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

Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.

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

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.

This is an addition to Synthes' existing non-cervical spinal fixation devices intended for 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). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The additional locking cap in this submission is manufactured of cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).

The provided text describes a 510(k) Summary for a medical device called the "Synthes Matrix System," which is an addition to an existing line of non-cervical spinal fixation devices. The document explicitly states that clinical data and conclusions were NOT needed for this device. This means that the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not available in this document because a clinical study was not performed or deemed necessary for this 510(k) submission.

The acceptance criteria and proof of meeting them are based on non-clinical performance data (bench testing), which demonstrated equivalence or superiority to predicate devices.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. (Refers to mechanical testing specimens, not human subjects or a data set for an AI model).
• Data Provenance: Not applicable in the context of human data. The data comes from bench testing of the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Experts: Not applicable. Ground truth for mechanical testing is established by engineering specifications and direct measurement, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. This is mechanical bench testing, not a clinical study requiring adjudication of diagnostic outcomes.

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

• MRMC Study: No. This device is a spinal implant, not an AI or diagnostic imaging device. No human reader studies were performed or relevant.

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

• Standalone Performance: Not applicable. This is a physical medical device (spinal implant), not an algorithm or AI.

7. The type of ground truth used

• Ground Truth: For mechanical testing, the ground truth is based on the physical properties and performance characteristics defined by engineering standards (e.g., ASTM F1717-11a) and compared against the performance of legally marketed predicate devices.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.

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

• Ground Truth for Training Set: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.

In summary, this 510(k) submission relied on non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices, and explicitly stated that clinical data was not required. Therefore, all questions pertaining to clinical study design, human data, expert review, and AI model specifics are not addressed by the provided document.

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