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The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent 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 sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scolosis, Scheuermann's Disease), tumor, stenoss, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusionenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct Java® System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.

In order to achieve additional levels of fixation the Vitality® Spinal Fixation System rods may be connected to the Instinct Java® System (05.5mm rod) or the Virage® OCT Spinal Fixation System (03.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct Java® System and Virage® OCT Spinal Fixation System package inserts for instructions for use.

Vitality®+ Power instruments and adapters are intended for use with the Zimmer Biomet Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws using a power surgical technique. Pedicle and iliac screws from the Vitality® Spinal Fixation System may be implanted in the non-cervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.

The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.

The system also includes instrumentation for insertion and removal and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.

The Vitality® Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java "Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.

The Vitality®+ Power Instrument System includes instrumentation to be used with power for the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws. The system includes reusable Vitality drills, taps, drivers and adapters to be used with an electric handpiece. The subject instruments are compatible for use with the Vitality® Spinal Fixation System implants.

The proposed instruments subject of this submission are intended for exclusive use with Zimmer Biomet Universal Power System.

The FDA 510(k) summary for the Vitality® Spinal Fixation System and Vitality®+ Power Instrument System describes non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and performance metrics for an AI device. The document pertains to a medical device for spinal fixation, explicitly mentioning implants, instruments, and surgical techniques, not an AI or algorithm-based system.

Therefore, many of the requested categories related to AI performance metrics (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this document. The provided text does not contain information on an AI device.

However, I can extract the information relevant to the non-clinical testing performed for the substantial equivalence determination of the Vitality® Spinal Fixation System and Vitality®+ Power Instrument System.

Acceptance Criteria and Device Performance for Vitality® Spinal Fixation System & Vitality®+ Power Instrument System:

• Clinical Literature Assessment |
  | Intended Use/Indications for Use | The Vitality® Spinal Fixation System is a non-cervical spinal fixation device for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5) in skeletally mature and adolescent patients. It is an adjunct to fusion for indications like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, pseudoarthrosis, and/or failed previous fusion. Also indicated for severe spondylolisthesis (Grade 3 and 4) of L5-S1. Pediatric pedicle screw fixation is limited to a posterior approach for adolescent idiopathic scoliosis.

The Vitality®+ Power Instrument System is intended for use with the Zimmer Biomet Universal Power System to facilitate preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws using a power surgical technique in non-cervical spine procedures (open and minimally invasive). |
| Materials | Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Instruments are reusable. |
| Sterility | Assumed to meet industry standards as part of overall substantial equivalence, though not explicitly detailed with specific data in this summary. |
| Manufacturing Methods | Same or similar to predicate devices. |
| Operational Principles | Substantially equivalent to predicate devices. |

Additional Information (where applicable based on the provided document):

1. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical testing for a physical medical device, not an AI algorithm evaluated on a data test set. The tests mentioned are "Cadaveric Testing" and "Clinical Literature Assessment," but no specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are provided for these.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe the evaluation of an AI device with a ground truth established by experts.
3. Adjudication method for the test set: Not applicable. No adjudication method for an AI test set is described.
4. 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 is not an AI device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The concept of "ground truth" in the context of AI evaluation does not apply to this device. The evaluation focuses on physical performance and substantial equivalence to existing devices.
7. The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable. This document describes a physical medical device, not an AI algorithm.

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