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The DePuy ACE Calcaneal Peri-Articular Plates are designed to assist the surgeon in the management of:

• Intra-articular fractures of the calcaneus
• Extra-articular fractures of the calcaneus

The plate profile is an enclosed box structure with a smaller anterior section, larger posterior section, a distal to posterior angled strut for additional strength and a number of anatomically relevant screw hole locations. The plate provides a low profile fit to reduce peroneal tendon irritation.

This submission is a 510(k) Pre-market Notification for a medical device, which typically argues for substantial equivalence to a predicate device rather than conducting a de novo study to establish performance against acceptance criteria. Therefore, the document does not contain the requested information about acceptance criteria or a study proving the device meets them.

Instead, the document focuses on demonstrating that the DePuy ACE Calcaneal Peri-Articular Plate is substantially equivalent to legally marketed predicate devices. This is a different regulatory pathway that does not involve the specific type of performance study you are asking about.

Here's why the requested information is absent:

• Substantial Equivalence: The core of a 510(k) submission is to show that a new device is "as safe and effective" as a predicate device already on the market. This is often done by demonstrating similar technological characteristics and intended use. Performance against specific, pre-defined acceptance criteria, proven by a dedicated study, is usually part of a Premarket Approval (PMA) application or a De Novo classification, not a 510(k).
• Device Type: This device is a bone fixation plate, a mechanical component. Its "performance" is typically assessed through mechanical testing (e.g., fatigue strength, torsional strength) rather than clinical efficacy studies in the way an AI algorithm's diagnostic performance might be. However, even such mechanical test results are not detailed in this 510(k) summary, which instead emphasizes material and design similarity to predicates.

Therefore, I cannot fill in the table or answer the specific questions about acceptance criteria, sample sizes, ground truth, or MRMC studies because this information is not provided in the given document. The document explicitly states the "Basis of Substantial Equivalence" as:

"The subject devices are essentially identical (except for size) to the predicate DePuy ACE calcaneal plate devices cleared by 510(k) on July 29, 1998, in that both are made from the same material; the indications remain the same and the design is essentially the same. The subject DePuy ACE calcaneal plates are similar in design and function to the predicate Synthes Calcaneal Plate (510(k) K915818). Based on the information provided in this premarket notification, DePuy considers the subject devices to be substantially equivalent to the existing DePuy ACE Calcaneal Plates and the Synthes calcaneal plates."

This statement confirms that the entire submission hinges on similarity to existing devices, not on a new study demonstrating performance against acceptance criteria.

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