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The SImmetry® Sacroiliac Joint Fusion is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.

The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged partially threaded or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 6.5mm-14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm-110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm-14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).

The provided document describes a 510(k) premarket notification for the "SImmetry® Sacroiliac Joint Fusion System." This is a medical device, specifically a smooth or threaded metallic bone fixation fastener, and the submission is a "Special 510(k)." Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modifications do not affect the indications for use or the fundamental scientific technology of the device.

Based on the nature of this submission (a Special 510(k)) and the information provided, no acceptance criteria or studies proving the device meets those criteria are included in the document. The document explicitly states:

• "No performance data is required to support this Special 510(k)."
• "This Special 510(k) does not involve any changes to the technological characteristics of the device. The principle of operation of the subject device is identical to that of the predicate device cleared under K141549, SImmetry Sacroiliac Joint Fusion System."

Therefore, I cannot provide the requested information. The FDA's clearance for this device (K151818) is based on its substantial equivalence to a previously cleared predicate device (K141549), and not on a new study demonstrating its performance against specific acceptance criteria.

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The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged lag or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 6.5mm - 14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm- 110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm - 14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies involving a test set, experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training sets.

The document is a 510(k) premarket notification from the FDA for the Zyga Technology, Incorporated's SImmetry® Sacroiliac Joint Fusion System. It discusses the device's classification, predicate devices, description, intended use, and a summary of non-clinical performance data.

The "Summary of Non-clinical Performance Data" section mentions:

• "Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K130092 predicate device."
• "Cadaveric testing demonstrates the subject devices can be safely implanted using the SImmetry surgical technique."
• "Additionally testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure."

However, it does not provide any specific acceptance criteria or detailed results of these tests (e.g., numerical values for torque, strength, or fatigue life). There's no mention of a test set, data provenance, experts, ground truth, or any methodology typically associated with validating an AI/ML medical device.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the studies as described in your prompt, as that information is not present in the provided text.

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The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac ioint disruptions and degenerative sacroiliitis.

The SImmetry Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for the 6.5mm diameter screws.

This document describes the regulatory submission for the SImmetry Sacroiliac Joint Fusion System, a medical device, and therefore does not contain information related to software or AI system performance, ground truth, or study designs typically associated with such. The document focuses on showing substantial equivalence to a predicate device through non-clinical bench testing.

Here's an analysis of the provided text based on the requested information regarding acceptance criteria and a study proving those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data, as this is a 510(k) submission for a modification to a previously cleared device, focusing on non-clinical bench testing.

• Sample Size: Not explicitly stated for bench tests (e.g., number of screws tested). It refers to "the worst case SImmetry implant" which suggests a limited number of samples were used for testing the specific modification.
• Data Provenance: The data is from "Non-Clinical bench tests" performed by Zyga Technology, Inc. There is no information regarding country of origin or whether it's retrospective or prospective, as these terms are not applicable to bench testing.

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

This information is not applicable. The "ground truth" here is established by standardized mechanical testing protocols (ASTM F1264 for bending fatigue and ASTM F543 for torsion). No human experts or clinical ground truth are involved in evaluating the performance of the device against these mechanical standards.

4. Adjudication Method for the Test Set

This is not applicable. The "test set" refers to mechanical bench testing, where outcomes are quantitative measurements based on engineering standards, not subjective interpretations requiring adjudication.

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

No. This type of study (MRMC) is relevant for evaluating human performance, often in conjunction with AI, typically in diagnostic imaging. The submission is for a medical implant and relies on non-clinical bench testing, not clinical studies involving human readers. Therefore, no effect size for human readers improving with or without AI assistance is provided.

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

No. This document describes a physical medical implant, not an algorithm or an AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by standardized mechanical test methods (ASTM F1264 for bending fatigue and ASTM F543 for torsion) and comparison against a legally marketed predicate device. The goal is to demonstrate that the modified device performs "as well or better" than the predicate under these objective engineering tests.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

This information is not applicable, as there is no "training set."

