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The Triton™ Sacroiliac Joint Fixation system is intended for fixation of sacroiliac joint distruptions, and intended for sacroiliac joint fusion for conditions including;
-sacroiliac joint disruptions,
-degenerative sacroiliitis
-to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
-Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

The Triton™ Sacroiliac Joint Fixation System is a multiple component system consisting of non-sterile instruments and sterile, cannulated Ø8mm, Ø12mm and Ø14mm Screws offered in multiple lengths. The Triton SI Screws are manufactured from medical-grade titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, Class C. The implants feature 3 fluted channels for bone collection and a tapered proximal tip. The Ø12mm and Ø14mm Screws feature multiple open and porous-filled windows for packing and disbursement of autograft and allograft materials.

This FDA 510(k) summary is for a medical device called the Triton™ Sacroiliac Joint Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood in the context of AI/ML device performance or clinical outcomes.

The provided document primarily focuses on non-clinical testing for mechanical properties (e.g., static pull-out, torsion, cantilever) to demonstrate the safety and effectiveness of the physical implant by comparing its mechanical characteristics to existing predicate devices.

Therefore, many of the requested categories related to AI/ML device performance, human expert involvement, ground truth, and training data cannot be extracted from this document, as they are not applicable to the type of 510(k) submission described.

Here's a breakdown based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists non-clinical mechanical tests, but doesn't explicitly state acceptance criteria as pass/fail thresholds against specific numerical values. Instead, it implies that the device's performance in these tests was comparable to that of predicate devices, leading to a conclusion of substantial equivalence.

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

Not applicable. The "test set" here refers to physical components of the device undergoing mechanical testing, not a dataset for AI/ML. The provenance would be the materials used in manufacturing the device components for these tests.

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

Not applicable. This is not AI/ML performance testing requiring expert ground truth for classification or prediction. The "ground truth" for mechanical testing is established by standard engineering principles and test methods, often performed by engineers or technicians.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication in the context of mechanical testing as described here. Results are objectively measured according to the ASTM standards.

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. This is not an AI/ML device that assists human readers.

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

No. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing is based on established engineering standards and measurements of mechanical properties (e.g., force, torque, displacement) as defined by ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device.

Summary of the Study Proving Device Acceptance Criteria (based on the provided document):

The Triton™ Sacroiliac Joint Fixation System underwent a series of non-clinical mechanical tests to demonstrate its performance and substantial equivalence to legally marketed predicate devices. These tests were conducted according to established ASTM standards:

• Static Pull Out (ASTM F543)
• Static Torsion (ASTM F543)
• Static Cantilever (ASTM F2193)
• Dynamic Cantilever (ASTM F2193)

The document concludes that the "differences in geometry are not significant and would not adversely affect the use of the product. The Triton™ System is substantially equivalent in material, size offerings, classification, anatomical location, manufacturing and sterilization methods, surgical approach, principle of operation, indications for use, and mechanical testing plan." This statement implies that the device successfully met the performance expectations by demonstrating comparable mechanical characteristics to the predicate devices, thereby establishing its safety and effectiveness for its intended use. The "ground truth" for these tests was the objective measurements obtained through adherence to the specified ASTM testing protocols.

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