(68 days)
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No
The summary describes a bone screw for ligament reconstruction and does not mention any AI or ML components or functionalities.
No
The device is a bone screw used for fixation during ligament reconstruction, which is a structural or supportive function rather than a therapeutic one (i.e., treating a disease or improving a health condition directly, beyond providing mechanical support).
No
The device is a bone screw used for fixation during ligament reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "canulated, sterile, single use bone screw, made of an ostecconductive biodegradable material," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone-tendon-bone or soft tissue grafts during ACL/PCL reconstruction. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a bone screw made of a biodegradable material. This is a physical implant used to hold tissues together.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
The Smith & Nephew PLC Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
Product codes
HWC
Device Description
The Smith & Nephew PLC Screw is a canulated, sterile, single use bone screw, made of an osteoconductive biodegradable material, poly DL-lactide-co-glycolide and calcium carbonate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
Results of product validation testing, in vitro degradation testing, and an in-vivo ovine study conclude that Results of product valuation testibits equivalent fixation to the BioRCI Screw. In addition, the PLC Screw is biocompatible and canable of a timely manner, and elicits an osteoconductive response in vivo.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K051310 page f2
Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810
978 749 1000 978 749 1599 fax www.smith-nephew.com JUL 2 6 2005