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The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1 ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2) spondylolisthesis,
3) trauma (i.e., fracture or dislocation),
4) spinal stenosis,
5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6) tumor,
7) pseudoarthrosis, and
8) failed previous fusion.

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The provided document describes the Aesculap® Implant Systems (AIS) S4 Spinal System Modification Lateral Offset Connectors and its premarket notification (K130291). The study proving the device meets acceptance criteria is a non-clinical performance study comparing the modified device to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "non-clinical testing" was performed, which typically suggests a laboratory-based test with a specific number of samples for each test type, but the exact count is not provided.
• Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical performance testing.

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

• Not applicable. This was a non-clinical, mechanical performance study, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the physical performance data itself, measured according to industry standards.

4. Adjudication Method for the Test Set

• Not applicable. This was a non-clinical, mechanical performance study. Adjudication methods are typically associated with clinical studies involving interpretation of data or images by multiple experts.

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

• No. This document describes a non-clinical mechanical performance study, not a clinical MRMC study.

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

• Not applicable. This device is a physical spinal implant component, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Mechanical performance data a per ASTM standards: The ground truth for this study was the quantifiable mechanical performance (e.g., strength, stiffness, fatigue resistance) measured according to the specified ASTM F1717-12 standards.

8. The Sample Size for the Training Set

• Not applicable. This was a mechanical performance study, not a machine learning or AI study that would typically involve a "training set."

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

• Not applicable. As above, this was a mechanical performance study, not an AI study.

Summary of the Study:

The study conducted was a non-clinical performance study on the S4 Lateral Offset Rod Connectors. It involved standardized mechanical tests (Static Axial Compression Bending, Dynamic Axial Compression Bending, and Static Torsion) as recommended by FDA Guidance for Spinal System 510(k)s and according to ASTM F1717-12. The acceptance criterion was that the modified device "meet or exceed the performance of the predicate devices" in these tests. The results demonstrated that the device successfully met this criterion, leading to a determination of substantial equivalence.

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