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The Fixano PF2 wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

The device is a balljoint-hinged external fixator capable of rotation and anqulation.

The provided text is a 510(k) summary for the Fixano PF2 device. This document is a premarket notification for a medical device submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the provided text, a "study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic performance is not applicable. The PF2 device is an external bone fixator, a physical medical device. The 510(k) process for such devices typically focuses on mechanical reliability, biocompatibility, and substantial equivalence to existing devices, rather than a diagnostic performance study as would be conducted for an AI/ML algorithm.

Therefore, many of the requested criteria, such as "acceptance criteria and the reported device performance" (in the context of diagnostic accuracy), "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set sample size and ground truth establishment," are not relevant or available in this type of document for this type of device.

Here's a breakdown of what can be inferred from the provided text, addressing the spirit of the request where possible, even if directly answering the prompt for an AI/ML study is not possible:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Implicit): Substantial equivalence to predicate devices (K993649 - EBI XFIX DFS Wristfix System and others). This means demonstrating that the PF2 device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate devices.
• Reported Device Performance: The document does not provide specific performance metrics in a table for an AI/ML context. For a mechanical device, performance would typically be assessed through engineering tests (e.g., strength, durability, fatigue resistance) or clinical studies on mechanical stability, which are not detailed in this summary. The summary highlights that "The PF2 device is similar in its intended use to predicate devices and existent methodologies."

2. Sample Size Used for the Test Set and Data Provenance:
* Not applicable for an AI/ML diagnostic performance study. For a physical device, this would typically refer to the number of devices tested mechanically or patients in a clinical trial. This information is not present in the 510(k) summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
* Not applicable. This relates to diagnostic interpretation. For a physical device, experts might be involved in design review or clinical evaluation, but "ground truth" as defined for AI/ML does not apply.

4. Adjudication Method:
* Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* No. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks. The PF2 is a surgical implant/fixator, not a diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. The PF2 is a physical medical device, not an algorithm.

7. The type of ground truth used:
* Not applicable in the AI/ML sense. "Ground truth" for a physical device usually relates to objective measurements (e.g., material strength tests, biomechanical stability) or clinical outcomes. The 510(k) process relies on demonstrating equivalence to devices with established safety and effectiveness.

8. The Sample Size for the Training Set:
* Not applicable. (No AI/ML algorithm is described.)

9. How the Ground Truth for the Training Set was Established:
* Not applicable. (No AI/ML algorithm is described.)

In summary, the provided document is a regulatory submission for a physical medical device (an external bone fixator) and does not describe an AI/ML or diagnostic performance study. Therefore, the detailed criteria for describing such a study cannot be met by this text. The "study" in this context is the 510(k) submission process itself, where pre-clinical testing (mechanical, biocompatibility) and comparison to predicate devices are the primary methods for demonstrating safety and effectiveness.

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