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The Ali Interbody Fusion System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. The Ali Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Ali Interbody Fusion is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Ali Interbody Fusion System is used to provide structural stability and maintain disc space distraction during intervertebral body fusion in the lumbosacral spine. The Subject Device implants are fabricated from PEEK (ASTM F2026) or Titanium (ASTM F136) with Titanium endplates. The Ali Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surqical approach and patient anatomy. Each cage assembly has a hollow center to allow placement of autograft and/or allograft. Fixation ridges on the superior and inferior endplates of the device help to grip the endplates and prevent expulsion.

The provided text describes the 510(k) premarket notification for the Ali Interbody Fusion System, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria.

Therefore, many of the requested details related to acceptance criteria, specific performance metrics, sample sizes for testing and training, expert qualifications, and ground truth establishment are not explicitly present in the provided text.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the nature of a 510(k) submission for an intervertebral body fusion device, the acceptance criteria are generally related to demonstrating similar mechanical and material properties to a predicate device, as well as adherence to specific ASTM standards for the materials used and device design. The "reported device performance" in this context refers to the demonstration that the subject device meets these established characteristics compared to the predicate.

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

• Sample Size: Not specified in the provided text. The term "engineering analysis" suggests a series of tests on manufactured devices, but the number of units tested is not mentioned.
• Data Provenance: Not specified. The "engineering analysis" would typically be conducted in a laboratory setting by the manufacturer or a contract testing facility.

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

• Not applicable/Not specified. This type of information is usually relevant for AI/ML device studies where expert consensus is used to label data. For a mechanical device like an interbody fusion system, ground truth is established through engineering and material science principles (e.g., destructive testing, fatigue testing, static compression tests), not expert interpretation of outputs.

4. Adjudication method for the test set:

• Not applicable/Not specified. Adjudication methods (e.g., 2+1, 3+1) are common in studies involving human interpretation (e.g., radiology reads) to establish consensus on "ground truth." This is not relevant for the type of engineering performance testing described.

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. An MRMC study is not mentioned and is not relevant for this type of mechanical interbody fusion device. This device is 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 device is an implanted medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device, inferred from the "engineering analysis" and "comparison of characteristics," would be based on:
  • Material specifications: Adherence to ASTM standards (e.g., F2026 for PEEK, F136 for Titanium).
  • Mechanical performance standards: Comparison to the known, acceptable mechanical performance characteristics of the predicate device (e.g., strength, fatigue resistance, subsidence resistance) which are established through standardized biomechanical testing.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML device that requires a training set.

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

• Not applicable. This device is not an AI/ML device.

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