(95 days)
The Smith & Nephew 5.0 Absorbable Polymer Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications: Shoulder (Bankart lesion repairs, SLAP lesion repairs, Acromioclavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Deltoid repairs), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions), Elbow, Wrist, and Hand (Scapholunate ligament reconstructions, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment), Knee (Extra-capsular repairs: Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament; Illiotibial band tenodesis, Patellar realignment and tendon repairs, including vastus medialis obliquous advancement).
Smith & Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318: Bankart Lesion Repair, Rotator Cuff Repair, Capsular Stabilization, Anterior Shoulder Instability Repair, Repair of ligaments and tendons of the elbow, foot, and ankle including the treatment of: Bunionectomy, Lateral ankle instability, Biceps tendon reattachment.
Smith & Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor: These 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).
Smith & Nephew Suture Anchors – Osteoraptor Suture Anchor: The Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy), Hip (Hip capsule repair, Acetabular labrum reattachment), 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), 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).
Smith & Nephew Suture Anchors – Twinfix Ultra HA Suture Anchor: The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder (Bankart repairs, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions), 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), Elbow (Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment).
Smith & Nephew Suture Anchors – OSTEORAPTOR Curved Suture Anchors: The Smith & Nephew OSTEORAPTOR Curved Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: 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).
Smith & Nephew Suture Anchors – Ultra Fast-Fix Meniscal Repair System, Ultra Fast-Fix AB Meniscal Repair System, Fast-Fix 360 Meniscal Repair System: The ULTRA FAST-FIX Meniscal Repair System is intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures. The ULTRA FAST-FIX AB Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX AB System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX AB System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures. The FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The FAST-FIX 360 System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
Smith & Nephew Suture Anchors - Healicoil Absorbable Suture Anchor: The Smith & Nephew HEALICOIL Absorbable Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder (Bankart lesion repairs, Slap lesion repairs, Capsular shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstruction, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions), 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), Elbow (Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment).
Smith & Nephew Absorbable Suture Anchors are provided in various composite absorbable materials. All of the Smith & Nephew Absorbable Suture Anchors are provided sterile, for single use only. All Smith & Nephew Absorbable Suture Anchors are pre-assembled onto an inserter, sized appropriately to accommodate the indicated procedures. Smith & Nephew Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s), and with attached stainless steel needle(s). In certain configurations, the Absorbable Suture Anchors are packaged with a guide and threaded dilator. All configurations of the Absorbable Suture Anchors are identical to the identified predicate devices.
The provided text describes a 510(k) premarket notification for various Smith & Nephew Suture Anchors. This document primarily focuses on establishing substantial equivalence to existing legally marketed devices, rather than presenting a study proving a device meets specific performance acceptance criteria through clinical trials or algorithm performance evaluation.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as they are not applicable to a 510(k) submission of this nature. The document highlights mechanical functional testing for insertion and pullout (fixation) force but does not provide specific acceptance criteria or detailed results of these tests.
Here's a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document states that "Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices."
However, no specific quantitative acceptance criteria (e.g., minimum pullout force, insertion force ranges) or numerical performance results are provided in the text. The acceptance criterion is implicit: performance must be substantially equivalent to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in: | "Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices." |
| - Insertion force | |
| - Pullout (fixation) force | |
| - Intended use | "identical indications for use" |
| - Design features | "identical design features" |
| - Operational principles | "identical operational principles" |
| - Material composition | "identical material composition" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document refers to "Ship Testing and Post-Shipment mechanical functional testing." This implies physical testing of the devices, not a test set for an algorithm or clinical data. No sample sizes for these tests are provided, nor is data provenance in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device 510(k) submission, not a study evaluating an AI/algorithm's performance against expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for an AI/algorithm evaluation. For the mechanical functional testing, the "ground truth" would be established by validated test methods and measurements against engineering specifications or predicate device performance.
8. The sample size for the training set
Not applicable. This document does not describe the development or training of an algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 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.