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The Acumed Ankle Syndesmosis Repair System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Acumed Ankle Syndesmosis Repair System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The Acumed Ankle Syndesmosis Repair System is intended to provide fixation during the healing process following a syndesmotic trauma.

The Acumed Ankle Syndesmosis Repair System contains a fibula button, a tibia button and a high strength fiber suture assembled onto a driver, and is provided in a sterile kit as two options, one with and one without a drill. The system also offers optional washers in a separate sterile kit. The driver and drill are part of the sterile kits and are not available individually.

The metal implants including the buttons and washers are manufactured from Titanium Alloy (Ti 6AL-4V ELI per ASTM F136) and the suture is manufactured from ultra-high-molecular-weight polyethylene (UHMWPE).

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets these criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device (Acumed Ankle Syndesmosis Repair System).

While it mentions that non-clinical bench testing was conducted to demonstrate substantial equivalence to a predicate device, it does not provide:

• A table of acceptance criteria and reported device performance. It only states that static and dynamic fatigue testing was conducted and that the system performs "statistically equivalent" to the predicate. No specific performance metrics or acceptance thresholds are given.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• If an MRMC comparative effectiveness study was done or its effect size.
• If a standalone performance (algorithm only) was done.
• The type of ground truth used. (This device is a hardware implant, not an AI/software device, so the concept of ground truth in the context of expert consensus or pathology is not applicable here).
• Sample size for the training set. (Again, not applicable for a hardware device unless referring to development iterations, which are not detailed).
• How ground truth for the training set was established. (Not applicable).

The document mentions that "Clinical testing was not required to support substantial equivalence," which further indicates that the detailed study information you are asking for, especially related to human readers or ground truth derived from clinical data, would not be present in this submission type.

In summary, the provided text details the regulatory clearance of a physical medical device based on substantial equivalence to a predicate device through non-clinical bench testing, not an AI/software-based diagnosis or image analysis system that would typically involve the detailed study characteristics you've requested.

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