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, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin 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 hemi-hip 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' SS Cemented TSI Hip Stems are manufactured from High Nitrogen Stainless Steel per ASTM-F1568 and ISO 5832-9. The SS Cemented TSI stem is a highly polished anatomically curved stem with a round cross-section intended for cemented use in total hip arthroplasty. The Cemented TSI Hip Stems are compatible with Signature Orthopaedics' Ceramic Femoral Heads (per K121297).

AI/ML Overview

This document describes the FDA's clearance of the Signature Orthopaedics Cemented TSI Hip Stem (K192024). However, the provided text does not contain details about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML-enabled medical device.

The document primarily focuses on the regulatory clearance process for a traditional medical device (a hip stem), establishing its substantial equivalence to previously cleared predicate devices. The "Performance Testing" section mentions:

Stem fatigue and neck fatigue testing per ISO 7206-4 and ISO 7206-6.
Engineering evaluations to verify performance is equal to or better than the predicate device.
Validation as non-pyrogenic.

These are standard mechanical and biocompatibility tests for orthopedic implants, not performance studies for AI/ML algorithms.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving an AI device meets them based on the provided text. The document does not describe an AI/ML-enabled device or its associated performance studies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features an abstract image of a human figure. To the right of this is the FDA logo, which has the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 19, 2020

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

Re: K192024

Trade/Device Name: Cemented TSI Hip STem 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: LZO Dated: May 18, 2020 Received: May 20, 2020

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number K192024

Device Name: Cemented TSI Hip 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

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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APPENDIX E 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:	June 19th, 2020
Classification:	Class II per 21 CFR 888.3353: Hip jointmetal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (LZO)
Predicate Devices:	Primary Predicate• Signature Orthopaedics Cemented TSI Hip Stem(K181340)Additional Predicate• Signature Orthopaedics Evolve Hip Stem (K133370)

Device Description:

Indications for Use:

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

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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

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:

Stem fatigue and neck fatigue testing per ISO 7206-4 and ISO 7206-6 were performed on the subject device. Also, engineering evaluations were conducted to verify that the performance of the SS Cemented TSI is equal or better than the predicate device and therefore adequate for anticipated in-vivo use. The subject device has been validated as non-pyrogenic.

Substantial Equivalence:

The SS Cemented TSI Hip Stem has the same intended use, indications for use and same design as the Signature Orthopaedics CoCr Cemented TSI Hip Stem (K181340). The subject devices has the same material as the Signature Orthopaedics Evolve Hip Stem (K133370) and non-clinical testing demonstrated that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate (21 CFR 807.92(b)(3)).

Regulation Number and Section

N/A