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When used as an intervertebral body fusion device, the LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine Cervical Interbody Fusion System implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

When used as a vertebral body replacement device, the ROI-C and MC+ implants are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.

ROI-C consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the anchors.

The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) feature two slots which allow for use with specially designed (and optional) supplemental fixation - the ROI-C Anchoring Plate. The Anchoring Plate, made of titanium alloy (TiAl6V4) can be inserted to obtain fixation to the vertebral bone, by locking in place to the PEEK implant via Locking Tabs.

MC+ consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an open or enclosed graft space design. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the Anchoring Clip.

MC+ is intended to be used with supplemental internal fixation (i.e. anchoring clips). MC+ is designed for use with one Anchor Clip. The mechanism by which the Anchoring Clip locks into the MC+ device is achieved via the mating slot in the anterior face and the anti-backout tabs of the Anchoring Clip itself.

The provided text is a 510(k) Summary for the LDR Spine Cervical Interbody Fusion System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing and comparison of design, materials, and indications for use. It is not a clinical study report for an AI/ML medical device.

Therefore, the document does not contain the information required to populate the requested table and answer the study-specific questions for an AI/ML device. The "acceptance criteria" discussed are related to mechanical performance of an implantable medical device, not diagnostic or predictive performance of an algorithm.

Here's what can be extracted and a clear statement about the absence of other requested information:

Acceptance Criteria and Device Performance (Mechanical)

Explanation of Missing Information:

The provided document describes an intervertebral fusion system (an implanted medical device), not an AI/ML software device. Therefore, the following information is not applicable or not present in the provided text:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set of clinical data for an algorithm is mentioned. The "test set" refers to mechanical testing of the physical implant.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth established by expert consensus is relevant for diagnostic AI. This document does not describe such a process.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to mechanical testing of an implant.
• 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, as this is not an AI device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical implant, "ground truth" would relate to mechanical properties or biological outcomes, not diagnostic labels. The document mentions compliance with ASTM standards for mechanical testing.
• The sample size for the training set: Not applicable, as this is not an AI device.
• How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided text is a 510(k) summary for a physical medical implant (intervertebral fusion system), and as such, it does not contain the type of AI/ML device performance data, study design, or ground truth information that your questions are designed to elicit.

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