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The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures and osteotomies.

The Sonoma Fibula Repair System includes all implants and instruments required for the fixation of fibula fractures and osteotomies. The Sonoma Fibula Repair System includes the Sonoma Fibula Rod, Sonoma Bone Screws, End Cap and related instruments. Sonoma's Fibula Rod differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws. The implants are composed of 316 stainless steel per ASTM F138.

Here's an analysis of the provided text regarding the Sonoma Fibula Repair System, outlining the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or provide detailed performance data from a study. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use, indications for use, and material composition.

However, based on the context of a 510(k) submission, the implicit "acceptance criteria" revolve around demonstrating comparable safety and effectiveness to legally marketed predicate devices. The "reported device performance" in this context refers to the similarities identified.

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

The document does not describe an independent test set with efficacy data. The submission is a 510(k) for "substantial equivalence" to existing predicate devices, rather than a de novo submission requiring extensive clinical trial data.

The "data provenance" primarily consists of referencing existing FDA clearances (K142945, K071944, K031438) for the predicate devices. This indicates a reliance on the previously established safety and effectiveness of those devices, rather than new, primary data from a study for this submission.

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

Not applicable. As no independent test set with efficacy data is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable. No independent test set is 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

Not applicable. This is not an AI-based device. It is a physical orthopedic implant system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI-based device.

7. The Type of Ground Truth Used

Not applicable. For a substantial equivalence claim for a physical implant, "ground truth" in the clinical efficacy sense (e.g., pathology, outcomes data) is typically established through a combination of:

• Engineering and Biomechanical Testing: (Though not explicitly detailed in this summary, would have been part of previous submissions for K142945).
• Clinical Experience with Predicate Devices: The long history of successful use of the predicate devices.
• Material Standards Compliance: Adherence to established ASTM standards for medical-grade materials.

8. The Sample Size for the Training Set

Not applicable. This is not an AI-based device that would require a training set.

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

Not applicable. This is not an AI-based device.

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The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures.

The Sonoma Fibula Repair System includes all implants and instruments required for the fixation of fibula fractures. The Fibula Repair System includes the Sonoma Fibula Rod, Sonoma Bone Screws, End Cap and related instruments. Sonoma's Fibula Rod differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws. The implants are composed of 316 stainless steel per ASTM F138.

The provided text describes the Sonoma Fibula Repair System, a medical device for fibula fracture fixation. It is a 510(k) premarket notification, which means it demonstrates substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness. Therefore, the information provided focuses on comparative performance rather than a standalone clinical study with detailed acceptance criteria and expert reviews, as would be typical for an AI/CADe device.

Based on the provided document, here's an analysis of the "acceptance criteria" and "study" as they relate to this specific device (a hardware implant):

1. Table of Acceptance Criteria and Reported Device Performance:

For a hardware implant like the Sonoma Fibula Repair System, "acceptance criteria" are generally based on mechanical performance standards to ensure the device is at least as safe and effective as existing predicate devices.

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

• Sample Size: Not explicitly stated as a number of devices. The "test set" in this context refers to the physical devices (Sonoma Fibula Repair System) that underwent mechanical testing. Standard testing typically involves a sufficient number of samples to achieve statistical confidence in the results according to the ASTM standard, but the exact count isn't provided.
• Data Provenance: The testing was "engineering analysis and mechanical testing." This indicates in-vitro laboratory testing, not human or animal data. The country of origin of the data is implied to be within the US, given the FDA submission. It is prospective testing on newly manufactured devices.

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

• Ground Truth for Mechanical Testing: For mechanical testing of an implant, the "ground truth" is established by adherence to recognized engineering standards (e.g., ASTM F1264-03(07)) and comparison to the known performance of predicate devices. There wouldn't be "experts" establishing ground truth in the sense of clinical experts for interpretation of images or patient outcomes. The experts involved would be engineers and material scientists developing, conducting, and interpreting the mechanical tests according to established protocols.
• Qualifications: While not explicitly detailed, such testing would be overseen by qualified engineers with expertise in biomedical engineering, materials science, and mechanical testing, likely adhering to good laboratory practices.

4. Adjudication Method for the Test Set:

• Adjudication: Not applicable in the context of mechanical testing of devices. Adjudication methods like "2+1" typically apply to clinical studies where human readers interpret data or images. The "adjudication" here is the pass/fail criteria defined by the ASTM standards and the demonstration of equivalence to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No MRMC Study: An MRMC comparative effectiveness study is not applicable as this is a physical implant, not an AI or imaging-based diagnostic/interpretive device. Therefore, there's no mention of human readers or AI assistance.

6. If a Standalone (Algorithm Only) Performance Study was Done:

• No Standalone Study (Algorithm): This device is a physical implant, not an algorithm or software. Therefore, an algorithm-only standalone performance study is not relevant or performed.

7. The Type of Ground Truth Used:

• Ground Truth Type:
  • Mechanical Performance Data: The ground truth for the device's mechanical performance is established by the results of standardized engineering tests (cyclic bending fatigue, static bending, static torsion) and direct comparison of these results to those of the predicate devices.
  • Material Composition Standards: ASTM F138 for 316 stainless steel.
  • Design Specifications: Comparison of dimensions and design features against predicate devices.

8. The Sample Size for the Training Set:

• Training Set (Not Applicable): This concept is specific to machine learning/AI algorithms. For a physical medical device, there isn't a "training set" in this sense. The design and manufacturing process are informed by engineering principles, material science, and the existing predicate device designs.

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

• Training Set (Not Applicable): As there is no "training set" in the AI sense, this question does not apply. The design of the Sonoma Fibula Repair System is informed by the principles proven by the predicate devices and established biomechanical understanding of fibula fixation.

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