(178 days)
The Flow-Screw is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the Flow-Screw can also be used to deliver injectable bone void fillers to a surgical site.
The Flow-Screw is cannulated and available in fully and partially threaded designs in various lengths. The Flow-Screw is fenestrated along its length which allows it to be used as a delivery system for injectable bone void fillers. The Flow-Screw implants are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or stainless steel conforming to ASTM F138 or ASTM F2229.
The provided text describes a medical device called the "Flow-Screw" and its substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML product.
The document is a 510(k) premarket notification decision letter from the FDA for a physical medical device (a bone fixation screw), not an AI/ML algorithm. Therefore, the questions related to AI/ML product evaluation (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
The "Substantial Equivalence" section mentions "Mechanical Performance" and "BVF Delivery" as criteria, stating:
- Mechanical Performance: "Mechanical testing demonstrates the substantial equivalence of the Flow-Screw relative to the identified predicates when subjected to static compression bending loads."
- BVF Delivery System: "The qualification testing (i.e., Injectability Testing, Experimental Void Fill Imaging Studies, Static Extraction Torque, BVF Characterization) was performed with ETEX Beta-bsm and CarriGen (K062630, K072355, K090242, K101557)"
However, these are not quantitative acceptance criteria in the format requested, nor do they detail the specifics of such studies as would be done for an AI/ML device.
Therefore, I cannot provide the requested information because the document describes a physical medical device and not an AI/ML product.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.