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The Xenco Medical Multilevel CerviKit is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (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) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.

The Xenco Medical Multilevel CerviKit is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with bone screws using an anterior approach. Plates are available in a variety of lengths addressing multiple levels of fixation. The Xenco Medical Multilevel CerviKit plate incorporates graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths.

This document is a 510(k) premarket notification for the Xenco Medical Multilevel CerviKit, a spinal intervertebral body fixation orthosis. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the provided text regarding acceptance criteria and performance study:

The provided document does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it describes a medical device (a spinal implant) whose acceptance is based on demonstrating substantial equivalence to existing predicate devices through non-clinical mechanical testing.

Therefore, many of the typical questions for an AI/ML device's acceptance criteria and study design (e.g., sample size for test set with data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the "study" (non-clinical testing) as described in this specific 510(k) submission.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)

1. A table of acceptance criteria and the reported device performance

For this device, the "acceptance criteria" are implied by the performance of the predicate devices. The "reported device performance" is that the Xenco Medical Multilevel CerviKit performed "equivalently" to the predicates in the specified non-clinical tests. The specific numerical thresholds for "equivalence" are not detailed in this summary but would be part of the full test reports referenced.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated in this 510(k) summary for the non-clinical tests. Typically, in mechanical testing for a spinal implant, a certain number of samples (e.g., n=5 or more) per test group would be used to establish statistical significance or demonstrate compliance with a standard.
• Data Provenance: Not applicable in the sense of patient data. This refers to laboratory-generated mechanical test data.
• Retrospective or Prospective: Not applicable. These are in vitro mechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. This is not a diagnostic device or an AI/ML algorithm that relies on expert human interpretation of medical images. The "ground truth" for mechanical testing is established by adherence to recognized ASTM standards and engineering principles. The experts involved would be mechanical engineers and biomedical engineers overseeing and conducting the tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. As this is mechanical testing, there is no human interpretation or adjudication in the medical imaging sense. The test results are quantitative measurements against predefined criteria in the ASTM standards.

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

• No MRMC study was done. This device is a physical implant, not an AI or imaging diagnostic tool.

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

• Not Applicable. This is not an algorithm.

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

• Ground Truth for Mechanical Performance: The "ground truth" for demonstrating substantial equivalence is based on established engineering and biomechanical principles captured in ASTM standards (e.g., ASTM F1717) and the established performance characteristics of the predicate devices. The physical properties and mechanical behavior of the device under simulated physiological loads are the "truth" being assessed.

8. The sample size for the training set

• Not Applicable. This device does not involve machine learning or a "training set."

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

• Not Applicable. As there is no training set for an AI/ML model.

Summary Specific to this Device Submission:

The Xenco Medical Multilevel CerviKit is a Class II medical device. Its acceptance and clearance are based on demonstrating substantial equivalence to legally marketed predicate devices. This equivalence is primarily supported by:

• Non-clinical (mechanical) testing: Static and dynamic compression testing (per ASTM F1717), static torsion testing (per ASTM F1717), and push-out testing for screws.
• Comparison of design, materials (Titanium alloy - Ti-6Al-4V ELI), and indications for use to predicate devices (K160702 Astura Medical ZION Anterior Cervical Fixation System and K080646 Biomet C-TekV MaxAnrm Anterior Cervical Plate).
• No clinical studies were performed.

The "study" that proves the device meets "acceptance criteria" here refers to the in-vitro mechanical testing, where the "acceptance criteria" are implied to be performance results comparable or superior to the predicate devices as per relevant ASTM standards.

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