(87 days)
The Apollo can be used whenever it is desirable to do a bone assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.
Apollo™ is a low cost, portable, easy-to-use bone densitometer which uses low dose x-ray technology to asses the bone density of the heel. Because Apollo 1 uses the DXA technique, a water bath is not required.
Here's an analysis of the provided text regarding the Norland Apollo™ Bone Densitometer, outlining the acceptance criteria and study information:
Norland Apollo™ Bone Densitometer Performance Analysis
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on comparing the Apollo™ to predicate devices rather than explicit, pre-defined acceptance criteria with quantifiable targets. However, based on the comparative table and descriptive text, we can infer the performance metrics considered important and the device's reported capabilities. This resembles how substantial equivalence is often demonstrated with respect to performance relative to established devices.
| Item | Acceptance Criteria (Inferred/Predicate) | Reported Apollo™ Performance |
|---|---|---|
| Precision (CV) | High Speed: ≤ 1.8% (pDEXA) | High Speed: 1.8% |
| High Precision: ≤ 1.4% (pDEXA) | High Precision: 1.2% | |
| Scan Time | High Speed: |
§ 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.