The Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws intended for use in fixation of soft tissue including ligament or tendon to bone for cruciate ligament reconstruction surgeries of the knee. The screws are also intended for use in the following procedures:

· ACL repairs
· PCL repairs
· Extra-capsular repairs
- · Medial collateral ligament
- Lateral collateral ligament
- · Posterior oblique ligament
· Patellar realignment and tendon repairs
- Vastus medialis obliquus advancement
· Illiotibial band tenodesis

Device Description

The PEEK RCI, Bio-Composite and SignaLoc Screws are interference screws which provide compression of the graft or tendon to the bony wall for biological fixation of the ligament, tendon or soft tissue to bone. The screws feature an internal cannulation to accept a guide wire and have the same drive feature. The screws have an external variable thread along the length of the tapered shape and a rounded head. Each screw is provided individually packaged sterile for single use. The PEEK RCI is manufactured from unreinforced PEEK and the SignaLoc and Bio-Composite is manufactured from a PEEK/Hydroxyapatite composite.

AI/ML Overview

The provided document is a 510(k) premarket notification decision letter from the FDA for the PEEK RCI, Bio-Composite, and SignaLoc Screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical performance testing. It does not describe a study involving an AI device or human-in-the-loop performance.

Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device, multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment for AI training sets is not applicable to this document.

However, I can provide the acceptance criteria and study information related to the non-clinical performance of the PEEK RCI, Bio-Composite, and SignaLoc Screws as detailed in the document.

Acceptance Criteria and Device Performance for PEEK RCI, Bio-Composite, and SignaLoc Screws (Non-Clinical)

The document primarily states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the PEEK RCI, Bio-Composite and Signaloc Screws are adequate for anticipated in-vivo use." The acceptance criteria for these tests are implied to be meeting the requirements and performance characteristics of the referenced ASTM and ISO standards, and demonstrating substantial equivalence to the predicate devices. Specific quantitative acceptance values are not explicitly stated in this FDA letter but would have been part of the manufacturer's detailed testing report.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Standard Reference	Reported Device Performance
Insertion Torque Testing	ASTM F543	Performance adequate for anticipated in-vivo use (meets standard requirements)
Torque to Failure Testing	ASTM F543	Performance adequate for anticipated in-vivo use (meets standard requirements)
Pullout Testing	ASTM F543	Performance adequate for anticipated in-vivo use (meets standard requirements)
Biocompatibility Evaluation	ISO 10993-1	Meets biocompatibility requirements
Pyrogenicity and Endotoxin Testing	AAMI ST72	Meets pyrogenicity and endotoxin requirements
Packaging and Shelf-Life Testing	ASTM F1980	Meets packaging and shelf-life requirements
Sterilization Validation	AAMI TIR 56, inclusive of EO and ECH Residual Testing per ISO 10993-7	Meets sterilization requirements (effective and residuals within limits)
Substantial Equivalence to Predicates	N/A (Comparative analysis)	Found substantially equivalent in intended use, indications for use, materials, design features, and sterilization to predicate devices.

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not specified in the provided document. Non-clinical testing typically involves a sufficient number of samples to ensure statistical validity per the relevant standards, but exact numbers are not disclosed here.
Data Provenance: The tests are non-clinical (laboratory/bench top) and engineering evaluations performed by the manufacturer, Signature Orthopaedics Pty Ltd. The country of origin for the data generation would be Australia (where the manufacturer is based) or potentially related testing facilities. The data is prospective in the sense that it was generated specifically for this submission to support the device's performance.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This document describes non-clinical performance testing of medical screws, not an AI device or a study requiring human expert ground truth for image interpretation or diagnosis.

4. Adjudication Method for Test Set:

Not applicable. As this is non-clinical bench testing, there is no "adjudication method" in the context of expert consensus or dispute resolution. The results are typically determined by calibrated equipment and adherence to standard protocols.

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

No. An MRMC study was not done as this is for a physical medical device (screws) and not an AI-assisted diagnostic or interpretative system.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used:

Not applicable in the context of expert consensus or pathology for clinical conditions. For non-clinical testing, the "ground truth" is established by the specifications and performance requirements defined in the referenced industry standards (ASTM, ISO, AAMI) and the properties of the predicate devices. The screws' ability to meet these specified physical and biological material properties serves as the ground truth.

