(165 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 (2.5mm) or small and large bones (4.0mm larger).
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 (2.3mm & 4.0mm) and fixation of intraarticular fractures of the humerus. femur and tibia (3.5mm & 5.0mm).
Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur, large bones and large bone fragments.
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 120mm. The Washer is available in 5.5mm to 13mm. The Screws are intended for standalone use.
The provided text is a 510(k) summary for the TDM Screw Systems, a medical device for bone fixation. It describes the device, its intended use, and its comparison to predicate devices, focusing on demonstrating substantial equivalence based on non-clinical performance testing.
However, the document does NOT contain information regarding:
- Acceptance criteria for an AI/software device.
- Study details (test set, training set, ground truth, expert involvement, MRMC study, human-in-the-loop performance, standalone performance) that would be relevant to an AI/software device. The document explicitly states: "Clinical data was not needed for this device."
The TDM Screw Systems are a traditional hardware medical device (screws for bone fixation), not an AI/software device. Therefore, the questions related to AI/software performance validation and study design (like MRMC, ground truth establishment, sample sizes for training/test sets for AI, expert consensus, etc.) are not applicable to the information provided in this document.
The document primarily relies on non-clinical performance testing to demonstrate substantial equivalence, specifically referencing:
- ASTM F543-17: "Standard Specification and Test Methods for Metallic Medical Bone Screws"
- ASTM F1264-16: "Standard Specification and Test Methods for Intramedullary Fixation Devices" (used as a guideline for screw three-point bend testing)
- LAL bacterial endotoxin testing
Conclusion based on the provided text:
This document describes the regulatory clearance of a physical medical device (bone screws) and not an AI/software device. Therefore, none of the requested information regarding AI acceptance criteria or study methodologies (test set/training set sizes, expert involvement, MRMC, standalone performance, ground truth establishment, etc.) can be extracted from this text. The acceptance was based on mechanical performance testing in accordance with established ASTM standards for metallic bone screws.
§ 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.