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510(k) Data Aggregation
(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
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