(149 days)
The Achilles ultrasonometer 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 EXPII 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 absorptometry at the spine or hip.
GE Healthcare's Achilles EXPII Bone Sonometer measures ultrasound variables of the os calcis to provide a Stiffness Index. This index indicates the risk of osteoporotic fracture in postmenopausal women, comparable to bone mineral density (BMD) measured by X-ray absorptiometry at the spine or hip. The device's performance was compared to its predicate device, the Achilles Express.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (Achilles EXPII vs. Achilles Express) |
|---|---|
| Equivalence in Stiffness Index results | Stiffness Index results from Achilles EXPII shown to be equivalent to Achilles Express in vivo. |
| Correlation (R value) of Stiffness Index values | High correlation (R=0.97) between the two devices. |
| Significant differences in Stiffness values | No significant differences found. |
| Precision error in older women | Comparable to that of X-ray absorptiometry. |
2. Sample size used for the test set and the data provenance
The document mentions "A clinical study GE3120 was performed". However, the sample size for this clinical study and the data provenance (e.g., country of origin, retrospective or prospective nature) are not provided in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text does not mention the use of experts or the establishment of ground truth in the context of radiologists or similar qualified professionals guiding the clinical study. The study focuses on comparing the device's output (Stiffness Index) with its predicate.
4. Adjudication method for the test set
The provided text does not describe any adjudication method like 2+1 or 3+1. The study appears to be a direct comparison of measurements between two devices.
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
This is not an MRMC comparative effectiveness study in the context of human readers and AI assistance. The Achilles EXPII is a diagnostic device for measuring bone health, not an AI-assisted interpretation tool for human readers. Therefore, an effect size of human reader improvement with/without AI is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device functions as a standalone device (an ultrasonometer) that measures physical properties to calculate a Stiffness Index. Its performance, as described, is independent of human interpretation or input for the primary measurement itself, though physicians use its output in conjunction with other clinical factors. The comparison made in the study (device vs. predicate device) is a standalone performance comparison.
7. The type of ground truth used
The "ground truth" in this context is the Stiffness Index values obtained from the predicate device, the Achilles Express Ultrasonometer. The study aimed to demonstrate that the Achilles EXPII’s measurements are equivalent to those of the legally marketed predicate. The predicate device itself (Achilles Express) would have been validated against a clinical truth, likely Bone Mineral Density (BMD) as measured by X-ray absorptiometry, which is mentioned as the comparative standard for the Stiffness Index in general.
8. The sample size for the training set
The provided text does not mention a training set in the context of machine learning or AI models. The Achilles EXPII is a measurement device, not explicitly based on a machine learning model that requires a training set.
9. How the ground truth for the training set was established
As there's no mention of a training set in the provided documentation, this question is not applicable.
{0}------------------------------------------------
K103633
MAY 1 1 2011
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | December, 10th, 2010 |
| Submitter: | GE Healthcare (GE Medical Systems (China) Co., Ltd)No.19, Changjiang Road,Wuxi National Hi-Tech Development Zone, Jiangsu, China |
| Primary Contact Person: | Chris PaulikRegulatory Affairs LeaderGE HealthcarePhone: 262-548-2010Fax: 262-546-0704 |
| Secondary Contact Person: | Dave BlonskiRA DirectorGE HealthcarePhone: 262-513-4072 |
| Fax: 262-997-1160 | |
| Device: Trade Name: | Achilles |
| Common/Usual Name: | Achilles EXPII |
| Classification Names: | 21CFR892.1180, Class II |
| Product Code: | MUA |
| Predicate Device: | P970040/S001 Achilles Express Ultrasonometer |
| Device Description: | Achilles EXPII measures ultrasound variables of the os calcis toprovide a clinical measure called Stiffness Index. The StiffnessIndex indicates risk of osteoporotic fracture in postmenopausalwomen comparable to bone mineral density (BMD) as measuredby X-ray absorptiometry at the spine or hip. |
| Intended Use: | Detail descriptions are included in section 11.The Achilles ultrasonometer measures ultrasound variables of theos calcis to provide a clinical measure called Stiffness Index. TheStiffness Index indicates risk of osteoporotic fracture inpostmenopausal 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 thephysicians in the diagnosis of osteoporosis in the same way as aret-scores or obtained by x-ray absorpiometry. Either the stiffnessindex t-score or x-ray absorptiometry t-score can be utilized by a |
.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circular border. The letters and the border are black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company.
GE Healthcare 510(k) Premarket Notification Submission
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.
The Achilles EXPII employs the same fundamental scientific Technology: technology as its predicate(s).
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The Achilles EXPII Bone sonometer 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:
A clinical study GE3120 was performed to determine the precision of the Achilles EXPII Bone sonometer and the correlation of the results for the Achilles EXPII and the Achilles Express. See section 20 of this premarket submission.
Stiffness Index results obtained from the Achilles EXPII was shown to be equivalent to those obtained by the Achilles Express in vivo. Linear regression of Stiffness Index values from the two devices demonstrated high correlation (R=0.97)
Comparison of Stiffness values demonstrated no significant differences.
See section 20 of this premarket submission.
Conclusion: GE Healthcare considers the Achilles EXPII to be as safe, as effective, and performance is substantially equivalent to the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like shapes.
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
Mr. Chris Paulik Regulatory Affairs Leader GE Medical Systems China Co., Ltd. No. 19 Changhiang Road National Hi-Tech Dev. Zone Wuxi, Jiangsu 214028 CHINA
MAY 1 1 2011
Re: K103633
Trade/Device Name: Achilles EXPII Bone Sonometer Regulation Number: 21 CFR 892.1180 Regulation Name: Bone sonometer Regulatory Class: II Product Code: MUA Dated: December 10.2010 Received: March 3, 2011
Dear Mr. Paulik:
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}------------------------------------------------
Image /page/4/Picture/0 description: The image shows a black and white logo. The logo is a circle with the letters 'GE' inside. The letters are stylized and intertwined. There are some white spots around the circle.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known):
Device Name: Achilles EXPII Bone Sonometer
Indications for Use:
The Achilles ultrasonometer 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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)
Mue Spate
Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K103633
15
§ 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.