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The AOS Calcaneal Plating System is intended for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

The AOS Calcaneal Plating System consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments (K161913 cleared November 4h 2016) and non-locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameter of 2.7 and 3.5mm. The plate system also includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially threaded cannulated screws.

This document describes the regulatory submission for the AOS Calcaneal Plating System (K182466). Due to the nature of the device (a metallic bone fixation appliance), the acceptance criteria and supporting study are primarily focused on mechanical performance and substantial equivalence to predicate devices, rather than the performance of an AI or software algorithm.

Here's an analysis of the provided information, addressing your questions to the extent possible given the context:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical "acceptance criteria" in a table format for specific performance metrics. Instead, the demonstration of equivalence relies on comparative mechanical testing and engineering analysis against a predicate device.

The submission states: "The results demonstrate that the AOS Calcaneal Plating is substantially equivalent to the predicate."

An "Engineering analysis” was also used to demonstrate substantial equivalence to the AOS Small Fragment Plating System Lite (K181035). While specific numerical results are not provided in this summary, the conclusion is that the performance testing and engineering analysis "demonstrated that the subject device had substantially equivalence performance." |
| Similar Indications for Use: The device must have the same or similar intended use as the predicate. | The indications for use are stated as: "fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone." The submission states, "The proposed system has the same indications for use..." |
| Similar Design and Fundamental Technology: The device must share similar design features and fundamental technological principles with the predicate. | The submission states: "The proposed system... is similar in shape and design, and has the same fundamental technology."

Similarities to predicates include:
• Same device classification
• Same cross sectional area
• Same thickness
• Same hole features |

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

• Test Set Sample Size: The document mentions "A worst case sample" was tested for the four-point bend test. This implies a very limited sample size, likely representative pieces or configurations rather than a large statistical sample of patient data. Specific numbers are not provided.
• Data Provenance: The mechanical testing data would be generated in a laboratory setting, likely in the US, given the submission is to the FDA. This is not patient data, so "retrospective or prospective" does not apply in the typical clinical sense. It is pre-clinical data.

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

This concept of "ground truth" established by experts typically applies to AI/software performance where human consensus or pathology reports define the correct output. For a mechanical device, the "ground truth" is established by recognized engineering standards and validated testing methodologies.

• No human experts were used to establish "ground truth" for the mechanical performance of the device in the way a radiologist would for an image. The "ground truth" is defined by the objective physical properties and mechanical behavior measured according to the standard.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation discrepancies, typically in AI studies. For mechanical testing, the results are quantitative measurements against an engineering standard.

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

No. An MRMC study is relevant for assessing human reader performance, usually with AI assistance. This submission is for a medical device (bone plate) and does not involve AI or human readers interpreting data.

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

No. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" is defined by:

• Engineering Standards: Specifically, ASTM F382-17 (Standard Specification for Metallic Bone Plates).
• Predicate Device Performance: The mechanical performance of the legally marketed predicate device (Synthes Modular Mini Fragment LCP System) served as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train an AI model. This submission is for a physical medical device.

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

Not applicable, as there is no AI training set.

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