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The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

The Biomet Microfixation Pectus Blu Support Bar and Stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric (children and adolescents) for which the rib cage across the sternum measures 7 inches (17.78 centimeters) or larger. The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years, but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively. These devices are intended to be used in professional healthcare facilities.

The Pectus Blu Support Bar and Stabilizers are made of titanium alloy (ASTM F136) and provided nonsterile for sterilization by the end user.

The provided text describes a medical device, the Pectus Blu Support Bar System, and its clearance process with the FDA. However, it does not contain any information about a study involving an AI device or its performance criteria. The document pertains to a traditional medical implant and its safety and effectiveness testing (mechanical, MR compatibility, biocompatibility).

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI device.

The prompt requires information about:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

None of this information is available in the provided text as it relates to an AI/software device. The document focuses on physical device characteristics and regulatory clearance for a metallic bone fixation appliance.

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