(70 days)
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No
The device description focuses on the material, design, and function of a mechanical screw for ACL fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an ACL fixation screw, which is an implantable device used to treat and stabilize torn ligaments, thereby providing therapy.
No
The device is described as an ACL fixation screw, which is an implant used for repair and not for diagnosing a condition.
No
The device description clearly states it is a physical screw made from titanium, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a screw made from implant grade titanium, intended for tibial fixation of hamstring tendon grafts. This is a surgical implant used within the body, not a device used to test samples outside the body.
- Intended Use: The intended use is for fixing a graft within the tibial tunnel during ACL reconstruction surgery. This is a therapeutic and structural function, not a diagnostic one.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The 9 x 25mm S.I.S. ACL Fixation Screw for Tibial Fixation of Hamstring Tendons Grafts functions the same as the Smith & Nephew RCI ACL Fixation screw for Hamstring Tendons Graft Fixation in the Tibial Tunnel.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The 9 x 25mm S.I.S. ACL Fixation Screw is substantially equivalent to the Arthrex Inc. Cannulated Sheathed Interference Screw, the Concept, Inc. Cannulated Conical Tip Interference Screw, the Depuy Kurosaka Fixation Screw, and the Smith & Nephew RCI ACL Fixation Screw with regard to basic design, intended use, material, and size. The screws are made from implant grade titanium (T16A14V ASTM F136) which is a well know and accepted material for implantable devices.
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
Tibial Tunnel (for fixation of hamstring tendons grafts)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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Smith & Nephew DonJoy Inc.
2777 Loker Avenue West arlsbad. CA 92008-6601 U.S Celenhone: (619) 438-909 elefax: (619) 438-3211
FEB 27 1997
mith = Nephew
SUMMARY OF SAFETY AND EFFECTIVENESS Q.
The 9 x 25mm S.I.S. ACL Fixation Screw is substantially equivalent to the Arthrex Inc. Cannulated Sheathed Interference Screw, the Concept, Inc. Cannulated Conical Tip Interference Screw, the Depuy Kurosaka Fixation Screw, and the Smith & Nephew RCI ACL Fixation Screw with regard to basic design, intended use, material, and size. The screws are made from implant grade titanium (T16A14V ASTM F136) which is a well know and accepted material for implantable devices. The 9 x 25mm S:I.S. ACL Fixation Screw for Tibial Fixation of Hamstring Tendons Grafts functions the same as the Smith & Nephew RCI ACL Fixation screw for Hamstring Tendons Graft Fixation in the Tibial Tunnel.
Smith & Nephew, Inc. DonJoy Division
Dan W. White
Dan W. Miller Director, Regulatory Affairs & Quality Assurance
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