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Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and are specifically designed for use with the Medtronic Navigation StealthStation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-Linkec System.

The Zavation Navigation instruments non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Zavation screw implants. The instruments are manufactured from stainless steel per ASTM F899

The provided text is a 510(k) summary for the Zavation Navigated Instrument System. It outlines the device description, indications for use, materials, and technological characteristics, as well as a list of predicate and reference devices. The "Performance Data" section mentions the types of testing performed but does not provide specific acceptance criteria or detailed results of those tests. It states:

• Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical System
• Mating Interface Assessments
• CMM Inspection
• Instrument Verification

It also mentions: "Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment."

Therefore, based only on the provided text, I cannot answer the questions comprehensively regarding specific acceptance criteria, reported device performance, sample sizes, expert involvement, or adjudication methods, as this detailed information is not present in the provided document.

The document primarily focuses on establishing "substantial equivalence" based on similar technological characteristics and types of performance testing, rather than reporting the quantitative results of those tests against specific acceptance criteria.

Therefore, I must state that the requested information (acceptance criteria, specific performance data, sample sizes, expert details, etc.) is NOT available in the provided text.

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The Zavation eZspand™ Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand™ Interbody System implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment.

The Zavation eZspand™ Interbody System implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including the Zavation Spinal System.

The Zavation eZspand™ Interbody System devices are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The implants are provided in a shape that accommodates a posterior, transforaminal or lateral approach to the lumbar spine. After insertion, the implant can be continuously expanded, within in the limitations of the design, to the desired height to suit the individual anatomical conditions of the patient. The devices are available in various footprints and geometric options to fit the anatomical needs of a wide variety of patients. The implants include an opening through the superior and inferior endplates of the device to facilitate fusion. The posterior opening of the device allows for the packing of autogenous bone graft material post expansion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The provided text is a 510(k) summary for the Zavation eZspand™ Interbody System, a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a clinical study or AI/software-related acceptance criteria.

Therefore, the information required to answer your prompt, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device), sample size for a test set, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details, is not present in this document.

This document details:

• Device Name: Zavation eZspand™ Interbody System
• Indications for Use: Spinal fusion procedures with autogenous bone graft in skeletally mature patients at L2-S1 for degenerative disc disease (DDD) with up to Grade I spondylolisthesis, after six months of non-operative treatment, used with supplemental internal fixation.
• Materials: Titanium alloy (Ti-6A1-4V), cobalt chrome alloy (Co-28Cr-6Mo), and medical grade PEEK Zeniva ZA-500 or Magnolia PEEK.
• Predicate Devices: K191339 Zavation eZspand™ Interbody System, K200084 Zavation IBF System, K192115 Sable™ Expandable Spacer.
• Technological Characteristics: Similar to predicate devices in basic design (lumbar interbody fusion device with expansion mechanism), sizes, materials, mechanical safety and performance, and intended use.
• Performance Data (Biomechanical): Biomechanical tests were performed according to ASTM standards for intervertebral body fusion devices, including Static/Dynamic Axial Compression, Static/Dynamic Shear, and Measuring Load Induced Subsidence. This demonstrates mechanical substantial equivalence to predicate devices.

In summary, the document describes the mechanical testing conducted on the device, not a study evaluating its performance in a clinical setting against acceptance criteria typical for AI/diagnostic devices.

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