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The Reform® Midline Cortical Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The modular system titanium bone screws have a dual-lead cortical-cancellous thread form and are offered in both cannulated and non-cannulated versions with diameters ranging from Ø4.5 -9.5mm. The cobalt chrome tulips are offered in both standard and reduction style. The cobaltchrome rods are offered in multiple lengths with a Ø4.75mm. Various connectors are also provided with this system.

This document describes the performance testing for the Reform® Midline Cortical Screw System (K173130), a medical device intended for posterior, non-cervical spinal fixation. The study evaluates the device's mechanical strength and equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by the comparison to predicate devices and the ASTM standards without explicit quantitative thresholds given in the provided text. The performance is reported as meeting these standards and being substantially equivalent.

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

• Sample Size for Test Set: The document does not specify the exact number of devices or components tested for each mechanical test (Static axial compression bending, Static torsion, Dynamic axial compression bending, Static tulip-shank dissociation). It only states that the testing was performed.
• Data Provenance: The data is produced from non-clinical mechanical testing. The origin is not country-specific in the provided text as it is laboratory testing against international standards (ASTM). It is inherently prospective in nature, as the tests are conducted to evaluate the device.

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

• This type of study does not involve human experts establishing "ground truth" for the test set in the way a clinical study or AI performance evaluation would. Instead, the "ground truth" or standard for performance is defined by the ASTM consensus standards (ASTM F1717, ASTM F1798) and the performance of legally marketed predicate devices. The evaluation is based on mechanical properties and engineering principles rather than expert human interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This is a non-clinical mechanical testing study based on established engineering standards and comparison to predicate devices, not a study requiring human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a non-clinical mechanical performance study of a spinal implant system, not an imaging or diagnostic AI-assisted workflow study involving human readers.

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

• No, a standalone algorithm performance study was not done. This device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" in this context is established by:
  • Consensus Engineering Standards: Specifically, ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ASTM F1798 (Standard Test Method for Static and Fatigue Shear/Compression Loading of Intervertebral Body Spinal Implants). These standards define the methodologies and expected performance characteristics for spinal implants.
  • Performance of Predicate Devices: The key aspect of the substantial equivalence determination is demonstrating that the Reform® Midline Cortical Screw System performs equivalently or better than the identified predicate devices (K150856 Reform Pedicle Screw System and K171082 JANUS Midline) under the same test conditions.

8. The Sample Size for the Training Set

• Not applicable. This is a non-clinical mechanical testing study of a physical device. There is no "training set" in the context of machine learning or AI.

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

• Not applicable, as there is no training set for this type of mechanical device study.

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