EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt by ENCORE MEDICAL, L.P.

EXPRT™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

Device Description

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the EXPRT™ Revision Hip System. This type of notification is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, and it typically does not include extensive clinical study data with acceptance criteria for device performance as would be found in a PMA (Premarket Approval) application or a more comprehensive clinical trial report for AI/software devices.

Instead, the document focuses on demonstrating substantial equivalence based on indications for use, material, design features, dimensions, surgical implantation technique, intended use, packaging, sterilization, and non-clinical testing.

Therefore, many of the requested items regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or not provided in this specific FDA 510(k) document.

However, I can extract the information that is present:

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

The document does not provide a table with specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics often associated with AI/diagnostic devices. Instead, the "performance" here refers to the device's ability to meet non-clinical testing standards and be substantially equivalent to predicates.

Acceptance Criteria (Implied)	Reported Device Performance
Demonstrates substantial equivalence to predicate devices in Indications, Material, Design, Dimensions, Surgical Technique, Intended Use, Packaging, Sterilization	"All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified."
Fatigue testing standards	"Fatigue testing. All testing has determined that the device is substantially equivalent to the predicate devices."
Bacterial endotoxin levels	"Bacterial endotoxin testing is equivalent to the previously cleared system."

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

This information is not provided as a formal clinical test set with specific sample sizes. The "testing" mentioned refers to non-clinical fatigue and endotoxin testing, not a clinical study on human subjects with a test set.

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)

This information is not applicable as there was no clinical study or test set requiring expert-established ground truth for performance evaluation of a diagnostic or AI algorithm.

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

This information is not applicable as there was no clinical study or test set 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 is not applicable as this is a physical medical device (hip replacement system), not an AI or diagnostic software.

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

This is not applicable as this is a physical medical device.

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

This is not applicable for the purpose of this 510(k). The "ground truth" for the device's safety and effectiveness is largely based on its similarity to legally marketed predicate devices and its ability to pass non-clinical engineering and material tests.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This is not applicable as this is a physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

March 2, 2017

Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758

Re: K163497

Trade/Device Name: EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem. EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt Regulation Number: 21 CFR 888.3310 Regulation Name: Hip Joint Metal/Polymer Constrained Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWZ. LZO. LWJ Dated: December 21, 2016 Received: December 22, 2016

Dear Ms. Hutto:

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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K163497
Device Name	EXPRTT™ Revision Hip System - EXPRTT™ Hip Distal Stem, EXPRT™™ Hip Standard Offset Proximal Body Implant, EXPRT™™ HipLateral Offset Proximal Body Implant, EXPRT™™ Hip Capture Bolt
Indications for Use (Describe)	EXPRTT™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for otherreconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It isintended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/14) TO BE COMPLETED. PLEASE REVIEW AND SUBMIT AGAIN. THANK YOU.

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510(k) Summary

Date: February 28, 2017

Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djosurgical.com

Trade Name	Common Name	Classification	Product Codes
EXPRT™ Revision Hip System - EXPRT™ Hip DistalStem, EXPRT™ Hip Standard Offset Proximal BodyImplant, EXPRT™ Hip Lateral Offset Proximal BodyImplant, EXPRT™ Hip Capture Bolt	Revision Hip Implant	Class II	KWZ, LZO, LWJ

Product Code	Regulation and Classification Name
KWZ	Hip joint metal/polymer constrained cemented or uncemented prosthesis per 21 CFR888.3310
LZO	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncementedprosthesis per 21 CFR 888.3353
LWJ	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR888.3360

Description:

Indications for Use:

EXPRT Revision Hip System – K161610 Predicate Devices:

Comparable Features to Predicate Device is comparable to the predicate devices in indications, material, design features, dimensions, surgical implantation technique, intended use, packaging, and sterilization.

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Key Differences in Subject Device to Predicate: The key difference between the subject device and the predicate device is the use of compatible components. The predicate device only allowed use with -4 offset femoral heads. The subject device will allow all configurations of DJO Surgical femoral heads.

Non-Clinical Testing: Fatigue testing. All testing has determined that the device is substantially equivalent to the predicate devices.

Endotoxin Assessment: Bacterial endotoxin testing is equivalent to the previously cleared system.

Clinical Testing: Clinical testing was not required

Conclusion: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.

Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”