The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.

Device Description

AI/ML Overview

The provided text is a 510(k) summary for the Hologic Hip Structural Analysis (HSA) Software Option for QDR X-Ray Bone Densitometers. While it details the device's intended use and substantial equivalence to predicate devices, it does not contain information on specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with such studies (e.g., sample sizes, ground truth establishment, expert qualifications, or MRMC studies).

The "Conclusion" section (H.4) states that the device is "substantially equivalent to the presently marketed Discovery Package for QDR Densitometers software (K023398) and the Advanced Hip Assessment (AHA) Software for GE Prodigy x-ray bone densitometers (K011917). No new safety and efficacy questions are raised with the HSA Software Option." This strongly suggests that the regulatory submission relied on substantial equivalence rather than a detailed performance study with explicit acceptance criteria for this specific device.

Therefore, most of the requested information cannot be extracted from the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not Available: The document does not specify any quantitative acceptance criteria for device performance (e.g., accuracy thresholds for CSA, CSMI, Z, or Buckling Ratio). It only states the device "allows the physician to estimate structural properties."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Available: The document does not mention any specific test set, its sample size, or the provenance of the data used for any testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Available: Since no specific test set or ground truth establishment process is described, information about the number or qualifications of experts is not present.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Available: No adjudication method is mentioned as no specific test set evaluation process is detailed.

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

Not Available: The document does not describe any MRMC study or any assessment of human reader improvement with or without AI assistance. This device is a software option for bone densitometers, providing measurements of structural properties, not necessarily an AI-assisted diagnostic tool that would typically undergo MRMC studies in this context.

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

Implied Standalone (but no performance metrics): The software itself is the algorithm, providing measurements. Therefore, its performance would inherently be "standalone" in generating these structural properties. However, there are no reported performance metrics for this standalone operation. The "Intended Use" states it "allows the physician to estimate structural properties," implying the software provides data to the physician, rather than fully automating a diagnostic conclusion.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Available: No ground truth type is specified, as no detailed performance study or validation against a ground truth is described.

8. The sample size for the training set

Not Available: The document does not mention a training set or its size.

9. How the ground truth for the training set was established

Not Available: No information is provided regarding the establishment of ground truth for a training set.

Summary Table of Available Information:

Section	Acceptance Criteria	Reported Device Performance
Acceptance Criteria	Not specified (Relied on substantial equivalence to predicate devices)	Not explicitly reported against specific criteria. The device "allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio."

Study Details	Information Found in Document
Test Set Sample Size	Not available
Data Provenance (Test Set)	Not available
Number of Experts (Ground Truth - Test Set)	Not available
Expert Qualifications (Ground Truth - Test Set)	Not available
Adjudication Method (Test Set)	Not available
MRMC Comparative Effectiveness Study	No, not mentioned.
Standalone Performance Study	Implied (the software is the standalone measurement tool), but no specific performance metrics reported.
Type of Ground Truth Used	Not available
Training Set Sample Size	Not available
Ground Truth for Training Set Establishment	Not available

Summary

{0}------------------------------------------------

K061561

JUL 2 8 2006

Section G 510(k) Summary

000081

{1}------------------------------------------------

H. 510(k) Summary

Manufacturing Establishment and Contact Information H.1

H.1.1 Manufacturer Name and Address:

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730

H.1.2 Establishment Registration Number:

1221300

H.1.3 Name, Title, and Telephone Number of Contact:

Jeanette Schier-Pugsley Regulatory Affairs Manager Phone: (781) 999-7300, ex. 7406 Fax: (781) 999-0614 jschierpugsley@hologic.com

Device Identification H.2

H.2.1 Device Trade Name:

Hip Structural Analysis (HSA) Software Option for the Hologic QDR X-Ray Bone Densitometers.

H.2.2 Common / Usual Name:

Software option for Bone Densitometers

H.2.3 Intended Use:

Device Classification H.3

H.3.1 Classification:

Class II

H.3.2 Classification Name and Rule

Bone Densitometer: 21 CFR 892.1170

{2}------------------------------------------------

H.3.3 Classification Panel

Radiology

H.3.4 Product Code

90 KGI

H.3.5 Predicate Devices

. 510(k) No.: K023398 Trade Name: Discovery Package for QDR Densitometers SE Date: November 8, 2002 Manufacturer: Hologic, Inc.

. 510(k) No .: K011917
Advanced Hip Assessment (AHA) Software for GE Prodigy x-Trade Name: ray bone densitometers.

August 3, 2001 SE Date:

Manufacturer: GE Lunar Corporation

H.4 Conclusion:

Based on the scientific literature and testing supplied in the 510(k) submission, the Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers is substantially equivalent to the presently marketed Discovery Package for QDR Densitometers software (K023398) and the Advanced Hip Assessment (AHA) Software for GE Prodigy x-ray bone densitometers (K011917). No new safety and efficacy questions are raised with the HSA Software Option.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars above it, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 8 2006

Ms. Jeanette Schier-Pugsley. RAC Regulatory Affairs Manager HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730

Re: K061561

Trade/Device Name: Hip Structure Analysis (HAS) Software Option for QDR X-Ray Bone Densitometers

Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: June 2, 2006 Received: June 5, 2006

Dear Ms. Pugsley:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/11 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "PA" are in the center of the logo in a large, bold font. The word "Centennial" is below the letters "PA". Three stars are below the word "Centennial".

Protecting and Promoting Public Health

{4}------------------------------------------------

Page 2 -

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.

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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other	240-276-0100

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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

{5}------------------------------------------------

A.2 Indications for Use Statement

510(k) Number (if known): 061561

Hip Structural Analysis (HSA) Software Option for QDR X-Ray Bone Device Name: Densitometers

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use

Over-The-Counter-Use

(Per 21 CFR 801.109)

(Optional Format 1)

Nancy Bradon
(Division Sign-Off)

Division of Reproductive. Abdo and Radiological Device >10(k) Number

000010

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.