(132 days)
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.
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:
-
- A patient database
-
- Customizable reporting
-
- Operation of the Achilles unit from the PC to provide ergonomic relief to the operator
-
- 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
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.
§ 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.