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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, 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, and fixed and adjustable rod to 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 a spinal implant system (Aesculap® Implant Systems S4 Spinal System), not a device that relies on algorithms or image analysis. Therefore, many of the requested categories for acceptance criteria and study details (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details, and ground truth establishment methods) are not applicable to this type of medical device submission.

The acceptance criteria for this device are based on mechanical performance and material characteristics, and its substantial equivalence to previously cleared devices.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable (N/A). This submission pertains to a spinal implant system, not a data-driven diagnostic or AI device. The "test set" here refers to physical components undergoing mechanical testing, not a dataset of patient information. The document does not specify the number of samples used for ASTM F1717 testing, nor the data provenance in the context of clinical data.

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 (N/A). "Ground truth" in this context would typically refer to clinical outcomes or diagnoses. For mechanical testing, the "ground truth" is established by adherence to a standardized test method (ASTM F1717). Experts are involved in developing and interpreting such standards, but not in establishing ground truth for individual test sets in the way it's done for AI models.

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

• Not applicable (N/A). Adjudication methods like 2+1 are used for resolving disagreements among multiple human readers for diagnostic tasks. Since this is a mechanical device, such methods are not relevant.

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

• Not applicable (N/A). MRMC studies are for evaluating diagnostic accuracy, especially with AI systems. This is a physical implant, not a diagnostic tool.

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

• Not applicable (N/A). This is a physical implant, not an algorithm.

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

• Not applicable (N/A) for clinical "ground truth." For the mechanical performance, the "ground truth" is defined by the ASTM F1717 standard and the performance of legally marketed predicate devices. The material composition "ground truth" is established by adherence to ISO 5832/3 and ISO 5832/2 standards.

8. The sample size for the training set

• Not applicable (N/A). This is a physical implant, not an AI model that requires a training set.

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

• Not applicable (N/A). As above, this is not an AI model.

Summary of the Study:

The study that proves the device meets the acceptance criteria is a mechanical performance study adhering to the ASTM F1717 standard for static and dynamic compression bending testing. The results of this testing were compared against the performance of predicate devices, and the S4 Spinal System was found to exhibit similar performance characteristics.

Additionally, the device's adherence to material standards (ISO 5832/3 and ISO 5832/2 for Titanium and Titanium alloy) and its similar design characteristics and indications for use to previously cleared predicate devices (S4 Spinal System, Blackstone Pedicle Screw System, Stryker XIA 3 Spinal System, and Depuy Expedium Spine System) form the basis of its acceptance and clearance via the 510(k) pathway for substantial equivalence. No clinical studies are referenced as part of this premarket notification.

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