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The KITE Distal Fibula Kit is indicated for:

• Diaphyseal and metaphyseal fractures of the distal fibula
• Intra and extra articular fractures of the distal fibula
• Non-unions of the distal fibula

The KITE Distal Fibula Kit is intended for the stabilization of distal lateral and posterior fibular fractures including those of the diaphysis and metaphysis and intra-articular fractures. The system is comprised of various plates and screws which allow it to be customized to a patient's anatomy and fracture pattern. The plate is secured in place via autolocking and cortical screws.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KITE Distal Fibula Kit, formatted as requested:

KITE Distal Fibula Kit Acceptance Criteria and Study Analysis

Below is a summary of the acceptance criteria and the studies performed to demonstrate the device meets these criteria, based solely on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Reported Performance: The summary states that performance data "demonstrates alignment" or "demonstrate substantial equivalence" and "demonstrate alignment acceptance criteria," indicating that the device met the specified criteria. However, explicit quantitative results for each test (e.g., specific bending strength values, torque values, pullout forces) are not provided in this 510(k) summary.

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

The provided text describes bench testing for mechanical properties and sterility, not clinical testing with human subjects or patient data. Therefore, the concepts of "test set" in terms of patient data, data provenance, and retrospective/prospective studies are not applicable here.

• Sample Size for Mechanical Testing: The specific number of plates or screws tested for each mechanical test (e.g., how many plates for 4-point bending, how many screws for torsional tests) is not specified in the provided summary.
• Data Provenance: Not applicable as it's mechanical bench testing, not clinical data.

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

Not applicable. The ground truth for mechanical and sterility testing is established by the specified ASTM standards and FDA guidance documents, which define the testing methodology and acceptance criteria. This does not involve human expert adjudication of results in the way clinical image analysis or diagnostic studies would.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1 consensus. The tests are either pass/fail based on objective mechanical properties or sterility criteria defined in standards and guidance documents.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., AI for medical imaging) to assess the impact of AI assistance on human reader performance. The KITE Distal Fibula Kit is a bone fixation appliance, and its clearance is based on mechanical performance and biocompatibility.

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

Not applicable. This device is a bone fixation kit, not an algorithm or AI-based diagnostic tool. The performance studies described are for the physical components of the kit.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Mechanical Standards: ASTM F382-17 (for plates) and ASTM F543-17 (for screws). These standards define the methods for measuring specific mechanical properties.
• FDA Guidance Documents: "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" for mechanical performance, and "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff" for LAL testing. These documents define the acceptance criteria that demonstrate safety and performance for these types of devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical medical implant.

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

Not applicable. As there is no training set for an AI/machine learning algorithm, there is no ground truth to establish for it.

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The short length Elos nails are intended for stabilizing various types of intertrochanteric fractures of the form. The long length Elos nails are intended for fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.

The Elos Intramedullary Nailing System consists of a titanium nail, cephalic screw, diaphyseal screw, optional closure cap, and a pre-assembled cannulated grub screw to lock cephalic screws. The short nails are available in lengths of 180mm and 10mm and 11mm in diameter. The short nails also have CCD angles of 122° and 127°. The 180mm short nail is available in one configuration for both left and right femurs and the 240mm nail is available in both left and right configurations. The long length nails are 11mm in diameter, in lengths of 300mm, 340mm, 380mm, 400mm, 420m, 440mm and 460 mm and are offered in left and right configurations. The long nails are also offered with CCD angles of 122° and 127°. The nails, screws, and closure cap undergo an anodic oxidation (Type II Anodization) treatment.

The provided text is a 510(k) summary for the Elos® Intramedullary Nailing System and describes the device's substantial equivalence to predicate devices, primarily through non-clinical performance testing (mechanical fatigue). This document does not describe a study involving an AI/software device that requires intricate acceptance criteria related to accuracy, sensitivity, specificity, and human reader performance.

Therefore, many of the requested elements for an AI/software device performance study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, based on the non-clinical performance testing described, here's an interpretation of the "acceptance criteria" and "study" as presented:

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

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

• Sample Size: Not explicitly stated as a "sample size" in the context of clinical data or image sets. For mechanical fatigue testing, this would refer to the number of devices or components tested. This information is not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data. The performance data is derived from non-clinical mechanical fatigue testing.

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

• Not applicable. Ground truth in this context is established through engineering and materials science principles for mechanical testing, not expert consensus on medical images or clinical outcomes.

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

• Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of medical data, which is not relevant for mechanical testing.

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 study is for a physical medical device (intramedullary nailing system), not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This refers to a physical device, not an algorithm.

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

• Mechanical performance specifications and industry standards for intramedullary nails. The "ground truth" is that the device must withstand certain forces and fatigue cycles without failure, as demonstrated by non-clinical bench testing.

8. The sample size for the training set:

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable. No training set.

Summary of the Study Proving Acceptance Criteria:

The study described is non-clinical performance testing, specifically focusing on mechanical fatigue.

• Methodology: The Elos® Intramedullary Nailing System components underwent mechanical fatigue testing.
• Objective: To demonstrate that the device components meet established performance requirements and are as safe and effective as legally marketed predicate devices (Stryker Gamma3™ Nail System, K032244 and K034002).
• Results: The testing "demonstrated that the Elos® Intramedullary Nailing System components met performance requirements and are as safe and effective as their predicate devices." It also showed that the "performance characteristics... are equivalent to those of other legally marketed intramedullary nail systems."
• Conclusion: This non-clinical data supported the determination of Substantial Equivalence to the predicate devices.

In essence, the "acceptance criteria" were the pre-defined engineering and performance specifications for intramedullary nails, and the "study" was the mechanical fatigue testing that verified the device met these specifications. The document heavily emphasizes the comparison to predicate devices, implying that their performance characteristics serve as the benchmark for "safety and effectiveness" in this context.

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