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When intended to promote fusion of the cervical spine and the thoracic spine (C1 - T3), the S4 Spinal System is intended for the following;

• DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Failed previous fusion
• Tumors

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -- T3) spine.

The use of the polyaxial screws is limited to placement in T1 - T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 The 64 Opinal System of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.

The S4 Spinal System is a medical device for spinal fusion. The 510(k) summary provided does not contain explicit acceptance criteria or the details of a study proving the device meets said criteria in the format requested. Instead, it indicates that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices - The Basic Elements' was completed where applicable."

Therefore, I cannot provide a direct answer to your request in the specified format from the provided text excerpt. The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed performance study with acceptance criteria.

However, I can extract information related to what aspects were considered for the 510(k) clearance, which implicitly implies that the device is expected to meet the performance standards set by the predicate devices.

Here's an analysis based on the provided text:

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

This information is not explicitly provided in the given text. The document states that "All required testing per [guidance document] was completed where applicable." This implies that standard tests relevant to orthopedic devices were performed, but the specific acceptance criteria for each test and the numerical performance results are not detailed.

2. Sample size used for the test set and the data provenance:

This information is not provided in the given text. The document refers to "testing" but does not specify the sample sizes or the nature of the data (e.g., in vitro, in vivo, clinical trial, retrospective, prospective, country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the given text. Since the document does not describe a clinical study with a "test set" requiring ground truth established by experts, this detail is absent.

4. Adjudication method for the test set:

This information is not provided in the given text. As there is no described clinical study, an adjudication method for a test set is not mentioned.

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 information is not provided in the given text. The S4 Spinal System is a mechanical implant, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant to this device and is not mentioned.

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

This information is not provided in the given text. As the device is a spinal implant, the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.

7. The type of ground truth used:

This information is not explicitly provided in the given text. Given that the clearance is based on substantial equivalence to predicate devices and adherence to general guidance for orthopedic devices, the "ground truth" would likely be derived from established biomechanical testing standards, material property tests, and the clinical history and performance of the predicate devices.

8. The sample size for the training set:

This information is not provided in the given text. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not applicable to this device as described.

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

This information is not provided in the given text, for the same reason as point 8.

Summary of available information regarding performance:

• Performance Data: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices - The Basic Elements' were done where applicable." This indicates that the device underwent mechanical and material testing to demonstrate its safety and effectiveness, consistent with regulatory requirements for similar orthopedic implants.
• Substantial Equivalence: The S4 Spinal System is deemed substantially equivalent in design to the following predicate devices:
  • Nex-Link Spinal System (K031985)
  • Vertex Spinal System (K042789, 042524)
  • Summit Spinal System (K013222, K030103, K041203)

This means that the S4 Spinal System's performance characteristics are considered comparable to these cleared devices, implying that it meets similar performance expectations and safety profiles. The specific "acceptance criteria" for the S4 Spinal System would therefore align with those established for its predicate devices and the relevant FDA guidance.

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