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The Eminent Spine Fang Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

The Eminent Spine Fang Plate System consists of a plate and screw. The plate, which is available in two sizes (24nm and 27mm), is designed with an 8° bend to conform to the anatomy of the anterior spine to prevent migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Additionally, the plate features two "fangs" that prevent rotation, and a screw slot for final fixation. The 5.5mm screws are available in 20mm and 25mm lengths.

The provided text describes the "Eminent Spine Fang Plate System" and states that "Mechanical test results demonstrate that the Eminent Spine Fang Plate System is substantially equivalent to the predicate device." However, the document does not provide specific acceptance criteria or the detailed results of the study proving the device meets those criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or training set details as this information is not present in the provided text.

The available information only states:

• Study performed: Mechanical testing.
• Outcome: The Eminent Spine Fang Plate System was determined to be substantially equivalent to the MacroPore OS Spinal System (K010911) based on these mechanical test results.

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The Black Widow Anterior Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing applications.

The Black Widow Anterior Buttress Plate is designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Specific system features include: Plate uniquely shaped to conform to anterior spine anatomy. Two peas which engage the vertebral body and prevent rotation. An extremely low profile plate with a full radius around the perimeter and a screw that sits flush with the anterior surface of the staple. A self-tapping screw in multiple lengths. The devices are manufactured from Ti6Al4V per ASTM F136. The plates are designed to be used in spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.

The provided text describes a medical device submission (K081770 for the Black Widow Anterior Buttress Plate System) to the FDA. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria, expert adjudication, or AI performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and AI performance is not applicable to this document because it describes a mechanical device that underwent mechanical testing for substantial equivalence, not a machine learning or AI-driven diagnostic device.

Here's why the specific questions cannot be answered from the provided text:

• Acceptance Criteria & Reported Performance: The document states that "Mechanical test results, conducted in accordance with ASTM F1717, demonstrate that the Black Widow Anterior Buttress Plate System is substantially equivalent to the predicate device." It does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or exact device performance values from these mechanical tests. It only states the conclusion of substantial equivalence.
• Sample Size (Test Set) & Data Provenance: This pertains to clinical or imaging data. As this is a mechanical device, no such "test set" of clinical data was used for evaluation in this submission.
• Number of Experts, Qualifications & Adjudication Method: These are relevant for studies involving human interpretation or clinical outcomes. They are not applicable to the mechanical testing performed for this device.
• MRMC Comparative Effectiveness Study: This is specific to AI or diagnostic imaging studies comparing human reader performance with and without AI. Not applicable here.
• Standalone Performance (Algorithm Only): This refers to AI algorithm performance without human intervention. Not applicable as no AI is involved.
• Type of Ground Truth: Ground truth (e.g., pathology, expert consensus) is established for clinical conditions or diagnostic accuracy. For a mechanical device, the "ground truth" would be engineering specifications and physical properties, which are evaluated through mechanical tests (like ASTM F1717).
• Sample Size (Training Set): This refers to data used to train AI models. Not applicable as no AI is involved.
• How Ground Truth for Training Set was Established: Again, not applicable as no AI training occurred.

In summary, the provided document from a 510(k) premarket notification for a spinal implant describes mechanical testing for substantial equivalence, not an evaluation of an AI or diagnostic device that would involve the specific criteria outlined in your request.

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