8. Sample Size for Training Set:

Not applicable. This device is not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

Not applicable. This device is not an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K230655

Trade/Device Name: PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 21, 2023 Received: March 9, 2023

Dear Mr. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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,

Yu-chieh	Digitally signed byYu-chieh Chiu -S
Chiu -S	Date: 2023.05.0316:29:42 -04'00'

Yu-Chieh Chiu, Ph.D. Acting Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230655

Device Name

PEEK RCI, Bio-Composite and SignaLoc Screw

Indications for Use (Describe)

· ACL repairs
· PCL repairs
· Extra-capsular repairs
- · Medial collateral ligament
- Lateral collateral ligament
- · Posterior oblique ligament
· Patellar realignment and tendon repairs
- Vastus medialis obliquus advancement
· Illiotibial band tenodesis

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
	Signature Orthopaedics Europe LtdUnit A, IDA Business & Technology Park GarrycastleAthlone Westmeath N37 DY26Ireland
510(k) Number	K230655
Device Trade Name:	PEEK RCI, Bio-Composite and SignaLoc Screws
Common Name:	Fastener, Fixation, Non-degradable, Soft Tissue
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:	Tuesday, May 2, 2023
Classification:	Screw, Fixation, Bone (HWC, 21 CFR 888.3040)Fastener, Fixation, Nondegradable, Soft Tissue (MBI, 21 CFR888.3040)
Predicate Devices:	Primary Predicate Device• Smith & Nephew Biosure PK Interference Screw (K083635)Predicate Devices• Smith & Nephew BioRCI Screw (K032224)• Valeris Medical Apollo Suture Anchor System and Titan Screws (K142230)Reference Devices• Innovasis, Inc Px HA PEEK IBF System (K151785)

Device Description:

{4}------------------------------------------------

of the tapered shape and a rounded head. Each screw is provided individually packaged sterile for single use. The PEEK RCI is manufactured from unreinforced PEEK and the SignaLoc and Bio-Composite is manufactured from a PEEK/Hydroxyapatite composite.

Indications for Use:

The Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws are RCI screws intended for use in fixation of soft tissue including ligament or tendon to bone for cruciate ligament reconstruction surgeries of the knee. The screws are also intended for use in the following procedures:

ACL repairs ●
PCL repairs ●
Extra-capsular repairs .
- Medial collateral ligament 。
- o Lateral collateral ligament
- o Posterior oblique ligament
Patellar realignment and tendon repairs ●
- Vastus Medialis obliquus repairs o
. Illiotibial band tenodesis

Summary of Technological Characteristics:

The PEEK RCI, Bio-Composite and Signaloc Screws share the following technological characteristics as the predicate devices:

. The PEEK RCI, Bio-Composite and Signaloc Screws have the same intended use as the primary and secondary predicate devices.
. The PEEK RCI, Bio-Composite and Signaloc Screws have the same indications for use as the Smith & Nephew Biosure PK Interference Screw.
. The PEEK RCI Screws are manufactured from the same material as the Smith & Nephew Biosure PK Interference Screw and the Valeris Medical Apollo Suture Anchor System and Titan Screws. The Bio-Compoiste and Signaloc Screws are manufactured from the same material as the Innovasis Px HA PEEK IBF System.
. The PEEK RCI, Bio-Composite and SignaLoc Screws have the same internal cannulation for a guide wire as the primary and secondary predicate devices.
. The PEEK RCI, Bio-Composite and SignaLoc Screws share the same drive feature as the Biosure PK Interference Screw.
. The PEEK RCI, Bio-Composite and Signaloc and the Smith & Nephew Biosure PK Interference Screw and the Smith & Nephew BioRCI Screw have a hemispherical head and are tapered.
. The PEEK RCI, Bio-Composite and Signaloc Screws are sterilised by the same method as the Smith & Nephew BioRCI Screw.

The following are the technological differences between the PEEK RCI, Bio-Composite and Signaloc Screws, and the predicate devices:

The PEEK RCI, Bio-Composite and Signaloc Screws are sterilised by a different method to the Smith & Nephew Biosure PK Interference Screw.
. The Bio-Composite and Signaloc Screws is manufactured from a PEEK and hydroxyapatite composite where the Smith & Nephew Biosure PK Interference Screw is manufactured from only PEEK.
. The PEEK RCI, Bio-Composite and Signaloc Screws are indicated for ACL/PCL repair, where the Valeris Medical Titan Mini Inteference Screw is not, all other indications are shared by the devices.

{5}------------------------------------------------

The Innovasis Px HA PEEK IBF System is a Posterior Lumbar Interbody Fusion . (PLIF) device not an Interference Screw, but is a permanent tissue/bone contacting device of a similar length range and identical material as the Bio-Composite and Signaloc Screws.

Performance Data:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of the PEEK RCI, Bio-Composite and Signaloc Screws are adequate for anticipated in-vivo use. No animal or clinical testing was required to support substantial equivalence. Non-clinical testing carried out included:

. Insertion Torque Testing per ASTM F543
Torque to Failure Testing per ASTM F543 .
Pullout Testing per ASTM F543 .
. Biocompatibility Evaluation per ISO 10993-1
Pyrogenicity and Endotoxin Testing per AAMI ST72 ●
. Packaging and Shelf-Life Testing per ASTM F1980
Sterilization Validation per AAMI TIR 56, inclusive of EO and ECH Residual Testing . per ISO 10993-7.

Conclusion:

The subject devices are substantially equivalent to the predicate devices since it has the same intended use, indications for use, materials, design features, and sterilization to either all or one of the predicate devices. Non-clinical testing results support the substantial equivalence claim. Therefore, the subject devices are expected to perform adequately during clinical use.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.