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The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Trauma (including fractures), 3) Tumors, 4) Deformity (defined as kyphosis, lordosis, or scoliosis), 5) Pseudarthrosis, and/or 6) Failed previous fusions.

The Remedy Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The REMEDY Cervical Plate System implant components are made from titanium alloy described by ASTM F136.

The REMEDY™ Cervical Plate System is a medical device designed for anterior interbody screw/plate fixation in the cervical spine. The device's acceptance criteria and the study proving its performance are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the REMEDY™ Cervical Plate System are based on demonstrating substantial equivalence to existing predicate devices through non-clinical mechanical testing, adhering to ASTM F1717 standards.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical tests (mechanical testing) for the device. For such tests, the "sample size" refers to the number of device samples (plates, screws, and system constructs) subjected to each specific test. The document does not specify the exact number of samples used for each test (e.g., how many plates were tested for static axial compression bending). However, adherence to ASTM F1717 typically involves testing multiple samples to establish statistical validity for the specified mechanical properties.

The data provenance is from laboratory testing, specifically mechanical tests conducted under controlled conditions to simulate physiological loads. There is no information regarding country of origin for the data, but it is standard for medical device testing to follow internationally recognized standards like ASTM. This is a prospective test in the sense that the new device was fabricated and then tested to meet defined criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to the provided device description. The REMEDY™ Cervical Plate System is a physical medical device (an implantable plate system), not a diagnostic algorithm or imaging device that requires expert interpretation to establish a "ground truth" for a test set. The performance is assessed through objective mechanical testing against established industry standards (ASTM F1717) and comparison to predicate devices, not through expert consensus on medical cases.

4. Adjudication Method for the Test Set

This section is not applicable as the device is a physical implant and its performance is determined by objective mechanical testing, not by human interpretation or clinical adjudication.

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 section is not applicable. The REMEDY™ Cervical Plate System is a surgical implant, not a diagnostic tool or AI-assisted system that would involve human readers or image interpretation. Therefore, an MRMC comparative effectiveness study is irrelevant to this device.

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

This section is not applicable. The REMEDY™ Cervical Plate System is a physical medical device, not an algorithm.

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

The "ground truth" for the REMEDY™ Cervical Plate System is based on established mechanical performance standards and material specifications as defined by ASTM F1717 and ASTM F136, respectively. The performance of the device samples in various mechanical tests (Static Axial Compression Bending, Dynamic Axial Compression Bending, and Static Torsion) serves as the "truth" against which the claims of substantial equivalence to predicate devices are made. The comparative performance against predicate devices, which have a history of safe and effective use, also forms part of this "ground truth."

8. The sample size for the training set

This section is not applicable. As a physical medical device, the REMEDY™ Cervical Plate System does not involve a "training set" in the context of machine learning or AI. Its design and manufacturing process are informed by engineering principles, material science, and the performance characteristics of existing predicate devices, rather than a data-driven training set.

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

This section is not applicable for the same reasons as #8. There is no "training set" or corresponding "ground truth" in the context of this physical medical device. The "ground truth" for its design and manufacturing would conceptually relate to foundational engineering principles, biomaterial science, and the performance history of similar devices.

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