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This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of nonabsorbable synthetic sutures.

The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:

Shoulder:

• 1. Bankart lesion repairs
• 2. SLAP lesion repairs
• 3. Acromio-clavicular separation repairs
• 4. Rotator cuff tear repairs
• 5. Capsular shift or capsulolabral reconstructions
• 6. Biceps tenodesis
• 7. Deltoid repairs

Foot and Ankle:

• 1. Hallux Valgus repairs
• 2. Medial or lateral instability repairs
• 3. Achilles tendon repairs/reconstructions
• 4. Midfoot reconstructions
• 5. Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand:
• 1. Scapholunate ligament reconstructions
• 2. Ulnar or radial collateral ligament reconstructions
• 3. Tennis elbow repair
• 4. Biceps tendon reattachment

Knee:

• 1. Extra-capsular repairs
• a. medial collateral ligament
• b. lateral collateral ligament
• c. posterior oblique ligament
• 2. Iliotibial band tenodesis
• 3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

The OBL Preloaded Series Anchor is intended for use only for the fixation of non-absorbable synthetic suture material for the following indications:

Shoulder:

• 1. Bankart lesion repairs
• 2. SLAP lesion repairs
• 3. Acromio-clavicular separation repairs
• 4. Rotator cuff tear repairs
• 5. Capsular shift or capsulolabral reconstructions
• 6. Biceps tenodesis
• 7. Deltoid repairs

Foot and Ankle:

• 1. Hallux Valgus repairs
• 2. Medial or lateral instability repairs/reconstructions
• 3. Achilles tendon repairs/reconstructions
• 4. Midfoot reconstructions
• 5. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

• 1. Scapholunate ligament reconstructions
• 2. Ulnar or radial collateral ligament reconstructions
• 3. Lateral epicondylitis repair
• 4. Biceps tendon reattachment

Knee:

• 1. Extra-capsular repairs:
• a, medial collateral ligament
• b. lateral collateral ligament
• c. posterior oblique ligament
• 2. Iliotibial band tenodesis

3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

*Pelvis:

• 2. Bladder neck suspension procedures

• This indication is marketed separately from the orthopedic indications under the trade name Cinch®

The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist, and hand. Examples of such procedures include:

Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs.

Foot and Ankle:
Hallux Valqus repairs, medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.

Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, unler or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.

Knee:
Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.

The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Bankhart Repair SLAP lesion repairs Capsular shift or capsulolabral Reconstructions Acomioclavicular 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

Elbow: Ulnar or radial liqament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee: Extra-capsular repairs: - Medial collateral liqament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs: - Vastus medialis obliquous advancement Iliotibial band tenodesis

The Smith & Nephew BIORAPTOR Curved 2.3 PK 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

Foot and Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

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

The Smith & Nephew TWINFIX Ultra Ti, PK, HA suture anchor families are intended for use 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: Ulnar or radial liqament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee: Extra-capsular repairs: - Medial collateral ligament । - Lateral collateral ligament । - Posterior oblique ligament - Iliotibial band tenodesis Patellar realignment and tendon repairs: - Vastus medialis obliquous advancement

Hip: Abductor tendon repair

The Smith & Nephew FOOTPRINT Ultra PK suture anchor family is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.

Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.

Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.

Hip: Distal row abductor tendon repair.

The HEALICOIL PK Suture Anchor (formerly Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor) is intended for use 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 i - । 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

Hip: Gluteal tendon repairs - -Gluteus medius and gluteus minimus repair

The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:

Hip Hip capsule repair · Acetabular labrum . reattachment/reconstruction

Shoulder Capsular stabilization · Bankart repair . Anterior shoulder instability ● SLAP lesion repairs ● Capsular shift or capsulolabral ● reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator Cuff 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 Bunionectomy

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

Smith & Nephew Non-Absorbable Suture Anchors are provided in various non-absorbable materials. All of the Smith & Nephew Non-Absorbable Suture Anchors are provided sterile, for single use only. All Smith & Nephew Non-Absorbable Suture Anchors are preassembled onto an inserter, sized appropriately to accommodate the indicated procedures. Smith & Nephew Non-Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s). In certain configurations, the Non-Absorbable Suture Anchors are packaged with a quide and awl. All configurations of the Non-Absorbable Suture Anchors are identical to the identified predicate devices.

The provided text is a 510(k) Premarket Notification from the FDA for several suture anchors manufactured by Smith & Nephew. It predominantly focuses on establishing substantial equivalence to existing predicate devices, rather than detailing a study that proves a device meets specific acceptance criteria.

