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The Suture Button Repair System is intended for fixation of bone and soft tissue in upper extremity orthopedic procedures requiring ligament or tendon reconstruction in the hand, wrist, forearm, elbow and shoulder.

The Suture Button Repair System is comprised of the following Suture Button configurations in conjunction with accessories: (1) Distal Bicep Suture Button Repair configuration, (2) IOL Suture Button-Repair configuration and (3) CMC Suture Button Repair configuration. The implants are provided sterile for single use. The instruments are provided non-sterile and shall be sterilized by the end user.

The provided FDA 510(k) summary for the "Suture Button Repair System" does not describe a study involving an AI/Machine Learning device or a diagnostic device that requires establishment of ground truth by experts or a multi-reader multi-case (MRMC) comparative effectiveness study.

Instead, this document is a 510(k) submission for a surgical implant (Suture Button Repair System) and focuses on demonstrating substantial equivalence to a predicate device. The performance testing described is primarily bench-top mechanical testing and standard regulatory tests for medical devices (sterilization, biocompatibility, stability).

Therefore, I cannot extract the information requested in your prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) because these concepts are not applicable to the type of device and submission described in the input document.

The document states:

• "Non-clinical performance testing for the Suture Button Repair System included sterilization validation... biocompatibility testing... stability testing... The Suture Button Repair System was also evaluated for strength and elongation during cyclic loading and ultimate load to failure conditions." (Page 4)
• "Bench top performance testing demonstrated substantially equivalent mechanical performance as the predicate device." (Page 5)

This indicates that the "study" proving the device meets acceptance criteria was a series of engineering/mechanical tests, not a clinical study involving interpretation of images or data by human readers or AI.

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The Skeletal Dynamics Midshaft Humerus Plating System is indicated for fixation of the humerus for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.

The Skeletal Dynamics Midshaft Humerus Plating System include Broad and Narrow Midshaft Humerus Plates and 4.5 mm Locking and Compression Screws made from medical grade titanium alloy. The bottom surface of the plates feature undercuts to facilitate bending, when necessary, to ensure the best fit for differing patient anatomy and oblong threaded slots for the screws. The locking screws feature a double lead locking thread on the head to mate with the plate's threaded slots.

This FDA 510(k) summary describes a medical device, the Skeletal Dynamics Midshaft Humerus Plating System, not an AI/ML powered device. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/ML device meets them (such as details on sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training and test sets) is not applicable and not present in this document.

The provided document instead focuses on demonstrating substantial equivalence to a predicate device through:

1. Acceptance Criteria and Device Performance (based on mechanical testing):

• ASTM F382: Standard Specification and Test Methods for Metallic Bone Plates.
• ASTM F543: Standard Specification and Test Methods for Metallic Bone Screws.
  Engineering analysis was used to establish substantial equivalence of the subject screw to the secondary predicate with respect to pullout testing. |

2. Details not applicable for AI/ML devices:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to physical components subjected to mechanical testing, not a dataset of patient images or clinical data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical devices is established through engineering specifications and standardized test methods, not expert human assessment.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 a medical implant, not an AI diagnostic or assistance tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the mechanical device, the "ground truth" is defined by the performance parameters outlined in the ASTM standards (e.g., strength, stiffness, fatigue life) that the device must meet or demonstrate equivalence to the predicate.
• The sample size for the training set: Not applicable. There is no "training set" for this type of device.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study conducted was a benchtop mechanical testing study designed to demonstrate the substantial equivalence of the Skeletal Dynamics Midshaft Humerus Plating System to its predicate device, the Synthes 4.5 mm Locking Compression Plate (LCP) System.

• Methods: The testing followed established ASTM standards: ASTM F382 for bone plates and ASTM F543 for bone screws. Additionally, engineering analysis was used for screw pullout testing equivalence to a secondary predicate (ARMAR™ / ARTIS™ Screws).
• Conclusion: The performance testing, comprising both mechanical testing and engineering analysis, demonstrated that the Skeletal Dynamics Midshaft Humerus Plating System is substantially equivalent to the predicate device in terms of safety and effectiveness. The minor differences in design did not negatively impact safety, effectiveness, or performance.

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