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The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in five variations with one size per variation. The implant is manufactured from titanium alloy per ASTM F136.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.

The provided document is a 510(k) clearance letter for a medical device (SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System), not an AI/ML medical device. As such, it does not contain any information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert ground truth establishment, adjudication methods, or MRMC studies, which are typical requirements for AI/ML device submissions.

The document is for a mechanical implant system and focuses on demonstrating substantial equivalence to a predicate device through:

• Identical indications for use.
• Identical technological design principles.
• Justifications and adoptions of existing performance testing (e.g., steam sterilization, FEA, pushout testing) from the predicate device (K241813), rather than new performance studies on clinical data or AI model outputs.

Therefore, I cannot extract the requested information to fill in the table or answer the questions related to AI/ML device validation.

Summary of why the requested information cannot be provided from the input:

• No AI/ML Component: The device is a physical implant (sacroiliac joint fusion system), not a software or AI-driven diagnostic/therapeutic device.
• Substantial Equivalence: The clearance is based on demonstrating substantial equivalence to a predicate device, meaning it relies on already established safety and efficacy data for a previous version or similar device, not de novo clinical trials or performance studies specific to an AI algorithm.
• Focus on Physical Properties: The "Performance Testing" section mentions engineering analyses (FEA, pushout testing) and sterilization, which are relevant to the physical characteristics and safety of an implant, not the diagnostic or analytical performance of an AI system.

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The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroillac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients underqoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in one size. The implant is manufactured from titanium alloy per ASTM F136.

The SI-TECHNOLOGY® SI-DESIS® XTM Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.

This document is a 510(k) summary for the SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System. Based on the provided text, the device itself is an implant for sacroiliac joint fusion, not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies (especially those related to AI/ML performance, ground truth, experts, and multi-reader studies) is not applicable to this submission.

The 510(k) summary describes non-clinical performance testing for the physical device to demonstrate substantial equivalence to predicate devices, but it does not involve any AI/ML components or associated performance metrics.

Here's a breakdown of why each requested item is not applicable in this context:

1. A table of acceptance criteria and the reported device performance: This typically refers to metrics like sensitivity, specificity, AUC for AI/ML devices. For a physical implant, "acceptance criteria" usually relate to mechanical strength, biocompatibility, and manufacturing quality. The document states "The results of these studies show the subject device is substantially equivalent to the predicate devices" for the performed mechanical tests, but does not provide specific numerical acceptance criteria or performance metrics in a table.

   • Performed Tests (Physical Device):
     • Static Shear Testing
     • Dynamic Shear Testing
     • Static Pushout Testing
     • Biomechanical Cadaver Testing
     • Simulated Use Testing

2. Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model for this implant. The testing involved mechanical and cadaveric studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) is not relevant for a physical implant's mechanical testing.

4. Adjudication method for the test set: Not applicable for a physical implant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI/ML software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML software.

7. The type of ground truth used: Not applicable in the AI/ML sense. For the physical device, the "ground truth" would be established by validated biomechanical testing methods and standards.

8. The sample size for the training set: Not applicable. This is for AI/ML software.

9. How the ground truth for the training set was established: Not applicable. This is for AI/ML software.

Conclusion: The provided document is for a physical medical device (an implant) and does not describe an AI/ML powered device. Therefore, the questions tailored for AI/ML device evaluations are not pertinent to this submission. The device demonstrated substantial equivalence through non-clinical performance testing, including mechanical and biomechanical studies, against existing predicate devices.

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The SI-TECHNOLOGY® SI-DESIS® Device is intended for sacroiliac joint fusion for conditions including sacroiliac (SI) joint disruptions and degenerative sacroiliitis.

The SI-TECHNOLOGY® SI-DESIS® Sacroiliac Joint Fusion Screw System consists of screws designed to assist in the healing of sacroiliac joints for fusion by providing fixation of large bones and large bone fragments of the pelvis. The screws are not intended to replace normal body structures. The screws are offered in 6.5 mm diameter cannulated, partially threaded or fully threaded configurations in various lengths. Additionally, optional supplemental 5 mm diameter screws are offered in various lengths and are to be used only in conjunction with the 6.5 mm screws for supplemental screw fixation to accommodate patient anatomy. The screws are manufactured from titanium alloy per ASTM F136.

This document describes the premarket notification (510(k)) for the SI-TECHNOLOGY® SI-DESIS® Screws, a medical device for sacroiliac joint fusion. The information provided is for device clearance, not for an AI/ML powered device. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here's the breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this traditional medical device clearance are typically defined by recognized standards and comparison to predicate devices, rather than specific performance metrics like accuracy, sensitivity, or specificity that would be used for an AI/ML device. The "reported device performance" refers to the results of non-clinical testing demonstrating equivalence to predicate devices.

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

This information is not applicable as the document describes non-clinical engineering testing of a physical medical device (screws), not a diagnostic or prognostic AI/ML system that would use a test set of data. The testing involves physical samples of screws, not patient data.

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

This information is not applicable for a physical device like screws. "Ground truth" in this context would refer to the established engineering standards (ASTM F543, ASTM F2193) and the documented performance of the predicate devices, which are objective and do not require expert consensus in the way an AI diagnostic system would.

4. Adjudication Method for the Test Set

This information is not applicable for the non-clinical testing of a physical device. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases to establish ground truth for AI algorithms.

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

This information is not applicable as the document describes the clearance of a physical medical implant (screws), not an AI/ML system. Therefore, no MRMC study looking at human reader improvement with AI assistance was performed.

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

This information is not applicable as the document is for a physical medical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

For the non-clinical engineering testing, the "ground truth" is established by:

• Recognized Industry Standards: ASTM F543 (Standard Specification for Metallic Medical Bone Screws) and ASTM F2193 (Standard Test Method for Static and Fatigue Testing of Sacroiliac Joint Fusion Implants). These standards define the mechanical properties and testing methodologies.
• Predicate Device Performance: The performance of legally marketed predicate devices (K112028 – Globus SI-LOK Sacroiliac Joint Fixation System, K021932 - Synthes 6.5 mm Cannulated Screw) served as a benchmark for comparison.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of clearing a physical medical device through non-clinical engineering tests. Training sets are relevant for machine learning algorithms.

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

This information is not applicable as there is no training set for a physical medical device clearance based on non-clinical testing.

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