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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: 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, and failed previous fusion (pseudoarthrosis).

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 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm parallel connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm parallel connectors can be used to link all Synthes USS 6.0mm rod systems to one another.

When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5mm tapered rods, the Matrix System can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.

In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.

The Synthes USS is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are snap-on parallel connectors which can connect spinal rods of the same or different diameters. The snap-on parallel connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05) and Nitinol (per ASTM F2063-05).

This document is a 510(k) summary for the Synthes Universal Spine System (USS), a medical device. It does not contain information about the acceptance criteria and the study proving the device meets said criteria as typically found in submissions for AI/ML-powered devices.

Here's why and what's missing:

• Device Type: The Synthes USS is described as non-cervical spinal fixation devices, including pedicle screws, hooks, and connectors. These are mechanical implants, not an AI/ML-powered or software-driven diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission for this type of mechanical implant primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through material testing, mechanical testing, and an assessment of design and performance characteristics, rather than clinical efficacy studies often associated with AI/ML devices.
• Missing Information: Consequently, the document does not include any of the requested information points because they are not applicable to this type of device submission:
  • No acceptance criteria table for AI performance metrics.
  • No information about sample sizes for test sets, data provenance, or ground truth establishment by experts for AI.
  • No adjudication methods, MRMC studies, or standalone algorithm performance data.
  • No training set information or ground truth establishment for training data.

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