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The SurgTech Interbody System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery and may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbar spine.

The SurgTech Interbody System is a system of intervertebral body fusion devices. The Posterior Lumbar device is a structural column in a generally rectangular shape having a rounded nose. Teeth are integral to the inferior and superior surfaces and there is a central cavity to be filled with autograft. The implants are available in an assortment of footprint, height and angulation combinations to accommodate a variety of anatomic requirements.

The provided text describes a 510(k) premarket notification for a medical device called the "SurgTech Interbody System." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific clinical acceptance criteria through a study with performance metrics.

Therefore, many of the requested details about acceptance criteria, study sample sizes, expert ground truth, adjudication methods, and MRMC studies are not applicable or available within this type of regulatory submission.

However, I can extract information regarding the performance testing that was conducted:

1. Table of acceptance criteria and reported device performance:
   The document does not specify quantitative acceptance criteria. Instead, it states that the device's performance was compared to predicate devices.

   Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
   Not specified (Qualitative: Substantially equivalent to predicate)	Not specified (Qualitative: Demonstrated substantial equivalence to predicate)

   Performance Testing Details Provided:

   • Mechanical Testing: Performed on the "worst case" SurgTech Interbody System device according to ASTM F2077. This included static and dynamic compression.
   • Subsidence Testing: Performed on the "worst case" SIS PL device according to ASTM F2267.
   • Conclusion: "The mechanical test results demonstrate that the SurgTech Interbody System performance is substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance: Not applicable. This was mechanical testing, not a clinical study on a patient test set. The provenance is internal testing by SurgTech Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was mechanical engineering testing, not clinical evaluation requiring expert ground truth.

4. Adjudication method for the test set: Not applicable.

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 not an AI-enabled device and no MRMC study was performed.

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

7. The type of ground truth used: For the mechanical tests, the "ground truth" was established by adherence to and successful completion of specified ASTM standards (ASTM F2077 for static/dynamic compression and ASTM F2267 for subsidence). The "substantial equivalence" claim is relative to the performance of predicate devices under similar testing.

8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device. The testing was physical mechanical testing.

9. How the ground truth for the training set was established: Not applicable.

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