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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 system consists of implants and instruments. The implants consist of monoaxial and polyaxial pedicle screws of varying diameters and lengths, iliac screws, reduction screws, open and closed offset connectors, blockers, pre-contoured and straight Titanium alloy and straight cobalt chromium rods, and transverse connectors of varying lengths. All implants are made of titanium alloy except for the addition of CoCrMo Alloy rods and one commercially pure titanium component within the transverse connectors. Re-usable surgical instruments are provided to facilitate placement of the implants.

The provided document is a 510(k) summary for the Zimmer Spine Instinct™ Java® System. It focuses on the substantial equivalence to predicate devices and does not describe a study involving patient data, clinical outcomes, or human readers for diagnostic purposes with AI assistance. Instead, it relies on engineering testing to demonstrate equivalence. Therefore, some of the requested information, such as expert ground truth, adjudication methods, MRMC studies, standalone performance with patient data, and training set information, is not applicable or available in this document.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

This document does not describe a test set involving patient data. The evaluation was based on engineering bench testing of the device components. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) is not applicable in this context. The "sample size" would refer to the number of device components tested, which is not specified but would be in line with the requirements of the ASTM standards.

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

Not applicable. The ground truth for device performance was established through compliance with recognized engineering standards (ASTM F1717-11a and ASTM F1798-97 (2008)) and demonstrated physical characteristics, not expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable, as no human readers or diagnostic interpretations of patient data were involved in establishing the performance of the device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not describe a clinical study (MRMC or otherwise) involving human readers or AI assistance. The evaluation focuses on the mechanical and material equivalence of the device to predicate devices through engineering testing.

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

Not applicable. This is not an AI/algorithm-based device in the sense of image analysis or diagnostic decision-making. Its performance is based on mechanical properties and material composition.

7. The Type of Ground Truth Used

The ground truth used was based on engineering standards and physical measurements of the device's mechanical properties, such as axial compression bending, static torsion, gripping capacity, flexion-extension moment, and AP(x) static pullout, as defined by ASTM F1717-11a and ASTM F1798-97 (2008).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this type of device evaluation.

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