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The PrimaLOKTM SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The PrimaLOKTM SP Interspinous Fusion System is intended for use at one level, with bone graft material and not intended for stand-alone use.

The PrimaLOKTM SP Interspinous Fusion System is a bilateral locking plate system which attaches to the spine at the spinous processes. It is available in various interspinous heights and widths to accommodate differing anatomic requirements.

The PrimaLOK™sp Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device for spinal fusion.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data or human evaluation. The performance data is derived from mechanical bench testing. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this summary for clinical evaluation. The "worst case" PrimaLOK™sp Interspinous Fusion System construct was tested, implying representative samples of the device were used for the mechanical tests.

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

Not applicable. The "ground truth" for this device's performance is established by mechanical engineering standards and measurements, not expert human assessment of images or clinical outcomes in the context of the provided information.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for human expert review of clinical data, which is not described here.

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

No. This document describes a premarket notification (510(k)) based on substantial equivalence, primarily supported by bench testing and comparison to predicate devices, not a clinical MRMC comparative effectiveness study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical medical implant. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to its evaluation.

7. The Type of Ground Truth Used

The ground truth used for assessing this device is based on mechanical engineering standards and measurements. Specifically, the performance was measured against a modified ASTM F1717 protocol, which outlines standardized tests for spinal implant constructs. The "ground truth" is the established mechanical properties required for such devices to be considered safe and effective in their intended use.

8. The Sample Size for the Training Set

No training set is applicable or described. This is a physical device evaluated through mechanical testing, not a machine learning model requiring a training set.

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

Not applicable, as no training set is described.

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