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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 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 collateral ligament 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 TWINFIX Ultra Ti suture anchor is manufactured from titanium, the TWINFIX Ultra PK suture anchor manufactured from polyetheretherketone grade LT3 and the TWINFIX Ultra HA suture anchor is manufactured from poly 1lactide/hydroxylapatite. All anchors are offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with suture, preassembled onto a stainless steel inserter and offered with and without needles.

The provided text describes an Indication Expansion for a medical device (TWINFIX Ultra Ti, PK, and HA suture anchors), seeking to add "Abductor tendon repair" to its intended uses. The submission focuses on demonstrating substantial equivalence to predicate devices and does not describe a study to establish new acceptance criteria or device performance for the new indication alone.

Instead, the submission states that:

• "The performance testing conducted includes static loading, dynamic loading and in vitro degradation properties that are substantially equivalent to the indicated predicates." (Section H)
• "Testing also demonstrates that the differences in the TWINFIX Ultra Ti, PK and HA families and the predicate devices do not raise any new issues of safety and efficacy." (Section H)
• "Since there are no changes to the design the technological characteristics remain the same." (Section G)

Therefore, the acceptance criteria are implicitly those established for the predicate devices and for general suture anchors, with the new indication being supported by demonstrating that the device's performance characteristics (static loading, dynamic loading, degradation properties) are equivalent to those already accepted for similar devices with similar indications. No new, specific acceptance criteria for "Abductor tendon repair" or a dedicated study for it are detailed.

Given this, I cannot fill the requested table or answer most of the questions about a new study proving devices meet acceptance criteria as such a study is not described in the provided text. The document is a 510(k) summary focused on demonstrating substantial equivalence rather than presenting new performance study data for novel acceptance criteria.

However, I can extract the following relevant information based on the premise of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The rest of the questions relate to a specific study demonstrating device performance against new acceptance criteria. Since this document focuses on substantial equivalence to existing devices and does not describe such a study for the indication expansion, I cannot answer them from the given text.

To reiterate, the provided text is a 510(k) summary for an indication expansion, which relies on demonstrating that the performance of the device (TWINFIX Ultra Ti, PK, and HA suture anchors) for the new indication (Abductor tendon repair) is substantially equivalent to that of already legally marketed predicate devices. It does not describe a de novo study to establish new performance criteria or a new study with the details requested in points 2-9 for the expanded indication.

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