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The Amplify Surgical DualXSLIM® T/PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. The Amplify Surgical DualXSLIM® T/PLIF is indicated for unilateral or bilateral implantation. The DualXSLIM® T/PLIF implants are intended for single use.

The purpose of this 510(k) is to offer the DualXSLIM® T/PLIF as additional sizes and lordosis options to the previously cleared DualX (K181397). The DualX implants are a family of expandable interbody fusion devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery. The DualXSLIM® T/PLIF implants are offered in a variety of sizes to accommodate patient anatomical needs. All implant components are manufactured from Ti-6A1-4V ELI per ASTM F136.

This document is a 510(k) summary for the Amplify Surgical DualXSLIM® T/PLIF intervertebral body fusion device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study of the device's diagnostic performance against specific acceptance criteria relevant to an AI/ML powered medical device.

Therefore, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies for an AI/ML device is not applicable or available in this document.

This document describes a traditional medical device (implant) and its mechanical performance testing, not a diagnostic AI/ML device.

Here's a breakdown of why each requested point is not applicable:

1. A table of acceptance criteria and the reported device performance: Not applicable. This document is for a physical implant, not an AI/ML diagnosis. It focuses on mechanical testing relative to standards (ASTM F2077, F2267) rather than diagnostic performance metrics (e.g., sensitivity, specificity).

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical "tests" (e.g., static/dynamic compression) on the device, not a test set for an algorithm. The "test sets" would be the manufactured devices themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no concept of "ground truth" established by experts in the context of mechanical testing for an implantable medical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to expert consensus for diagnostic ground truth, which is not relevant here.

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 AI-assisted diagnostic devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For mechanical tests, the "truth" is determined by the physical properties measured against engineering standards.

8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established: Not applicable, for the same reason as above.

In summary, this 510(k) document is for an intervertebral body fusion device and details mechanical performance testing, not the diagnostic performance of an AI/ML algorithm. Therefore, the specific questions related to AI/ML device performance and validation cannot be answered from this provided text.

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