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The AxCess® Expandable Interbody System is a lumbar intervertebral body fusion device and is indicated for spinal fusion procedures to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. The devices are intended for use at either one or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies for surgery should be skeletally mature and have had six months of conservative treatment.

The device is not intended to be used as a stand-alone device. For all the above indications the devices must be used with supplemental internal spinal fixation system that have been cleared for use in the lumbar spine, including Pedicle Screw and Hook Systems, and Spinal Plate Systems.

The AxCess® Expandable Interbody System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The AxCess® Expandable Interbody System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate per the patient's anatomical needs. AxCess® Expandable Interbody System implant is to be filled with autogenous bone graft and/or allograft.

The AxCess® Expandable Interbody System implants are manufactured from titanium alloy (Ti-6AI-4V ELI) components per ASTM F136 and cobalt chrome alloy (Co-28Cr-6Mo) components per ASTM F1537.

Here's an analysis of the provided FDA 510(k) summary regarding the AxCess® Expandable Interbody System, based on your requested framework. It's important to note that this document is a summary and often details about specific acceptance criteria and study methodologies, especially for software or AI-driven devices, are abbreviated or not explicitly stated in this format.

Key Observation: The provided document is for a mechanical medical device (intervertebral body fusion device), not a software or AI-driven diagnostic device. Therefore, many of your requested criteria, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "training set size/ground truth," are not applicable to this type of device and are not mentioned in the submission. The acceptance criteria here relate to physical performance and safety, not diagnostic accuracy.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study referenced is "non-clinical testing" which includes:

• Static and Dynamic Axial Compression per ASTM F2077
• Static and Dynamic Compression Shear per ASTM F2077
• Subsidence per ASTM F2267

The conclusion states that these tests demonstrate "the strength of the AxCess® [is] sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The specific details of the individual test results (e.g., actual load values, fatigue cycles) are not provided in this public summary but would have been part of the full 510(k) submission.

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

• Sample Size: Not explicitly stated. For mechanical testing, the "sample size" refers to the number of devices or components tested. This information is typically found in the full test report, not the summary.
• Data Provenance: Not applicable in the context of clinical data for AI/software devices. The provenance here refers to the materials used (Titanium alloy and Cobalt Chrome alloy) and the application of engineering standards (ASTM). The testing itself is laboratory-based non-clinical testing.

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

• This is not applicable as this is a mechanical device, not an AI/software diagnostic device that requires expert-established ground truth from medical images or clinical data. The "ground truth" for mechanical testing is defined by the ASTM standards and the physical properties of the materials and design.

4. Adjudication method for the test set:

• Not applicable for mechanical device testing. Adjudication typically refers to the process of resolving discrepancies among human readers or between AI and human disagreement in diagnostic studies. Mechanical tests are typically performed to engineering specifications.

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 a mechanical interbody fusion device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical device, not an algorithm. The "standalone performance" here would be its mechanical performance without human intervention, which is what the ASTM tests assess.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for this device's performance is established by recognized consensus standards like ASTM F2077 (Static and Dynamic Axial Compression) and ASTM F2267 (Subsidence). These standards define the test methods and performance requirements for intervertebral body fusion devices. The device's performance is compared against the performance of predicate devices tested to the same standards.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.

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

• Not applicable. (See #8)

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