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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 and 4.0mm polyaxial screws of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.

This is a medical device submission, specifically a 510(k) premarket notification for a spinal system. These submissions do not typically include information about AI/ML algorithms, performance metrics like sensitivity/specificity, or human reader studies. Instead, they focus on demonstrating substantial equivalence to a predicate device through engineering and biocompatibility testing.

Therefore, for the input provided, there is no information about:

• Acceptance criteria in terms of AI/ML performance metrics.
• A study proving the device meets AI/ML acceptance criteria.
• Sample sizes for test sets or data provenance in the context of AI/ML.
• Number of experts for ground truth or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone AI algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document states the following regarding 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"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where applicable."

This indicates that standard engineering and biocompatibility testing was performed to demonstrate the safety and effectiveness of the modified components (cross connector and smooth shank screws) and their substantial equivalence to the predicate device. However, specifics of these tests (e.g., fatigue testing, pull-out strength, etc.) and their acceptance criteria are not detailed in this summary.

In summary, the provided document does not contain the type of information requested about AI/ML device performance. It is a regulatory submission for a physical medical device (spinal implant) that relies on demonstrating substantial equivalence through standard device testing, not AI/ML performance evaluation.

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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 and 4.0mm polyaxial screws of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.

The provided text describes a 510(k) summary for the S4 Spinal System and indicates that the device has undergone performance testing. However, it does not contain details about specific acceptance criteria, study methodologies, sample sizes, or ground truth establishment typically found in a clinical study report.

Instead, it states:

"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. In addition, testing per the 'Spinal System 510(k)s' was completed where applicable."

This implies that the device met the general requirements outlined in the FDA's guidance documents for spinal systems, which typically include mechanical and biocompatibility testing. It does not provide the specific "acceptance criteria" or the "reported device performance" in a quantitative manner as requested. It also lacks information on clinical study aspects like ground truth, expert opinions, or MRMC studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or clinical study details based on the provided text. The document is a regulatory submission summary rather than a detailed performance study report.

Ask a specific question about this device