(89 days)
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.
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.
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).
§ 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.