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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 PSI Hip Femoral Component with HA Coating is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture or the failure of previous arthroplasty. Each PSI stem is specifically designed for clinical cases where the patient would see added benefit from a femoral component designed to match the natural bone geometry of the femur.

The Kairos™ Orthopaedics Patient Specific Implant (PSI) Hip Femoral Component with HA Coating is designed using the patient's natural bone geometry to construct an implant to better fit and fill the patient's femoral canal relative to other commercially available standard hip stems. Since each stem is matched to a particular patient, a precise device description cannot be provided, as the device design will vary from patient to patient depending upon their unique, naturally occurring bone geometry. Kairos™ Orthopaedics specifies eight design parameters that define an "envelope" of dimensional limits within which all PSI stems are defined.

The provided text describes a 510(k) premarket notification for the Kairos™ Orthopaedics Patient Specific Implant (PSI) Hip Femoral Component with HA Coating. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing acceptance criteria and the results of a formal study proving the device meets those criteria.

Therefore, many of the requested elements for the study that proves device performance against acceptance criteria are not present in this 510(k) summary.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" in the typical sense of a target performance metric for the device (e.g., accuracy, sensitivity, specificity for diagnostic devices; specific mechanical endurance thresholds for implants). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

The "acceptance criteria" in this context are implicitly that the Kairos™ PSI Hip Femoral Component with HA Coating performs as safely and effectively as, and does not raise new questions of safety or effectiveness compared to, the predicate device.

The reported device "performance" is primarily demonstrated through:

• Feature Comparison: The detailed table comparing characteristics between the subject and predicate devices. The implicit "acceptance" is that these characteristics are sufficiently similar or, where different, do not negatively impact safety or effectiveness.
• Engineering Stress Analysis: "an engineering stress analysis was performed on the envelope of design parameters to ensure fatigue performance of the PSI Hip Femoral Component with HA Coating comparable to a clinically proven standard hip stem."
• Mechanical Testing: "Mechanical testing performed by Kairos™ Orthopaedics on a representative PSI stem verified these stress analysis calculations."

Table of Implicit "Acceptance Criteria" and Reported "Performance":

Study Details (Based on the provided text, many elements are N/A)

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

   • Sample Size: Not explicitly stated as a "test set" in the context of a clinical performance study. The mechanical testing was done on "a representative PSI stem." The engineering stress analysis was performed on "the envelope of design parameters." This is engineering/materials testing, not a clinical trial.
   • Data Provenance: N/A for clinical data. Engineering and mechanical testing would have been conducted in-house by Kairos™ Orthopaedics.

2. 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):

   • N/A. This is not a study assessing diagnostic accuracy or expert-interpreted data. The "ground truth" for the mechanical performance would be established by industry standards, engineering principles, and lab measurements.

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

   • N/A. Not applicable to engineering stress analysis or mechanical testing of an implant.

4. 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:

   • N/A. This is not an AI/diagnostic device.

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

   • N/A. This is not an algorithm or AI device. The mechanical testing and stress analysis could be considered "standalone" performance evaluations of the device itself.

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

   • For the engineering stress analysis and mechanical testing, the "ground truth" would be established by relevant ASTM or ISO standards for implant fatigue and material properties, along with established engineering mechanics principles. The aim was to ensure "fatigue performance... comparable to a clinically proven standard hip stem."

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not a machine learning or AI device. The design parameters are based on the patient's natural bone geometry, facilitated by imaging (CT or X-Ray).

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

   • N/A. Not applicable as there is no training set. The "ground truth" for individual patient designs would be the patient's actual anatomy derived from CT or X-ray data.

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