(85 days)
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No
The device description and intended use are purely mechanical, describing a suture anchor and its application in surgical procedures. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a suture anchor used for reattaching soft tissue to bone, which is a surgical tool rather than a therapeutic treatment itself designed to alleviate or cure a disease or condition.
No
The device, the Smith & Nephew OSTERAPTOR Curved Suture Anchor, is described as a surgical implant for reattaching soft tissue to bone, which is a therapeutic function, not a diagnostic one. Its intended uses are repairs and reconstructions, not the identification or assessment of a medical condition.
No
The device description clearly states it is a bioabsorbable suture anchor manufactured from PLLA/HA and comes preloaded with suture and a stainless steel inserter, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "reattachment of soft tissue to bone" for various anatomical sites. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "bioabsorbable suture anchor" with preloaded suture and an inserter. This is a physical implant used during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) 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. This device does not perform any such tests on samples.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Smith & Nephew OSTERAPTOR Curved 2.3 suture anchors are intended for the fixation of soft tissue to bone in the Hip, Shoulder, Foot, Ankle, Elbow, Wrist, Hand and Knee as follows:
Hip
Hip capsule repair - Acetabular labrum reattachment
Shoulder
Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair
Knee
- Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
- Patellar realignment and tendon repairs
– Vastus medialis obliquous advancement Iliotibial band tenodesis
Foot and Ankle
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Product codes
MAI, JDR
Device Description
The Smith & Nephew OSTERAPTOR Curved 2.3 Suture Anchor is bioabsorbable 2.3 mm suture anchor manufactured from PLLA/HA and comes preloaded with nonabsorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a flexible stainless steel inserter.
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
Hip, Shoulder, Foot, Ankle, Elbow, Wrist, Hand and Knee
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
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)
The performance testing demonstrates that the insertion, pull out and suture slide properties of the OSTEORAPTOR Curved 2.3 anchors are substantially equivalent to the Smith & Nephew OSTEORAPTOR 2.3 anchors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810
978 749 1000 978 749 1599 Fax www.smith-nephew.com