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The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 ioin: b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spin; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The S4 Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spin: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the S4 Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies). idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture of dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the S4 Spinal System are intended for sacral/illac attachment only. Hooks and transverse connectors of the system are intended for posterior throracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

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 is a 510(k) summary for the S4 Spinal System and does not contain information about acceptance criteria for a study, nor does it describe a study proving the device meets specific acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on:

• Substantial Equivalence: It states that the S4 Spinal System additions are substantially equivalent to existing components of the S4 Spinal System. This is the primary claim for 510(k) submissions, not a demonstration of meeting specific performance criteria through clinical studies.
• Device Description: Details the components and materials of the S4 Spinal System.
• Indications for Use: Specifies the medical conditions and patient populations for which the device is intended.
• Technological Characteristics: Compares the new components to predicate devices, noting similar shapes, sizes, and materials.
• Performance Data: This section broadly 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 statement on "Performance Data" refers to non-clinical (e.g., mechanical, biocompatibility) testing required by guidance documents for orthopedic devices, not clinical studies assessing diagnostic accuracy or performance against specific acceptance criteria for AI or diagnostic devices. There is no mention of:

• A table of acceptance criteria and reported device performance (in terms of clinical metrics).
• Sample sizes for test sets, data provenance, or ground truth.
• Numbers or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Training set details.

Therefore, I cannot fulfill the request as the essential information related to acceptance criteria and a study proving device performance (in the context implied by the questions, i.e., clinical or AI performance) is absent from the provided text. The document is for a spinal implant system, and the "performance data" mentioned would typically refer to mechanical and material safety, not diagnostic or AI performance.

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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.

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