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The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The FIREBIRD SI Fusion System (formally SambaScrew 3D SI Fusion System) is a temporary multiple component system consisting of non-sterile 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-6AI-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 provided text is a 510(k) summary for the Orthofix FIREBIRD SI Fusion System. It describes the device, its intended use, and a summary of non-clinical performance testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the document in relation to your request about acceptance criteria and the study proving the device meets them:

Key Finding:

The document describes non-clinical mechanical testing to demonstrate substantial equivalence for a bone screw, not a medical imaging or AI-enabled device requiring clinical performance studies with human readers, ground truth establishment, or multi-reader multi-case (MRMC) studies. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (sensitivity, specificity, human reader improvement, etc.) is not applicable to this specific submission.

The "acceptance criteria" here relate to engineering specifications and mechanical performance of a medical implant, as assessed by ASTM standards.

Let's break down what information is available and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of mechanical tests performed and the standards they were conducted under. It does not provide specific numerical acceptance criteria (e.g., "must withstand X N of force") or the exact numerical results for each test (e.g., "device withstood Y N of force"). It refers to Appendices (e.g., Appendix B: Static Cantilever Beam Testing 10117508AA) where these results would presumably be detailed. Without access to these appendices, specific performance numbers cannot be reported in a table.

However, based on the type of device and the nature of the 510(k) submission, the "acceptance criteria" are implicitly that the new 9mm FIREBIRD SI Screws perform comparably or better than the predicate/reference devices in the mechanical tests, thereby demonstrating substantial equivalence.

Inferred Acceptance Criteria (Based on context of a 510(k) for a mechanical implant):

• Device mechanical properties (strength, fatigue life etc.) meet or exceed those specified in the relevant ASTM standards for the intended use.
• Device mechanical properties are substantially equivalent to the predicate device (SambaScrew 3D SI Fusion System) and reference device (SAMBA Screw System).

Reported Device Performance (Qualitative, as specific numbers are not provided in the summary):

• The mechanical tests (Static and Dynamic cantilever beam, Static Torsion, Static Axial Pull-Off) were conducted in accordance with ASTM F2193 and ASTM F543.
• The conclusion states: "The performance and technological characteristics of the subject device are similar to the reference device (K121148) in terms of design, materials and performance characteristics." and "There are no significant differences between the subject device, predicate device and reference device, which would adversely affect the use of the product."

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

• Sample Size: Not explicitly stated in the summary for the mechanical tests. For mechanical testing of medical devices, sample sizes are typically small (e.g., n=5 or n=10 per test) as determined by the specific ASTM standard.
• Data Provenance: The tests were "conducted" as part of the submission, presumably by the manufacturer or a third-party testing lab. The location/country of origin of the data is not specified, but the submission is to the US FDA. The nature of the study is non-clinical engineering testing, not clinical data, so the retrospective/prospective distinction is not applicable in the typical sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• N/A. This information is relevant for clinical studies, especially those involving AI for diagnostic interpretation. For a bone screw's mechanical performance, "ground truth" is established by the physical testing and measurement against engineering standards. There are no clinical "experts" establishing a diagnostic ground truth here.

4. Adjudication Method for the Test Set

• N/A. Adjudication is relevant for ambiguous clinical cases in diagnostic studies. For mechanical testing, the results are quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is a mechanical implant, not an imaging device or AI-assisted diagnostic tool. MRMC studies are used to assess the impact of a new diagnostic method (often AI) on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

• N/A. This device does not involve an algorithm or AI.

7. Type of Ground Truth Used

• Engineering Standards and Measurements: The "ground truth" for this device's performance is derived from the physical properties and mechanical behavior of the screws as measured in laboratory tests, compared against the requirements of ASTM standards and the performance of predicate devices.

8. Sample Size for the Training Set

• N/A. There is no "training set" as this is not an AI/machine learning product.

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

• N/A. As above, no training set.

In summary, the provided document describes a 510(k) submission for a mechanical medical implant (bone screw) that relies on non-clinical performance data (mechanical testing) to demonstrate substantial equivalence. It does not involve clinical performance data, AI algorithms, or diagnostic capabilities that would necessitate the types of "acceptance criteria" and "study proofs" typically requested for AI/imaging devices (e.g., sensitivity, specificity, human reader studies, expert adjudication).

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