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The T-FIX® 3DSI Joint Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including;

• sacroiliac joint disruptions
• degenerative sacroiliitis
• to augment immobilization and stabilization of the sacrolliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of thoracolumbar fusion and
• acute, non-acute and non-traumatic fractures involving the sacroiliac joint

The T-FIX® 3DSI Joint Fusion System, a line extension of the EVOL® -SI Fusion System (K190025), is intended to treat dysfunctions of the sacroiliac joint. The subject T-FIX® 3DSI Joint Fusion System includes cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body. The subject T-FIX® screw is headless so that it may be implanted with a zero profile. The distal portion of the screw has a single lead thread and the proximal end has a double lead thread. The subject T-FIX® is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis thereby preventing motion of the sacroiliac joint. The subject T-FIX® screws are made from a titanium alloy Ti-6A1-4V Grade 23 per ASTM 3001 and offered with a HA nano surface treatment.

This document is a 510(k) summary for a medical device called the T-FIX® 3DSI Joint Fusion System. It details the device's indications for use and compares its technological characteristics and performance to predicate devices to establish substantial equivalence.

Based on the provided text, the device is a smooth or threaded metallic bone fixation fastener (product code OUR) and the approval process is for a Class II device. The device is intended for fixation of sacroiliac joint disruptions and fusion for conditions including degenerative sacroiliitis, augmentation of sacropelvic fixation in lumbar/thoracolumbar fusion, and acute/non-acute/non-traumatic fractures involving the sacroiliac joint.

The provided text does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance, nor does it define such acceptance criteria. The "performance testing" described is mechanical testing of the physical device and non-pyrogenicity endotoxin testing.

Therefore, I cannot provide a response fulfilling the request for acceptance criteria and study details related to AI/ML device performance. This document pertains to the regulatory clearance of a physical implantable medical device, not a software or AI/ML-driven diagnostic or assistive device.

To directly address the specific points of your request based on the available document:

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

   • Acceptance Criteria (Mechanical): The device must demonstrate "substantial equivalent performance" to identified predicates based on specific mechanical tests.
     • ASTM F543 (Static cantilever bending, Axial Pullout, Torque to Failure, and Dynamic cantilever bending)
     • ASTM F2193
   • Reported Performance (Mechanical): "In all, the biomechanical testing results demonstrate that the T-FIX® 3DSI Joint Fusion System is substantially equivalent to the predicate device."
   • Acceptance Criteria (Non-Pyrogenicity): The implants must meet the 20 endotoxin units (EU)/device pyrogen limit specification.
     • ANSI/AAMI ST72
     • USP
   • Reported Performance (Non-Pyrogenicity): "the worst case subject EVOL® -SI Joint Fusion System implants verify that the subject implants (line extension T-FIX® 3DSI) meet the 20 endotoxin units (EU)/device pyrogen limit specification..."

2. Sample size used for the test set and the data provenance: Not applicable/not stated. The performance evaluation is based on mechanical properties of the device, not a data-driven test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and test results.

4. Adjudication method for the test set: Not applicable.

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: Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.

7. The type of ground truth used: Not applicable in the context of diagnostic performance. For mechanical testing, the ground truth is the specified performance thresholds per ASTM and ANSI/AAMI standards.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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