Signature Orthopaedics' Evolve UniPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head is indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

Acute femoral head or neck fracture
. Fracture dislocation of the hip
Avascular necrosis of the femoral head ●
Non-union of femoral neck fractures
Certain high subcapital and femoral neck fractures in the elderly ●
. Degenerative arthritis involving only the femoral head

Device Description

The Evolve™ UniPolar Head is a metallic (per ISO 5832-12) ball with a tapered bore. The head connects to a femoral stem from Signature Orthopaedics' range via taper sleeve. The taper sleeve is manufactured from cobalt-chromium alloy per ISO 5832-12, and includes a 12/14 taper. The head's outer surface is highly polished to articulate against the patient's natural acetabulum as part of a hip hemi-arthroplasty.

AI/ML Overview

This document is a 510(k) premarket notification for the Evolve™ UniPolar Head, a hip prosthesis. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a novel device requiring extensive clinical studies with acceptance criteria and ground truth evaluations typically seen for AI/ML devices or new technologies.

Therefore, many of the requested items related to acceptance criteria, ground truth, expert adjudication, MRMC studies, and standalone performance for AI/ML are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Not explicitly stated as numerical criteria, but implied by successful completion)	Reported Device Performance
Mechanical Performance	Range of motion analysis	Adequacy for anticipated in-vivo use (implied)	Adequate
	Component connection strength testing	Adequate for anticipated in-vivo use (implied)	Adequate
	Fretting corrosion testing	Adequate for anticipated in-vivo use (implied)	Adequate
	Femoral stem fatigue testing	Adequate for anticipated in-vivo use (implied)	Adequate
Material Composition	Metallic material (head)	Conformance to ISO 5832-12	Conforms to ISO 5832-12
	Taper sleeve material	Conformance to ISO 5832-12	Conforms to ISO 5832-12
Design Similarity	Articular surface and taper connection geometry	Similar to Signature Orthopaedics CoCr Femoral Head (K121297)	Similar to K121297
Intended Use	Hemi-hip arthroplasty	Similar to Signature Orthopaedics BiPolar Head (K133370) and Smith & Nephew Tandem UniPolar Head (K896580)	Similar to K133370 & K896580

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is a series of non-clinical tests and engineering evaluations. These are outlined in the "Performance Testing" section:

Range of motion analysis
Component connection strength and fretting corrosion testing
Femoral stem fatigue testing

The report states that these tests were conducted "to verify that the performance of the Evolve™ UniPolar Head is adequate for anticipated in-vivo use." The conclusion is that "Non-clinical testing results support the substantial equivalence claim. The Evolve UniPolar Head is expected to perform adequately during clinical use."

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

Not applicable / Not provided. This document details a 510(k) submission for a traditional medical device (hip prosthesis) based on mechanical and material engineering testing, not a data-driven device like AI/ML. There is no "test set" in the sense of a dataset for an algorithm. The "data" provenance would refer to the origin of the materials and manufacturing, and the engineering tests are conducted in a lab setting.

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 applicable / Not provided. Ground truth, in the context of expert consensus, is not relevant for the mechanical and material testing performed for this device. The "ground truth" for these tests is the physical measurement and observation of the device's behavior under simulated conditions.

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

Not applicable / Not provided. Adjudication methods are used to resolve discrepancies in human expert labeling or diagnosis for ground truth establishment, which is not part of this device's testing.

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 applicable. This is a physical medical device, not an AI/ML diagnostic aid. MRMC studies are not relevant.

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

Not applicable. This is a physical medical device. There is no algorithm to evaluate in standalone mode.

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

Engineering/Physical Ground Truth: The "ground truth" for the performance testing is based on established engineering principles, material science standards (e.g., ISO 5832-12), and physical measurements obtained from laboratory testing (e.g., range of motion, connection strength, fretting corrosion, fatigue). Outcomes data might be considered relevant in post-market surveillance for long-term device performance but is not part of this premarket submission.

8. The sample size for the training set

Not applicable / Not provided. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering development, which could be seen as an iterative "training" process in product design, but not through statistical learning from a data set.

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

Not applicable / Not provided. As there is no "training set" in the ML sense, there is no ground truth needing establishment for it. The "ground truth" for design decisions and manufacturing quality would be established through engineering specifications, material standards, and quality control processes.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces suggesting community and support.

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

March 17, 2015

Signature Orthopaedics Pty Ltd. Dr. Declan Brazil Managing Director 7 Sirius Road Lane Cove, NSW 2066 Australia

Re: K143184 Trade/Device Name: Evolve™ UniPolar Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL Dated: February 9, 2015 Received: February 11, 2015

Dear Dr. Brazil:

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

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

Page 2 - Dr. Declan Brazil

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 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 yours,

Lori A. Wiggins -S

for

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

Enclosure

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

INDICATIONS FOR USE STATEMENT 1

510(k) Number (if Known): K143184

Device Name: Evolve™ UniPolar Head

Indications For Use:

Acute femoral head or neck fracture ●
. Fracture dislocation of the hip
Avascular necrosis of the femoral head ●
Non-union of femoral neck fractures
Certain high subcapital and femoral neck fractures in the elderly ●
. Degenerative arthritis involving only the femoral head

Prescription Use: Yes Over-The-Counter Use: No AND/OR (Part 29 CFR 801 Subpart D) (Part 29 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Signature Orthopaedics Pty Ltd

510(K) SUMMARY 2

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device Trade Name:	Evolve™ UniPolar Head
Common Name:	Hip Prosthesis
Contact:	Dr. Declan BrazilManaging Director
Prepared By:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066AustraliaPhone: +61 (2) 9428 5181Fax: +61 (2) 8456 6065
Date Prepared:	October 21st, 2014
Classification:	Class II per 21 CFR 888.3360: Prosthesis, Hip, Hemi-,Femoral, Metal (KWL)
Predicate Devices:	Substantial equivalence to the following devices is claimed:● Signature Orthopaedics Origin Total Hip System CoCrFemoral Head (K121297)● Signature Orthopaedics BiPolar Head (K133370)● Smith & Nephew Tandem UniPolar Head (K896580)● Global Manufacturing Technology MSA Hip System(K102172)

Device Description:

Indications for Use:

. Acute femoral head or neck fracture

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

Signature Orthopaedics Pty Ltd

. Fracture dislocation of the hip
Avascular necrosis of the femoral head
Non-union of femoral neck fractures ●
Certain high subcapital and femoral neck fractures in the elderly ●
Degenerative arthritis involving only the femoral head ●

Performance Testing:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Evolve™ UniPolar Head is adequate for anticipated in-vivo use. Non-clinical testing included:

. Range of motion analysis
Component connection strength and fretting corrosion testing ●
. Femoral stem fatigue testing

Substantial Equivalence:

The Evolve UniPolar Head's design is similar to the Signature Orthopaedics CoCr Femoral Head (K121297), including articular surface and taper connection geometry, to allow use with Signature Orthopaedics existing femoral stem range. The Evolve UniPolar Head's design and intended use are similar to the Signature Orthopaedics BiPolar Head (K133370) and Smith & Nephew Tandem UniPolar Head (K896580). Non-clinical testing results support the substantial equivalence claim. The Evolve UniPolar Head is expected to perform adequately during clinical use.

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.