The Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone Densitometers. The software expands the range of bone densitometry reference data to include ages 3-20 years of age. The software provides a comparison of measured Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values in children. These data may be used for comparative purposes at the discretion of the physician.

Device Description

The Pediatric Reference Database is a software option which simply extends the existing, commercially available reference databases' ability to generate a Z-score for younger subjects. The Pediatric Reference Database for the Hologic QDR Series X-Ray Bone Densitometers provides AP Spine, Hip and "Total" body bone densitometry reference data for male, white American children. This software is used in conjunction with previously existing software in the QDR Series Densitometers which calculates and reports results relative to sex, ethnicity and age-matched values. The reference database is used to expand the range of bone densitometry reference values to include age 3-20 years of age. The software provides a comparison of Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values. Patient results for each analysis region can be compared to reference values both graphically and numerically to each category of the age dependent reference Bone Mineral Density (BMD) values. The sex and ethnicity of the patient are generated with a marker placed at the position corresponding to the estimated patient BMD and age. Deviation "scores," are computed, quantifying (in standard deviation units) the difference between the patient's estimated BMD and the mean population standard (Z-score) reference data. In addition, the patient BMD is expressed in percent of the age matched mean in percent of the pediatric mean.

AI/ML Overview

The provided text describes a Pediatric Reference Database for Hologic QDR Series X-Ray Bone Densitometers, a software option that extends the existing reference databases to include ages 3-20 years.

Here's an analysis of the acceptance criteria and the study as per your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy) with thresholds. Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to predicate devices. The study's reported "performance" is implicitly that the device functions as intended by providing a Z-score and comparison to age-matched values for pediatric populations, which is consistent with the function of the predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Substantial equivalence to predicate devices for bone densitometry reference data.	The Pediatric Reference Database is a software option which simply extends the existing, commercially available reference databases' ability to generate a Z-score for younger subjects (ages 3-20).
Ability to generate a Z-score for younger subjects (3-20 years).	Patient results for each analysis region can be compared to reference values both graphically and numerically. The facility to view all three of the age-dependent reference Bone Mineral Density (BMD) values... Deviation "scores" are computed, quantifying (in units of standard deviation units) the difference between the patient's estimated BMD and the mean population standard (Z-score) reference data.
Expansion of bone densitometry reference values to include ages 3-20 years, male, white American children, for Spine, Hip and Forearm.	The Pediatric Reference Database... provides AP Spine, Hip, and Forearm bone densitometry reference data for male, white American children... to include age 3-20 years of age.
No new safety and effectiveness questions raised.	"No new safety and effectiveness questions are raised with the inclusion of these expanded reference values." This statement is part of the conclusion for substantial equivalence.

Note: The document focuses on demonstrating substantial equivalence, which is a regulatory pathway. It does not provide a traditional performance study with explicit numerical metrics (e.g., accuracy, precision of the Z-score calculation itself, or clinical outcomes). The "study" here is the collection and presentation of reference data.

Detailed Study Information:

The provided text does not describe a traditional study in the sense of an experiment to test the performance of the device against a cohort. Instead, it describes a reference database that enhances an existing device's functionality. Therefore, many of the requested details about a "study" (like test sets, ground truth establishment for test sets, expert adjudication methods, MRMC studies, standalone performance, and training sets) are not directly applicable or are not explicitly stated in the provided text.

Based on the information given, here's what can be inferred or explicitly stated:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a "test set" for performance evaluation, as this document is about establishing a reference database. The database itself comprises the reference data. The size of the population from which the reference data was collected is not stated.
- Data Provenance: The reference data is for "male, white American children." This indicates the data origin is from the United States and is retrospective in the sense that it represents a collected population. It's not a prospective study to test a hypothesis about the device's performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated/Not applicable. The "ground truth" here is the reference data itself, representing a healthy pediatric population's BMD values. The process of collecting and validating this reference data (e.g., how the healthy population was defined, how measurements were ensured to be accurate) is not detailed. There's no mention of experts establishing a "ground truth" for individual cases in a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no "test set" in the context of diagnostic performance requiring adjudication of results.
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:
- No, an MRMC study was not done. This device is a reference database, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, but the device inherently functions "standalone" as a reference. The software provides Z-scores based on the input BMD measurement and patient demographics. It's a computational tool, not an AI algorithm that makes diagnostic interpretations. Its "performance" is its ability to correctly reference the input BMD against its stored database.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Database Values derived from a healthy population. The "ground truth" is the established set of age-, sex-, and ethnicity-matched Bone Mineral Density values for healthy children. The methodology for establishing this healthy population baseline is not detailed in the provided text, but it would typically involve anthropometric measurements, medical history, and DEXA scans from a large, representative cohort of healthy children.
The sample size for the training set:
- Not explicitly stated. The term "training set" is not used, as this is a reference database, not a machine learning model. The size of the population from which the "Pediatric Reference Database" data was derived is not provided.
How the ground truth for the training set was established:
- Not explicitly stated, but implied as a collected reference population. The "ground truth" for this reference database would have been established through a systematic collection of Bone Mineral Density (BMD) measurements from a cohort of healthy male, white American children across the age range of 3-20 years, using validated DEXA scanning protocols. The process would involve defining inclusion/exclusion criteria for "healthy," performing scans, and statistically characterizing the BMD distribution to create age-specific means and standard deviations.

