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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.

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