The Signature Orthopaedics Arlington PLIF/TLIF system is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of nonoperative treatment prior to surgery. The device is to be used with autogenous bone graft. The Arlington PLIF/TLIF is used to facilitate fusion in the lumbar spine and are placed using either a PLIF or TLIF approach. Arlington PLIF/TLIF system is intended for use with supplemental internal fixation products.

Device Description

The Signature Orthopaedics Arlington PLIF/TLIF cages are manufactured from PEEK OPTIMA LT1 per ASTM-F2026.

The Arlington PLIF/TLIF cage is intended for implantation by a posterior or transforminal approach. The device consists of a rectangular cage geometry with a bulleted tip to ease insertion and serrated teeth on the inferior and superior surfaces to resist expulsion from the disc space. The center of the cage is hollow to allow loading of bone graft.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Arlington PLIF/TLIF Cage, an intervertebral body fusion device. The purpose of this notification is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request, highlighting what information is available and what is not available within this document:

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

The document provides the following:

Acceptance Criteria (Standard)	Reported Device Performance (Testing Conducted)
ASTM-F2077 Test Method for Intervertebral Body Fusion Devices	Static and dynamic axial compression and compression shear testing
ASTM-F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression	Subsidence testing

Detailed reported performance (e.g., specific load values, deflection, or subsidence measurements) is NOT provided in this document. The document only states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Arlington PLIF/TLIF is adequate for anticipated in-vivo use" and "Non-clinical testing results support the substantial equivalence decision." This implies that the device met the requirements of the standards, but the specific numerical outcomes are absent.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size: Not specified. The document states "non-clinical testing and engineering evaluations" were conducted, but does not mention how many test samples (e.g., cages) were used for each test.
Data provenance: Not explicitly stated as retrospective or prospective given this is non-clinical performance testing. The manufacturer is Signature Orthopaedics Pty Ltd from Australia, implying the testing was conducted either in Australia or at an accredited testing facility that may be in another country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document describes non-clinical, mechanical performance testing of an implantable device, not a diagnostic or AI-driven device that requires human expert review for "ground truth."

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

Not applicable. As above, this is mechanical testing, not a study involving human adjudication of clinical data.

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. This notice is for a physical implant (intervertebral cage), not an AI diagnostic or assistance tool. Therefore, no MRMC study or AI-related effectiveness is mentioned or relevant here.

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

Not applicable. This is for a physical medical device, not an algorithm or software.

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

For mechanical testing, the "ground truth" refers to the established standards and specifications (ASTM-F2077 and ASTM-F2267) and the physical properties and behavior of the materials and device under controlled testing conditions. There is no biological or expert consensus "ground truth" as would be for diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

Not applicable. No training set is involved.

Summary of available information:

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on material composition, intended use, indications for use, and a statement that non-clinical mechanical performance testing (static/dynamic axial compression, compression shear, and subsidence testing) against specific ASTM standards (F2077, F2267) was conducted and supported equivalence. However, it does not provide the detailed quantitative results of these performance tests, nor does it address evaluation criteria relevant to AI/diagnostic devices.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.

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

November 29, 2017

Re: K172020

Trade/Device Name: Arlington PLIF/TLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 27, 2017 Received: October 30, 2017

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 (21 CFR Part 807); labeling (21 CFR Part 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);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

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

510(k) Number (if known) K172020

Device Name Arlington PLIF/TLIF Cage

Indications for Use (Describe)

The Signature Orthopaedics Arlington PLIF/TLIF system is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have at least six months of nonoperative treatment prior to surgery. The device is to be used with autogenous bone graft. The Arlington PLIF/TLF is used to facilitate fusion in the lumbar spine and are placed using either a PLIF or TLIF approach. Arlington PLIF/TLIF system is intended for use with supplemental internal fixation products.

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)

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2 510(K) SUMMARY

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device Trade Name:	Arlington PLIF/TLIF Cage
Common Name:	Lumbar Intervertebral Fusion Device
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 29th, 2017
Classification:	Class II per 21 CFR 888.3080: Intervertebral Body FusionDevice (MAX)
Predicate Devices:	● Primary Predicate:● DePuy Concorde Curve (K101923)● Additional Predicates:● Spineart DYNAMIK Lumbar Interbody Device (K081888)● DePuy Lumbar I/F (P960025).

Device Description:

The Signature Orthopaedics Arlington PLIF/TLIF cages are manufactured from PEEK OPTIMA LT1 per ASTM-F2026.

Indications for Use:

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spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of nonoperative treatment prior to surgery. The device is to be used with autogenous bone graft. The Arlington PLIF/TLIF is used to facilitate fusion in the lumbar spine and are placed using either a PLIF or TLIF approach. Arlington PLIF/TLIF system is intended for use with supplemental internal fixation products.

Performance Testing:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Arlington PLIF/TLIF is adequate for anticipated in-vivo use. Nonclinical testings carried out on the Intervertebral Fusion Devices mentioned above were:

. Static and dynamic axial compression and compression shear testing
Subsidence testing ●

Standard Used for Performance Testing

ASTM-F2077 Test Method for Intervertebral Body Fusion Devices
. ASTM-F2267 Standard Teest Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Substantial Equivalence:

The Arlington PLIF/TLIF cage has the same intended use, indications for use, materials and similar design as the DePuy Concorde Curve (K101923), Spineart DYNAMIK Lumbar Interbody Device (K081888) and DePuy Lumbar I/F (P960025). Non-clinical testing results support the substantial equivalence decision. The subject devices are expected to perform adequately during clinical use.

Conclusion:

Technical comparison of the subject and predicate devices demonstrates substantial equivalence in device design, intended use, indications for use and material. Non-clinical data support the substantial equivalence of the device.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.