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The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy

Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair (4.75 SwiveLock C Only), Meniscal Root Repair (4.75 SwiveLock C Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only), MPFL Repair/Reconstruction(3.9 SwiveLock Only)

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Unar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair

Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 – 5.5 mm PEEK SwiveLock suture anchors only), and Proximal Hamstring Repair (4.75 - 5.5 mm PEEK SwiveLock suture anchors only).

The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with an anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock Anchor, which seeks to obtain pediatric indications and an extended shelf life for an existing device. It largely focuses on mechanical testing, a review of clinical literature, and real-world data to demonstrate substantial equivalence to predicate devices, rather than an AI-powered device's performance study.

Therefore, many of the requested details regarding acceptance criteria for an AI device, specific study methodologies (like MRMC, standalone AI performance), ground truth establishment for AI training/testing, expert qualifications, and adjudication methods are not present in the provided document. The document details testing for a physical medical device (suture anchor).

However, I can extract information related to the performance data and the "study" (testing) that was done to support the submission for the physical device.

Acceptance Criteria and Device Performance (Based on Provided Text)

The "acceptance criteria" here refer to the standards the physical device needed to meet to demonstrate substantial equivalence, particularly concerning the proposed modifications (pediatric indication, extended shelf life).

Study Details (Based on Provided Text)

1. Sample sized used for the test set and the data provenance:

• Mechanical Testing: Not explicitly stated (e.g., number of anchors tested), but it was performed on the "subject device" and "predicate device." No geographical provenance is specified.
• Clinical Literature: The text states "Clinical literature was provided on the subject devices involving the proposed patient population of skeletally mature pediatric patients." The number of studies or patients is not specified. It's a retrospective review of existing data.
• Real World Data/Evidence: "Real World Data/Evidence is provided from the Surgical Outcomes System registry." The sample size (number of patients) is not specified, but it compares "patients less than 22 years of age versus patients greater than 22 years of age." The provenance of this registry data (e.g., country of origin) is not specified. This is retrospective data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This concept is not applicable here as the "ground truth" for a physical medical device's performance primarily comes from engineering and clinical outcome data, not expert consensus on image interpretation. For the clinical literature review and RWD, the "truth" is established by the clinical outcomes themselves, as documented in studies and registries.

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

• This concept applies to interpreting complex data, typically images or clinical scenarios, often for AI or diagnostic devices. It is not relevant to the mechanical/biological testing or the clinical literature/RWD review described for this physical medical device.

4. 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:

• No. This study type is for evaluating reader performance with and without AI assistance for diagnostic or prognostic devices. It is not relevant for a physical medical device like a suture anchor.

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

• No. This applies to AI algorithms. Not relevant for this physical medical device.

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

• Mechanical Testing: Ground truth established through direct physical measurement and engineering standards (e.g., force applied, displacement measured).
• Pyrogenicity Testing: Ground truth established by laboratory assay results meeting specified pyrogen limits.
• Clinical Literature/Real World Data: Ground truth is clinical outcomes data (e.g., success of repair, complications, patient outcomes), as documented in published literature and registries.

7. The sample size for the training set:

• Not applicable in the context of this device. This pertains to machine learning models. This submission is for a physical medical device.

8. How the ground truth for the training set was established:

• Not applicable. This pertains to machine learning models. This submission is for a physical medical device.

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The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior

Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure · Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.

The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

The anchor is constructed from a hollow braid of polyester with a single loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester.

The anchor is preloaded on a disposable inserter and will be sold sterile for single use.

This document is a 510(k) premarket notification for the Arthrex FiberTak Suture Anchor. It details the device's indications for use, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Here's an analysis based on your request:

No AI/ML device is described in this document. This 510(k) submission is for a physical medical device: a suture anchor. Therefore, the questions related to AI/ML device acceptance criteria, study design, ground truth, and reader studies are not applicable.

The document primarily focuses on demonstrating that the Arthrex FiberTak Suture Anchor is substantially equivalent to existing predicate devices (K200341: Arthrex Self-punching FiberTak Suture Anchor and K171020: Arthrex SutureTak Suture Anchor), and that new indications (Gluteal Tendon Repair, Capsular Repair (Hip), and Joint Capsule Closure (Knee)) are supported by performance data and similarity to reference devices.

However, I can extract information relevant to performance acceptance criteria and the study that proves the device meets them for this physical medical device, framed within what's typically expected for a 510(k) for a non-AI/ML device.

Acceptance Criteria and Device Performance (for a physical medical device)

For a physical medical device like the Arthrex FiberTak Suture Anchor, acceptance criteria are typically related to mechanical performance, biocompatibility, and sterility, often demonstrating equivalence or non-inferiority to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of anchors tested, number of cycles) for the cyclic pull-out testing or bacterial endotoxin testing. This level of detail is typically found in the full test reports referenced in the 510(k), but not always explicitly stated in the summary.
• Data Provenance: Not specified, but generally, such testing for FDA submissions would be conducted in controlled laboratory environments, likely in the US or by labs with recognized accreditations. The data is prospective, generated specifically for this submission.

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

• This is not applicable as the document describes a physical medical device, not an AI/ML diagnostic or prognostic tool. Ground truth in this context is established through quantitative mechanical testing and laboratory assays (e.g., bacterial endotoxin test), rather than expert interpretation of images or patient outcomes for diagnostic purposes.

4. Adjudication Method for the Test Set

• Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI interaction or diagnostic image interpretation studies, not for physical device performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• Not applicable. MRMC studies are specific to evaluating diagnostic performance, often comparing human readers with and without AI assistance for tasks like image interpretation. This document is about a mechanical implant.

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

• Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

• For the mechanical performance (cyclic pull-out): The "ground truth" is defined by the quantitative mechanical properties measured (e.g., force, displacement, cycles to failure) as per established test standards and protocols. The "truth" is that the device performs equivalently to previously cleared products based on these objective measurements.
• For biocompatibility: The "ground truth" is adherence to pre-defined pyrogen limits as per recognized standards (EP 2.6.14/USP ).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

Summary for this specific device:

The Arthrex FiberTak Suture Anchor is a physical medical device. Its acceptance criteria are based on demonstrating substantial equivalence to already marketed predicate devices, primarily through:

• Mechanical performance: Cyclic pull-out testing showing statistical equivalence to the predicate device and suitability for new indications compared to reference devices.
• Biocompatibility: Bacterial endotoxin testing confirming it meets pyrogen specifications.
• Design and manufacturing equivalence: Showing similar basic design, intended use, materials, manufacturing processes, and sterilization to predicate devices.

The "study" in this context refers to the engineering and laboratory testing (cyclic pull-out tests, bacterial endotoxin tests) rather than clinical trials or AI performance evaluations. The goal is to prove that the device is as safe and effective as its predicates.

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