
. Support merging the database with older version of Achilles product with the database used with the newer Achilles ultrasonometers, which is stored on the device.
. Support remote control of EXPII's measurement and retrieve measurement results
Support customized report printing .
. Support DICOM

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, contrasting with the white background.

GE Healthcare 510(k) Premarket Notification Submission

This software does not change the intended use of Achilles series device.

Achilles OsteoReportN is PC-based software used with the Intended Use: Achilles family of ultrasonometers to provide a patient database, customized reporting, and communication with Health Information Systems. Achilles OsteoReportN together with the Achilles ultrasonometers measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index.

The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip. Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

Technology:

Achilles OsteoReportN employs the same fundamental scientific technology as its predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for GE Healthcare. The text is in a simple, sans-serif font. The words "GE" and "Healthcare" are next to each other.

510(k) Premarket Notification Submission

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The Achilles OsteoReportN and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analysis .
Requirements Reviews .
Design Reviews ●
Testing on unit level (Module verification) .
Integration testing (System verification) .
Performance testing (Verification) .
Safety testing (Verification) .
Simulated use testing (Validation) .

Summary of Clinical Tests:

The subject of this premarket submission, Achilles OsteoReportN, did not require clinical studies to support substantial equivalence.

Conclusion:

GE Healthcare considers the Achilles OsteoReportN to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

Image /page/3/Picture/17 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and connected, and the circle has a decorative, swirling pattern around its edge.

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in bold and is in all caps. The text is likely the header of a document or website.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 25, 2013

GE Medical Systems China Co., Ltd. c/o Mr. Liu Zhao Regulatory Affairs Leader · No 19 Changjang Road, National Hi-Tech Dev. Zone Wuxi, Jiangsu, 214028 CHINA

Re: K123238

Trade/Device Name: Achilles OsteoReportN Regulation Number: 21 CFR 892.1180 Regulation Name: Bone sonometer Regulatory Class: Class II Product Code: MUA, LLZ Dated: January 11, 2013 Received: January 16, 2013

Dear Mr. Zhao:

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 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

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Page 2 - Mr. Liu Zhao

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.

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 Diagnostics and Radiological Health 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/ReportalProblem/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,

Smh

for

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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510(k) Number (if known): K 123238 Device Name: Achilles OsteoReportN

Indications for Use

The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

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

Over-The-Counter Use (Part 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)

Santo Josef J.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K123238

Page 1 of 1

Regulation Number and Section

§ 892.1180 Bone sonometer.

(a)
Identification. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document.