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The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach. The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained.

The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.

The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mature patients and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the thoracic, lumbar and sacral areas of the spine. The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis or for revision of a failed previous fusion.

The system consists of implants and instruments. The implants consist of monoaxial and polvaxial pedicle screws of varying diameters and lengths, blockers, pre-contoured and straight rods, and transverse connectors of varying lengths. All implants are made of titanium alloy, with the exception of one commercially pure titanium component within the transverse connectors.

Re-usable surgical instruments are provided to facilitate placement of the implants.

In addition, the Instinct Java System is compatible with the transverse connectors currently cleared for the market as part of the Sequoia Spinal System, identified in K082032. Furthermore, the Instinct Java may be connected to the NexLink Band & In-Line Rod Connector, identified in K062505, K060634, K052566, K052247, K031985.

The implants and instruments are provided non-sterile. Instructions for Use are provided that contain validated cleaning and sterilization instructions for the user.

This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion. This decision should be made based on the risk/benefit ratio for each patient.

The subject of this 510(k) is the addition of screw and rod lengths, an alternative thread design on the pedicle screw head, a new driver, and new instrument containers and implant caddies.

The provided text describes a 510(k) premarket notification for a medical device, specifically the Zimmer Spine Instinct™ Java® System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study in the context of an AI/ML device.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance Criteria and Reported Device Performance (Table): The document does not define specific performance metrics or acceptance criteria for a new device's function, nor does it report the device's performance against such criteria. It focuses on the equivalence of mechanical properties to existing devices.
• Sample size for the test set and data provenance: No test set information is provided.
• Number of experts and qualifications for ground truth: No ground truth establishment is described.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does provide in relation to "acceptance criteria" and "study":

The document states that substantial equivalence was confirmed through mechanical testing, which served as the "study" to demonstrate that the new device meets the performance characteristics of its predicates.

Acceptance Criteria (Implicit) and Reported "Device Performance":

Explanation:

The "acceptance criteria" in this context are the standards and requirements set forth by the specified ASTM standards and the need for validated cleaning/sterilization. The "reported device performance" is simply that the device conforms to these standards and that the instructions were validated. This is not a quantitative reporting of performance metrics but rather a qualitative statement of compliance.

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