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The OsteoCentric Integrated Hip Fastener System is indicated for stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

The OsteoCentric Integrated Hip Fastener System is indicated for femoral neck fractures including intracapsular, transcervical, and subcapital fractures.

The OsteoCentric Integrated Hip Fastener System is internal fixation of intertrochanteric and femoral neck fractures of the proximal femur. The OsteoCentric Integrated Hip Fastener System consists of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. Integrated Hip Fasteners which are lag screws implanted through the femoral neck and head are offered in Ø11, Ø13, & Ø15mm sizes with lengths ranging from 50 – 140mm in 5mm increments. Hip side plates are offered in 1-hole to 19-hole configurations (48 – 330mm length). 6.0mm support fasteners are offered in 55 – 125mm lengths. 5.2mm shaft fasteners are offered in 28 – 46mm locking fasteners for the trochanter plate are offered in 16 – 40mm lengths. Compression and attachment screws are also available. Devices are provided non-sterile. All implantable devices are manufactured from stainless steel per ASTM F138.

This document is a 510(k) Premarket Notification from the FDA regarding the OsteoCentric Integrated Hip Fastener System. It does not describe an AI/ML medical device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it concerns a traditional medical device (metallic bone fixation appliances) and its substantial equivalence to previously cleared predicate devices.

Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and reader performance for an AI/ML device is not present in the provided text. The document focuses on the physical characteristics of the hip fastener system (e.g., sizes, materials) and its intended use for treating hip fractures.

To answer your request, if this were an AI/ML device submission, the FDA would require detailed information on its performance, typically including:

1. Acceptance Criteria and Performance Table: This would outline the metrics (e.g., sensitivity, specificity, AUC) the device needed to achieve and the reported performance.
2. Sample Size and Data Provenance: Details on the number of cases in the test set, their origin (e.g., multi-site, geographical distribution), and whether the data was collected retrospectively or prospectively.
3. Ground Truth Experts: The number and qualifications of clinicians who established the definitive diagnosis for the test cases.
4. Adjudication Method: How disagreements among experts were resolved to form the ground truth (e.g., majority vote, senior expert arbitration).
5. MRMC Study: If applicable, a human-in-the-loop study comparing diagnostic accuracy with and without AI assistance, quantifying the improvement.
6. Standalone Performance: The algorithm's performance without human interaction.
7. Type of Ground Truth: Whether the ground truth was based on expert consensus, pathology, long-term outcomes, or other definitive sources.
8. Training Set Sample Size: The number of cases used to train the AI model.
9. Training Set Ground Truth: How the ground truth for the training data was established.

Since this document pertains to a mechanical medical device, none of this information is relevant or provided within the text.

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