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· Sacroiliac joint dysfunction that is a direct result of sacrolliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Device Description

The Deltacor TORPEDO Implant System® consists of canulated spiral-shaped titanium implants (CP Ti Grade 4, ASTM F67) and a placement. The structured surface and special shape of the implant is intended to prevent rotation or displacement of the sacroiliac joint (SI). The cannulated implant can be augmented into the bone in a controlled manner using the laterally inserted holes between the helix. The placement instrument uses a guide wire to achieve precise placement. The TORPEDO Implant System® offers a minimally invasive option for treating SI joint dysfunction.

AI/ML Overview

The medical device in question, the TORPEDO Implant System®, is a canulated spiral-shaped titanium implant designed for sacroiliac fusion. This document focuses on the performance testing conducted to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria specific to its AI functionality.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for device performance in the way one might expect for software or diagnostic AI. Instead, it details various mechanical tests and their corresponding ASTM standards, implying that meeting these standards or demonstrating comparable performance to predicate devices is the acceptance criterion.

Test Type	Standard / Method	Reported Performance / Conclusion
Static Torsion Testing	ASTM F543-17	Device underwent this testing. Conclusion: "The totality of the non-clinical and clinical data provided in the 510(k) submission demonstrate that the TORPEDO Implant System® is as safe, as effective, and is substantially equivalent to the cited predicate devices." (Implies satisfactory performance against this standard comparable to predicates)
Static Axial Pull-Out Testing	ASTM F543-17	Device underwent this testing. Conclusion: "The totality of the non-clinical and clinical data provided in the 510(k) submission demonstrate that the TORPEDO Implant System® is as safe, as effective, and is substantially equivalent to the cited predicate devices." (Implies satisfactory performance against this standard comparable to predicates)
Static Four-Point Bending Fatigue Testing	ASTM F1264-16	Device underwent this testing. Conclusion: "The totality of the non-clinical and clinical data provided in the 510(k) submission demonstrate that the TORPEDO Implant System® is as safe, as effective, and is substantially equivalent to the cited predicate devices." (Implies satisfactory performance against this standard comparable to predicates)
Dynamic Bending Fatigue Testing	ASTM F3574-22	Device underwent this testing. Conclusion: "The totality of the non-clinical and clinical data provided in the 510(k) submission demonstrate that the TORPEDO Implant System® is as safe, as effective, and is substantially equivalent to the cited predicate devices." (Implies satisfactory performance against this standard comparable to predicates)
Biocompatibility	Referenced BoneTrust® (K182313) and BoneTrust® Mini Implant System (K200573)	"The Deltacor TORPEDO Implant System® is substantially equivalent to the reference devices with respect to biological safety and mechanical performance testing methodology." (Implies meeting the biocompatibility standards established by the referenced devices)

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

The document refers to "non-clinical and clinical data" but does not explicitly detail the sample size for the test set in the context of device performance. The "clinical data" mentioned are general, including "sales and complaints data, clinical literature, and patient-level clinical data." This suggests that the clinical evidence relies on a broader compilation rather than a distinct, prospectively designed test set with a defined sample size for performance evaluation like an AI study would have.

The provenance of the data is not specified in detail (e.g., country of origin, retrospective or prospective for the "patient-level clinical data").

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

This information is not applicable as the device is a physical implant and not an AI/software device that relies on expert ground truth for its performance assessment. The "ground truth" for this type of device is established through mechanical testing, material science, and clinical outcomes (as observed in existing literature and patient data), rather than expert consensus on image interpretation or diagnosis.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of data (e.g., medical images) where discrepancies need to be resolved to establish ground truth.

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:

This information is not applicable as the device is a physical implant and not an AI system. Therefore, it does not involve human readers interpreting data with or without AI assistance.

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

This information is not applicable as the device is a physical implant and does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For this physical device, the "ground truth" is derived from:

Mechanical Testing: Adherence to defined ASTM standards for static torsion, axial pull-out, and bending fatigue.
Biocompatibility: Demonstrated equivalence to similar devices with established biological safety.
Clinical Data: General "sales and complaints data, clinical literature, and patient-level clinical data" which would implicitly reflect real-world outcomes and safety profiles, aligning with the concept of "outcomes data" to support its safety and effectiveness.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical implant, not an AI model that requires a training set.

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

This information is not applicable for the same reasons as point 8.

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