Search Results

The Synthes USS (including USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click' X Monoaxial, Pangea, Pangea Monoaxial, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (18-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion 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, Scheucrmann'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 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, and ClampFix) 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 CerviFix System. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, and ClampFix),

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

The Synthes ClampFix System is a result of design modifications to the predicate devices. It is substantially equivalent to the predicates in design, function, material, and intended use.

This document describes the Synthes ClampFix System, a medical device. Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that no clinical test set was used, and therefore, no specific sample size or data provenance details are available. The evaluation relied on non-clinical bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical test set was used, no experts were involved in establishing ground truth for a test set related to clinical performance. The "ground truth" for substantial equivalence was established through non-clinical bench testing, likely by engineers and product specialists adhering to relevant standards.

4. Adjudication Method for the Test Set

As no clinical test set was conducted, no adjudication method was applied.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted. The document states that clinical data and conclusions were not needed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical spinal fixation system, not an algorithm or AI. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply.

7. Type of Ground Truth Used

The ground truth used was based on bench testing results and comparison of the device's design, function, and materials to legally marketed predicate devices, demonstrating substantial equivalence.

8. Sample Size for the Training Set

Since this is a physical medical device and not an AI/algorithm, the concept of a "training set" in the context of machine learning does not apply. The development of the device would have involved engineering design, prototyping, and testing, but not a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

As the concept of a "training set" is not applicable, there is no information on how its ground truth was established. The device's design and performance are validated through engineering principles and compliance with medical device regulations.

Ask a specific question about this device