Single Energy (SE) Femur Exams are used to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Clinical correlation is advised as these features may be consistent with atypical femur fractures, a complication associated with long term use of antiresorptive therapy.

Device Description

The proposed Hologic ® Single Energy (SE) Femur scan allows for the visualization of bone deformities of the femur, specifically focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Hologic's Discovery (K023398) bone densitometer models: Discovery A, C, W, and SL consist of an examination table and a C-arm. At opposite ends of the C-arm an x-ray tube and a linear multi-detector array are mounted. The patient is positioned on the examination table between the x-ray tube and the detector array. The detector and x-ray source scan the patient axially using an x-ray fan beam perpendicular to the direction of movement. The xray source can be pulsed at a constant voltage to acquire exams as in the case of Hologic's Instant Vertebral Assessment (IVA) exams reviewed and cleared by FDA (K060111). Currently, two types of IVA scans are in use on the Discovery A, C, W, and SL bone densitometers; the IVA and the IVA-HD (High Definition). Both scans are used for the visualization of vertebral bone deformities. The IVA scan has a 10 second scan time, whereas the IVA-HD has a 15 second scan time. IVA-HD scans use a thinner aperture resulting in higher resolution and a lower total dose than IVA scans. The high resolution image of the single energy IVA-HD scan makes it ideal for use as a scan to visualize deformities in the femur.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study demonstrating the device meets those criteria. Instead, it focuses on establishing substantial equivalence to a predicate device.

However, based on the context, we can infer the implicit acceptance criteria and how the study "proves" the device meets them through that substantial equivalence.

Here's an attempt to structure the information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Implied from Substantial Equivalence)
Technological Characteristics: Must be substantially equivalent to the predicate device in:
- Method of Deformity Assessment	Visual (Same as predicate)
- Fundamental Device Technology	DXA Bone Densitometer (Same as predicate)
- Imaging Scan	IVA-HD (Same as predicate)
- Image Acquisition Mode	Single Energy Fan Beam Scan (Same as predicate)
- Acquisition Speed for 15.7" Scan	15 seconds (Same as predicate)
- X-ray Technique Factors	140 kVp @ 5 ma (Same as predicate)
- Vertical Resolution	1.4 lp/mm (Same as predicate)
- X-ray Aperture	0.25 mm (W) x 61 mm (L) (Same as predicate)
- Entry Dose	0.025 mGy (Same as predicate)
- Image Display	On-screen display with image tools (Same as predicate)
Safety and Effectiveness: No new safety and effectiveness questions raised.	Risk assessment performed, concluded no new safety/effectiveness questions were raised by expanding the intended use of the identical IVA-HD scan to the femur.
Intended Use: Consistent with the visualization of bone deformities.	Visualization of focal reaction or thickening along the lateral cortex of the femoral shaft, consistent with the predicate's use for visualizing bone deformities (of the spine).

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

The document states: "The information provided in the 510(k) submission is acceptable for the demonstration of substantial equivalence to the predicate device with respect to physical performance and testing".

Test Set Sample Size: Not explicitly stated. The submission relies on the established performance of the identical IVA-HD scan used in the predicate device (K060111). No new clinical data or specific test set for the SE Femur Exam is detailed.
Data Provenance: Not explicitly stated for a new test set. The submission focuses on the technological equivalence to an existing, cleared device (IVA-HD). Therefore, the "data" effectively comes from the prior clearance of the IVA-HD technology, which was already deemed safe and effective.

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

Not applicable. This submission does not describe a new clinical study involving expert interpretation of a test set to establish ground truth for this specific device. The justification is based on technical equivalence to an already cleared device.

4. Adjudication Method for the Test Set

Not applicable. As no new clinical test set with expert ground truth establishment is described, an adjudication method is not mentioned.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The submission focuses on technological equivalence rather than comparative effectiveness with human readers.

6. Standalone Performance Study

No, a standalone (algorithm only without human-in-the-loop performance) study is not described for the SE Femur Exam. The device is a software option that produces images for visual assessment by a clinician. Its "standalone performance" is implicitly tied to the image quality and characteristics, which are asserted to be identical to the IVA-HD scan already cleared.

7. Type of Ground Truth Used

Not applicable for a new study. The "ground truth" for the device's capability to visualize bone deformities is based on the prior clearance and established performance of the IVA-HD technology, which this device uses. The device's function is to visualize features, not to provide an automated diagnosis requiring an independent ground truth for accuracy metrics.

8. Sample Size for the Training Set

Not applicable. This device is a software option that uses an existing imaging technology (IVA-HD scan) on an existing bone densitometer. It does not describe a new AI algorithm that undergoes a training phase with a specific dataset. The software itself is largely the same as the predicate's IVA-HD acquisition software; only the intended anatomical region for imaging has changed.

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

Not applicable, as there is no specific "training set" for a new AI algorithm described in this submission.

Summary

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K130277
Page 1 of 4

Section 5 -510(k) Summary

Date Prepared: January 31, 2013

MAY 3 1 2013

1.0 Manufacturing Establishment and Contact Information

1.1 Manufacturer Name and Address:

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730

1.2 Establishment Registration Number:

1221300

Name, Title, and Telephone Number of Contact: 1.3

Name: Eileen M. Boyle Regulatory Affairs Specialist III Title: Phone: (781) 999-7781 (866) 652-8674 Fax : eileen.boyle@hologic.com Email :

2.0 Device Identification

2.1 Device Trade Name: Hologic® Single Energy (SE) Femur Exam

2.2 Common/Usual Name

Software for Bone Densitometers

2.3 Proposed Intended Use:

Page 1 of 4

ﺎ

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2.4 Comparison of the Indication for Use:

The proposed indication for use of the SE Femur scan is substantially equivalent to that of the predicate device. Like the proposed device, the predicate device is indicated for the visualization of bone deformities. The predicate device is indicated for the visualization of vertebral bone deformities (as well as for the visualization of abdominal aortic calcifications), whereas the proposed device is for the visualization of bone deformities of the femur.

