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The Anterior Spine Truss System (STS) Interbody Fusion Device is indicated for use in skeletally mature patients with 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.

This document describes a 510(k) premarket notification for a medical device called the "Anterior Spine Truss System (STS) Interbody Fusion Device." This device is an intervertebral body fusion device made from Ti6Al4V alloy, designed with an open architecture truss to support bone growth and fusion. It's intended for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, and must be used with supplemental fixation and bone graft.

Based on the provided text, the document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering performance testing (mechanical, MR compatibility). It does NOT describe a clinical study involving human patients, nor a study on an Artificial Intelligence (AI) device.

Therefore, I cannot provide information on acceptance criteria and study details related to an AI/Machine Learning device's performance against human readers or standalone performance, expert ground truth establishment, or sample sizes for training/test sets in the context of an AI study.

The acceptance criteria and "study" described in this document are related to the physical properties and mechanical performance of the implied medical device itself, not an AI component.

Here's what can be inferred about the "acceptance criteria" and "study" from the provided text, related to the physical device:

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

The document doesn't provide a direct table of specific acceptance limits alongside the exact numerical results for each test. Instead, it lists the performance standards that the device was tested against. The "reported device performance" is implicitly that the device met these standards, allowing for a finding of substantial equivalence.

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

• Sample size: Not applicable in the context of a clinical study or AI model test set. For mechanical and MR testing, "samples" would refer to the number of physical devices tested to statistically demonstrate compliance with the standards. This specific number is not provided in the document, but it's typically a small number of devices (e.g., 5-10 per test) as per the individual ASTM standards.
• Data provenance: Not applicable. These are engineering tests performed on the device itself, not on patient data.

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 there is no "ground truth" in the context of a clinical or AI study. The "ground truth" for the device's performance is established by the engineering standards themselves and the results of the physical tests.

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

This is not applicable as there are no expert readers or interpretations to adjudicate in these engineering and MR compatibility tests.

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 is not applicable. This document describes an interbody fusion device, not an AI or imaging diagnostic device that would involve human readers.

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

This is not applicable. This document describes a physical medical implant, not an algorithm.

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

The "ground truth" for this device's performance is compliance with established engineering and material standards (ASTM standards), demonstrated through physical testing of the device.

8. The sample size for the training set:

This is not applicable as there is no training set mentioned for an AI model.

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

This is not applicable as there is no training set mentioned for an AI model.

In summary, this document is a 510(k) submission for a physical medical device (an interbody fusion device) and does not involve AI or machine learning technology, nor does it describe a clinical study with human patients in the typical sense of evaluating diagnostic or treatment effectiveness through patient outcomes. The "study" refers to the engineering performance testing to demonstrate the device meets predefined physical and material requirements.

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