(136 days)
The GE Lunar Visceral Fat Software option used on GE Lunar DEXA bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in a male or female population between the age of 18 and 90 with a BMI between 18.5 and 40, excluding pregnant women. The content that is estimated is the Visceral Fat Mass and Visceral Fat Volume. The values can be displayed in user defined statistical formats and trends.
The estimated visceral fat content is useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment, can affect the relative amounts of visceral fat content in the android region. The GE Lunar Visceral Fat Body Composition Software option does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases/conditions for which visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.
The Visceral Fat Software option is part of a GE Lunar DXA bone densitometer. It uses data from a DXA total body scan to estimate the visceral adipose tissue (visceral fat), mass and volume within the android region in a male or female population between the age of 18 and 90 with a BMI between 18.5 and 40.
Here's a summary of the acceptance criteria and the study details for the GE Lunar Visceral Fat Software, based on the provided 510(k) Premarket Notification:
Acceptance Criteria and Device Performance
The provided document implies the acceptance criteria were based on demonstrating substantial equivalence to a predicate device (GE Lunar Body Composition Software option, K071570) and showing comparable performance to the accepted research standard for VAT imaging, Computed Tomography (CT), in a clinical trial. However, specific quantitative acceptance criteria (e.g., accuracy thresholds, correlation coefficients) are not explicitly stated in the provided text.
The document states: "A clinical trial was performed to compare dual-energy x-ray absorptiometry (DXA) estimated visceral fat adipose tissue (VAT) with the accepted research standard for VAT imaging, computed tomography (CT), using the Advantage Windows Tissue Volume option (K963345)."
Therefore, the reported device performance is that the "GE Lunar Visceral Fat Software... performs as well as the devices currently on the market," which is supported by the comparison to the CT standard in the clinical trial. Without explicit quantitative results from the trial in this summary, a detailed table with specific reported device performance cannot be generated.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial equivalence to predicate device (K071570) | Achieved |
| Comparable performance to CT as the research standard for VAT imaging | Achieved |
| Safe for intended use and conforms to applicable standards | Achieved |
Study Information
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text. The document only mentions "A clinical trial was performed."
- Data Provenance: Not explicitly stated in the provided text (e.g., country of origin). The study is described as a "clinical trial," implying prospective data collection, but this is not explicitly confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not explicitly stated.
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:
- Multi-reader multi-case (MRMC) comparative effectiveness study: No, this type of study was not described. The clinical trial compared the DXA estimated VAT to CT, not human readers with and without AI assistance. The device is a software option that estimates visceral fat, not an assistive AI for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Study: Yes, a standalone study was done. The clinical trial directly compared the "dual-energy x-ray absorptiometry (DXA) estimated visceral fat adipose tissue (VAT) with the accepted research standard for VAT imaging, computed tomography (CT)." This implies the algorithm's output was compared against the ground truth without human intervention in the estimation process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: The accepted research standard for VAT imaging, Computed Tomography (CT), using the Advantage Windows Tissue Volume option (K963345).
8. The sample size for the training set:
- Training Set Sample Size: Not explicitly stated in the provided text.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not explicitly stated. The document focuses on the clinical trial used for validation, not the development or training phase of the algorithm.
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.