Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemilhip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are 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 BiPolar Head consists of a stainless steel outer shell (per ISO5832-9) and a UHMWPE insert (per ASTM F648). The outer shell is highly polished to articulate against the patient's natural acetabulum. The insert articulates against a Signature Orthopaedics 22 or 28mm cobalt-chrome femoral head (K121297). The femoral head connects to a femoral stem from Signature Orthopaedics' range to complete the hip hemiarthroplasty.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically a BiPolar Head and a Femoral Head for hip hemiarthroplasty.

This document describes the device, its indications for use, and the basis for its substantial equivalence to previously cleared devices. It does not present a study proving the device meets acceptance criteria in the way an AI/ML algorithm or a diagnostic tool would be evaluated. Instead, it describes performance testing for a mechanical orthopedic implant.

Therefore, many of the requested elements for an AI/ML model acceptance criteria study are not applicable or cannot be extracted from this document, such as:

Table of acceptance criteria and reported device performance (in the context of AI/ML metrics): The document lists performance testing but not in terms of AI metrics like sensitivity, specificity, or AUC against specific thresholds.
Sample size for test set and data provenance: Not applicable as this is a mechanical test rather than a data-driven model evaluation.
Number of experts and qualifications for ground truth: Not applicable.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth: Not applicable in the AI/ML sense. "Ground truth" here refers to established engineering standards and physical performance.
Sample size for training set/how ground truth for training set was established: Not applicable.

What can be extracted or inferred regarding "acceptance criteria" and "study" for this device:

1. Acceptance Criteria and Reported Device Performance (Mechanical Testing Context):

Acceptance Criteria Category	Reported Device Performance
Bacterial Endotoxin Levels	Evaluated on the finished form using the LAL method. Implies meeting regulatory limits for endotoxins.
Range of Motion Analysis	Conducted to verify adequate performance for anticipated in-vivo use. (Specific values not provided, but implicitly met if cleared).
Component Connection Strength and Fretting Corrosion Testing	Conducted to verify adequate performance for anticipated in-vivo use. (Specific values not provided, but implicitly met if cleared).
BiPolar Head Disclamping Resistance Testing	Conducted to verify adequate performance for anticipated in-vivo use. (Specific values not provided, but implicitly met if cleared).

Note: The document states these tests were conducted to "verify that the performance of the 40-42mm BiPolar Heads are adequate for anticipated in-vivo use." The exact acceptance thresholds (e.g., minimum torque, maximum fretting, specific range of motion degrees) are not detailed in this FDA letter, but presumably, they were defined by the manufacturer based on relevant ASTM/ISO standards and validated as part of their submission.

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

Sample Size: Not explicitly stated. The testing would involve a physical sample of the manufactured devices. The number of units tested for each specific performance criterion (e.g., how many heads for disclamping resistance) is not provided in this summary.
Data Provenance: Not applicable in the geographic data sense. This involves non-clinical testing and engineering evaluations of physical devices.

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

Not applicable in the context of expert review of images/data for ground truth. This is engineering-based performance testing. The "experts" would be the engineers, technicians, and quality control personnel performing and interpreting the mechanical tests according to established standards.

4. Adjudication Method for the Test Set:

Not applicable. This is not a human reader study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, this is not applicable to a mechanical medical device submission of this nature.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used:

In the context of a mechanical device, "ground truth" is defined by established engineering standards, material specifications (e.g., ISO5832-9 for stainless steel, ASTM F648 for UHMWPE), and validated test methods (e.g., for range of motion, connection strength, disclamping resistance). The performance of the device is measured against these objective physical and mechanical criteria.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of an AI/ML model for this mechanical device.

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

Not applicable given the non-AI/ML nature of the product and testing described.

Summary

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

January 29, 2018

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

Re: K163081 Trade/Device Name: 40-42mm BiPolar Head and 22mm Femoral Head Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY Dated: January 19, 2018 Received: January 22, 2018

Dear Declan 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 (21 CFR 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

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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" (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.

Katherine D. Kavlock -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K163081

Device Name

40-42mm BiPolar Head and 22mm Femoral Head

Indications for Use (Describe)

· 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

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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2 510(K) SUMMARY

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device Trade Name:	40-42mm BiPolar Head and 22mm Femoral Head
Common Name:	Hip Prosthesis
Contact:	Dr. Declan BrazilManaging Director of Signature Orthopaedics
Prepared By:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066AustraliaPhone: +61 (2) 9428 5181Fax: +61 (2) 8456 6065
Date Prepared:	January 19th, 2018
Classification:	Class II per 21 CFR 888.3390: Hip joint femoral (hemi-hip)metal/polymer cemented or uncemented prosthesis (KWY)
Predicate Devices:	Primary Predicate:• Signature Orthopaedics BiPolar Head (K133370)• Signature Orthopaedics Femoral Head (K121297)Secondary Predicate:• DePuy Self-Centering Hip (K812672)• Medacta Bipolar Heads (K091967)Reference Predicate:• Signature Orthopaedics UniPolar Head (K143184)

Device Description:

Indications for Use:

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemihip arthroplasty only, where the natural acetabulum does not require replacement. The

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Evolve UniPolar Head and BiPolar Head are 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

Performance Testing:

Bacterial endotoxin levels were evaluated on the finished form of the subject device using the LAL method. Non-clinical testing and engineering evaluations were conducted to verify that the

performance of the 40-42mm BiPolar Heads are adequate for anticipated in-vivo use. Non-clinical testing included:

Range of motion analysis
Component connection strength and fretting corrosion testing
. BiPolar head disclamping resistance testing

Substantial Equivalence:

The 40-42mm BiPolar Heads have the same intended use. indications for use, materials and design as the Signature Orthopaedics BiPolar Heads (per K133370). The 40-42mm BiPolar Heads differ from the Signature Orthopaedics BiPolar Heads (per K133370) only in the size range. The 40-42mm BiPolar Heads expand Signature Orthopaedics BiPolar Heads' size range to match the 40-42mm diameter DePuy Self Centering Hip (per K812672) and Medacta Bipolar Head (per K091967) sizes. The 22mm Femoral Head is identical to the Signature Orthopaedics Femoral Heads (per K121297) excluding the outer diameter, which has been reduced to 22mm for compatibility with the 40-42mm BiPolar Heads. Non-clinical testing results support the substantial equivalence claim.

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.