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is a series of non-clinical bench tests.

• Study Design: Mechanical testing was performed on "the worst case SImmetry implant" using established ASTM standards.
• Tests Conducted:
  • Bending fatigue per ASTM F1264
  • Torsion per ASTM F543
• Objective: To demonstrate that the modified SImmetry Sacroiliac Joint Fusion System performs as well as or better than its predicate device (K111801).
• Conclusion: The tests demonstrated that the implants perform "as well or better than the predicate devices," leading to the conclusion of substantial equivalence based on mechanical performance.

This type of submission focuses on demonstrating the safety and effectiveness of a device modification through engineering principles and comparative mechanical performance, rather than clinical efficacy, for which a different type of study would be required.

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The SImmetry™ Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

The SImmetryTM Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for the 6.5mm diameter screws. The revised surgical technique manual for the new modified version of the SImmetry™ Sacroiliac Joint Fusion System contain instructions for adding autologous graft material to the sacroiliac joint to help ensure fusion.

The provided document is a 510(k) summary for a medical device modification, specifically for the "SImmetry™ Sacroiliac Joint Fusion System Modification." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about an AI/ML device or its performance criteria, study design, or results in the context of diagnostic accuracy.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is typically found in documents detailing the clinical validation of a diagnostic or AI-powered medical device, which is not the nature of this submission.

Summary of what the document does indicate:

• Device: SImmetry™ Sacroiliac Joint Fusion System
• Modification: The revised surgical technique manual for the new modified version contains instructions for adding autologous graft material to the sacroiliac joint to help ensure fusion.
• Purpose of Submission: To demonstrate substantial equivalence of the modified device to the predicate device (K102907).
• Conclusion: Equivalence is based on the same indications for use, design features, operational principles, material composition, and mechanical performance when compared to the predicate device.
• Impact of Modification: The document states that the modification does not affect the intended use, alter the fundamental scientific technology or performance of the device, or raise any new questions of safety or effectiveness. It also states that adding autologous graft material does not require testing to ensure substantial equivalence.

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The SImmetry™ Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

The SImmetry Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm.

The provided text describes the SImmetry™ Sacroiliac Joint Fusion System which is a fixation device/bone screw, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and testing (like MRMC studies, training set details, or ground truth for AI) are not applicable to this submission.

The "study" referenced in this 510(k) is a non-clinical performance evaluation comparing the device's mechanical properties to predicate devices to establish substantial equivalence.

Here's the information extracted and categorized based on the available text:

Acceptance Criteria and Device Performance for SImmetry™ Sacroiliac Joint Fusion System

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify a numerical sample size for each mechanical test. It refers to "test data" and "test results" in a general sense.
• Data Provenance: The data is from "mechanical testing" performed by the manufacturer, Zyga Technology, Inc. The country of origin is not explicitly stated, but the company is based in Minneapolis, Minnesota, USA, implying the testing was likely conducted in the USA. The testing is for non-clinical performance of the device, not patient data, so "retrospective or prospective" is not applicable in the typical clinical study sense.

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

• Not Applicable. This is a mechanical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for a test set. The "ground truth" for mechanical testing is established by engineering standards and measurement techniques.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a mechanical device performance study, there's no "adjudication" for human interpretation of results in the traditional sense. The mechanical testing results are compared directly against established performance benchmarks or predicate device results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers with vs. without AI Assistance:

• No. This is a non-AI medical device; therefore, an MRMC study and AI assistance effects are not applicable.

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

• Not Applicable. This product is a physical medical device (bone screw), not an algorithm or software. "Standalone performance" in the context of AI does not apply.

7. The Type of Ground Truth Used:

• For the mechanical performance testing, the "ground truth" is typically derived from engineering standards, material science principles, and direct comparative measurements against a legally marketed predicate device's known performance characteristics. It's not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As there is no training set, there is no ground truth to establish for it in this context.

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