(120 days)
The DPX Series Bravo, Duo Bone Densitometer provides an estimate of BMD at the spine, proximal femur and forearm regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.
The use of the DPX Series Bravo, Duo Bone Densitometer is restricted to prescription use only.
The DPX series Bravo, Duo Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm²) of the spine, femur and forearm. This BMD value can then be compared to a reference population at the sole discretion of the physician.
The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.
This document describes the equivalence study for the GE LUNAR DPX series Bravo, Duo Bone Densitometer.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate: LUNAR PRODIGY) | Reported Device Performance (DPX series Bravo, Duo) |
|---|---|
| In vivo BMD spine correlation with predicate: r > 0.983 | r > 0.983 (The actual reported value is ">0.983" for correlation with Prodigy, implying it met or exceeded this specific threshold) |
| In vivo average BMD values with predicate: Very similar | Very similar (Average BMD values obtained in 45 subjects in vivo were very similar with Prodigy and DPX series Bravo, Duo) |
| In vitro short-term precision (%CV): Not explicitly stated, but 0.983) and the qualitative similarity of average BMD values. Other metrics are presented as being "comparable" to currently marketed devices, which implies the acceptance criterion was roughly "within the expected range for similar devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 45 subjects
- Data Provenance: In vivo data, implying it was collected from human participants. The country of origin is not specified in the provided text, but the manufacturer (GE LUNAR Corporation) is based in Madison, WI, USA. The study design is prospective as it involves collecting data for the purpose of comparing the new device to the predicate in subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a bone densitometer, the "ground truth" for BMD is typically the measurement from a reference device (the predicate in this case) rather than expert interpretation of images.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The study directly compares numerical BMD measurements from two devices, not interpretations requiring adjudication.
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
An MRMC study was not done. This device is a bone densitometer, which provides quantitative measurements of BMD. It does not involve human readers interpreting images in a way that would typically be evaluated in an MRMC study with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this study is effectively a standalone (algorithm only) performance evaluation. The device generates a numerical BMD value without human intervention in the measurement process itself. The study evaluates the output of the new device (DPX series Bravo, Duo) against the output of the predicate device (Prodigy).
7. The Type of Ground Truth Used
The ground truth used for performance comparison is the measurements obtained from a legally marketed predicate device (LUNAR PRODIGY). In this context, the predicate device's measurements serve as the reference standard to establish substantial equivalence.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set. In the context of a 510(k) for a device like a bone densitometer, there might not be an explicit "training set" in the machine learning sense. The device's calibration and underlying algorithms would have been developed prior to this equivalence study, likely using internal data and engineering principles, but details of that development are not part of this summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as there is no explicit mention of a training set or its ground truth establishment in this summary.
§ 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.