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When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).

The Spine Next SHIRAZ JAVA Top Loading Spinal Fixation System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with the bone graft. These implanted are intended to be removed after development of a solid fusion mass. The system includes screws, rods, connectors and transverse connectors.

All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.

The provided text describes a 510(k) premarket notification for the Spine Next SHIRAZ JAVA Spinal Fixation System. It details the device, its indications for use, and cites biomechanical testing according to specific ASTM standards. However, it does not provide information about acceptance criteria, reported device performance in a table, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred and what is missing:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative values. The acceptance criteria for a 510(k) submission generally revolve around demonstrating substantial equivalence to a legally marketed predicate device, often through meeting industry standards.
• Reported Device Performance: Not reported in a table format. The document states that "Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM 1798." These standards inherently define test methods and performance metrics (e.g., strength, durability, fatigue life), but the results of these tests (the actual performance data) and how they met specific acceptance thresholds are not provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not mentioned. For biomechanical testing, this would typically refer to the number of test specimens (e.g., screws, rods, constructs) tested.
• Data Provenance: Not mentioned. Biomechanical testing data would generally be generated in a lab setting, so "country of origin" is less relevant than for clinical data, but the specific lab or testing facility is not named. The studies are prospective in nature as they involve testing physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this is biomechanical testing, not a study involving human interpretation or clinical data where expert ground truth would be established. The "ground truth" for biomechanical testing is typically defined by the physical loads applied and the measured deformation/failure, evaluated against engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for biomechanical 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

• No MRMC study was mentioned. This type of study is relevant for imaging or diagnostic devices involving human interpretation, not for mechanical implants like spinal fixation systems.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For biomechanical testing, the "ground truth" is defined by the objective physical measurements and engineering principles governed by the ASTM standards (F1717 and F1798). This involves applying defined loads and measuring mechanical responses (e.g., stiffness, yield strength, ultimate strength, fatigue cycles to failure).

8. The sample size for the training set

• Not applicable. This is not a machine learning device, so there is no training set.

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

• Not applicable.

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When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a pedicle screw fixation system, the JAVA Spinal Fixation System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Spine Next SHIRAZ JAVA Spinal Fixation System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after development of a solid fusion mass. The system includes screws, rods, and connectors.

All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.

This document, K031265, describes the Spine Next SHIRAZ JAVA Spinal Fixation System. However, it does not contain the information needed to fill out the table regarding acceptance criteria and device performance as it pertains to AI/ML or diagnostic performance. This submission is for a traditional medical device (spinal fixation system), not a software as a medical device (SaMD) or an AI-powered diagnostic tool. Therefore, the requested information on AI/ML-related performance metrics, such as sample size, ground truth, expert adjudication, or MRMC studies, is not applicable or available in this document.

The document primarily focuses on:

• Device Description and Materials: The system includes screws, rods, and connectors made from Titanium Alloy (Ti6A4V).
• Indications for Use: Treatment of severe spondylolisthesis and various acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine as an adjunct to fusion.
• Performance Data: Biomechanical testing was performed in accordance with ASTM F1717 and ASTM F1798. These are standards for mechanical properties of spinal implant systems, not for diagnostic accuracy or algorithmic performance.
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices (Moss Miami K021880).

Therefore, I cannot provide the requested information for acceptance criteria and study proving AI device meets acceptance criteria, as this device is a physical spinal fixation system and not an AI-driven one.

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