(176 days)
The APEX for QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR® X-Ray Bone Densitometers.
IVA scans are intended for the visualization or quantitative assessment of vertebral body deformities. IVA also allows the visualization of abdominal aortic calcifications and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.
Software option for Bone Densitometers
The provided text is a 510(k) summary for the APEX 2.0 Software for QDR X-Ray Bone Densitometers. It explicitly states that no new safety or efficacy questions are raised with the APEX 2.0 Software and that it is substantially equivalent to a predicate device (Discovery Package for Hologic QDR X-Ray Bone Densitometers - K023398).
This type of submission for a substantially equivalent device often relies on demonstrating that the new device meets the same performance characteristics as the predicate device or that any differences do not raise new questions of safety or effectiveness. As such, the text does not include detailed acceptance criteria and a study report proving the device meets specific performance metrics in the way a novel device might. Instead, the "proof" is the claim of substantial equivalence.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, details on ground truth for test and training sets) are not present in this 510(k) summary because the focus is on equivalence rather than de novo performance demonstration.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of acceptance criteria or performance metrics for the APEX 2.0 Software itself. Its "performance" is considered equivalent to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
Not provided. The submission focuses on substantial equivalence to a predicate device, not on a new clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not provided.
4. Adjudication Method:
Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
Not provided. The submission does not mention an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not explicitly stated. Given it's software for bone densitometers that produces measurements, standalone performance is implied in the context of its function, but a specific standalone performance study report with metrics is not included in this summary.
7. The Type of Ground Truth Used:
Not explicitly stated for the APEX 2.0 software's validation. For bone densitometers in general, ground truth for BMD measurements is typically established through phantom scans, comparison to quantitative CT, or long-term clinical outcomes (though the latter is less common for device ground truth). Since this is a software update for an existing device, it's likely the ground truth methodology for the predicate device's core functions would apply.
8. The Sample Size for the Training Set:
Not provided.
9. How the Ground Truth for the Training Set Was Established:
Not provided.
Summary of what is present:
- Acceptance Criteria/Performance Goal: Substantial Equivalence to the predicate device (Discovery Package for Hologic QDR X-Ray Bone Densitometers, K023398). The document states, "No new safety or efficacy questions are raised with the APEX 2.0 Software."
- Study Proving Acceptance Criteria: The submission itself, by demonstrating that the device is substantially equivalent to the predicate (K023398), serves as the "study" in this context. It implies that the new software does not alter the fundamental safety or effectiveness characteristics of the bone densitometer.
- Device Performance: The device performs its intended functions (estimation of BMD, comparison to reference values, fracture risk estimation, vertebral deformity assessment, body composition analysis, discrimination of bone from prosthetics, and visualization/quantitative assessment of vertebral body deformities and abdominal aortic calcifications) in a manner equivalent to the predicate.
§ 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.