(13 days)
The EXPERT-XL Hand and/or Forearm Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density BMD (in g/cm3) of the forearm and/or hand region provided for by the EXPERT-XL Bone Densitometer.
The EXPERT-XL Hand and/or Forearm Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density BMD (in g/cm3) of the forearm and/or hand region provided for by the EXPERT-XL Bone Densitometer.
The provided text does not contain detailed information about acceptance criteria, a comprehensive study design, or specific performance metrics as typically expected for medical device evaluations. The document is a 510(k) summary, which provides a high-level overview for regulatory clearance.
Based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with predicate device (DPX series) for BMD results | Correlates highly (r = 0.96) with corresponding regions measured on DPX series. |
| In-vivo short-term precision (CV) for all sites | 2% or under |
| Radiation exposure | 12 mrem |
| Comparability to predicate device's precision | Comparable to that shown on DPX series densitometers. |
| Comparability to predicate device's BMD results | Comparable to the DPX results. |
Missing Information:
- Specific numerical thresholds for "highly correlated" (e.g., r > 0.95).
- Specific numerical thresholds for acceptable precision (e.g., CV
§ 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.