The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF systems are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The Brisbane and Gladstone ALIF systems may be used as stand-alone devices or in conjunction with supplemental fixation. When used as a stand-alone device the subject devices must be used with all three screws.

Device Description

The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF cages are manufactured from PEEK-OPTIMA LT1 per ASTM-F2026. The Screws for Brisbane and Gladstone ALIF cages are manufactured from Ti6A14V alloy per ISO 5832-3 and ASTM-F136.

The Brisbane and Gladstone ALIF cages consist of a wedge-shaped geometry and intended for implantation by an anterior approach. The cages are hollow to allow loading of bone graft. The cages are wedge shaped to restore lordosis of the fused vertebral bodies. The superior and inferior surfaces have serrated teeth to resist expulsion. The cages have three holes each on their anterior faces to facilitate the use of titanium bone screws. The use of the bone screws make the subject cages stand-alone cages. The superior and inferior surfaces of Brisbane ALIF cage is Titanium Plasma Spray (TPS) coated per ASTM-F1580.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for medical devices, specifically artificial intervertebral fusion devices (Brisbane ALIF Device, Gladstone ALIF Device). The information provided is for a physical medical device (an implantable cage for spinal fusion), not an AI/ML-based medical device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) is not applicable to this document.

The document discusses the mechanical and material performance testing of the device, which are the relevant acceptance criteria for this type of physical implant.

Here's a breakdown of the relevant information from the document regarding acceptance criteria and performance studies, adapted to the context of a physical device:

Acceptance Criteria and Device Performance for a Physical Implantable Device

Since this is a physical medical device (an intervertebral fusion device), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to its mechanical, material, and functional performance, not diagnostic accuracy or AI algorithm performance.

Here's how the information in the document aligns with your request, reinterpreted for a physical device:

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

The document lists the types of non-clinical tests performed, implying that the device met the acceptance criteria for these tests as defined by the ASTM standards. Specific numerical results or pass/fail thresholds are not detailed in this summary.

Acceptance Criteria (Test Type)	Reported Device Performance (Implied)
Cages (Worst Case - FEA identified):
Static and dynamic compression and compression shear (ASTM-F2077)	Adequate for anticipated in-vivo use (Met)
Subsidence (ASTM-F2267)	Adequate for anticipated in-vivo use (Met)
Screw insertion (ASTM-F543)	Adequate for anticipated in-vivo use (Met)
Screw pull-out (ASTM-F543)	Adequate for anticipated in-vivo use (Met)
Screw torque to failure (ASTM-F543)	Adequate for anticipated in-vivo use (Met)
Coating (Brisbane ALIF cage):
Powder Chemistry (ASTM-F1580)	Adequate for anticipated in-vivo use (Met)
Coating Chemistry (ASTM-F1580)	Adequate for anticipated in-vivo use (Met)
Coating Thickness (ASTM-F1854-09)	Adequate for anticipated in-vivo use (Met)
Percent Porosity (ASTM-F1854-09)	Adequate for anticipated in-vivo use (Met)
Coating Roughness (ASTM-F854-09)	Adequate for anticipated in-vivo use (Met)
Static Shear (ASTM-F1044-05)	Adequate for anticipated in-vivo use (Met)
Static Tensile (ASTM-F1147-05)	Adequate for anticipated in-vivo use (Met)
Shear Fatigue (ASTM-F1160-05)	Adequate for anticipated in-vivo use (Met)
Abrasion (ASTM-F1978-00)	Adequate for anticipated in-vivo use (Met)

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for each test. For mechanical testing, this typically refers to the number of devices or components tested according to the respective ASTM standards.
Data Provenance: The tests were "Non-clinical testing and engineering evaluations" conducted by Signature Orthopaedics Pty Ltd (located in Australia). The data is retrospective in the sense that it was generated prior to submission for regulatory review.

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

Not Applicable. This concept is relevant for AI/ML diagnostic devices where human experts establish ground truth for image interpretation. For a physical device, the "ground truth" is established by the physical properties and mechanical performance measured against industry standards (ASTM). The experts involved would be engineers and material scientists.

4. Adjudication method for the test set:

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus in human interpretation of data for AI/ML ground truth. For physical testing, adherence to a standard (e.g., ASTM) and internal quality control procedures guides the interpretation of results.

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. MRMC studies are for evaluating the performance of AI/ML diagnostic tools with human readers. This document describes a physical medical device.

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

Not Applicable. This refers to AI algorithm performance. The "performance" here is the physical device's mechanical and material properties.

7. The type of ground truth used:

Engineering Standards and Specifications: The "ground truth" for this physical device's performance is established by recognized engineering and material standards, specifically ASTM (American Society for Testing and Materials) standards. The manufacturer demonstrated that the device adheres to these standards, which are internationally recognized benchmarks for material and mechanical properties relevant to medical implants.

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of a physical medical device; this term is used for AI/ML model development.

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

Not Applicable. As above, no training set for a physical device.

In summary, the provided document is a regulatory submission for a physical medical implant, not an AI/ML software device. Therefore, many of the requested criteria related to AI/ML performance evaluation are not applicable. The document confirms that non-clinical testing (mechanical, material, and coating properties) was conducted according to relevant ASTM standards to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices.

Summary

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

November 29, 2017

Re: K172019

Trade/Device Name: Brisbane ALIF Device, Gladstone ALIF Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD 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) K172019

Device Name

Brisbane ALIF Device, Gladstone ALIF Device

Indications for Use (Describe)

X 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 TradeName:	Brisbane ALIF DeviceGladstone ALIF Device
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 Fusion Device(OVD)
PredicateDevices:	Primary Predicate:Spine MIDLINE II-TiTM (K141942)Additional Predicates:Benvenue Medical Inc Luna 360 Interbody System (K142023)K2M Chesapeake Spinal System (K133494)Spineart DYNAMIK Lumbar Interbody Device (K081888)Reference Predicate:Signature Orthopaedics NOOSA Anterior Lumbar Plate Screw(K163625)

Device Description:

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surfaces of Brisbane ALIF cage is Titanium Plasma Spray (TPS) coated per ASTM-F1580.

Indications for Use

Performance Testing:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Brisbane ALIF and Gladstone ALIF cages are adequate for anticipated invivo use. Non-clinical testings carried out on the worst case of the two systems as identified Finite Element Analysis (FEA) were:

Static and dynamic compression and compression shear testing per ASTM-F2077
. Subsidence testing ASTM-F2267
. Screw insertion testing per ASTM-F543
Screw pull-out testing per ASTM-F543
. Screw torque to failure testing per ASTM-F543

Also the coating on the Brisbane ALIF cage has undergone the following testings:

Powder Chemistry per ASTM-F1580
. Coating Chemistry per ASTM-F1580
. Coating Thickness per ASTM-F1854-09
. Percent Porosity per ASTM-F1854-09
. Coating Roughness per ASTM-F854-09
Static Shear per ASTM-F1044-05
. Static Tensile per ASTM-F1147-05
. Shear Fatigue per ASTM-F1160-05
Abrasion per ASTM-F1978-00

Substantial Equivalence:

The Brisbane and Gladstone ALIF cages have the same intended use, indication for use, materials and similar design as the Centinel Spine MIDLINE II-Ti™ (K141942), K2M Chesapeake Spinal System (K133494), Spineart DYNAMIK Lumbar Interbody Device (K081888), Benvenue Medical Inc Luna 360 Interbody System (K142023) and Signature Orthopaedics NOOSA Anterior Lumbar Plate Screw (K163625). Non-clinical testing results support the substantial equivalence decision. The subject devices are expected to perform adequately during clinical use.

Conclusion:

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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.