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The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical fixation in skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is intended to be used as an adjunct to fusion in the 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 in The SF Opinar Oystom "Oneice" or styles, rods of varying lengths, and fixed and various styles of rod connectors. All implant components are top loading and top tightening. The Styles of Four connectors: Annoufactured from Titanium alloy in accordance with 150 5832/3 and ISO 5832/2.

Acceptance Criteria and Device Performance Study for the S4 Spinal System

This document outlines the acceptance criteria and the study conducted to demonstrate the performance of the Aesculap® Implant Systems S4 Spinal System, specifically focusing on the line extension to add a new parallel rod connector.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA guidance for spinal system 510(k) submissions recommends non-clinical testing to demonstrate substantial equivalence. The acceptance criteria for these tests are implicitly defined as demonstrating performance that is at least equivalent to the identified predicate devices.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated in the provided documents. The studies likely involve a sufficient number of test samples to be statistically significant for mechanical tests as per ASTM standards, but the exact count is not given.
• Data Provenance: The studies were non-clinical mechanical tests conducted in a laboratory setting. The country of origin for the data is not specified but would typically be where these tests were performed (e.g., within Aesculap's facilities or a designated testing laboratory). This is retrospective data in the sense that it's generated for pre-market notification to compare a new device against existing standards and predicates.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. For non-clinical mechanical performance testing of medical devices like spinal systems, "ground truth" is established through physical measurements and adherence to recognized industry standards (e.g., ASTM F1717-11a), rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be engineers and technicians proficient in conducting and interpreting these specific biomechanical tests.

4. Adjudication Method

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data (e.g., medical images). For mechanical testing, the results are quantitative and objective, measured directly from the physical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is not relevant for this type of non-clinical mechanical performance testing. MRMC studies are used to assess the impact of a diagnostic or assistive AI device on human reader performance, which doesn't apply to the S4 Spinal System's mechanical properties.

6. Standalone Performance Study

• Yes. The described performance data focuses on the "subject Aesculap S4 Parallel Rod Connector" itself, indicating a standalone evaluation of its mechanical properties. The tests (Static Axial Compression Bending, Dynamic Axial Compression Bending, Static Torsion) evaluate the device's inherent mechanical performance against established ASTM standards and in comparison to predicate devices, without human interaction as part of the performance metric.

7. Type of Ground Truth Used

• Standardized Mechanical Test Results and Predicate Device Performance Data: The ground truth for these tests is based on the quantitative results obtained from applying recognized ASTM standards (ASTM F1717-11a) to the device and comparing these results to the known performance of legally marketed predicate devices. The "truth" is whether the new connector's performance metrics meet or exceed those of the established predicate devices under the specified test conditions.

8. Sample Size for the Training Set

• Not Applicable. This is a non-clinical mechanical performance study, not an AI or algorithm-based study that requires a training set.

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

• Not Applicable. As no training set was used, this question is not applicable.

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