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Posterior Components: When used as posterior pedicle screw fixation system in skeletally mature patients, the Synthes USS, including the Click'X and USS VAS components, and the Dual-Opening USS and Synthes Small Stature USS (which includes small stature), is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous spinal fusion, and pseudoarthrosis. When treating patient's with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct. In addition, in skeletally mature patients, the Synthes USS, including the Click'X and USS VAS components and the Dual-Opening USS and Small Stature USS (which includes small stature and pediatric patients) is intended for the treatment of severe spondylolisthesis (grade 3 and 4) of the L5-S1 vertebra in patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation are L3-S2/ilium. When used as a posterior non-pedicle screw fixation system, in skeletally mature patients, the Synthes USS, and the Dual-Opening and Small Stature USS (which includes small stature and pediatric patients) are intended for the treatment of degenerative disc disease (as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis. kyphosis, and/or lordosis, Scheuermann's Disease) fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion.

Anterior Components: When used as an anteriolateral system, in skeletally mature patients, the Synthes USS, Dual-Opening USS and Small Stature USS (which includes small stature and pediatric patients), is intended for anteriolateral screw and/or staple fixation for the following indications: degenerative disc disease (as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion (levels T8-L5). In addition, when used with 3.5/6.0 mm parallel connectors, the Synthes USS can be linked to the CerviFix™ System. When used with 5.0/6.0 mm parallel connectors the Small Stature USS can be linked to the USS and Dual-Opening USS.

Synthes USS. Click'X. USS VAS. Small Stature and Dual-Opening Systems are multi-component systems comprised of rods (5.0mm and 6.0mm), screws (sideopening, dual-opening and dual core) and hooks (side opening and dual opening), transconnectors, transverse bars, parallel connectors, collars, nuts, staples and washers.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria.

The document is a 510(k) summary for a medical device called "Synthes USS, Click'X, USS VAS, Small Stature and Dual-Opening Systems". It describes the device, its components (rods, screws, hooks, etc.), and its indications for use as a spinal fixation system.

The core of the document is the FDA's letter granting premarket notification (510(k)) clearance, indicating that the device is substantially equivalent to legally marketed predicate devices. This regulatory document does not typically include detailed performance data, sample sizes, ground truth establishment, or clinical study results in the manner requested.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS Is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the theracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scallosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, the Synthes Small Stature USS is intended for treatment of severe spondylofisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including small stature) and pediatric patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.

When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Small Stature USS is intended for scollotic, lordotic, or kyphotic deformities (such as scoliosis, Schuermann's disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine.

The anterior components of the Synthes Small Stature USS when used in skeletally mature patients (Including small stature) and pediatric patients are intended for anterclateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine-(levels 78-L5),

In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Universal Spinal System

The Synthes Small Stature USS consists of a variety of rods, hooks, station is also, avgileble The Synthes Sthair Stature OOO Consisted of a variety of Feat, Normentation is also available to facilitate implantation of the device components.

Certain implant components from the Synthes Small Stature USS can be used to connect the se Geltain Implant components from the Synthes Synthes posterior spinal systems (USS or CerviFix).

This is a 510(k) premarket notification for a medical device (Synthes Small Stature USS), not a study report or clinical trial. Therefore, the document does not contain the requested information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or type of ground truth.

The document is a regulatory approval letter from the FDA, stating that the device is substantially equivalent to a predicate device already on the market. It outlines the device description, indications for use, and regulatory classification. It does not present data from any specific study proving the device meets acceptance criteria.

To answer your request, I would need a different type of document, such as a clinical study report, a scientific paper detailing performance evaluation, or a submission that includes detailed testing results.

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