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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, staples, 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 text describes a 510(k) premarket notification for the "S4 Spinal System Modification Dual Rod Extension." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing, rather than a clinical study with acceptance criteria measuring device performance on patients or human readers.

Therefore, many of the requested sections are not applicable to the information contained within this 510(k) summary.

Here's a breakdown of what can be extracted and what information is not present:

1. A table of acceptance criteria and the reported device performance

Study that proves the device meets the acceptance criteria:
Non-clinical testing was performed according to FDA Guidance for Spinal System 510(k)'s. This included:

• Static Axial Compression per ASTM 1717-12
• Dynamic Axial Compression per ASTM F1717-12
• Static Torsion per ASTM 1717-12

The results of these studies showed that the subject S4 Staples "meet or exceed the performance of the predicate devices," thereby demonstrating substantial equivalence.

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

This information is not provided in the document. The testing described is non-clinical (mechanical bench testing), and typically, the sample sizes for such tests are reported as the number of devices or test specimens, not patient data. Data provenance (country of origin, retrospective/prospective) is also not applicable for non-clinical bench testing.

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)

This is not applicable. The "ground truth" for non-clinical mechanical testing is typically the measured mechanical properties against established standards or predicate device performance, not expert consensus on clinical findings.

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

This is not applicable. Adjudication methods are relevant for clinical studies where subjective assessments (e.g., image interpretation) require consensus among experts. This document describes non-clinical mechanical testing.

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

This is not applicable. This document describes a medical device (spinal implant) and its non-clinical mechanical performance. There is no mention of AI, human readers, or clinical effectiveness studies in an MRMC format.

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

This is not applicable. This document describes a medical device (spinal implant), not an algorithm or AI system.

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

The "ground truth" for this non-clinical study is the mechanical performance of the predicate devices and established ASTM standards (ASTM 1717-12). The S4 Staples' performance was compared against these benchmarks.

8. The sample size for the training set

This is not applicable. There is no "training set" mentioned or implied in the context of this non-clinical mechanical performance testing for a spinal implant. Training sets are relevant for machine learning algorithms.

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

This is not applicable as there is no training set.

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