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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 polyaxial 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 in 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.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing for the Instinct Java System, not a clinical study involving a "test set" in the context of diagnostic AI or clinical trials. Therefore, information about a test set sample size, country of origin, or retrospective/prospective data is not applicable. The testing was performed on the device components themselves.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable as the study involves bench testing of a physical medical device (spinal fixation system), not an AI algorithm requiring expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

This is not applicable for a bench testing study of a physical medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench testing of a physical medical device, not an AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. The device is a physical spinal fixation system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established through adherence to specified ASTM standards (ASTM F-1717:2004) for mechanical performance (static, dynamic compression bending, static torsion) and validated cleaning and sterilization protocols for the non-sterile components.

8. The Sample Size for the Training Set

This information is not applicable. The document describes bench testing of a physical medical device, not an AI system requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for a physical medical device. The "ground truth" for the device's design and manufacturing is adherence to engineering specifications and regulatory standards.

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