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The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
• Elbow: Tennis elbow repair
• Knee: Medial and lateral collateral ligament repair.
• Wrist: Scapholunate ligament reconstruction.

The VersaPEEK™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaPEEK™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
• Elbow: Tennis elbow repair
• Knee: Medial and lateral collateral ligament repair.
• Wrist: Scapholunate ligament reconstruction.

The MicroTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MicroTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
• Elbow: Ulnar/Medial Collateral Ligament Repair
• Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
• Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.

The VersaLat™ Ti Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator Cuff Repair, Biceps Tenodesis
• Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis
• Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.

The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as:
• Shoulder: Rotator Cuff Repair, Biceps Tenodesis
• Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Illiotibial Band Tenodesis.
• Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.

The VersaTap™ Suture Anchor is a self-tapping suture anchor. This anchor is designed to combine the advantages of both PEEK and Titanium. The titanium tip makes the product self-tapping, whilst the majority of the anchor is manufactured from PEEK to minimize post-operative imaging effects.

The VersaPEEK™ Suture Anchor is manufactured completely from PEEK. This material composition minimizes post-operative imaging effects. The suture anchor is designed for ultimate mechanical properties (pullout strength, tensile strength, etc). The VersaPEEK™ Suture Anchor also has a variety of suture/suture tape configurations.

The MicroTiTM Suture Anchor is a small screw-in suture anchor used in a variety of small-joint applications. Despite its small diameter, the specially engineered thread combines with cortical bone to provide tremendous pull-out strength.

The VersaLat™ Ti Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.

The VersaLat™ Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.

The provided document is a 510(k) Premarket Notification from the FDA for several suture anchor devices (VersaTap™, VersaPEEK™, MicroTi™, VersaLat™ Ti, and VersaLat™ Suture Anchors). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing. It does not involve AI/ML technology, imaging, or human reader studies.

Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance" in the context of an AI/ML study, "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details," are not applicable to this type of submission.

The study described here is a mechanical and biocompatibility assessment of medical devices, not an AI/ML performance study.

Here's an adaptation of the requested information based on the provided document:

Acceptance Criteria and Study for Suture Anchors (Non-AI/ML Medical Device)

The provided submission, K242296, for the VersaTap™, VersaPEEK™, MicroTi™, VersaLat™ Ti, and VersaLat™ Suture Anchors, is a 510(k) Premarket Notification. The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove performance of an AI/ML algorithm or derive clinical effectiveness from human reader studies.

The acceptance criteria and supporting studies are based on non-clinical testing to ensure the new devices are as safe and effective as their predicates.

1. Table of Acceptance Criteria (for Non-Clinical Testing) and Reported Device Performance

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

This is not an AI/ML study with a "test set" of data in the traditional sense. It's a medical device submission based on non-clinical bench testing and comparison to predicates.

• Sample Size:
  • For mechanical testing (insertion torque, static pullout), specific sample sizes would have been used per test standards (e.g., ASTM, ISO). These exact numbers are not detailed in the summary document but are implied to be sufficient for demonstrating equivalence.
  • For biocompatibility, the assessment relies on the prior clearance of the same materials and processes in predicate devices. New testing (e.g., non-pyrogenic) would involve a sample size relevant to that specific test.
• Data Provenance: The data provenance is from bench laboratory testing conducted by Ortho-Design (Pty) Ltd in South Africa. It is prospective testing of the new devices and comparison to the known performance and characteristics of the already cleared predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This is not applicable as this is not an AI/ML study involving human interpretation of data where "ground truth" is established by experts in an annotation or diagnostic capacity.
• The "ground truth" in this context is established by engineering and biocompatibility standards and the documented performance of legally marketed predicate devices, as determined by mechanical and chemical testing.

4. Adjudication Method for the Test Set

• Not applicable. There is no human interpretation or diagnostic "test set" requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant to AI/ML software where the aim is to evaluate how AI assistance impacts human reader performance (e.g., in medical imaging diagnosis). This submission pertains to physical medical devices (suture anchors) and their mechanical/biocompatibility characteristics.

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

The "ground truth" for demonstrating substantial equivalence for these suture anchors is established through:

• Engineering Standards: Adherence to recognized national and international standards for mechanical testing of bone anchors (e.g., those referenced in the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions').
• Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices (cleared in K212381), which serve as the benchmark for equivalence.
• Material Biocompatibility Data: Established safety profiles of the materials (PEEK, Titanium) as used in previously cleared medical devices, and specific biocompatibility testing (e.g., pyrogenicity) performed on the subject devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML study involving a "training set" of data.

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

• Not applicable. As there is no "training set," there is no ground truth established for it.

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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 SwiveLock 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:

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

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

· Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis and MPFL Repair/Reconstruction

• · Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
  · Elbow: Biceps Tendon Reattachment, Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)

· Hip: Capsular Repair, Acetabular labral repair

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 the 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. It aims to expand the indications for use of the 3.9mm BioComposite SwiveLock suture anchor to include MPFL Repair/Reconstruction. The submission focuses on demonstrating substantial equivalence to a predicate device (K192532).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No clinical studies involving human readers or AI performance are mentioned in this document. This 510(k) pertains to a physical medical device and its mechanical/biocompatibility performance, not a software device that interprets images or data. Therefore, many of the requested sections below are not applicable.

2. Sample size used for the test set and the data provenance

• Mechanical Testing: The document does not specify the sample size for the mechanical testing (pull-out strength).
• Bacterial Endotoxin Testing: The document does not specify the sample size for the bacterial endotoxin testing.
• Data Provenance: Not applicable as this is laboratory testing of a device, not clinical data from patients.

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

Not applicable. Ground truth for mechanical and endotoxin testing is established by standard laboratory methods and specifications, not by expert consensus on clinical data.

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

Not applicable. Adjudication methods are relevant for expert consensus on clinical data, not for laboratory 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

No MRMC comparative effectiveness study was done or is referenced in this document. This filing is for a physical medical device (suture anchor), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device.

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

• Mechanical Testing: Ground truth is defined by established "published literature" regarding the required pull-out strength for MPFL repair/reconstruction.
• Bacterial Endotoxin Testing: Ground truth is defined by established regulatory and quality standards (USP , USP , FDA Guidance, EP 2.6.14) for pyrogen limits.

8. The sample size for the training set

Not applicable. This is a physical device and does not involve a "training set" in the context of machine learning.

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

Not applicable. This is a physical device and does not involve a "training set" or "ground truth" establishment in the context of machine learning.

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