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The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including:

• sacroiliac joint disruptions, ●
• degenerative sacroiliitis, ●
• to augment immobilization and stabilization of the sacroiliac ioint 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 sacroillac ioint. ●

The FIREBIRD SI Fusion System is a temporary multiple component system consisting of nonsterile instruments, sterile 11mm and 12mm FIREBIRD SI Screws and non-sterile 9mm FIREBIRD SI Screws. The FIREBIRD SI Screws are manufactured from medical-grade titanium alloy (Ti-6Al-4V ELI) with lengths ranging from 25mm to 70mm.

The 11mm FIREBIRD SI Screw is a cannulated screw featuring multiple fenestrations along the shaft, with a tapered proximal end and dual-pitch threads. The 12mm FIREBIRD SI Scew is a cannulated screw featuring multiple fenestrations along the shaft, with a single pitch thread on the proximal and distal ends. The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The 9mm FIREBIRD SI Screw features multiple fenestrations along the shaft and maintains a single pitch thread along the proximal and distal ends of the screw.

The FIREBIRD SI Fusion System allows for packing of autograft and allograft materials.

The principle of operation is based on the bone screw implants which are designed to prevent and minimize motion / micro motion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion.

The provided text is a 510(k) summary for the FIREBIRD SI Fusion System. It states that there are no changes to the technological characteristics, intended use, or overall risks associated with the device compared to its predicate device. Therefore, no new design verification or validation testing was required for this particular submission. The summary explicitly states that the previous testing performed for earlier 510(k) clearances (K201664, K200696, and K183342) is applicable.

This means the document does not contain the information requested regarding acceptance criteria and study details for the current K203138 submission because new studies were not conducted. It refers to previous clearances.

To answer your request, I would need access to the 510(k) summaries or supporting documentation for the predicate devices mentioned, specifically:

• K201664 - Orthofix Inc. - FIREBIRD SI Fusion System (Primary Predicate)
• K200696 (Mentioned as having applicable testing)
• K183342 (Mentioned as having applicable testing)

Without access to those specific documents, I cannot provide the detailed acceptance criteria and study information you've requested.

However, based on the provided text, I can state the following:

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

• Not provided in this document. The document states "no new design verification or validation testing was required" for this submission (K203138). It refers to previous 510(k)s for relevant data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided in this document. This device is a bone fixation system, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation in the way you're describing. Its testing would involve mechanical and biocompatibility assessments, not clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided in this document.

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/Not provided in this document. This device is a physical implant, not an AI diagnostic tool.

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

• Not applicable/Not provided in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided in this document for the reasons stated above (physical implant, not an AI/diagnostic device). "Ground truth" for this type of device would typically relate to mechanical properties (e.g., strength, fatigue life) matching specific standards or predicate performance, and biocompatibility.

8. The sample size for the training set

• Not applicable/Not provided in this document. No AI training set is relevant for this physical device.

9. How the ground truth for the training set was established

• Not applicable/Not provided in this document.

In summary: The provided document is a 510(k) summary for a physical medical device (bone fixation system). It leverages previous clearances for its substantial equivalence argument, stating that no new testing was required for this specific submission (K203138) because the device's technological characteristics, intended use, and risks are unchanged from its predicates. The questions you've posed (especially those about AI, readers, ground truth establishment, training sets) are highly relevant for AI/Software as a Medical Device (SaMD), but generally are not directly applicable to the type of device described in this 510(k) (a physical implantable screw system).

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