Search Results

a. OIC Cannulated Screw System is used for adult and pediatric patients as indicated for pelvic, small and longbone fracture fixation. OIC 6.5/7.3mm cannulated screws are indicated for large bones and large bone fragments such as ankle arthodeses, intercondylar femur fractures, pediatric femoral neck fractures (6.5mm cannulated screws only), sacroiliac joint disruptions, and subtalar athrodeses. OIC 4.0mm cannulated screws are indicated for the fracture fixation of small bones and small bone fragments such as metatarsal and phalangeal osteotomies, fractures of the tarsals and metatarsals, tarsometatarsal and metatarsophalangeal athrodeses, osteochondritis dissecans, and other small fragment cancellous bone fractures.
b. The OIC Sliding Hip Screw (SHS) System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in subtrochanteric, intertrochanteric, and basilar neck fracture. The SHS is indicated for stable fractures, and unstable fractures in which a stable medial buttress can be reconstructed. The SHS provides controlled collapse and compression of fracture fragments. This results in stable fixation and prevents undue stress concentration on the implant.

Not Found

This FDA 510(k) clearance letter pertains to medical devices (OIC Cannulated Screw System and OIC Sliding Hip Screw System), not an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria and a study to prove the device meets those criteria (especially points related to AI/ML performance metrics, ground truth, experts, and training/test sets) is not applicable to this document.

The document primarily focuses on the substantial equivalence determination for orthopedic implants, referencing regulations like 21 CFR 888.3030 and product codes KTT, HWC. This type of clearance is based on comparison to legally marketed predicate devices, and the evaluation does not typically involve the kinds of performance studies, expert consensus, or training/test set analyses relevant to AI/ML device submissions.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates the primary route for clearance, which is historical comparison.

Therefore, I cannot provide the requested table and study details as they are not present or relevant in the provided document.

Ask a specific question about this device