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The GLADIATOR™ Bipolar System is indicated for the following conditions:

• 1. pathological fractures of the femoral neck
• 2. non-union of femoral neck fractures
• 3. aseptic necrosis of the femoral head and neck
• 4. primary pathology in the young involving the femoral head but with a non-deformed acetabulum.

The design features of the GLADIATOR™ Bipolar System are summarized below:

• . Shells manufactured from cast CoCr allov
• . Shells available in O.D. sizes 36-65mm
• . Bearing insert manufactured from cross-linked UHMWPE
• Bearing insert available in I.D. (femoral head) sizes 22, 28, 32, 36mm .
• Locking and support rings manufactured from UHMWPE .
• All components permanently assembled during production .

The provided document is a 510(k) summary for the GLADIATOR™ Bipolar System, a Class II medical device. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics (like sensitivity, specificity, accuracy, etc.) typically associated with AI/software devices.

Instead, this 510(k) focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

Here's why the requested information is absent and what the document does provide:

• Type of Device: The GLADIATOR™ Bipolar System is a hip prosthesis, a physical implant. The questions you've asked are most relevant to software-as-a-medical-device (SaMD) or AI-powered diagnostic/prognostic devices, which rely on data analysis for performance measurement.
• Regulatory Pathway: The 510(k) pathway for substantial equivalence does not typically require the type of clinical performance study to establish specific numerical acceptance criteria (e.g., sensitivity, specificity) for a physical implant device in the same way it would for a diagnostic algorithm. Instead, it relies on demonstrating similar design features, materials, and intended use as a predicate device, along with verification and validation (V&V) testing to ensure the device performs as intended and is safe. The document states, "The indications for use of the GLADIATOR™ Bipolar System are identical to the previously cleared predicate device. The design features and materials of the subject device are substantially equivalent to those of the respective predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices."

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI/software device, as this information is not present in the provided submission for a physical hip implant.

What the document does confirm is that the GLADIATOR™ Bipolar System was deemed "substantially equivalent" to a legally marketed predicate device by the FDA (K062693). This regulatory determination is the primary "acceptance criterion" for this type of device and submission.

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