Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
Inflammatory joint disease including rheumatoid arthritis
Correction of functional deformity including congenital hip dysplasia
Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems are intended for cemented fixation only.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

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

Device Description

The Logical C-Series Acetabular Shell is a metal backed cementless acetabular cup that is compatible with a highly cross-linked polyethylene liner from the Origin Total Hip System predicate device (K121297), as well as the Logical Constrained Liner and Logical 20° Hooded Liner. The shell's substrate is manufactured from Ti6A14V alloy per ASTM F136. The outer surface of the shell is sequentially coated with commercially pure titanium (per ASTM F1580) and Hydroxylapatite (per ISO 13779-2). The shell is available in no-hole. 3-hole or multi-hole configurations to allow use of bone screws for supplemental fixation.

The Logical Constrained Liner and the Logical 20° Hooded Liner are line range extensions to the Logical Liner per K121297. The Logical Constrained Liner differs from the original range in that it provides greater than 180 degree head coverage to constrain the head within liner. The Logical 20° Hooded Liner differs from the original range in that it incorporates a 20° hood as opposed to the original 10° hood. The Logical Constrained Liner and Logical 20° Hooded Liner are manufactured from highly crosslinked polyethylene (XLPE) identical to the Logical Liner per K121297. The Logical Constrained Liner further incorporates a titanium alloy collar to support the liner's rim. Furthermore, the Logical Constrained Liner is assembled with the Logical Shell and Logical Constrained Liner Collar via titanium alloy snapring. The Logical Constrained and 20° Hooded Liners articulate with a femoral head of appropriate diameter.

AI/ML Overview

The provided text is a 510(k) summary for the Logical C-series Acetabular Shell, Logical Constrained Liner, and Logical 20° Hooded Liner. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness through a traditional clinical study with acceptance criteria for device performance.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample sizes for test/training sets, expert involvement, and ground truth establishment is not explicitly detailed in the provided document in the context of a new efficacy study.

However, I can extract information related to the non-clinical performance testing conducted to support substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

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

The document does not provide specific acceptance criteria or quantitative performance results in a table format for the device itself against novel safety and effectiveness endpoints. Instead, it states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Logical C-Series Shell, Constrained Liner and 20° Hooded Liner devices are adequate for anticipated in-vivo use." The conclusion drawn is that "Non-clinical testing results support the substantial equivalence claim." This implies that the device's performance, as measured by the non-clinical tests, was comparable to or met the established performance of the predicate devices.

2. Sample size used for the test set and the data provenance

The document describes "non-clinical testing and engineering evaluations." This typically refers to laboratory-based tests on physical samples of the medical device components. It does not refer to clinical patient data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable here. The sample sizes for these engineering tests are also not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided as the document describes engineering and non-clinical performance testing of mechanical components, not a study evaluating diagnostic accuracy or a similar clinical outcome requiring expert ground truth establishment.

4. Adjudication method for the test set

This information is not applicable and not provided for the same reasons as point 3.

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

This information is not applicable and not provided. The device in question is an orthopedic implant (hip replacement components), not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable and not provided. The device is an orthopedic implant, not an algorithm.

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

This information is not applicable and not provided as it relates to non-clinical engineering tests on device components. The "ground truth" in this context would be the objective measurements and engineering standards applied to the device components during laboratory testing.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/machine learning study requiring training data.

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

This information is not applicable and not provided for the same reasons as point 8.

Summary of available information related to performance testing:

The device's performance was evaluated through the following non-clinical tests:

Range of motion analysis
Shell stiffness testing
Modular component connection strength testing
Cup-Liner Push Out testing
Head-Liner Assembly / Disassembly Testing
Liner-Shell Assembly Testing
Various coating characterization, abrasion and adhesion strength testing

These tests were conducted to demonstrate that the device performs "adequately for anticipated in-vivo use" and to support "substantial equivalence" to predicate devices. The specific quantitative results or direct acceptance criteria for each test against which the device's performance was measured are not detailed in this 510(k) summary. The implication is that the device met the performance benchmarks implicitly or explicitly established based on the predicate devices or relevant industry standards.

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 depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, interconnected design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.

June 3, 2016

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

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

Re: K153131

Trade/Device Name: Logical C-series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: MEH, LPH, KWZ Dated: April 20, 2016 Received: April 25, 2016

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

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(21 CFR Part 807); labeling (21 CFR Parts 801); medical device 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.

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.

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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INDICATIONS FOR USE STATEMENT 1

510(k) Number (if Known): - - K153131

Device Name: Logical C-Series Shell, Constrained Liner and 20° Hooded Liner

Indications For Use:

Non-inflammatory degenerative joint disease including osteoarthritis or ● avascular necrosis
Inflammatory joint disease including rheumatoid arthritis
. Correction of functional deformity including congenital hip dysplasia
Traumatic injury involving the hip joint including traumatic arthritis or femoral . head or neck fracture
Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

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
(Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use:	No
(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)

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510(K) SUMMARY 2

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device Trade Name:	Logical C-Series Shell, Constrained Liner and 20° HoodedLiner
Common Name:	Total 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:	October 26th, 2015
Classification:	Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymersemi-constrained cemented or nonporous uncemented prosthesis(MEH)Class II per 21 CFR 888.3358: Hip joint metal/polymer/metalsemi-constrained porous-coated uncemented prosthesis (LPH)Class II per 21 CFR 888.3310: Hip joint metal/polymerconstrained cemented or uncemented prosthesis (KWZ)
Predicate Devices:	Substantial equivalence to the following devices is claimed:• DePuy Pinnacle Duofix HA Acetabular Cup Prosthesis(K031495)• Howmedica Osteonics Trident Acetabular Shells: PS-HA (K001448)• DePuy Pinnacle Constrained Acetabular Liner(K043058, K052079, K071117)• Pinnacle Acetabular System (K001534, K000306)• Signature Origin Total Hip System (K121297)• DePuy Duraloc Constrained Liner (K951301, K972596)• Smith & Nephew Reflection Constrained Liner(K021803, K033442)

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Device Description:

Indications for Use:

. Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
. Inflammatory joint disease including rheumatoid arthritis
. Correction of functional deformity including congenital hip dysplasia
. Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

. Acute femoral head or neck fracture
. Fracture dislocation of the hip

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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 Logical C-Series Shell, Constrained Liner and 20° Hooded Liner devices are adequate for anticipated in-vivo use. Non-clinical testing included:

Range of motion analysis
. Shell stiffness testing
. Modular component connection strength testing
. Cup-Liner Push Out testing
Head-Liner Assembly / Disassembly Testing
. Liner-Shell Assembly Testing
. Various coating characterization, abrasion and adhesion strength testing

Substantial Equivalence:

The Logical C-Series Shell, Constrained Liner and 20° Hooded Liner devices have similar intended use, indications for use, materials and design to the predicate devices. Non-clinical testing results support the substantial equivalence claim. The Logical C-Series Shell, Constrained Liner and 20° Hooded Liner devices are expected to perform adequately during clinical use.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.