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, Pegasus and Spartan 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 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

Signature Orthopaedics' Spartan Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. The Spartan Stem has a triple tapered geometry and features a titanium and hydroxyapatite plasma spray proximal coating below its resection line for cementless fixation in total hip arthroplasty.

AI/ML Overview

This document is a 510(k) premarket notification from Signature Orthopaedics Pty Ltd. for their Spartan Hip Stem. It establishes substantial equivalence to predicate devices based on indications for use, material, design, and non-clinical performance testing.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

Critical Observation: The provided document is for a medical device (hip stem prosthesis), not a software or AI-based diagnostic device. Therefore, the questions regarding AI/software performance metrics like "acceptance criteria table with device performance," "sample size for test set," "ground truth establishment," "MRMC study," and "standalone algorithm performance" are not applicable in the context of this device.

The acceptance criteria and performance evaluation for a hip stem prosthesis primarily revolve around mechanical properties, biocompatibility, and intended use, verified through non-clinical (and sometimes clinical) testing as described below.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, acceptance criteria relate to its physical and functional performance, materials, and design, rather than diagnostic accuracy.

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Conclusion
Mechanical Performance	Range of Motion Testing (per ISO 21535)	Performed. (Implicitly, the device met the standards of ISO 21535 for range of motion, as no issues are raised regarding this.)
	Stem and Neck Fatigue FEA (Finite Element Analysis)	Performed. (Implicitly, the FEA results supported the device's fatigue performance, indicating it can withstand anticipated loading.)
	Stem and Neck Fatigue Testing	Performed. (Implicitly, the physical fatigue testing demonstrated the stem and neck's ability to endure cyclic loading without failure within the expected lifespan.)
	CoCr Head Disassembly Test	Performed. (Implicitly, the CoCr head showed adequate resistance to disassembly, indicating secure attachment during use.)
	Ceramic Head Static Burst Test, Fatigue and Post-Fatigue Burst Test	Performed. (Implicitly, the ceramic heads met burst strength requirements both initially and after fatigue, demonstrating structural integrity.)
	Ceramic Head Pull-Off and Torsion Test	Performed. (Implicitly, the ceramic heads exhibited sufficient resistance to pull-off and torsional forces, ensuring stable connection.)
Biocompatibility	Non-pyrogenic Validation	The subject device has been validated as non-pyrogenic. (This means it does not induce fever, indicating good biocompatibility.)
Material Compliance	Material Composition	Manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. (This confirms compliance with established international and American standards for implantable titanium alloys.)
Design Characteristics	Triple Tapered Geometry	The Spartan Stem has a triple tapered geometry. (This is a design feature, not directly an acceptance criterion in itself, but its performance in the mechanical tests would confirm the acceptability of this design.)
	Titanium and Hydroxyapatite Plasma Spray Proximal Coating	Features a titanium and hydroxyapatite plasma spray proximal coating below its resection line for cementless fixation. (This is a design feature intended for bone ingrowth and fixation. Its effectiveness is indirectly supported by the overall substantial equivalence claim for a cementless device.)
Intended Use	Cementless Fixation Only	Intended for cementless fixation only. (This aligns with its design features and distinguishes it from cemented stems, and is consistent with the predicate device.)
Labeling/Indications	Indications for Use Alignment	The Spartan Stem has the same indications for use as its predicate devices. These include various degenerative conditions, inflammatory disease, functional deformity, traumatic injury, and failed previous hip surgery. (This is a key element for claiming substantial equivalence and indicates the device is suitable for the same patient population and clinical scenarios as already cleared devices.)

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

Since this is a mechanical device, not a software intended for diagnostic interpretation:

Test Set Sample Size: Not in terms of 'cases' or 'patient data'. Instead, the "sample size" would refer to the number of physical device units tested for each mechanical test (e.g., how many stems for fatigue testing). This specific number is not explicitly stated in the provided document, but it's understood to be sufficient to demonstrate statistical validity for the type of engineering tests conducted.
Data Provenance: The tests are "non-clinical testing and engineering evaluations" conducted by the manufacturer, Signature Orthopaedics Pty Ltd., which is based in Australia. The data is derived from laboratory-based, prospective mechanical and material testing of the device prototypes. No patient or human data is involved.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable for a hip stem prosthesis. "Ground truth" in this context is established by engineering standards and validated material properties, not by expert medical interpretation of images or patient data. The experts involved would be engineers, material scientists, and quality control specialists performing the tests and comparing results against established ISO/ASTM standards. Their qualifications would be in biomechanics, materials science, and mechanical engineering.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication (e.g., 2+1, 3+1 for clinical consensus) is used for clinical data interpretation or image reading tasks. For engineering test results, the "adjudication" is against pre-defined engineering pass/fail criteria and adherence to relevant industry standards (e.g., ISO, ASTM). Test results either meet the specification or they don't; there isn't a subjective "adjudication" process as there would be for clinical endpoint determination or image truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI or new imaging techniques on human reader performance for diagnostic tasks. Since the Spartan Hip Stem is a physical implant, not a diagnostic tool, such a study would be irrelevant. The substantial equivalence claim is based on engineering principles and performance comparable to existing cleared devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study was not done. This term applies to the performance of an AI/algorithm without human intervention in a diagnostic workflow. It's irrelevant to a hip stem. The "standalone performance" of the hip stem is its mechanical performance and safety, which was evaluated through the non-clinical tests listed.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is:

