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The system intended for fixation of fractures, osteotomies, and non-unions, involving the radius, ulna, and carpals. Additionally, the wrist fusion plates may be used for wrist arthrodesis.

The Avanti Distal Radius and Forearm System includes volar plates, wrist fusion plates, spanning plates, forearm plates, ulnar plates, and cannulated screws, with screw and peg fasteners, for the fixation of fractures, malunions, and osteotomies. Distal radius and forearm fixation plates may be placed on the volar or dorsal surface of the radius and along the shaft of the radius and ulna on the carpal bones. Features of the system include pre-contoured plates to fit the anatomy of the distal radius, a low-profile design to minimize soft tissue irritation, low contact design to optimize blood supply, and bi-planar angulated screw holes for ease of drilling and to optimize fixation and subchrondral support. All plates are manufactured from medical grade stainless steel per ASTM F138 or ASTM F139 and are electropolished per ASTM F-86. The Volar PEEK Plate has a polyetheretherkeytone that is preassembled to the plate and is sourced from Invibio, LTD. The PEEK insert allows insertion of both locking and non-locking fasteners with an infinite variable angle up to 11 degrees using the drill guide provided in the system. All plates include low-profile geometry to minimize soft tissue irritation and the option of compression or locking cortical screws. The Avanti Distal Radius and Forearm System includes self-tapping screws, listed below, that are manufactured from medical grade stainless steel per ASTM F138, electropolished per ASTM F-86, and are compatible with all Avanti plate configurations. All fasteners but the Cannulated Screw are intended to be used with the plates. The cannulated screws can be used for fracture fixation that is appropriately sized for the device which is determined through surgeon discretion.

The provided text describes a 510(k) premarket notification for the "Avanti Distal Radius and Forearm System," a metallic bone fixation appliance and accessories. This is a medical device submission, and the content focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of diagnostic or predictive performance.

Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.

Here's why and what information can be extracted:

• This is a 510(k) submission for a physical medical device (orthopedic implants), not a software or AI-based diagnostic/predictive device. The criteria for clearance are based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, typically through bench testing (non-clinical performance).
• The "study" refers to non-clinical performance testing, not a clinical trial comparing performance against acceptance criteria for a diagnostic measure.

Information that can be extracted relevant to the "study":

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

2. Sample size used for the test set and the data provenance:
Not applicable. This is not a study involving human or image-based test sets. The "test set" here refers to physical devices or components used in mechanical bench testing. The summary does not specify the number of devices or components tested for each non-clinical test, nor their provenance in the context of "data provenance."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study requiring expert-established ground truth for a diagnostic outcome.

4. Adjudication method for the test set:
Not applicable.

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-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not a standalone algorithm.

7. The type of ground truth used:
Not applicable in the context of diagnostic performance. For the described non-clinical testing, the "ground truth" implicitly refers to established material properties and mechanical performance standards (ASTM standards) that the device must meet to be considered equivalent to its predicates.

8. The sample size for the training set:
Not applicable. There is no "training set" in the context of an AI/ML algorithm.

9. How the ground truth for the training set was established:
Not applicable.

In summary: The provided document is a regulatory submission for a physical medical device, not a software or AI product. The "study" referenced is non-clinical bench testing to demonstrate mechanical performance and substantial equivalence to existing devices, not a study of diagnostic accuracy or reader performance. Therefore, most of the questions are not relevant to this document.

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