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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 < 2.5%).
- Specific numerical thresholds for acceptable radiation exposure in comparison to the predicate device or a safety limit.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
This information is not provided in the document. The study described relies on correlation with a predicate device, not on expert adjudication of diagnostic outcomes.
4. Adjudication Method:
This information is not applicable/not provided. The study focuses on correlation and precision of quantitative measurements (BMD), not on diagnostic interpretation requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted or described. The device is for quantitative measurement (Bone Mineral Density) and is an "accessory software option" for an existing densitometer, not a diagnostic imaging interpretation tool that would typically involve human readers.
6. Standalone Performance:
Yes, a standalone performance assessment was conducted in terms of correlation with the predicate device and in-vivo precision. The device itself calculates BMD values without human intervention for the primary measurement.
7. Type of Ground Truth Used:
The "ground truth" for the device's performance relies on:
- Correlation with a predicate device (DPX series) results: The DPX series itself is the established standard for BMD measurement that has already received 510(k) clearance.
- In-vivo precision measurements: This establishes the repeatability of the device's own measurements.
8. Sample Size for the Training Set:
The document does not provide information on the sample size used for any potential training set. Given that this is an "accessory software option" for an established densitometer (EXPERT-XL), the machine learning or algorithm training aspects are not detailed. It's more likely that the software implements established densitometry algorithms rather than being a de novo AI model requiring extensive training data in the modern sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. If there was algorithm training involved, the document does not describe its methodology or how ground truth was established for that purpose.
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NOV - 8 1996
Image /page/0/Picture/1 description: The image shows the word "LUNAR" in a bold, sans-serif font. The letters are large and closely spaced, creating a solid block of text. The word is in black against a white background, providing a high contrast that makes it easily readable.
MADISON, WI 53713
(608) 274-2663
10.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
313 W. BELTLINE HIGHWAY
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
| Contact Person: | Kenneth D. BurokerLUNAR Corporation313 West Beltline HighwayMadison, WI 53713 |
|---|---|
| Phone: | (608) 288-6460 |
| Fax: | (608)-274-0853 |
| Date: | October 23, 1996 |
| Device/Trade Name: | EXPERT-XL Forearm and Hand Acquisition and AnalysisSoftware |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer21CFR 892.1170 |
| Predicate Device: | K915535 Forearm Software for Lunar DPX SeriesK953032 Hand Software for Lunar DPX Series |
10.1 DESCRIPTION OF THE DEVICE:
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.
10.2 SUMMARY OF TECHNICAL CHARACTERISTICS
Scans of the forearm or hand region take about 10 seconds. The EXPERT-XL Forearm and Hand software results correlate highly (r = 0.96) with the corresponding regions measured on the DPX series, which already has 510(k) clearance. Also, the average short term precision (CV) in vivo is 2% or under for all sites, which is comparable to that shown on DPX series densitometers. The radiation exposure of 12 mrem is higher than that for DPX series densitometers but remains low compared to the maximum permissible dose to the extremities.
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10.3 CONCLUSION
The BMD results for the EXPERT-XL forearm/hand software option are comparable to the DPX results and have similar precision. No new safety and effectiveness questions are raised with the EXPERT-XL forearm and hand software accessory.
Signed
Kenneth D. Buroker Printed Name ....
Director, Regulatory Affairs Title
§ 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.