The Australis Spinal System is indicated for use as lumbar intervertebral body fusion devices for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The Australis Spinal System is intended to be used with autograft and/or allograft bone graft material comprised of cancellous and/or corticocancellous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Australis ALF cage. The Australis Spinal System is indended for use with supplemental fixation, such as the Prism Surgical Aurora® Anterior Lumbar Plate System.

Device Description

The Prism Surgical Designs Australis® Anterior Lumbar Interbody Fusion (ALIF) Cage System (also referred to as Australis® Spine System and Australis® Spinal System) implants are intended to replace lumbar interbody discs and to fuse adjacent vertebral bodies following anterior lumbar discectomy stabilization and/or alignment of the lumbar spine. The Australis® ALIF cage is designed to be implanted via an anterior approach to the spine. The devices consist of wedge-shaped geometry to restore lordosis of the fused vertebral bodies and serrated teeth with three titanium pins on the inferior and superior surfaces to resist expulsion The center of the device is hollow to accept autograft and/or allograft bone graft material comprised of cancellous and/or corticocancellous bone graft to promote arthrodesis. The Australis® ALIF Cage System is to be used in conjunction with supplemental fixation.

The Australis® ALIF is offered in a variety of footprints and heights to accommodate the anatomical needs of patients. The Australis® ALIF is manufactured from PEEK per ASTM F2026 with titanium pins per ASTM F136 and ISO 5832-3 and tantalum marker beads per ASTM F560 and ISO 13782.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Australis® Anterior Lumbar Cage System." It describes the device's indications for use, technological characteristics, and performance data from non-clinical testing.

Based on the provided document, the device is an intervertebral body fusion device, and the acceptance criteria and study focus on its mechanical performance for spinal fusion in a non-clinical setting.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format with specific thresholds. Instead, it refers to industry standards (ASTM) and a qualitative conclusion of "sufficiency" and "substantial equivalence" to predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Strength for Intended Use:
- Withstand static axial compression (per ASTM F2077)	"The results of this non-clinical testing show that the strength of the Australis® Anterior Lumbar Cage is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (This implies the device met or exceeded the performance of the predicate device under static axial compression.)
- Withstand static compression shear (per ASTM F2077)	"The results of this non-clinical testing show that the strength of the Australis® Anterior Lumbar Cage is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (This implies the device met or exceeded the performance of the predicate device under static compression shear.)
- Withstand dynamic axial compression (per ASTM F2077)	"The results of this non-clinical testing show that the strength of the Australis® Anterior Lumbar Cage is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (This implies the device met or exceeded the performance of the predicate device under dynamic axial compression.)
- Withstand dynamic compression shear (per ASTM F2077)	"The results of this non-clinical testing show that the strength of the Australis® Anterior Lumbar Cage is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (This implies the device met or exceeded the performance of the predicate device under dynamic compression shear.)
- Resist subsidence (per ASTM F2267)	"The results of this non-clinical testing show that the strength of the Australis® Anterior Lumbar Cage is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (This implies the device demonstrated adequate resistance to subsidence based on the standard.)
Equivalent to Predicate Devices:	"The overall technology characteristics and mechanical performance data lead to the conclusion that the Australis® Anterior Lumbar Cage System is substantially equivalent to the predicate device." (This is the overarching conclusion, implying all tested performance aspects are comparable to established predicate devices.) The predicate devices listed include K122639, K172349, K200541, K183705, and K200352. The document doesn't provide specific quantitative comparisons to each predicate for each test.

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

The document explicitly states: "The Australis® Anterior Lumbar Cage has been tested in the following test modes:..." and lists the ASTM standards. This implies non-clinical (bench) testing was conducted on physical samples of the device.

Sample Size: The document does not specify the precise number of devices tested for each mode. ASTM standards for mechanical testing often specify sample size requirements, but these are not cited in this summary.
Data Provenance: The testing is non-clinical, meaning it was performed in a laboratory setting, not on patient data. The manufacturer is based in Australia (Prism Surgical Designs Pty Ltd, Milton, Queensland), indicating the company's origin, though the testing itself could have been conducted anywhere. It's a prospective study in the sense that the tests were specifically designed and executed to evaluate the new device's performance against established standards and predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is not applicable to this type of study. This is a non-clinical, mechanical performance study, not a clinical study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists interpreting images). The "ground truth" for these tests is defined by the physical properties and behavior of the material and device under specified mechanical loads, as measured by testing equipment according to ASTM standards.

4. Adjudication Method for the Test Set

This question is not applicable as it relates to clinical studies where different interpretations might need to be resolved. In a mechanical performance study, the results are typically quantitative measurements that do not require adjudication.

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

This question is not applicable. This is a mechanical performance study of an intervertebral cage, not an AI-assisted diagnostic or interpretative device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This is a hardware device (spine cage), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this study is essentially the physical, measurable performance of the device under controlled mechanical test conditions, as defined by established ASTM standards. It's not based on expert consensus, pathology, or clinical outcomes data, as these are non-clinical bench tests. The comparative aspect is against the performance of predicate devices, which have already demonstrated sufficient mechanical integrity.

8. The Sample Size for the Training Set

This question is not applicable. Hardware devices like the Australis® Anterior Lumbar Cage System do not have "training sets" in the context of machine learning. The design and manufacturing processes are informed by engineering principles, material science, and the performance characteristics of predicate devices, rather than data-driven training.

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

This question is not applicable for the reasons stated above (no training set for a hardware device).

Summary

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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.

December 22, 2020

Prism Surgical Designs Pty Ltd % Nathan Wright, M.S. Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K202820

Trade/Device Name: Australis® Anterior Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 23, 2020 Received: October 28, 2020

Dear Mr. Wright:

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.

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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 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 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,

Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K202820

Device Name

Australis® Anterior Lumbar Cage System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	[X] Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY

Submitter's Name:	Prism Surgical Designs Pty Ltd
Submitter's Address:	15/43 Lang ParadeMilton, Queensland 4064 Australia
Submitter's Telephone:	+61 7 3720 8882
Contact Person:	Nathan Wright MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	September 23, 2020
Trade or Proprietary Name:	Australis® Anterior Lumbar Cage System
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

Prism Surgical Designs Australis® Anterior Lumbar Cage System

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cage. The Australis Spinal System is intended for use with supplemental fixation, such as the Prism Surgical Aurora® Anterior Lumbar Plate System.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are similar between the subject and predicates:

Indications for Use
Technological Characteristics ●
Materials of manufacture ●
Sizes

			Table 5-1 Predicate Devices
--	--	--	-----------------------------	--

510kNumber	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K122639	SynCage Evolution Spacer	DePuy Synthes Spine	Primary
K172349	InFill® Interbody Fusion Device	Pinnacle Spine Group, LLC	Additional
K200541	Hive™ Stand-alone AnteriorLumbar Interbody System	HD LifeSciences LLC	Additional
K183705	IndentiTi Porous Ti InterbodySystem	Alphatec Spine, Inc.	Additional
K200352	Axis Spine Technologies ALIF	Axis Spine Technologies Ltd	Additional

PERFORMANCE DATA

The Australis® Anterior Lumbar Cage has been tested in the following test modes:

Static axial compression per ASTM F2077 ●
Static compression shear per ASTM F2077 ●
Dynamic axial compression per ASTM F2077 ●
Dynamic compression shear per ASTM F2077 ●
. Subsidence per ASTM F2267

The results of this non-clinical testing show that the strength of the Australis® Anterior Lumbar Cage is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Australis® Anterior Lumbar Cage System is substantially equivalent to the predicate 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.