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The Wolff's Law Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:

• Degenerative Disc Disease (DDD) – as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;

• · Spondylolisthesis;
• Spinal Stenosis:
• · Trauma (including fractures);
• · Tumor;
• · Deformity (i.e., scoliosis, kyphosis, and/or lordosis);
• · Pseudoarthrosis; and
• · Failed previous fusions

The Spinal Simplicity Wolff's Law Anterior Cervical Plate System is a dynamic cervical plate designed for the anterior cervical spine (C2-C7). The Wolff's Law Plate System consists of one-level plates in multiple lengths with both fixed- and variable-angle screws. The plates are translatable and use a nitinol Compression Element to provide continuous compression at each level. The Wolff's Law Cervical Plate consists of components made from titanium alloy Ti6Al4V ELI per ASTM F136 and superelastic nitinol per ASTM F2063. The fixed and variable screws are made from Titanium alloy Ti6Al4V ELI per ASTM F136. The Anterior Cervical Plate System is provided to the end-user sterile and is single use.

The FDA 510(k) summary for the "Wolff's Law Anterior Cervical Plate System" describes non-clinical performance testing rather than a study involving an AI/CAD software device with specific acceptance criteria and human readers.

Therefore, I cannot provide information on the following as it is not present in the provided document:

• A table of acceptance criteria and the reported device performance for an AI/CAD device.
• Sample size used for the test set and data provenance.
• Number of experts used to establish the ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone performance (algorithm only) of an AI/CAD device.
• Type of ground truth used for an AI/CAD device.
• Sample size for the training set.
• How the ground truth for the training set was established.

However, based on the provided document, I can extract information related to the performance study of the Wolff's Law Anterior Cervical Plate System (a medical device, not an AI/CAD software):

1. Type of Study:
Non-clinical mechanical tests were performed to establish substantial equivalence for the Wolff's Law Anterior Cervical Plate System. Clinical performance testing was explicitly not performed for this submission.

2. Tests Performed and Guidance:
The study utilized FDA Guidance Document "Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff" and the following ASTM tests:

• ASTM F1717 Static Compression Bending
• ASTM F1717 Static Torsion
• ASTM F1717 Static Tension Bending
• ASTM F1717 Dynamic Compression Bending
• ASTM F543 Axial Screw Pullout/Pushout
• ASTM F2129 & ASTM F3044 Corrosion Testing
• ASTM F1877 Particulate Analysis
• ASTM F2004 Transformational Temperature

3. Purpose of the Study:
The purpose of these non-clinical tests was to demonstrate that the Wolff's Law Anterior Cervical Plate System is capable of performing as intended and is substantially equivalent to the legally marketed predicate device. The document explicitly states: "Performance testing device has mechanical performance substantially equivalent to that of the predicate."

4. Acceptance Criteria (Implied):
While not explicitly presented in a table in the provided text, the acceptance criteria for these mechanical tests are implicitly that the Wolff's Law Anterior Cervical Plate System must have mechanical performance substantially equivalent to the predicate device(s). This substantial equivalence is assessed against the standards outlined in the FDA Guidance Document and the specific ASTM standards listed. The document does not provide specific numerical thresholds or target values that define "substantial equivalence" in this summary.

5. Predicate Devices:
The predicate devices used for comparison are:

• K083020 DynaTran™ Anterior Cervical Plating (ACP) System
• K143626 SC-AcuFix® Ant-Cer Dynamic Cervical Plating System
• K051665 Synthes Vectra-T System

In summary, the provided document details non-clinical mechanical testing for a spinal implant, not an AI/CAD system. Therefore, most of the requested information regarding AI/CAD specific acceptance criteria and study details are not applicable or available in this text.

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