Engineering Standards and Specifications: Adherence to established international and national standards for orthopedic implants (e.g., ISO 21535, ISO 5832-3, ASTM F136).
Material Properties: Verified material characteristics (e.g., Ti6Al4V composition, non-pyrogenicity).
Predicate Device Performance: The "ground truth" for substantial equivalence is that the new device performs similarly and is as safe and effective as the legally marketed predicate devices, as demonstrated by meeting comparable engineering performance metrics.

8. Sample Size for the Training Set

This concept is not applicable. "Training set" refers to data used to train machine learning models. A hip stem device does not have a "training set" in this sense. Its design and manufacturing processes are based on established engineering principles, material science, and experience with previous hip implant designs and their long-term clinical outcomes (which inform the design specifications, but not through a machine learning "training" process).

9. How the Ground Truth for the Training Set was Established

As "training set" is not applicable, the establishment of "ground truth" for a non-existent training set is also not applicable. The underlying engineering knowledge and design parameters that guide the creation of such a device are based on decades of biomechanical research, clinical data from existing implants, and material science, all contributing to the design and testing specifications used.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 5, 2020

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

Re: K192883

Trade/Device Name: Spartan 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: July 1, 2020 Received: July 8, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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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1 INDICATIONS FOR USE STATEMENT

510(k) Number (if Known): K192883

Device Name: Spartan 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

Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus and Spartan 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 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 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)

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2 510(K) SUMMARY

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device TradeName:	Spartan Hip Stem
Common Name:	Cementless 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:	1st of July, 2020
Classification:	Class II as per 21 CFR 888.3353 Hip jointmetal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (MEH)Class II as per 21 CFR 888.3353 Hip jointmetal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis. (LZO)
Predicate Devices:	Primary Predicate• DePuy's Actis Stem (K150862, K160907)Additional Predicate• Signature Orthopaedics' Origin Stem (K121297, K161155)• Signature Orthopaedics' Logical C-Series Shell (K153131)• Signature Orthopaedics' Cemented TSI Stem (K181340)

Device Description:

Signature Orthopaedics' Spartan Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. The Spartan Stem has a triple tapered

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geometry and features a titanium and hydroxyapatite plasma spray proximal coating below its resection line for cementless fixation in total hip arthroplasty.

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' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, ioint 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
o Certain high subcapital and femoral neck fractures in the elderly
. Degenerative arthritis involving only the femoral head

Summary of Technological Characteristics:

The Spartan Hip Stem shares the following technological characteristics as its predicate devices:

. The Spartan Stem is intended for cementless fixation which is the same intended use as one or more of the predicate devices.
The Spartan Stem has the same indications for use as its predicate devices.
. The Spartan Stem is manufactured from the same materials as its predicate devices.
The Spartan Stem has the same proximal coating as Signature Orthopaedics' Logical C-Series Shell.
. The Spartan Stem's taper connection is identical to Signature Orthopaedics' Origin Stem and Cemented TSI Stem.

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The Spartan Stem has the same femoral head options as Signature Orthopaedics' Origin Stem and Cemented TSI Stem.
. The Spartan Stem's geometry is similar to DePuy's Actis Stem.
. The Spartan Stem has the same size range as DePuy's Actis Stem.

The following are the technological differences between the Spartan Stem and its predicate devices:

. Some of the Spartan Stem's design features differ from the predicate devices.
The Spartan Stem's coating differs from Signature Orthopaedics' Origin Hip Stem.
The Spartan Stem's trunnion surface finish differs from Signature Orthopaedics' Cemented TSI Stem.

Performance Testing:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Spartan Hip Stem is adequate for anticipated in-vivo use. No animal or clinical testing was required to support substantial equivalence. Non-clinical testing carried out included:

Range of Motion testing as per ISO 21535
. Stem and Neck Fatigue FEA
. Stem and Neck Fatigue Testing
. CoCr Head Disassembly Test
Ceramic Head Static Burst Test, Fatigue and Post-Fatigue Burst Test
. Ceramic Head Pull-Off and Torsion Test

The subject device has been validated as non-pyrogenic.

Substantial Equivalence Conclusion:

Signature Orthopaedics' Spartan Stem has the same intended use, indications for use, material and similar design features as DePuy's Actis Stem (K150862 and K160907), and Signature Orthopaedics' Origin Stem (K121297), Logical C-Series Shell (K153131) and Cemented TSI Stem (K181340) and non-clinical testing support the substantial equivalence claim.

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.