The DPX Series Bravo, Duo Bone Densitometer provides an estimate of BMD at the spine, proximal femur and forearm regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.

The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.

The use of the DPX Series Bravo, Duo Bone Densitometer is restricted to prescription use only.

Device Description

The DPX series Bravo, Duo Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm²) of the spine, femur and forearm. This BMD value can then be compared to a reference population at the sole discretion of the physician.

The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.

AI/ML Overview

This document describes the equivalence study for the GE LUNAR DPX series Bravo, Duo Bone Densitometer.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Predicate: LUNAR PRODIGY)	Reported Device Performance (DPX series Bravo, Duo)
In vivo BMD spine correlation with predicate: r > 0.983	r > 0.983 (The actual reported value is ">0.983" for correlation with Prodigy, implying it met or exceeded this specific threshold)
In vivo average BMD values with predicate: Very similar	Very similar (Average BMD values obtained in 45 subjects in vivo were very similar with Prodigy and DPX series Bravo, Duo)
In vitro short-term precision (%CV): Not explicitly stated, but <0.27% is presented for the new device and compared to "currently marketed devices"	< 0.27%
In vivo short-term precision (%CV) for spine: Comparable to currently marketed devices (e.g., Prodigy and DPX-L)	Approximately 1.2%
In vivo short-term precision (%CV) for total proximal femur: Comparable to currently marketed devices (e.g., Prodigy and DPX-L)	Approximately 0.80%
In vivo short-term precision (%CV) for forearm sub regions BMD: Comparable to currently marketed devices (e.g., Prodigy and DPX-L)	Approximately 1.7%
Radiation exposure: Comparable to predicate devices (Prodigy and DPX-L)	2.0 mrem per measurement (reported as comparable to predicate)

Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than strict pre-defined numerical acceptance criteria for all metrics. The primary criterion that is explicitly quantified and met is the correlation coefficient (r > 0.983) and the qualitative similarity of average BMD values. Other metrics are presented as being "comparable" to currently marketed devices, which implies the acceptance criterion was roughly "within the expected range for similar devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 45 subjects
Data Provenance: In vivo data, implying it was collected from human participants. The country of origin is not specified in the provided text, but the manufacturer (GE LUNAR Corporation) is based in Madison, WI, USA. The study design is prospective as it involves collecting data for the purpose of comparing the new device to the predicate in subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For a bone densitometer, the "ground truth" for BMD is typically the measurement from a reference device (the predicate in this case) rather than expert interpretation of images.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The study directly compares numerical BMD measurements from two devices, not interpretations requiring adjudication.

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

An MRMC study was not done. This device is a bone densitometer, which provides quantitative measurements of BMD. It does not involve human readers interpreting images in a way that would typically be evaluated in an MRMC study with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, this study is effectively a standalone (algorithm only) performance evaluation. The device generates a numerical BMD value without human intervention in the measurement process itself. The study evaluates the output of the new device (DPX series Bravo, Duo) against the output of the predicate device (Prodigy).

7. The Type of Ground Truth Used

The ground truth used for performance comparison is the measurements obtained from a legally marketed predicate device (LUNAR PRODIGY). In this context, the predicate device's measurements serve as the reference standard to establish substantial equivalence.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set. In the context of a 510(k) for a device like a bone densitometer, there might not be an explicit "training set" in the machine learning sense. The device's calibration and underlying algorithms would have been developed prior to this equivalence study, likely using internal data and engineering principles, but details of that development are not part of this summary.

9. How the Ground Truth for the Training Set Was Established

This information is not provided as there is no explicit mention of a training set or its ground truth establishment in this summary.

Summary

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JUL 2 5 2003

GE Medical Systems : (7:14:10)

der and des Mems 1507

11.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).

Contact Person:	James P. RaskobGE LUNAR Corporation726 Heartland TrailMadison, WI 53717
Phone:	(608) 826-7425
Fax:	(608) 826-7825
Date:	March 25, 2003
Device/Trade Name:	DPX Series Bravo, Duo Bone Densitometer
Common Name:	Bone Densitometer
Classification Name:	Bone Densitometer21CFR 892.1170
Predicate Device:	LUNAR PRODIGY510(k) K982267LUNAR DPX-Alpha and DPX-L510(k) K904980

DESCRIPTION OF THE DEVICE: 11.1

The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.

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SUMMARY OF TECHNICAL CHARACTERISTICS 11.2

The DPX series Bravo. Duo Bone Densitometer performs a 90 second scan, with a total skin exposure dose of 2.0 mrem per measurement. The radiation exposure of 2.0 mrem is comparable to the predicate Prodigy and DPX-L bone densitometers.

The BMD spine estimations in vivo provided by the DPX series Bravo, Duo correlate r>0.983 with the Prodigy. The average BMD values obtained in 45 subjects in vivo were very similar with Prodigy and DPX series Bravo, Duo. The average short-term precision (%CV) in vitro was <0.27%. The short-term %CV in vivo was approximately 1.2% for spine, 0.80% for total proximal femur and 1.7% for forearm sub regions BMD. These values are comparable to those shown on currently marketed devices.

11.3 CONCLUSION

The DPX series Bravo, Duo Bone densitometer is substantially equivalent to currently marketed devices. No new safety and effectiveness questions are raised with the DPX series Bravo, Duo Bone Densitometer.

James P. Rashol
__ and the word "Signed"

James P. Raskob Name

Safety and Regulatory Engineering Manager Title

Summary of Safety, Effectiveness Page 2 of 2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2003

Mr. James P. Raskob Safety and Regulatory Engineering Manager GE Lunar Corporation General Electric Company 726 Heartland Trail MADISON WI 53717

Re: K030962

Trade/Device Name: DPX Series Bravo Duo Bone Densitometer Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: 90 KGI Dated: July 2, 2003 Received: July 3, 2003

Dear Mr. Raskob:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3.0 INDICATION FOR USE FORM

501(k) Number (if known) .
K030962

DPX Series Bravo, Duo Bone Densitometer

. Indications For Use:
Device name:

The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.

The use of the DPX Series Bravo, Duo Bone Densitometer is restricted to prescription use only. The operator's manual for the DPX Series Bravo, Duo system contain the following statement:

"United States 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)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Over-the-Counter Use (Optional Format 1-2-96)

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Regulation Number and Section

§ 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.