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The Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial, Pangea Monoaxial, Dual-Opening and the Small Stature USS (which includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0 mm parallel connectors, the Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial, Pangea Monoaxial and Dual-Opening USS can be linked to the CerviFix® System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea™), the Click'X® Monoaxial, Pangea Monoaxial and Dual-Opening USS Systems.

In addition, Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial, Pangea Monoaxial and the Dual-Opening USS can be interchanged with all USS 6.0 mm rods and transconnectors.

The Pangea™ Monoaxial Screws and Hooks are similar to the cleared SYNTHES Click'X Monoaxial System (K031175). Both are components of the Universal Spinal System (USS). Pangea Monoaxial includes dual-core screws and a variety of hook profiles. The Synthes Pangea Monoaxial Screws and Hooks are fabricated from titanium alloy, conforming to ASTM F-1295.

The provided text is a 510(k) summary for the Synthes Pangea™ Monoaxial Screws and Hooks, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials with acceptance criteria typically found in PMA submissions or for AI/ML-driven devices.

Therefore, the document does NOT contain information regarding:

• Acceptance Criteria and Reported Device Performance in the form of a table.
• Sample sizes for test sets (as clinical or software performance testing, in the sense of AI/ML, is not the primary focus here).
• Data provenance or number of experts/qualifications for ground truth establishment.
• Adjudication methods.
• Multi Reader Multi Case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance studies.
• Type of ground truth used (pathology, outcomes data, etc., specific to AI/ML).
• Sample size for the training set or how ground truth for the training set was established.

Based on the provided text, the device meets regulatory requirements by demonstrating substantial equivalence to a predicate device.

Study that proves the device meets the acceptance criteria (Substantial Equivalence):

The submission demonstrates substantial equivalence to the predicate device, K031175 - SYNTHES Click'X Monoaxial System. The description highlights that the Pangea™ Monoaxial Screws and Hooks "are similar to the cleared SYNTHES Click'X Monoaxial System (K031175)" and are both components of the Universal Spinal System (USS).

The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This "finding of substantial equivalence" is the regulatory mechanism by which this device "meets the acceptance criteria" for market entry.

The supporting documentation for such a 510(k) would typically include:

• Mechanical Testing: To demonstrate that the Pangea™ Monoaxial Screws and Hooks meet similar mechanical performance standards (e.g., strength, fatigue, static and dynamic testing) as the predicate device, as per relevant ASTM or ISO standards for spinal fixation systems. While not explicitly detailed in the provided snippet, this is a standard expectation for such orthopedic devices.
• Material Equivalence: The document states the components are "fabricated from titanium alloy, conforming to ASTM F-1295," suggesting material equivalence to the predicate or other approved devices.
• Design Comparison: A detailed comparison of the design features (dual-core screws, hook profiles) to the predicate to establish that any differences do not raise new questions of safety or effectiveness.

Without access to the full 510(k) submission, specific performance data from these tests cannot be extracted or presented in a "table of acceptance criteria and reported device performance." The "acceptance criteria" in this context are primarily the regulatory requirements for demonstrating substantial equivalence to a predicate, which includes showing similar intended use, technological characteristics, and performance (often through non-clinical testing).

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