Search Results

Indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. OsteoMed Subtalar Implants are intended for single use only.

The OsteoMed Subtalar Implant System is a spacer for stabilization of the subtalar joint made of Titanium Alloy. The OsteoMed Subtalar implants are offered in diameters of 6.0 to 12.0mm and in lengths of 10.0 to 15.0mm. Guide wires, cannulated screwdrivers and sizers will also be a part of the system.

The provided documents (K031155) pertain to a 510(k) premarket notification for a medical device: the "OsteoMed Subtalar Implant System." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance metrics for a novel technology, especially one involving AI or image analysis.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not available in the provided document.

The 510(k) summary explicitly states that equivalence for this device is based on similarities in intended use, material, design, and operational principle to a predicate device (Kinetikos Medical Subtalar MBA System, K960692). This type of submission does not typically include a clinical study with performance metrics in the way your request describes for a diagnostic or AI-based device.

Key points from the document relevant to its submission type:

• Device Type: Subtalar Implant System (a physical orthopedic implant).
• Purpose of Submission: To establish substantial equivalence to a legally marketed predicate device.
• Basis for Equivalence: Similarities in intended use, material (Titanium Alloy), design, and operational principle to the Kinetikos Medical Subtalar MBA System (K960692).
• Claim: "Due to the similarity of materials and design to the predicate device, OsteoMed believes that the OsteoMed Subtalar Implant System does not raise any new safety or effectiveness issues."

In summary, none of the requested information regarding acceptance criteria and a study proving device performance in the context of diagnostic or AI device evaluations can be extracted from K031155 because it is a submission for a physical implant based on substantial equivalence, not a performance study for software or a new diagnostic method.

Ask a specific question about this device