Search Results

aap's Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aap's Washers may be used with the screws in certain applications. Specific indications, which are dependent in part on the diameter of the screw, include: scaphoid fractures and other fractures of the hand; metatarsal fractures and other fractures of the foot; malleolar fractures, ligament fixation of the proximal humerus; wrist, ankle, shoulder and elbow fractures; fractures of the pelvis and acetabulum: femoral neck and fractures: femoral supracondvlar fractures; and tibial plateau fractures.

The aan Cannulated Screws and Washers are manufactured of Titanium Allov (Ti 6A1 4V E.L.I.) and 316 L Stainless steel. The age Cannulated Screws are available in various lengths and various thread diameters. The aap Washers are available in the appropriate sizes to fit with the screws and are manufactured of Titanium Alloy (Ti 6A1 4V E.L.I.) and 316 L Stainless Steel.

Unfortunately, the provided text does not contain specific acceptance criteria or details of a study proving the device meets them. The document is a 510(k) summary for a medical device (aap Cannulated Screws and Washers) and a letter of substantial equivalence from the FDA.

Here's why it doesn't provide the requested information:

• 510(k) Summary Purpose: A 510(k) summary is primarily intended to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device, not to present detailed study results proving performance against specific acceptance criteria. Substantial equivalence means it has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, that it does not raise different questions of safety and effectiveness.
• Focus on Equivalence, Not Performance Standards: The document focuses on comparing the new device's materials, intended use, and technological characteristics to existing predicate devices. It states that the "ago Cannulated Screws and Washers are substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." This is a regulatory statement, not a performance metric from a study.
• "Performance Standards" Section: The "Performance Standards" section only states: "Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable Harmonized Standards ISO 9001/ EN 46001." These are manufacturing and quality system standards, not specific performance acceptance criteria for the device itself (e.g., tensile strength, fatigue life, screw pull-out force, etc.) and there is no study described to show the device meets these. The mention of ASTM requirements implies that certain material properties meet ASTM standards, but specific values or a study where these were measured and compared to an acceptance criterion are absent.

Therefore, I cannot fill out the requested table or answer most of the detailed questions about a performance study, as that information is not present in the provided text.

If this were a document containing such a study, the information would typically be found in sections detailing mechanical testing, clinical trials, or benchtop evaluations with explicit endpoints and statistical analyses.

Ask a specific question about this device