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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:

• 1. A patient database
• 2. Customizable reporting
• 3. Operation of the Achilles unit from the PC to provide ergonomic relief to the operator
• 4. 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.

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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

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.

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