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510(k) Data Aggregation
(116 days)
Single Energy (SE) Femur Exams are used to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Clinical correlation is advised as these features may be consistent with atypical femur fractures, a complication associated with long term use of antiresorptive therapy.
The proposed Hologic ® Single Energy (SE) Femur scan allows for the visualization of bone deformities of the femur, specifically focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Hologic's Discovery (K023398) bone densitometer models: Discovery A, C, W, and SL consist of an examination table and a C-arm. At opposite ends of the C-arm an x-ray tube and a linear multi-detector array are mounted. The patient is positioned on the examination table between the x-ray tube and the detector array. The detector and x-ray source scan the patient axially using an x-ray fan beam perpendicular to the direction of movement. The xray source can be pulsed at a constant voltage to acquire exams as in the case of Hologic's Instant Vertebral Assessment (IVA) exams reviewed and cleared by FDA (K060111). Currently, two types of IVA scans are in use on the Discovery A, C, W, and SL bone densitometers; the IVA and the IVA-HD (High Definition). Both scans are used for the visualization of vertebral bone deformities. The IVA scan has a 10 second scan time, whereas the IVA-HD has a 15 second scan time. IVA-HD scans use a thinner aperture resulting in higher resolution and a lower total dose than IVA scans. The high resolution image of the single energy IVA-HD scan makes it ideal for use as a scan to visualize deformities in the femur.
The provided text does not contain detailed information about specific acceptance criteria and a study demonstrating the device meets those criteria. Instead, it focuses on establishing substantial equivalence to a predicate device.
However, based on the context, we can infer the implicit acceptance criteria and how the study "proves" the device meets them through that substantial equivalence.
Here's an attempt to structure the information based on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Implied from Substantial Equivalence) |
|---|---|
| Technological Characteristics: Must be substantially equivalent to the predicate device in: | |
| - Method of Deformity Assessment | Visual (Same as predicate) |
| - Fundamental Device Technology | DXA Bone Densitometer (Same as predicate) |
| - Imaging Scan | IVA-HD (Same as predicate) |
| - Image Acquisition Mode | Single Energy Fan Beam Scan (Same as predicate) |
| - Acquisition Speed for 15.7" Scan | 15 seconds (Same as predicate) |
| - X-ray Technique Factors | 140 kVp @ 5 ma (Same as predicate) |
| - Vertical Resolution | 1.4 lp/mm (Same as predicate) |
| - X-ray Aperture | 0.25 mm (W) x 61 mm (L) (Same as predicate) |
| - Entry Dose | 0.025 mGy (Same as predicate) |
| - Image Display | On-screen display with image tools (Same as predicate) |
| Safety and Effectiveness: No new safety and effectiveness questions raised. | Risk assessment performed, concluded no new safety/effectiveness questions were raised by expanding the intended use of the identical IVA-HD scan to the femur. |
| Intended Use: Consistent with the visualization of bone deformities. | Visualization of focal reaction or thickening along the lateral cortex of the femoral shaft, consistent with the predicate's use for visualizing bone deformities (of the spine). |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The information provided in the 510(k) submission is acceptable for the demonstration of substantial equivalence to the predicate device with respect to physical performance and testing".
- Test Set Sample Size: Not explicitly stated. The submission relies on the established performance of the identical IVA-HD scan used in the predicate device (K060111). No new clinical data or specific test set for the SE Femur Exam is detailed.
- Data Provenance: Not explicitly stated for a new test set. The submission focuses on the technological equivalence to an existing, cleared device (IVA-HD). Therefore, the "data" effectively comes from the prior clearance of the IVA-HD technology, which was already deemed safe and effective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission does not describe a new clinical study involving expert interpretation of a test set to establish ground truth for this specific device. The justification is based on technical equivalence to an already cleared device.
4. Adjudication Method for the Test Set
Not applicable. As no new clinical test set with expert ground truth establishment is described, an adjudication method is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The submission focuses on technological equivalence rather than comparative effectiveness with human readers.
6. Standalone Performance Study
No, a standalone (algorithm only without human-in-the-loop performance) study is not described for the SE Femur Exam. The device is a software option that produces images for visual assessment by a clinician. Its "standalone performance" is implicitly tied to the image quality and characteristics, which are asserted to be identical to the IVA-HD scan already cleared.
7. Type of Ground Truth Used
Not applicable for a new study. The "ground truth" for the device's capability to visualize bone deformities is based on the prior clearance and established performance of the IVA-HD technology, which this device uses. The device's function is to visualize features, not to provide an automated diagnosis requiring an independent ground truth for accuracy metrics.
8. Sample Size for the Training Set
Not applicable. This device is a software option that uses an existing imaging technology (IVA-HD scan) on an existing bone densitometer. It does not describe a new AI algorithm that undergoes a training phase with a specific dataset. The software itself is largely the same as the predicate's IVA-HD acquisition software; only the intended anatomical region for imaging has changed.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specific "training set" for a new AI algorithm described in this submission.
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