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The Interbody Cage is 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 non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Interbody Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK) or titanium alloy. The devices are intended to be implanted either one device per level when used in the ALIF, Banana, or Lateral styles, and one or two devices per level when used in the PLIF/TLIF style.

Tantalum pins are embedded in the PEEK versions of the implants to help allow for radiographic visualization.

This document is a 510(k) premarket notification for an Interbody Cage and does not contain the specific type of detailed acceptance criteria and study results typically found in performance studies for AI/ML-driven medical devices. The device is a physical implant, not a software algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission.

However, I can extract the relevant "performance data" that addresses the device's equivalence to predicates, which serves as the "acceptance criteria" and "study" in the context of this 510(k) submission.

Here's a summary of the information that can be extracted, adapting the request to the nature of the provided document:

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

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

• The document mentions "worst-case size testing submitted as part of K113478" and "Additional testing (compression) per ASTMF F2077." However, it does not specify the sample size for these tests for the current submission or the original K113478.
• Data Provenance: The tests are likely prospective mechanical tests conducted on the manufactured devices/materials, rather than clinical data from human subjects. The country of origin of the data is not specified but is implicitly tied to the manufacturer/testing labs involved in the 510(k) process.

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

• Not Applicable. This is a mechanical device submission. "Ground truth" in the sense of expert clinical annotation is not relevant here. Engineering standards and physical measurements are used.

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

• Not Applicable. Mechanical testing against industry standards (e.g., ASTM F2077) does not involve adjudication in this manner.

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 is for a physical interbody fusion cage, not an AI-assisted diagnostic or therapeutic device.

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

• Not Applicable. This is for a physical interbody fusion cage.

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

• Based on engineering standards and physical properties: The "ground truth" for this device's performance evaluation lies in meeting established mechanical testing standards (e.g., ASTM F2077 for compression strength of intervertebral body fusion devices), material specifications (ASTM F2026, ASTM F560, ASTM F136), and demonstrating equivalence in design (geometry, footprint) to predicate devices. The goal is to show that the new variations (materials, sizes) do not introduce new safety or effectiveness concerns compared to already cleared devices.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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Lumbar System Indications: The Aurora Spine Interbody Fusion System devices are 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). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

Cervical System Indications: The Aurora Spine Interbody Fusion System is indicated for use as an intervertebral body fusion device 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 level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.

The Aurora Spine Interbody Fusion System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights and lordotic configurations with an open architecture to accept packing of autograft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.

The Aurora Spine Interbody Fusion System is a medical device, and its acceptance criteria are based on mechanical testing to demonstrate substantial equivalence to a predicate device. There is no clinical study involving human patients or AI reported in this document.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not applicable. The document describes non-clinical mechanical testing, not a test set of patient data.
• Data Provenance: Not applicable. The data is from mechanical testing performed on the device components, not from patient data.

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

• Not applicable. This device's acceptance is based on mechanical engineering standards, not expert clinical interpretation of data.

4. Adjudication method for the test set:

• Not applicable. As described, no human adjudication was involved in the mechanical testing for substantial equivalence.

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:

• No MRMC comparative effectiveness study was done. This document explicitly states, "Clinical data and conclusions were not needed for this device." There is no mention of AI.

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

• Not applicable. This is a physical medical device (interbody fusion system), not an algorithm or AI.

7. The type of ground truth used:

• The "ground truth" for this device's acceptance is adherence to established ASTM (American Society for Testing and Materials) standards for mechanical properties and the demonstration of substantial equivalence to a legally marketed predicate device (Tyber Medical Interbody System, K130573) based on these mechanical tests.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned or required for this type of device submission, as it involves mechanical testing and not machine learning or AI.

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

• Not applicable. As there is no training set, there is no corresponding ground truth establishment process.

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