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, Aria, Remedy, TSI and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve and Cemented TSI 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 Signature Orthopaedics' Cemented TSI Hip Stems are manufactured from Forged CoCr per ASTM-F799. The Cemented TSI stem is a highly polished anatomically curved stem with a round cross-section intended for cemented use in total hip arthroplasty.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Cemented TSI Hip Stem). It focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical performance testing for a new type of device.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/algorithm performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test and training sets, expert ground truth establishment, or multi-reader studies is not applicable to this type of regulatory filing.

This document describes a conventional medical device (a hip stem), not an AI or algorithm-driven device. The "acceptance criteria" here relate to manufacturing, material properties, and mechanical performance, not diagnostic accuracy or AI model performance.

Here's how to address the prompt given the nature of the document:

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

The "acceptance criteria" for this device are established through performance testing and engineering evaluations to show that the device is suitable for its intended use and substantially equivalent to predicate devices. These are not performance metrics like sensitivity/specificity, but rather material and mechanical properties.

Acceptance Criteria (Implied)	Reported Device Performance (Summary from Document)
Biocompatibility: Non-pyrogenic	"The subject device has been validated as non-pyrogenic."
Mechanical Strength/Durability (Stem Fatigue): Withstand cyclic loading without failure	"Stem fatigue testing" was carried out on worst-case sizes, implying satisfactory results to deem it safe for in-vivo use.
Mechanical Strength/Durability (Head Disassembly/Burst/Pull-Off): Secure attachment and integrity of head components.	"CoCr Head Disassembly Test," "Ceramic Head Static Burst Test," and "Ceramic Head Pull-Off Test" were carried out. Implies satisfactory results to ensure secure and functional head attachment.
Range of Motion: Allow adequate physiological movement of the hip joint.	"Range of motion testing" was carried out, implying satisfactory results for functional use.
Material Composition (CoCr per ASTM-F799): Conform to specified material standard.	"The Signature Orthopaedics' Cemented TSI Hip Stems are manufactured from Forged CoCr per ASTM-F799."
Fixation Method (Cemented): Suitable for specified implantation method.	"The Cemented TSI stem... intended for cemented use in total hip arthroplasty."
Substantial Equivalence: Demonstrate similar technological features and safety/effectiveness as predicate devices.	Extensive comparison of technological characteristics provided, stating same intended use, indications, materials (for cemented use), similar design, taper connection, and surface finish to predicates. Non-clinical testing results support the claim.

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

Sample Size: The document mentions "worst case sizes of the stems" were tested for performance (fatigue, head tests). It does not specify a numerical sample size (e.g., N=x units tested) for these mechanical tests.
Data Provenance: Not explicitly stated as "retrospective" or "prospective" as these terms usually apply to clinical or algorithm studies. The testing is non-clinical (benchtop) and conducted by the manufacturer, Signature Orthopaedics Pty Ltd, located in Lane Cove, NSW, Australia.

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

Not Applicable. This is a mechanical device, not an AI diagnostic algorithm. "Ground truth" in this context refers to established material properties and mechanical performance standards, verified through engineering tests, not human expert interpretation of images or clinical data.

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

Not Applicable. This concept applies to expert consensus in clinical data labeling for AI training/testing, which is not relevant for this mechanical device.

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. No MRMC study was done, as this is not an AI/imaging device designed to assist human readers.

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

Not Applicable. No standalone algorithm performance was assessed as there is no algorithm under review.

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

Implicit Ground Truth: For this device, the "ground truth" is defined by established engineering standards, material specifications (e.g., ASTM-F799), and biomechanical principles that dictate the functional requirements and safety of a hip implant. Performance is evaluated against these predefined, objective engineering benchmarks, not subjective human interpretation or clinical outcomes data in a study context (though long-term clinical performance is a general goal of such devices once marketed).

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not Applicable. As there is no training set for an AI model, this question is irrelevant to the device described.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

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

Re: K181340

Trade/Device Name: Cemented TSI Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI Dated: Mav 18, 2018 Received: May 21, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

February 11, 2019

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Daniel S. Ramsey -S 2019.02.11 15:14:33 -05'00'

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 STATEMENT 1

510(k) Number (if Known): _ K181340

Device Name: Cemented TSI Stem

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

Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve and Cemented TSI 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

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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2 510(K) SUMMARY

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device Trade Name:	Cemented TSI Hip Stem
Common Name:	Cemented Hip Replacement 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:	May 18th, 2018
Classification:	Class II per 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis (JDI)
Predicate Devices:	Primary Predicate• Signature Orthopaedics TSI Stem (K102172, re-branded from Global MSA)Additional Predicate• Signature Orthopaedics Evolve Stem (K133370)• Smith & Nephew Synergy Cemented Stem (K990369)Reference Predicate

Device Description:

Indications for Use:

. Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis

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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
o Failed previous hip surgery including internal fixation or joint fusion, hemiarthroplasty, surface replacement, or reconstruction, 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

Performance Testing:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Cemented TSI Hip Stems are adequate for anticipated in-vivo use. The following non-clinical testings were carried out on the worst case sizes of the stems:

. Range of motion testing
. Stem fatigue testing
CoCr Head Disassembly Test
. Ceramic Head Static Burst Test
. Ceramic Head Pull-Off Test

The subject device has been validated as non-pyrogenic.

Substantial Equivalence:

That Signature Orthopaedics' Cemented TSI stems have the same intended use, indication for use, materials and similar design features as the Signature Orthopaedics Evolve Stem (K133370), Smith & Nephew Synergy Cemented Stem (K990369) and the Signature Orthopaedics TSI Stem (K102172). Non-clinical testing results support the substantial equivalence claim.

Comparison of technological characteristics

Reconstructive total hip joint replacement is the technological principle for both the subject devices and the predicate devices. The subject and predicate devices are based on

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the following same technological elements:

. The indication for use of the subject devices is the same as one or more of the predicate devices
. The intended surgery sites of the subject devices matches the intended surgerv sites of at least one of the predicates
. The subject devices are manufactured from the same material as at least one of the predicates
. The subject devices are for use with cemented fixation, in line with at least one of the predicates
. The size range of the subject devices fall within the size range of the predicates
The taper connection is identical to at least one of the predicates
. The device design (profile) is similar to at least one of the predicates
. The surface finish is identical to at least one of the predicates

The following technological differences exist between the subject and predicate devices:

Some of the design features are different between the subject and predicate devices
The metallic material used on at least one of the predicates differs to what is used . in the subject devices
. The taper connection differs to at least one predicate device
The surface finish differs to at least one predicate device

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.