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The intended use of the Gamma3® Nail System includes the following:

Trochanteric Gamma3® Nail: The Trochanteric Gamma3® Nail is intended for use in stabilizing various types of stable and unstable intertrochanteric fractures including peritrochanteric fractures.

Long Length Gamma3® Nail: The Long Length Gamma3 Nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fractures and femoral shaft fractures.

The Trochanteric Gamma3® Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3® Nail indications may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.

The Gamma3® U-Blade Lag Screw may be used with either the Gamma3® Trochanteric Nail or the Long Length Gamma3® Nail to treat patients with highly osteoporotic bone or metastatic disease in the femoral head, short femoral head/neck fragments, or unstable intertrochanteric fractures with missing medial-caudal bone support.

The Gamma3® Nail System is a family of intramedullary nails for basilar neck, intertrochanteric, subtrochanteric and femoral shaft fractures and consists of nails, lag screws, locking screws and set screws. The subject device is a line extension to the Gamma3 Nail System previously cleared in 510(k)s K034002 and K032244 to provide additional components and accessories to the system.

This 510(k) Premarket Notification describes a line extension to an existing intramedullary nail system (Gamma3 Nail System). It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a regulatory submission for a medical device and focuses on establishing substantial equivalence to previously cleared predicate devices. Substantial equivalence claims are based on comparing the new device's technological characteristics, materials, and intended use to a legally marketed predicate device, rather than on new performance studies with specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document. The document primarily serves to inform the FDA that the new components (line extension) are within the scope and safety profile of the already approved Gamma3 Nail System.

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Gamma3 Trochanteric Nail: The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Gamma-Ti and Gamma® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.

Long Length Gamma3 Nail: The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.

This Special 510(k) submission is a line extension intended to address modifications to the Gamma-Ti Nail System and the Gamma3 Nail System cleared in K013468 and K032244 respectively. The new components in the Gamma3 Nail System include additional sizes of Trochanteric Nails, Long Nails, shorter Lag Screws, additional Cap Screws and additional lengths of Locking Screws. The new components will be fabricated from the same material, titanium alloy, as the components in the predicate nail systems.

The provided text is a 510(k) Summary for a medical device called the "Gamma3 Nail System Line Extension." It details the submission information, device identification, and indications for use. However, it does not contain the specific information required to answer your questions about acceptance criteria and a study proving those criteria are met.

This document is a regulatory submission for a line extension of an existing device, focusing on demonstrating substantial equivalence to predicate devices. It relies on the materials and mechanical properties being comparable, rather than presenting a performance study with acceptance criteria in the way you've outlined.

Here's why the required information isn't present in the provided text:

• Acceptance Criteria and Reported Device Performance (Item 1): The document states, "Testing demonstrates the comparable mechanical properties of the subject Gamma3 Nail System to the predicate devices." It does not provide specific acceptance criteria (e.g., minimum bending strength, fatigue life) or quantified performance results against those criteria. The comparison is qualitative ("comparable").
• Sample Size and Data Provenance (Item 2): Not mentioned. The "testing" likely refers to benchtop mechanical testing, not clinical data or a test set of data points derived from patients.
• Number of Experts and Qualifications (Item 3): Not applicable, as there's no mention of a study involving expert review or ground truth establishment in this context.
• Adjudication Method (Item 4): Not applicable.
• MRMC Comparative Effectiveness Study (Item 5): Not applicable. This is a medical implant, not an AI diagnostic tool requiring human-in-the-loop performance measurement.
• Standalone Performance (Item 6): Not applicable, as this is a physical medical device, not an algorithm.
• Type of Ground Truth (Item 7): Not applicable. The "ground truth" for this device's regulatory approval is its substantial equivalence to predicate devices based on material and mechanical properties, not clinical outcomes or expert consensus on image interpretation.
• Sample Size for Training Set (Item 8): Not applicable. This isn't an AI/ML model.
• Ground Truth for Training Set (Item 9): Not applicable.

In summary, the provided document is a regulatory filing for a medical implant line extension, focusing on demonstrating substantial equivalence through material and mechanical comparability. It does not include the type of performance metrics, study design, and ground truth establishment typically associated with the evaluation of diagnostic software or AI-powered devices.

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