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The ODi Ultimate Compression Hip Screw will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures, intracapsular fractures and some high subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. The installed device is not intended for weight bearing prior to the fracture showing evidence of union.

The Orthopedic Designs, Inc. Ultimate Compression Hip Screw is a cannulated lag screw to be used with a standard side plates for fracture fixation and stabilization of the proximal femur until bony union can occur. ODi will manufacture the hip screw system from 316L and 22-13-5 stainless steel, which meet ASTM F138-92 and ASTM F1314-95 respectively. The 22-13-5 is used on the side plate and the lag screw tang where greater strength is desired. These materials are compatible and similar to those used in other marketed devices of similar design, dimension and configuration. The distal end of the hip screw is keyed, but not threaded, thereby allowing the screw to slide within the barrel of the side plate while preventing rotation of the screw within the head of the femur. Several keyed sizes are available to be compatible with specific side plate systems of similar design. Immediate compression may be obtained with the use of a compression screw threaded into the inner canal of the screw. A locking element is provided on the compression screw to prevent a common natural migration of the compression screw from the lag attachment Additionally the hip screw has deployable tangs, comparable to several marketed anchor devices, that may be deployed if necessary to increase purchase of the lag screw. These anchors may also be retracted for removal of the lag screw if and when it is necessary. The hip screw and instruments are similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution. A range of screw component sizes and lengths sizes will be made available, offering a range of fracture compression. The components are designed to be manually or mechanically inserted using common (e.g. American Orthopedic) manual and power instrumentation.

The provided text does not describe an acceptance criteria or a study that proves the device meets acceptance criteria. Instead, it is a 510(k) premarket notification for a medical device: the ODi Ultimate Compression Hip Screw.

This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than establishing and meeting novel performance acceptance criteria through clinical or scientific studies.

Here's a breakdown of why this information is not present in the provided text, and what is included:

• Acceptance Criteria and Device Performance: The document states, "No performance standards applicable to the fixation bone screw have been established by the FDA." and "However the 316-L and 22-13-5 stainless steel used to manufacture the ODi Ultimate Compression Hip Screw meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F138-92 and ASTM F1314-95 respectively)." This is the closest it comes to "acceptance criteria," but these are material specifications, not performance criteria for the device itself. There is no reported device performance data in relation to specific acceptance criteria.
• Sample Size for Test Set and Data Provenance: No test samples or data provenance are mentioned, as no performance study was conducted.
• Number of Experts and Qualifications: Not applicable, as no ground truth establishment through expert review was performed for a performance study.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not conducted or mentioned. The document relies on substantial equivalence.
• Standalone Performance (Algorithm only): Not applicable, as this is a mechanical orthopedic device, not an algorithm.
• Type of Ground Truth: Not applicable, as no performance study was conducted.
• Sample Size for Training Set: Not applicable.
• Ground Truth for Training Set: Not applicable.

What the document does provide in relation to regulatory submission is:

• Device Description: Details on material, design, function, and available sizes.
• Indications for Use: What the device is intended for.
• Contra-indications for Use: When the device should not be used.
• Predicate Devices: A list of previously cleared devices to which the ODi Ultimate Compression Hip Screw is claimed to be substantially equivalent. This is the core of a 510(k) submission: demonstrating that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
• Material Standards: Conformance to ASTM material standards for the stainless steel used.

In summary, this document is a 510(k) summary for a mechanical device, which relies on substantial equivalence to predicate devices rather than independent performance studies to establish unique acceptance criteria and prove their satisfaction.

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