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The Vitality® Spinal Fixation System implants 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 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. scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, 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 fusion by autogenous 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 pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. 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 (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use.

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 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 provided document is a 510(k) premarket notification letter from the FDA to Zimmer Biomet Spine, Inc., regarding the Vitality® Spinal Fixation System. It confirms the device's substantial equivalence to previously marketed predicate devices.

However, the document does not contain specific acceptance criteria, reported device performance data in a table format, or details about a study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy. This type of information is typically found in a clinical study report or a more detailed performance evaluation, which is not part of this FDA clearance letter.

The "Performance Data" section in the 510(k) summary only mentions mechanical testing of the modified screw implants against ASTM standards (ASTM F1798 and ASTM F1717) to support substantial equivalence. It states: "In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate device(s)."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving those criteria were met, specifically regarding clinical or diagnostic performance, sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown of what can be extracted or inferred from the document regarding its performance aspects:

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

   • Acceptance Criteria (Inferred from mechanical testing standards): The device (specifically, modified screw implants) must meet the performance requirements stipulated by ASTM F1798 (axial grip strength, torsional grip strength, and flexion/extension moment grip strength) and ASTM F1717 (static compression bending, dynamic compression bending, and static torsion). These standards define the expected mechanical properties and limits for spinal fixation devices.
   • Reported Device Performance: "In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate device(s)." This indicates that the device met the mechanical performance requirements of the specified ASTM standards and was comparable to the predicate.

2. Sample sized used for the test set and the data provenance:

   • The document does not specify the number of samples (e.g., individual screws) used in the mechanical tests.
   • Data provenance is not mentioned, as these are in vitro mechanical tests, not clinical studies with patient data.

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

   • Not applicable as this document describes mechanical performance testing, not a diagnostic or clinical efficacy study requiring expert review or ground truth labeling by medical professionals.

4. Adjudication method for the test set:

   • Not applicable for mechanical testing.

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 mechanical spinal fixation system, not an AI-assisted diagnostic tool or imaging device.

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

   • Not applicable. This is a mechanical device.

7. The type of ground truth used:

   • For the mechanical tests, the "ground truth" would be the engineering specifications and performance limits defined by the ASTM F1798 and ASTM F1717 standards.

8. The sample size for the training set:

   • Not applicable, as this is a mechanical device and not an AI/machine learning system that requires a "training set."

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

   • Not applicable.

In summary, the provided FDA letter confirms mechanical substantial equivalence but does not offer the details of a clinical or diagnostic performance study as requested in the prompt.

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