The Total Body Software is used with the Prodigy bone densitometer system. This software provides an estimate of BMD, fat and lean tissue mass. The BMD value can then be compared to a reference population at the sole discretion of the physician.

Device Description

The Total Body Software for the Prodigy bone densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2), lean and fat tissue mass of the total body.

AI/ML Overview

Acceptance Criteria and Study for Prodigy Total Body Software:

This device is a bone densitometer software, and its primary function is to provide estimations of Bone Mineral Density (BMD), lean tissue mass, and fat tissue mass. The acceptance criteria and supporting study focus on the correlation and precision of these measurements compared to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Correlation with predicate device (LUNAR DPX) for BMD estimations.	r > 0.98 with the DPX.
Similarity of average BMD, lean, and fat tissue mass values compared to predicate device.	Very similar to the results obtained on a DPX in 46 subjects.
Short-term precision (%CV) in vivo for total body BMD.	< 1%
Short-term precision (%CV) in vivo for lean and fat tissue mass (expressed as a total mass difference).	< 1.5% (equivalent to 300g)
Total skin exposure dose per measurement.	0.13 mrem
Scan Time	5 minutes

Conclusion of Equivalence:	Substantially equivalent to currently marketed software (LUNAR DPX Total Body Software and LUNAR DPX Total Body Tissue Q Software). No new safety and effectiveness questions are raised.

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

Sample Size: 46 subjects.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) summary, it is generally assumed that these studies are typically prospective clinical performance studies conducted in a controlled environment.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This type of device (bone densitometer software) uses physical measurements rather than subjective interpretation by experts for its primary output (BMD, lean/fat tissue mass). Therefore, the concept of "experts establishing ground truth" in the diagnostic image interpretation sense does not directly apply here.
The "ground truth" for the test set is established by the measurements obtained from the predicate device (LUNAR DPX Total Body Software), which is itself a validated bone densitometer. The comparison is between the new device's readings and the predicate device's readings. The predicate device's performance would have been established through prior clinical validation.

4. Adjudication Method for the Test Set:

Not applicable. The study involves direct comparison of quantitative measurements (BMD, mass) between two devices on the same subjects, not expert adjudication of subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This device is an automated measurement system and does not involve human readers interpreting images. The study focuses on the agreement between the device's measurements and those of a predicate device.

6. Standalone Performance Study (Algorithm Only):

Yes, the study described is a standalone performance study in the sense that it evaluates the algorithm's (software's) output by comparing its quantitative measurements directly against those of a predicate device. There is no human-in-the-loop performance evaluated in this summary.

7. Type of Ground Truth Used:

Instrumental/Comparative Ground Truth: The ground truth is established by the measurements obtained from a legally marketed and presumably validated predicate device, the LUNAR DPX Total Body Software. The new device's measurements are compared to the predicate device's measurements.

8. Sample Size for the Training Set:

The document does not explicitly state the sample size for a training set. For a bone densitometer software, development often involves extensive internal testing and calibration using phantoms and potentially a large retrospective dataset for algorithm refinement, but this information is not typically included in a 510(k) summary as a distinct "training set" size. The 46 subjects mentioned are for the validation/test set.

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

As the training set sample size and its specific details are not provided, the method for establishing ground truth for a hypothetical or implied training set is also not detailed. However, generally for such devices, ground truth for algorithm development and calibration would involve:
- Phantom Studies: Using known, precisely measured physical phantoms with established BMD and composition.
- Comparison to Reference Methods: Potentially comparative studies against DEXA gold standards or other validated technologies if available during early development.
- Clinical Data with Predicate Device Correlation: Using data where the predicate device's measurements serve as the reference.

Summary

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K983564

Quantitation

313 W. BELTLINE HIGHWAY

MADISON, WI 53713

(608) 274-2663

8 1498

10.0 510(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:	Kenneth D. BurokerLUNAR Corporation313 West Beltline HighwayMadison, WI 53713
Phone:	(608) 288-6460
Fax:	(608) 274-0853
Date:	October 9, 1998
Device/Trade Name:	Prodigy Total Body Software
Common Name:	Bone Densitometer
Classification Name:	Bone Densitometer21CFR 892.1170
Predicate Device:	LUNAR DPX Total Body Software510(k) K884625/BLUNAR DPX Total Body Tissue QSoftware510(k) K935454

10.1 DESCRIPTION OF THE DEVICE:

The Total Body Software for the Prodigy bone densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2), lean and fat tissue mass of the total body.

10.2 SUMMARY OF TECHNICAL CHARACTERISTICS

The Prodigy Bone Densitometer performs a 5-minute total body scan, with a total skin exposure dose of 0.13 mrem per measurement.

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The BMD estimations in vivo provided by the Prodigy correlate r>0.98 with the DPX. The average BMD, and lean and fat tissue mass values obtained in 46 subjects were very similar to the results obtained on a DPX. The average short-term precision (%CV) in vivo was <1% for total body BMD, and <1.5% (300g) for lean and fat tissue mass. These values are comparable to those shown on currently marketed devices.

10.3 CONCLUSION

The Prodigy Total Body Software application is substantially equivalent to currently marketed software. No new safety and effectiveness questions are raised with the Prodigy Total Body Software application.

Kuntell Aunch
Signed

Kenneth D. Buroker
Printed Name

Director, Regulatory Affairs Title

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Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 DEC 1998

Kenneth D. Buroker Director, Regulatory Affairs Lunar Corporation 313 West Beltline Highway Ma ison, WI 53713

K983564 Prodigy Total Body Software Dated: October 9, 1998 Received: October 13, 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 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 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/cdri/dsmadsmaman.html".

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive Abdominal, Ear, Nose and Throa 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) K983564
Device Name: PRODIGY Total Body Software .
. Indications for use:

The Total Body Software requires a 5-minute exposure, with a total effective dose of 0.13 mrem. This software is substantially equivalent to the DPX Total Body software and poses no new safety or efficacy concerns.

The use of the Prodigy Bone Densitometer is restricted to prescription use only. The operator's manual for the Prodigy system contains 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)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices,
S.(k) Number. K98 3564

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

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.