Summary

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Hologic®, Inc. May 10, 2004

AUG 1 1 2004

Hologie Reference Database 510(k) Premarket Notification

Section F.

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510(k) Summary of Safety and Effectiveness:

Pediatric Reference Database

K04H266

Submitter:	Hologic, Inc.
Submitter Address:	35 Crosby DriveBedford, MA 01730
Contact Person:	Richard L. Follett, V.P., Regulatory Affairs and Quality Assurance
Phone Number:	(781) 999-7506
Fax:	(781) 280-0669
Date Prepared:	May 7, 2004
Device TradeName:	Pediatric Reference Database
Device CommonName:	BoneDensitometer
Device ClassificationName:	Bone Densitometer21 CFR 892.1170
Predicate Devices:	Lunar Pediatric Reference Data (K001812)Expanded.LUNAR Reference Data (K964307)NHANES Reference Data for QDR (K963363)Hologic® Discovery Package for QDR (K023398)Hologic® QDR Explorer X-Ray Bone Densitometer (K033224)ODR 4500 X-Ray Bone Densitometer (K943505)

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Hologic®. Inc. May 10, 2004

Hologic Reference Database 510(k) Premarket Notification

Device Description:

The Pediatric Reference Database is a software option which simply extends the existing, commercially available reference databases' ability to generate a Z-score for younger subjects.

The Pediatric Reference Database for the Hologic QDR Series X-Ray Bone Densitometers provides AP I lie rediance Reference Batalensitometry reference data for male, white American children. The Spine, This and "Hotel in conjunction with previously existing software in the QDR Series I culaine relevelos band is results to sex, ethnicity and age-matched values. The reference Densitometers while realigate of bone densitometry reference values to include age 3-20 years of age. database is used to exparison of Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values.

Patient results for each analysis region can be compared to reference values both graphically and I uncility to vach allery of the age dependent reference Bone Mineral Density (BMD) values quantitution of + or the sex and ethnicity of the patient are generated with a marker placed at the position corresponding to the estimated patient BMD and age. Deviation "scores," are computed, quantifying (in eorroponants to are estation units) the difference between the patient's estimated BMD and the mean population standated (Z-score) reference data. In addition, the patient BMD is expressed in percent of the age matched mean in percent of the pediatric mean.

Intended Use:

The Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone The roundters. The software expands the range of bone densitometry reference data to include ages 3-20 years of age. The software provides a comparison of measured Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values in children. These data may be used for comparative purposes at the discretion of the physician.

Conclusion:

••

The Pediatric Reference Database is substantially equivalent to currently marketed software. No new safety and effectiveness questions are raised with the inclusion of these expanded reference values.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2004

Ms. Anastasia C. Randall Senior Regulatory Affairs Specialist HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730

Re: K041266

Trade/Device Name: Pediatric Reference Database Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: 90 KGI Dated: July 13, 2004 Received: July 14, 2004

Dear Ms. Randall:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bection b 10(t) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosare) to regary the Medical Device Amendments, or to econimer of they 2011-11-11 11:47 pm accordance with the provisions of the Federal Food, DNA and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetion (110.) that be neview, subject to the general controls provisions of the Act. The r ou may, therefore, mains 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 such additional controls. Existing major regulations affecting your device can may or subject to sales advanced 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 that I DA has made a ceretre and regulations administered by other Federal agencies. You must comply or any I coolar started and 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) I ms letter will anow you to ocgin hanteling of substantial equivalence of your device to a legally premarket notification. The PDA miding of dassification 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 If you desire specific advice for your dones to the following numbers, based on the regulation number at the top of the letter:

8xx. Ixxx	(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 Adultionaly, for questions on the promote the regulation entitled, "Misbranding Office of Comphanos at (2017 97 1000 (21 CFR Part 807.97) you may obtain. Other general by Ference to premarket notified to the Act may be obtained from the Division of Small information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 1901) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Bugdon

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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Hologic®, Inc. May 10, 2004

Section D.

Indications for Use Statement

510(k) Number (if known): _KOU 1266

Device Name: _Pediatric Reference Database

Indications for Use:

The Pediatric Reference Database is a software option used with Hologic QDR Series X-1
1 The Pediatic Reference Database is a soltware openabase is for use in determining Z-Ray Bone Delishometers: The Pears at the discretion of the physician.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

) (PLEASE DO NOT WRITE SECONDRED) OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter-Use

(Per 21 CFR 801.109)

(Optional Format 1)

Vaind C. Syper

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K044 266

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.