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When used as a posterior pedicle screw fixation system, the Synthes Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-pedicle screw fixation system, the Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System is also intended for scoliotic, or kyphotic deformities (such as scoliosis, Schevermann's disease); degenerative disk disease (back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), and fractures of the posterior thoracolumbar spine (levels 74-S2). In addition, when using the parallel rod connector, the USS can be connected to the Posterior Cervical/Thoracic Hook/Rod System.

The overall levels of fixation are T4-S2.

The Synthes Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System currently consists of rods, hooks, clamps and screws. These components were previously cleared in K951626, K951794, K962608, K963045, K963357, and K964416. This 510(k) submission is extending the region of the posterior spine in which the USS hook and rods may be used (i.e., from T8-S2 to T4-S2). In addition to these components Synthes is adding a new parallel rod connector. The connector is intended to allow a rod (3.5mm) to rod (6mm) connection with the Posterior Cervical/Thoracic Hook/Rod System.

The provided text describes a medical device, the SYNTHES Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System, and its regulatory clearance. However, it does not contain information typically found in a study proving a device meets acceptance criteria, particularly for an AI/ML-driven device.

The document is a 510(k) summary and an FDA clearance letter for a spinal fixation system, focusing on substantial equivalence to previously cleared devices rather than a performance study with specific acceptance criteria as you've outlined.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance studies, which are not detailed here for this type of medical device clearance.

Here's a breakdown of what can be inferred or determined from the text, and what cannot:

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

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

• Not applicable for this document. This document describes mechanical testing for physical characteristics of a medical implant, not a clinical study involving a test set of 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. No expert review of a test set is mentioned.

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

• Not applicable. No test set requiring expert adjudication is described.

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

• Not applicable. This device is a physical spinal implant, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This device is a physical spinal implant.

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

• For the mechanical testing, the "ground truth" would be the standards set by ASTM F1717 for static and fatigue performance, against which the device's physical performance was measured.
• For the substantial equivalence determination, the "ground truth" is the performance and safety profiles of the predicate devices (Liberty Posterior Spinal System K964254 and Titanium Spinal Rod System K970635).

8. The sample size for the training set

• Not applicable. This document does not describe a machine learning training set.

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

• Not applicable. This document does not describe a machine learning training set or its ground truth establishment.

In summary: The provided text is a regulatory submission for a physical medical device. It demonstrates compliance through mechanical testing against industry standards (ASTM F1717) and substantiates equivalence to previously cleared predicate devices. It does not involve clinical performance studies with patient data, human reader evaluations, or AI/ML components as implied by the structure of your questions.

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