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The Zavation Z-Link Lumbar is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Z-Link Lumbar is to be filled with autogenous bone graft material.

The Zavation Z-Link Lumbar includes a PEEK spacer, titanium interbody plate and screws. The spacer component is assembled to an interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes four holes for inserting two bone screws in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.

The provided text describes a medical device, the "Zavation Z-Link Lumbar," and its 510(k) premarket notification. This document is a regulatory submission for a medical device and does not contain information about an AI/ML-based device. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device cannot be answered from this text.

The document discusses the substantial equivalence of a physical intervertebral body fusion device to predicate devices based on mechanical performance data.

Here's an analysis of what is available in the document, which pertains to the physical device rather than an AI/ML system:

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

The document states: "Mechanical test results demonstrated that the Zavation Z-Link Lumbar is substantially equivalent to the predicate devices." It also lists the ASTM standards used for testing:

• ASTM F2077, Test Methods for Intervertebral Body Fusion Devices
  • Static Axial Compression
  • Dynamic Axial Compression
  • Static Shear
  • Dynamic Shear
• ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
• ASTM Draft F04.25.02.02, Static Pushout Test Method for Intervertebral Body Fusion Devices.

However, the specific numerical acceptance criteria (e.g., minimum load, maximum displacement) and the exact reported performance values from these tests are not provided in this summary. The submission concludes that the device meets the criteria by stating "substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document pertains to mechanical testing of a physical device. "Test set" in the context of an AI/ML model's performance study does not apply here. For mechanical tests, the "sample size" would refer to the number of physical devices tested. This information is not provided in the document. Data provenance (country of origin, retrospective/prospective) is irrelevant for mechanical testing of a manufactured product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "ground truth" for a physical device's mechanical performance is established through standardized engineering tests, not by expert interpretation of data.

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

This question is not applicable. Adjudication methods are relevant for subjective interpretations (e.g., medical image reading) in clinical studies, not for objective mechanical performance 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 question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software.

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

This question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software.

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

The "ground truth" for this physical device is its mechanical performance as measured against established engineering standards (ASTM F2077, ASTM F2267, ASTM Draft F04.25.02.02).

8. The sample size for the training set

This question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software model that requires a training set.

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

This question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software model.

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