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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 sacroillac joint 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 sacroiliac joint.

The FIREBIRD SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as both non-sterile, cannulated screws of various lengths and diameters with multiple fenestrations on their shafts. The FIREBIRD SI Screws are constructed from medical- grade titanium alloy (Ti-6Al-4V ELI). 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 FIREBIRD SI Screw allows for packing of autograft and allograft materials.

FIREBIRD SI Fusion System consists of cannulated, fenestrated 9mm, 11mm, and 12mm diameter implants in lengths ranging from 25mm to 70mm. The 9mm diameter implant maintains a single pitch thread along the entire shaft of the 11mm diameter implant features a tapered proximal end and dual-pitch threads. The 12mm diameter implant maintains a single pitch thread form on the proximal and distal ends.

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. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

The 510(k) summary states that the device is identical to a previously cleared device, and therefore, its performance characteristics are the same. It does not contain a study proving the device meets new acceptance criteria. Instead, it relies on the predicate device's prior clearance to establish equivalence.

Therefore, I cannot provide the requested information from the given text as it does not contain a standalone study with acceptance criteria and reported device performance.

Here's why and what information is available:

• No Acceptance Criteria or Reported Device Performance: The document explicitly states, "The performance and technological characteristics of the subject device are unchanged as the subject 9mm FIREBIRD SI Screw is identical to the predicate FIREBIRD SI Fusion System 9mm FIREBIRD SI Screw (K203138) in terms of design, materials and performance characteristics." This means Orthofix is not presenting new performance data for this submission; they are asserting that its performance is equivalent to the predicate.
• No Test Set/Ground Truth Information: Since no new performance study is detailed, there's no information on sample size, data provenance, expert ground truth establishment, or adjudication methods for a test set.
• No MRMC or Standalone Performance Study: The document doesn't describe any studies involving human readers with or without AI assistance, nor does it detail a standalone algorithm performance study. This is expected as the device is a physical bone fixation system, not an AI/software device.
• No Training Set Information: Without a new performance study, there's no mention of a training set or how its ground truth would be established.

The core of this 510(k) submission is to demonstrate that the new version of the FIREBIRD SI Fusion System (specifically, the sterile-packaged 9mm screws) is substantially equivalent to an already cleared version. It relies on the prior approval and testing of the predicate device.

To answer your request, here's what the document does provide, although it doesn't directly address "acceptance criteria and a study that proves the device meets them" for this specific submission:

1. A table of acceptance criteria and the reported device performance:
Not available in the document. The document asserts equivalence to a predicate device, implying its performance is already known and accepted from the predicate's clearance.

2. Sample sized used for the test set and the data provenance:
Not available in the document. No new test set described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not available in the document. No new ground truth establishment described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not available in the document. No new test set described.

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:
No, this is not applicable. The device is a physical bone fixation screw system, not an AI/imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not applicable. The device is a physical bone fixation screw system, not an algorithm.

7. The type of ground truth used:
Not applicable. No new ground truth described for this submission. The basis for clearance is substantial equivalence to a predicate device, which would have undergone its own testing based on engineering standards and clinical data for its intended use.

8. The sample size for the training set:
Not applicable. No training set is mentioned as this is not an algorithm-based device.

9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned.

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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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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 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.

This document is a 510(k) premarket notification for the Orthofix FIREBIRD SI Fusion System. It primarily addresses the addition of nano-scale descriptors to the device labeling and explicitly states that the device's technological characteristics, performance data, and other critical aspects remain unchanged since its prior clearance (K200696). Therefore, there is no new study or new acceptance criteria presented in this document for the FIREBIRD SI Fusion System itself.

The document refers to studies from a predicate device (K200052 – Orthofix Inc. – PTC Systems) to support the nano-surface descriptors. These studies focused on surface characterization and in vitro cellular studies to demonstrate increased proliferation and alkaline phosphatase activity in human stem cells with the PTC modified surface.

Since the core device is unchanged and no new performance studies for the FIREBIRD SI Fusion System are detailed in this 510(k) submission, a table of acceptance criteria and reported device performance directly from this document cannot be created for the FIREBIRD SI Fusion System in the way requested. Instead, I will summarize the information provided regarding the reliance on prior clearances and the nature of the supporting data for the nano-surface descriptors.

Summary regarding Acceptance Criteria and Study for FIREBIRD SI Fusion System (K201664):

This 510(k) submission (K201664) for the FIREBIRD SI Fusion System does not introduce new acceptance criteria for the device's overall function or new studies to demonstrate its performance. The submission's purpose is to add nano-scale descriptors to the labeling.

The document explicitly states:

• "The technological characteristics of the FIREBIRD SI Fusion System are unchanged since the prior clearance K200696."
• "The performance data of the FIREBIRD SI Fusion System are unchanged since the prior clearance K200696. No new mechanical testing was performed for the FIREBIRD SI Fusion System as there are no design changes to the device."
• "The previously cleared indications for use, intended use, design, specifications, contraindications, warnings or precautions remain the same as previously cleared under K200696."

Therefore, the acceptance criteria and supporting studies for the overall device performance would be found in the K200696 submission.

However, the submission does refer to data used to support the nano-surface descriptors, which were previously cleared under predicate K200052. The details on this specific aspect are provided below, but it's important to note these studies are not for the overall performance of the FIREBIRD SI Fusion System as a fusion device, but rather for a specific material characteristic.

1. Table of acceptance criteria and the reported device performance

As no new performance data or acceptance criteria are presented for the FIREBIRD SI Fusion System in this 510(k) submission (K201664), a direct table cannot be provided. The submission relies on prior clearances.

However, regarding the nano-surface descriptors, which is the focus of this particular 510(k) (K201664):

Note: These are derived from the limited information provided in K201664, which heavily references prior 510(k)s (K200696 for the device itself and K200052 for the nano-surface technology). Full details would be in those respective submissions.

Supporting Information for the nano-surface descriptors (based on referenced K200052):

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified in this document. It refers to "in vitro cellular studies using HMSCs and normal human osteoblasts (NHOst) cells." The number of cells, replicates, or experiments is not detailed.
• Data Provenance: In vitro cellular studies. Country of origin not specified, but typically lab-based studies for medical device material properties are conducted by the manufacturer or a contract research organization. Retrospective or prospective is not applicable as it's a lab study, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Experts: Not applicable for in vitro cellular studies. The "ground truth" for such studies would be the objective measurements of cellular activity (proliferation, enzyme activity) quantified by laboratory equipment and interpreted by scientific personnel.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable for in vitro cellular studies. Data would be analyzed statistically, and results would be based on predefined scientific protocols and statistical significance.

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:

• MRMC Study: No. This is an orthopedic implant for physical fixation and fusion, supported by mechanical and in vitro cellular studies. It is not an AI-assisted diagnostic device.

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

• Standalone Performance: Not applicable. This is an implanted medical device, not a software algorithm.

7. The type of ground truth used:

• Ground Truth: For the in vitro cellular studies referenced (from K200052), the "ground truth" would be the quantified biological responses of human stem cells and osteoblasts (e.g., cell counts for proliferation, enzymatic assay readings for alkaline phosphatase activity).

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is an experimental study for material characterization and biological response, not a machine learning model requiring a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned.

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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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