(209 days)
The TDM Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.
Cannulated Screw System:
The Cannulated Screw System is intended to be used for fracture of the hand or foot or small and large bones.
Headless Compression Cannulated Screw System:
The Headless Compression Cannulated Screw System is intended to be used for a wide range of different indications in the hand, wrist and joint fusion (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur.
The TDM Screw Systems consist of a family of devices intended for internal bone fixation of fractures, fusions, osteotomies, non unions, and malunions. The subject devices are constructed from Titanium alloy (ASTM F136) and are comprised of cannulated screws, headless compression cannulated screws, limited sliding screws, compression screws, and washers. The subject devices are available in diameters ranging from 2.5mm to 7.5mm and lengths ranging from 10mm to 125mm. The Washer is available in 5.5mm to 13mm. The Screws are intended for standalone use.
The provided text is related to an FDA 510(k) clearance for a medical device called the "TDM Screw System". It describes the device, its indications for use, and a summary of performance data. However, the document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria for an AI/algorithm-driven system.
Therefore, the information requested in your prompt regarding acceptance criteria, study design for AI/algorithm performance (e.g., test/training sets, expert ground truth, MRMC studies, standalone performance), and similar details are NOT present in the provided FDA 510(k) clearance document.
This document is for a physical medical device (metallic bone fixation fasteners), not an artificial intelligence or algorithmic diagnostic/decision-support system. The "Performance Data" section specifically mentions "The following testing was performed in accordance with the ASTM F543-17 and ASTM F1264-16: - Torsional - Pullout - 3-Point Bending". These are mechanical engineering tests for the physical properties of the screws, entirely unrelated to AI or software performance.
Therefore, I cannot populate the requested tables and information as the provided text does not contain the type of study data you are asking about for an AI/algorithm-driven device.
§ 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.