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The CoreLink Lateral Plate System (LPS) is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink LPS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Alternatively, the CoreLink LPS may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

The CoreLink Lateral Plate System (LPS) is comprised of a lumbar plate and screws. The lumbar plate has a sliding, spring loaded lock tab for each screw position to prevent back-out of the screw. The plate is available in a 2-screw or 4-screw version and in multiple lengths for single level fixation. The screws are available in various lengths and 2 diameters.

This document is a 510(k) premarket notification for a medical device, specifically a Spinal Intervertebral Body Fixation Orthosis. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance against a set of acceptance criteria for diagnostic or AI-driven systems.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these relate to AI/diagnostic device validation, are not applicable or extractable from this document.

The document discusses mechanical performance testing to demonstrate that the device is sufficient for its intended use and substantially equivalent to legally marketed predicate devices. However, this is not the type of performance data typically associated with the "device performance" and "acceptance criteria" structure you are asking about for AI/diagnostic devices.

Here's an attempt to fill in relevant sections based on the provided text, while explicitly noting where the requested information is not applicable due to the nature of the device (a spinal fixation system, not a diagnostic AI):

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

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

This information is not applicable as the document describes mechanical testing of a physical implant rather than a study involving human or animal subjects that generate data in the context of AI/diagnostic device validation. The "tests" refer to laboratory mechanical assessments of the device components.

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 information is not applicable. Ground truth, in the context of diagnostic or AI systems, is not relevant for the mechanical testing of a spinal fixation device.

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

This information is not applicable. Adjudication methods are typically used for expert review and consensus in diagnostic or AI studies and are not relevant for mechanical device testing.

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

There was no MRMC comparative effectiveness study done. This device is a passive spinal implant, not an AI-assisted diagnostic or treatment system involving human readers.

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

There was no standalone algorithm performance study done. This device is a passive spinal implant, not an algorithm.

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

This information is not applicable. "Ground truth" in the diagnostic/AI sense is not established for the mechanical properties of a spinal implant. The "truth" for this device lies in its adherence to established ASTM standards for mechanical strength and material composition.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this device is a physical implant, not an AI model requiring machine learning.

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

This information is not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

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The NuVasive Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The NuVasive Lateral Plate System consists of a variety of plates, screws, bolts, and Implant components can be rigidly locked to suit the individual locking nuts. pathology and anatomical conditions of the patient.

This document (K061789) is a 510(k) Premarket Notification for the NuVasive Lateral Plate System.

Based on the provided text, a conventional acceptance criteria and study that proves the device meets specific performance metrics, as one might find for software or diagnostic devices, was not conducted and is not present in this document. This document instead follows the regulatory pathway for medical devices seeking substantial equivalence to already legally marketed predicate devices.

Here's an breakdown of why the requested information isn't available and what was done instead:

Explanation of Absence of Requested Information for K061789

The provided document is a 510(k) Premarket Notification, which is a regulatory submission to the FDA. For devices seeking clearance via the 510(k) pathway, the primary goal is to demonstrate "substantial equivalence" to a predicate device already on the market. This typically involves comparing device features, intended use, materials, and technological characteristics, and often includes non-clinical performance testing (e.g., mechanical testing). It generally does not require de-novo clinical studies with acceptance criteria based on performance metrics like sensitivity, specificity, or reader improvement.

Specifically, the document states:

• "H. Summary of Clinical Tests (Not Applicable)." (Page 1) This explicitly indicates that no clinical trials were performed to demonstrate performance in humans for this submission.
• "Data was provided which demonstrated the NuVasive Lateral Plate to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function." (Page 1) This is the core of a 510(k) submission.

Therefore, the following requested sections cannot be filled from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable; no such criteria or performance reporting for clinical metrics are present.
2. Sample sized used for the test set and the data provenance: Not applicable; no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set requiring expert ground truth was used.
4. Adjudication method: Not applicable; no clinical test set requiring adjudication was used.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable; no clinical study was performed.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable; this device is a physical implant, not an algorithm.
7. The type of ground truth used: Not applicable; no clinical ground truth was established for performance metrics.
8. The sample size for the training set: Not applicable; this device is a physical implant, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable; this device is a physical implant, not an AI/ML algorithm requiring a training set.

What Was Done Instead (Based on the Document):

The substantial equivalence was demonstrated through:

• Comparison of Indications for Use: The NuVasive Lateral Plate System has indications for use that are considered equivalent to predicate devices for spinal instability due to various conditions (fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous surgery) in thoracic, thoracolumbar, lumbar, and lumbosacral regions.
• Design, Material, and Function Equivalence: The document states that "substantial equivalence is based upon equivalence in indications for use, design, material, and function." This implies that the design of the plates, screws, bolts, and locking nuts, the materials used for these components, and how they function (e.g., interlocking mechanisms, stability) were demonstrated to be similar enough to predicate devices.
• Non-Clinical Tests: "Mechanical testing was presented." This is the primary form of 'testing' mentioned for physical implants in a 510(k). This testing would typically assess aspects like fatigue strength, pull-out strength, bending stiffness, and torsional rigidity to ensure the device can withstand physiological loads and perform its intended mechanical function safely, similar to predicate devices. The specific acceptance criteria and results of these mechanical tests are not detailed in this summary document but would have been part of the full 510(k) submission.

In summary, this document is a regulatory clearance letter and summary for a physical medical device. It relies on demonstrating substantial equivalence and mechanical testing, not clinical studies with performance acceptance criteria as typically seen for diagnostics or AI/ML devices.

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