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The Lanx Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The Lanx Anterior Cervical Plate System is suitable for use to provide temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease (neck or radicular pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis), or pseudoarthrosis and/or failed previous fusion between and including levels C2 and C7.

Warning: This device is not cleared for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Lanx Anterior Cervical Plate System consists of anterior plates and bone screws that are used to build a construct to provide stabilization of the anterior cervical spine to support fusion. The system contains plates and screws of various sizes that allow the surgeon to address single or multi-level cervical spine conditions. The material for components of the Lanx Anterior Cervical Plate System is implant grade titanium alloy (Ti-6Al-4V ELI).

Here's an analysis of the provided text regarding the Lanx Anterior Cervical Plate System's acceptance criteria and study information:

This document is a 510(k) Summary and an FDA clearance letter for a medical device. This type of submission primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or detailed performance through extensive clinical studies as required for a PMA (Premarket Approval). Therefore, much of the information typically sought for AI/ML device studies (like performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) might not be explicitly detailed, as the regulatory pathway is different.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "Performance testing" and "Mechanical testing," implying the use of physical samples of the device and potentially comparison to predicate devices, rather than a dataset of patient images or clinical outcomes.
• Data Provenance: Not applicable in the context of this device clearance. The data provenance would relate to the mechanical testing conducted on the device components themselves.
• Retrospective or Prospective: Not applicable. In this context, testing would be conducted on manufactured devices, usually in a laboratory setting.

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

• Number of Experts: Not applicable. For mechanical performance testing, "ground truth" is typically defined by engineering specifications, material standards, and established testing protocols. Human experts are involved in designing and executing these tests, but not in establishing a "ground truth" in the diagnostic sense.
• Qualifications of Experts: Not specified. Presumably, engineers and technicians qualified in biomechanics, materials science, and medical device testing would have been involved.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation (e.g., diagnostic image reading, clinical assessment) where disagreements among readers need to be resolved to establish ground truth. For mechanical testing, results are typically quantitative and objective, measured against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic aid on human reader performance, typically in imaging applications. The Lanx Anterior Cervical Plate System is an implantable medical device, not a diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This concept applies to AI/ML algorithms. The Lanx Anterior Cervical Plate System is a physical implant, not an algorithm. Performance is assessed through mechanical testing and comparison to a predicate device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical performance testing, the ground truth would be defined by engineering specifications, material science standards (e.g., ASTM or ISO standards for medical implants), and established biomechanical testing protocols. The "substantial equivalence" ground truth is established by demonstrating that the device performs equivalently to a legally marketed predicate device based on these engineering metrics.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The design of the device is based on established engineering principles and prior research in spinal fixation.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary and Context:

It is crucial to understand that this document describes a 510(k) clearance process for a physical implantable device. The focus of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, primarily through non-clinical (e.g., mechanical) testing and comparison of intended use, technological characteristics, and materials. This is different from the regulatory pathway for AI/ML-driven diagnostic devices or novel therapeutic devices that might require extensive clinical trials and detailed performance metrics as described in the prompt's questions. The information provided in the 510(k) summary is typical for this type of device and regulatory submission.

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