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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, USS Polyaxial, and USS Iliosacral) 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 (T8-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: degencrative 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), turnor, 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, USS Polyaxial, and USS Iliosacral) 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 Monoaxial, USS Polyaxial, and USS Iliosacral).

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, USS Polyaxial, and USS Iliosacral) can be interchanged with all USS 6.0 mm rods and transconnectors.

The Synthes USS Polyaxial and Synthes USS Iliosacral Systems are additions to Synthes' existing posterior thoracolumbar spine systems. The Synthes USS Polyaxial and Synthes USS Iliosacral Systems consist of a family of screws and connectors designed to facilitate construct assembly and complex spine manipulation. The systems are intended for additional rod fixation in the ilium and sacrum. The systems contain a variety of different connectors for attachment to the ilium and to the S2 pedicle. The implants are all manufactured from either Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295 or Commercially Pure Titanium (CpTi), the same as the predicates.

This document is a 510(k) summary for the Synthes USS Polyaxial System and Synthes USS Iliosacral System. It states that non-clinical performance and conclusions were sufficient, and clinical data was not required for this device. Therefore, a study proving the device meets acceptance criteria, as per the detailed request, was not performed or deemed necessary.

The provided information focuses on demonstrating substantial equivalence to predicate devices through bench testing, rather than presenting a performance study with detailed acceptance criteria and reported device performance in a clinical or simulated clinical setting.

Here's a breakdown based on the document's content, noting where information is not available:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified. This refers to non-clinical bench testing.
• Data Provenance: Not specified. The testing is non-clinical bench testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as no clinical data or ground truth requiring expert consensus was used for this 510(k) submission. The evaluation was based on engineering bench tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable; no expert adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a multi-reader multi-case comparative effectiveness study was not done. This device is a surgical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable; this is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable for the performance evaluation. The "ground truth" for substantial equivalence was the performance of the predicate devices in terms of design, function, and material properties, evaluated through bench testing.

8. The sample size for the training set:

• Not applicable; there was no training set as no AI/algorithm was developed or evaluated.

9. How the ground truth for the training set was established:

• Not applicable; there was no training set.

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