(85 days)
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Richards 4.0 mm Cannulated Screw, Alphatec Titanium Cannulated Mini Lag Screw System
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
No.
The device is a screw intended for fracture fixation, which is a structural support device rather than one that treats or cures a disease.
No
Explanation: The device, Synthes 3.5 mm and 4.0 mm Cannulated Screws, is described as an implant for fracture fixation. Its function is to fix bones, not to diagnose a condition or disease.
No
The device description clearly describes physical screws made of metal, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fracture fixation of small bones and small bone fragments." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device (screws) used for mechanical support.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of those things.
This device is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fracture fixation of small bones and small bone fragments.
Product codes
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Device Description
Synthes 3.5 mm and 4.0 mm Cannulated Screws are available in multiple thread length configurations (partially or fully threaded). The 3.5 mm Cannulated Screws feature reverse cutting flutes and cortical threads. The 4.0 mm Cannulated Screws feature self-drilling/self-tapping tips, reverse cutting flutes and cancellous threads. Both screws are used in conjunction with a guide wire for precise placement in bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and small bone fragments
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
mechanical testing: Based on mechanical testing, Synthes 3.5 mm and 4.0 mm Cannulated Screws are at least equivalent to Synthes 2.7 mm Cortex Screws.
Key Metrics
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Predicate Device(s)
Synthes 2.7 mm Cortex Screws
Reference Device(s)
Richards 4.0 mm Cannulated Screw, Alphatec Titanium Cannulated Mini Lag Screw System
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
,
(610) 647 - 9700 Contact: Angela J. Silvestri August 1996
Synthes Sterile 3.5 mm and 4.0 mm Cannulated Screws are compared to Synthes 2.7 mm Cortex Screws.
Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fracture fixation of small bones and small bone fragments. Synthes 3.5 mm and 4.0 mm Cannulated Screws are available in multiple thread length configurations (partially or fully threaded). The 3.5 mm Cannulated Screws feature reverse cutting flutes and cortical threads. The 4.0 mm Cannulated Screws feature self-drilling/self-tapping tips, reverse cutting flutes and cancellous threads. Both screws are used in conjunction with a guide wire for precise placement in bone.
Additionally, the Richards 4.0 mm Cannulated Screw and the Alphatec Titanium Cannulated Mini Lag Screw System are commercially available devices that are also similar to Synthes 3.5 and 4.0 mm Cannulated Screws.
Synthes 3.5 mm and 4.0 mm Cannulated Screws will be provided sterile; gamma radiation will be used to sterilize the device.
Based on mechanical testing, Synthes 3.5 mm and 4.0 mm Cannulated Screws are at least equivalent to Synthes 2.7 mm Cortex Screws.