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The Mecta-C 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 spine fusions with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) psuedarthrosis, and/or 6) failed previous fusion. This device system is intended for anterior cervical intervertebral body fusions only.

The Mecta-C Cervical Plate consists of single and multilevel plates up to four levels used to stabilize the cervical spine in order to promote fusion. The cervical plates are offered with lengths between 20 and 92mm and are made of Ti6AI4V ELI (ISO 5832-3/ASTM F 136). The plate is fixed on the vertebral body either by means of fixed angle or variable angle screws. Screws are available in 4mm and 4.5mm diameters with a length between 12mm and 22mm. The screws consist of an inner locking screw and the outer main screw shaft and are available with a self-tapping or a self-drilling tip. The main screw shaft is made of Ti6AI4V ELI (ISO 5832-3/ASTM F 136) and the locking screw is made of Ti6Al4V ELI (ISO 5832-3/ASTM F 136). The cervical plates and screws are available both in sterile and unsterile packaging.

This document describes the Mecta-C Cervical Plate, a medical device for stabilizing the cervical spine. The acceptance criteria and the study proving it meets these criteria are based on biomechanical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The study conducted was a series of biomechanical tests designed to demonstrate the "substantial equivalence" of the Mecta-C Cervical Plate to existing predicate devices.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not specify the exact number of samples (implants) tested for each biomechanical test. However, it indicates that "tests were performed on a two level construct as suggested in the ASTM F1717 standard," and "the Mecta-C Cervical Plate was tested using the worst-case device for each of the following tests." This implies that multiple constructs were tested to determine the "worst-case" and then that configuration was used for the formal tests.
• Data Provenance: The study was conducted as part of a 510(k) premarket notification for regulatory clearance. The country of origin of the data is not explicitly stated, but the applicant/sponsor is Medacta International SA from Switzerland, with a contact in the USA. The tests follow international standards (ASTM F1717) and FDA guidance, suggesting a globally recognized testing methodology. The data is retrospective in the sense that the performance of the device was evaluated after its design and manufacturing, but within a controlled, laboratory setting.

3. Number of Experts and Qualifications for Ground Truth Establishment

This section is not applicable to this type of device and study. The "ground truth" for a mechanical device like a cervical plate is based on objective, quantifiable physical and mechanical properties, not expert clinical interpretation of data (like images). The "ground truth" here is the established performance characteristics of the predicate devices and the performance standards outlined in ASTM F1717.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication involves human reviewers reconciling differences, which is not relevant for biomechanical testing where results are quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic or interpretive devices where human performance with and without AI assistance is evaluated. This device is a surgical implant undergoing mechanical performance assessment.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This section is not applicable as the Mecta-C Cervical Plate is a physical implant, not an algorithm or AI system. Its performance is inherent to its mechanical design and material properties, tested directly in a laboratory setting.

7. Type of Ground Truth Used

The "ground truth" used for this study was primarily:

• Biomechanical Standards: Specifically, the ASTM F1717 standard for spinal implant constructs.
• Predicate Device Performance Data: The performance of the Mecta-C Cervical Plate was compared against the known performance of legally marketed predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set

This section is not applicable. This study does not involve a "training set" in the context of machine learning or AI models. The design and manufacturing process of the Mecta-C Cervical Plate are based on engineering principles and material science, not statistical learning from a dataset.

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reasons as point 8.

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