(47 days)
The ORCA-DX® Bone Densitometer provides an estimate of BMD for the heel and forearm.
The ORCA-DX® Bone Densitometer requires a 4-second exposure for BMD with a skin entrance dose of <10 mrem. This instrument is comparable to the Lunar PIXI densitometer. The ORCA-DX® Bone Densitometer poses no new safety or efficacy concerns.
The use of the ORCA-DX® Bone Densitometer is restricted to prescription use only. The operator's manual for the system contains the following statement:
"Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
The ORCA-DX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) for the heel and forearm, using dual-energy x-ray absorptiometry.
Here's a breakdown of the acceptance criteria and study information for the LUNAR ORCA-DX Bone Densitometer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety: Total exposure dose (lower than predicate and safe) | Radiation exposure is <10 mrem, which is "lower than that for the predicate device" and "low compared to the maximum permissible dose for extremities." |
| Effectiveness: Correlation with predicate device results | BMD estimations correlate ~0.95 with results obtained on the predicate device (LUNAR PIXI). |
| Effectiveness: Short-term BMD precision (in vivo) | Short-term BMD precision (%CV) in vivo is <1.5%, described as "comparable to previously registered devices." |
| General Safety & Effectiveness (Implicit): Comparability | The device is stated to be "comparable to previously registered devices that demonstrate similar precision" and "No new safety and effectiveness questions are raised." The FDA's substantial equivalence determination implies that the device is as safe and effective as the predicate. |
| Exposure Time: | Requires a 4-second exposure. This is not explicitly an acceptance criterion but a technical characteristic that contributes to the safety profile (lower dose due to shorter exposure) and efficiency of the device, making it implicitly favorable. |
| Regulatory Compliance (Implicit): Prescription Use Only | "Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician." This indicates compliance with regulatory requirements for prescription devices, which is an implicit acceptance criterion for market clearance. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The information provided is a summary of technical characteristics and a statement of comparability, rather than a detailed study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth for any test set. The study focuses on correlation and precision compared to a predicate device, not on expert-adjudicated ground truth.
4. Adjudication method
The document does not mention any adjudication method for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that an MRMC comparative effectiveness study was conducted, nor is there any mention of AI assistance in this document. The device is a bone densitometer, an imaging hardware device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone algorithm performance. The device itself is a standalone system for measuring BMD, and its performance is assessed against a predicate device's output. There isn't an "algorithm only" component in the context of typical AI/software device studies.
7. The type of ground truth used
The "ground truth" in this context is established by the predicate device (LUNAR PIXI). The study assesses the ORCA-DX's ability to produce highly correlated and precise BMD estimations relative to the predicate device, implying the predicate's output serves as the reference standard for this substantial equivalence submission. It is not based on expert consensus, pathology, or outcomes data in the traditional sense for a diagnostic algorithm.
8. The sample size for the training set
The document does not specify any training set size. This device is not described as involving machine learning or AI that would require a distinct training set. The performance is assessed based on direct comparison to the predicate and precision measurements.
9. How the ground truth for the training set was established
As there's no mention of a training set in the context of an AI/ML algorithm, there's no information on how ground truth for a training set was established. The "ground truth" for the performance evaluation itself is the predicate device's measurements.
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Image /page/0/Picture/1 description: The image shows the text "DEC 8 1998" at the top and the word "LUNAR" in large, bold, black letters below it. The text "DEC 8 1998" is smaller and less prominent than the word "LUNAR". The overall impression is that the image is a logo or heading for something related to the word "LUNAR".
MADISON, WI 53713 313 W. BELTLINE HIGHWAY
(608) 274-2663
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 10.0
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
| Contact Person: | Kenneth D. Buroker |
|---|---|
| LUNAR Corporation | |
| 313 West Beltline Highway | |
| Madison, WI 53713 | |
| Phone: | (608) 288-6460 |
| Fax: | (608) 274-0853 |
| Date: | October 21, 1998 |
| Device/Trade Name: | ORCA-DX Bone Densitometer |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer |
| 21CFR 892.1170 | |
| Predicate Device: | LUNAR PIXI |
| 510(k) K970224 |
10.1 DESCRIPTION OF THE DEVICE
The ORCA-DX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) for the heel and forearm, using dual-energy x-ray absorptiometry.
SUMMARY OF TECHNICAL CHARACTERISTICS 10.2
The ORCA-DX® Bone Densitometer requires a 4-second exposure, with a total exposure dose of <10 mrem. The radiation exposure of <10 mrem is lower than that for the predicate device and is low compared to the maximum permissible dose for extremities. The BMD estimations correlate ~0.95 with results obtained on the predicate device. The short-term BMD precision (%CV) in vivo is <1.5% and is comparable to previously registered devices.
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Summary of Safety and Effectiveness Page 2 of 2
10.3 CONCLUSION
The results from the ORCA-DX Bone Densitometer are comparable to previously registered devices that demonstrate similar precision. No new safety and effectiveness questions are raised with the ORCA-DX Bone Densitometer.
Signature
Kenneth D. Buroker
Printed Name
Director, Regulatory Affairs
Title
10/21/98
Date
Date
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of a human figure.
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1098 8 DEC
Kenneth D. Buroker Director, Regulatory Affairs Lunar Corporation 313 West Beltline Highway Madison, WI 53713
K983724 ORCA-DX Bone Densitometer Dated: October 21, 1998 Received: October 22, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI
Dear Mr. Buroker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrfvdsmardsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE FORM 3.0
Page 1 of 1
- 510(k) Number (if known) __ .
- Device Name: ORCA-DX® Bone Densitometer .
- Indications for use: .
The ORCA-DX® Bone Densitometer provides an estimate of BMD for the heel and forearm.
The ORCA-DX® Bone Densitometer requires a 4-second exposure for BMD with a skin entrance dose of <10 mrem. This instrument is comparable to the Lunar PIXI densitometer. The ORCA-DX® Bone Densitometer poses no new safety or efficacy concerns.
The use of the ORCA-DX® Bone Densitometer is restricted to prescription use only. The operator's manual for the system contains the following statement:
"Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
Vinnit li. Sezmm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
§ 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.