Since the identical IVA-HD scan is used, the SE Femur scan and IVA scans offer the same fundamental device technology, image acquisition mode, acquisition speed, x-ray technique factors, vertical resolution, x-ray aperture, radiation dose, and image display supported by the bone densitometer. No changes were made to the image acquisition software, report structure, or performance specifications. No new safety and effectiveness questions were raised following the risk assessment for the proposed expansion of the IVA scan's intended use. Therefore, the expanded indication for use statement has no effect on the bone densitometer's safety or effectiveness.

3.0 Device Classification

3.1 Classification: Class II
3.2 Classification Name and Rule Bone Densitometer: 21 CFR 892-1170
3.3 Classification Panel Radiology
3.4 Product Code તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ વિભાગમાં આવેલું એક ગામના લોકોનો મુખ્યત્વે આવ
3.5 Prescription Use The use of the Single Energy (SE) Femur Exam is restricted to prescription use only.

3.6 Predicate Devices

. 510(k) No: K060111 Trade Name: IVA (MXA-II) software option for the X-Ray bone densitometer SE Date: 4/4/2006 Manufacturer: Hologic, Inc.

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4.0 Device Description

Hologic's Discovery (K023398) bone densitometer models: Discovery A, C, W, and SL consist of an examination table and a C-arm. At opposite ends of the C-arm an x-ray tube and a linear multi-detector array are mounted. The patient is positioned on the examination table between the x-ray tube and the detector array. The detector and x-ray source scan the patient axially using an x-ray fan beam perpendicular to the direction of movement. The xray source can be pulsed at a constant voltage to acquire exams as in the case of Hologic's Instant Vertebral Assessment (IVA) exams reviewed and cleared by FDA (K060111). Currently, two types of IVA scans are in use on the Discovery A, C, W, and SL bone densitometers; the IVA and the IVA-HD (High Definition). Both scans are used for the visualization of vertebral bone deformities. The IVA scan has a 10 second scan time, whereas the IVA-HD has a 15 second scan time. IVA-HD scans use a thinner aperture resulting in higher resolution and a lower total dose than IVA scans. The high resolution image of the single energy IVA-HD scan makes it ideal for use as a scan to visualize deformities in the femur.

Comparison of Technological Characteristics: 5.0

The Single Energy (SE) Femur Exam is substantially equivalent to that of the predicate device. Like the proposed device, the predicate device is indicated for the visualization of bone deformities. The comparison table summarizes the technological characteristics of the Single Energy Femur Exam and the IVA the predicate device:

Device Characteristics	Proposed 510(k) DeviceSingle Energy Femur Exam	Hologic, Inc.IVA (K060111)
Method of DeformityAssessment	Visual )	Same
Fundamental DeviceTechnology	DXA Bone Densitometer	Same
Exam Site	Femoral shaft	Lumbar and Thoracic Spine
Imaging Scan	IVA-HD	IVA-HD
Image Acquisition Mode	Single Energy Fan Beam Scan	Same
Acquisition Speed for 15.7"Scan	15 seconds	Same
X-ray Technique Factors	140 kVp @ 5 ma	Same
Vertical Resolution	1.4 lp/mm	Same
X-ray Aperture	0.25 mm (W) x 61 mm (L)	Same
Entry Dose	0.025 mGy	Same
Image Display	On screen display with imagetools	Same
Device Output	Image of femoral shaft	Image of Lumbar and ThoracicSpine

Comparison table of the Single Energy Femur Exam and IVA:

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K130277
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6.0 Performance Testing

The SE Femur and IVA-HD scans offer the same fundamental device technology, image acquisition mode, acquisition speed, x-ray technique factors, vertical resolution, x-ray aperture, radiation dose, and image display supported by the bone densitometer. The Single Energy (SE) Femur Exam has the same technological characteristics as the predicate device. The identical IVA-HD scan is used for the acquisition of the lumbar and thoracic spine scan as is used for the proposed device for the acquisition of the SE Femur scan. The sole difference is in the positioning of the patient so that the targeted region (spine or femur) is imaged. No changes have been made to the software and both SE Femur and IVA scans can be viewed on the DXA system's screen and a report can be printed.

The information provided in the 510(k) submission is acceptable for the demonstration of substantial equivalence to the predicate device with respect to physical performance and testing

7.0 Substantial Equivalence

The Single Energy (SE) Femur Exam software is substantially equivalent to commercially IVA software option (K060111) which allows visualization of bone deformities. The predicate device provides substantially equivalent or the same intended use, features and functions as the proposed device.

8.0 Conclusion

The Hologic Single Energy (SE) Femur Exam software allows visualization of bone deformities. The features and functions are substantially equivalent to those of the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2013

Hologic, Inc. % Ms. Eileen M. Boyle Senior Regulatory Affairs Specialist 35 Crosby Drive BEDFORD MA 01730

Re: K130277

Trade/Device Name: Single Energy (SE) Femur Exam Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: May 15, 2013 Received: May 16, 2013

Dear Ms. Boyle:

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 contrôls provisions of the Act include requirements for annual registration, listing of devices, good-manufacturing practice, labeling, and-prohibitions against-misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2 - Ms. Boyle

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/ default.hum. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

· for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use

510(k) Number (if known): K130277

Device Name: Single Energy (SE) Femur Exam

Indications for Use:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

سر

Sm.h.7)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Office of InVitro Diagnostic Device Evaluation and Safety

K130277 510(k) _______________________________________________________________________________________________________________________________________________________________________

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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.