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The Smith & Nephew BIORAPTOR◊ Suture Anchor is indicated 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 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

Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchors are indicated 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 BIORAPTOR◊ Suture Anchor is intended for the reattachment of soft tissue to bone.

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

The Smith & Nephew BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchors are fixation devices intended to provide secure attachment of soft tissue to bone. The devices consist of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. The BIORAPTOR Curved 2.3 PK Suture Anchors are preassembled to a flexible insertion device.

The provided FDA 510(k) clearance letter and summary for the BIORAPTOR Suture Anchors primarily focus on demonstrating substantial equivalence to a predicate device, particularly concerning a packaging modification. As such, the document does not contain the typical acceptance criteria and detailed study data (like sample size, expert consensus, MRMC studies, etc.) that would be found in a submission for a novel or significantly modified AI/medical imaging device.

The "Performance Data" section specifically mentions non-clinical testing related to the packaging modification. Therefore, I will extract information related to these non-clinical tests and frame them as 'acceptance criteria' and 'reported performance' for the device's packaging.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for BIORAPTOR Suture Anchors (Packaging Modification)

The described study proves that the modified packaging for the BIORAPTOR Suture Anchors meets the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states "Non-clinical testing was completed on the subject device for the proposed packaging modification," but does not specify the exact sample size used for these tests.
• Data Provenance: The tests are non-clinical, conducted by the manufacturer (Smith & Nephew, Inc.). The document does not specify the country of origin for the data beyond the company's US headquarters (Andover, MA). These were likely prospective tests performed on the new packaging design.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable to the type of non-clinical, packaging-related testing described. There is no 'ground truth' in the clinical sense (e.g., diagnosis, pathology) that requires expert consensus. The "ground truth" here is the adherence to engineering specifications and performance standards for packaging.

4. Adjudication Method for the Test Set

• This information is not applicable as the testing is engineering/laboratory-based for packaging performance, not clinical interpretation of data that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC study was not done. This type of study is relevant for AI/imaging devices where human readers interpret diagnostic images, often with and without AI assistance. The device in question is a physical suture anchor, and the described studies are non-clinical evaluations of its packaging.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This concept applies to AI algorithms. The described studies are physical tests of a medical device's packaging.

7. The Type of Ground Truth Used

• The "ground truth" for these non-clinical tests is based on pre-defined engineering specifications and performance standards for medical device packaging (e.g., ISO or ASTM standards for sterile barrier systems, shelf life, and shipping integrity). It is not clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This concept applies to machine learning models. The tests performed are physical, non-clinical evaluations related to manufacturing and packaging.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This concept applies to machine learning models.

Summary of Limitations Based on Document Content:

The provided document details a 510(k) submission for a suture anchor with a packaging modification. The testing described is therefore focused on demonstrating that this packaging change does not compromise the device's safety, effectiveness, or equivalence to its predicate. The detailed information typically requested for AI/software devices (like expert consensus, MRMC studies, training data details) is not relevant or present in this type of submission for a physical, mechanical device's packaging.

Ask a specific question about this device

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 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.

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.

Ask a specific question about this device

The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Elbow, Wrist, and Hand
Biceps tendon reattachment
Lateral epicondylitis repair
Ulnar or radial collateral ligament reconstructions

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
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

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

Non-bioabsorbable 2.3 mm suture anchor manufactured from PEEK Optima® polymer with attached non-bioabsorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a stainless steel inserter.

The provided text is a 510(k) summary for the BIORAPTOR PK Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, particularly material composition. It does not contain the kind of detailed information about acceptance criteria, specific device performance metrics, study designs (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC, standalone) that your request outlines.

Therefore, I cannot extract the requested information from the provided text. The document states:

• "The performance testing conducted demonstrates that the insertion and fixation properties of the BIORAPTOR PK anchor are substantially equivalent to the Smith & Nephew BIORAPTOR OC and the Smith & Nephew KINSA anchors."

This is a general statement of equivalency based on performance testing, but it does not provide the specific data points, acceptance criteria, or methodological details required to answer your questions comprehensively.

In summary, the document does not contain the information needed to fill out your request.

Ask a specific question about this device