(85 days)
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The PIXI Bone provides an estimation of Bone Mineral Density (BMD in g/cm2) for the regions of the forearm and heel (os calcis).
The provided text is a 510(k) summary for the LUNAR PIXI Bone Densitometer. It discusses the device's technical characteristics and claims comparability to predicate devices. However, it does not include a study that defines explicit acceptance criteria and then presents results showing the device meets those criteria.
Instead, the document focuses on demonstrating that the PIXI device's performance metrics (BMD estimation correlation, in vitro precision, and in vivo precision) are "comparable" to previously cleared devices. It does not set a specific threshold or target value that the PIXI must meet to be considered acceptable.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about the study proving it meets acceptance criteria, because such information is not present in the provided text.
Here's what can be extracted based on the information given, highlighting the missing elements:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated as Criteria) | Reported Device Performance |
|---|---|
| BMD Estimation Correlation | r = 0.998 (with actual density of calcium hydroxyapatite pellets) |
| Average Short Term Precision (%CV) In Vitro | 0.68 % |
| Average Short Term Precision (%CV) In Vivo (Forearm) | 1.5 % |
| Average Short Term Precision (%CV) In Vivo (Os Calcis) | 1.97 % |
| Radiation Exposure | 20 mrem (higher than predicate, but low compared to max permissible for extremities) |
Missing Information:
- Explicit, quantitative acceptance criteria (e.g., "BMD correlation must be > 0.99", "In vivo precision must be
§ 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.