The document lists the product names, their intended uses (which are identical to those of the predicate devices), and states that the substantial equivalence is based on identical indications for use, design features, operational principles, material composition, and performance to the predicate devices. It also mentions "Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Non-Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices."

However, the document does not contain the detailed information required to answer the specific questions about acceptance criteria and a study design that proves a device meets those criteria. The provided text is a regulatory clearance document, not a clinical study report or a detailed engineering test report.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: The document states that the anchors "are substantially equivalent" in performance, but it doesn't provide a table of quantitative acceptance criteria (e.g., minimum pullout strength in Newtons) or the specific measured performance values for the new devices and predicates.
• Sample size used for the test set and the data provenance: While "Ship Testing and Post-Shipment mechanical functional testing" is mentioned, the sample sizes, type of data (e.g., in-vitro, ex-vivo), or provenance (country of origin, retrospective/prospective) are not detailed.
• Number of experts used to establish the ground truth for the test set and their qualifications: This type of information is typically related to clinical image interpretation or diagnosis studies, not mechanical testing of implants. There's no mention of experts establishing a "ground truth" in this context.
• Adjudication method for the test set: Not applicable as there's no mention of expert review or clinical assessment.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI-assisted image interpretation studies, not mechanical device clearance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): In the context of mechanical testing mentioned, the "ground truth" would be the measured physical properties (e.g., force, displacement), but the document does not specify the methods or a reference standard in detail.
• The sample size for the training set: Not applicable, as there's no machine learning algorithm involved.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory approval letter for a medical device based on substantial equivalence to predicate devices, and as such, it does not contain the detailed study design and results (acceptance criteria, sample sizes, ground truth establishment, expert involvement, etc.) typically found in a clinical or performance study report. The statement "Ship Testing and Post-Shipment mechanical functional testing for insertion and pullout (fixation) force demonstrates that the Non-Absorbable Suture Anchors are substantially equivalent to the currently marketed predicate devices" is the extent of the performance data provided, without specific numerical detail or study methodology.

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The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications;

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 epicylitis 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

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is nonabsorbable 2.3 mm suture anchor manufactured from PEEK and comes preloaded with non-absorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a flexible stainless steel inserter.

The provided text describes the 510(k) summary for the BIORAPTOR Curved 2.3 PK Suture Anchor. It details the device's intended use and a comparison to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, which are common for AI/ML devices.

This document pertains to a physical medical device (suture anchor) and focuses on demonstrating substantial equivalence to a predicate device through functional testing (insertion, pull out, suture slide properties). The questions posed are more relevant to the evaluation of AI/ML-based medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any performance testing.
• Data Provenance: Not specified. This typically refers to the source of patient data for AI/ML models, which is not applicable here as it's a physical device.

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)

• Number of Experts & Qualifications: Not applicable. Ground truth for physical device performance (like pull-out strength) is typically established through direct measurement and engineering standards, not expert consensus as would be the case for image interpretation or diagnostic AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in expert opinions, which is not described for this physical device testing.

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

• MRMC Study: No. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a suture anchor.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: No. This refers to the performance of an AI algorithm on its own, without human interaction. This is not applicable to a physical suture anchor.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For physical device testing, "ground truth" would be established through direct physical measurements of properties such as insertion force, pull-out strength, and suture slide characteristics using standardized testing methods. The document states "performance testing demonstrates that the insertion, pull out and suture slide properties... are substantially equivalent."

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no AI/ML algorithm being "trained" for this physical device.

9. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable. (See answer to #8).

Summary of the Study:

The provided document describes a non-clinical performance study to demonstrate substantial equivalence of the BIORAPTOR Curved 2.3 PK Suture Anchor to its predicate device, the BIORAPTOR 2.3 PK Suture Anchor (K071586).

• Acceptance Criteria (Implicit): The implicit acceptance criterion is that the new device's "insertion, pull out and suture slide properties" are "substantially equivalent" to those of the predicate device. This typically means the measured values for these properties fall within acceptable ranges or demonstrate similar statistical distributions compared to the predicate.
• Study Design: Performance testing was conducted.
• Reported Performance: The testing "demonstrates that the insertion, pull out and suture slide properties of the BIORAPTOR Curved 2.3 PK anchors are substantially equivalent to the Smith & Nephew BIORAPTOR 2.3 PK anchors."
• Key takeaway: This is a submission for a physical medical device, not an AI/ML device, hence the lack of information pertaining to AI/ML specific evaluation criteria.

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