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The IFS Bone Fixation Devices are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Warning: IFS Bone Fixation Devices are not indicated for spinal fixation.

The IFS Bone Fixation Devices consist of cancellous, malleolar, or cortical screws ranging from 6 to 160mm in length and 1.5mm to 7.3mm in diameter. Threaded, spaded or blunt guide wires range from 0.028 to 0.188 of an inch in diameter and 4 to 12 inches in length. All IFS Bone Fixation Devices are manufactured using 316L stainless steel.

The provided text is a 510(k) summary for a medical device (IFS Bone Fixation Devices) seeking clearance from the FDA. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials to prove safety and effectiveness through specific acceptance criteria and performance studies.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way a de novo or PMA submission would.

Here's why and what information is available:

• No specific acceptance criteria or performance study results: The core of a 510(k) is to show that the new device is "substantially equivalent" to an already legally marketed predicate device. This means the new device has "similar design attributes, material, and intended use" and the same technological characteristics as the predicate. It does not typically involve setting specific performance metrics (like sensitivity, specificity, accuracy) and then conducting a new study to meet those targets.
• Focus on substantial equivalence: The provided text explicitly states: "There are no significant differences between bone fixation devices and the other devices as listed in the Substantially Equivalent Devices. The IFS Bone Fixation Devices and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, experts, or ground truth, as this information is not part of a 510(k) summary focused on substantial equivalence.

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