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The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are intended to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these devices for ACL/PCL repair and reconstruction for the adult and pediatric patient population.

The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are comprised of a suture loop that may include passing sutures and/or metallic button. The suture loop and passing sutures are braided nonabsorbable surgical sutures. The button is made of titanium with holes to permit suture passage and assembly with Arthrex sutures.

The proposed devices are available in various device models referred to as TightRope® ABS, Implant; TightRope®, PCL; ACL TightRope® RT; ACL TightRope® II RT; ACL TightRope® II RT, Double Loaded Passing Sutures; BTB TightRope® II; BTB TightRope® II, Double Loaded Passing Sutures; and TightRope® II ABS, Implant Open.

This document describes the 510(k) premarket notification for Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices, seeking to expand their indications to include the pediatric patient population. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices for this new patient group.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of an AI/ML device where performance metrics like sensitivity, specificity, etc., are usually evaluated on a separate test set. Instead, the provided information relates to:

• Mechanical Testing (Ultimate Load & Cyclic Displacement): The sample sizes for these tests are not explicitly stated in the summary but generally involve a specific number of devices/constructs for each test condition.
• Clinical Literature Review: This involves reviewing existing clinical studies, so the "sample size" is the cumulative number of patients across all included studies. The provenance is "clinical literature" implying published research.
• Real-World Data/Evidence: Derived from the "Surgical Outcomes System registry." The country of origin is not specified, but registries often collect data from multiple institutions, potentially spanning different regions. This is retrospective data.

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

This information is not applicable. The submission is for a medical device (fixation appliances) and not an AI/ML diagnostic or predictive algorithm that relies on expert-established ground truth for its performance evaluation for this specific 510(k) submission. The "ground truth" for mechanical tests is defined by engineering specifications and physical measurements. For clinical effectiveness, it's defined by patient outcomes in surgical settings described in clinical literature and registries.

4. Adjudication Method for the Test Set

This information is not applicable. As stated above, this is a mechanical device, not an AI/ML system requiring human adjudication for ground truth establishment.

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

This information is not applicable. This 510(k) submission is for a mechanical surgical fixation device, not an AI-assisted diagnostic or imaging device that would typically involve MRMC studies.

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

This information is not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

• Mechanical Testing (Ultimate Load & Cyclic Displacement): The ground truth is based on the physical properties and performance characteristics measured according to established engineering and biomechanical testing standards.
• Clinical Literature: The ground truth is clinical outcomes and effectiveness observed in human patients as reported in peer-reviewed medical literature.
• Real-World Data/Evidence: The ground truth is patient outcomes recorded in a surgical registry.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/ML algorithm that employs a "training set."

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

This information is not applicable. This is not an AI/ML algorithm that employs a "training set."

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The Arthrex Knotless Mini TightRopes are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct to external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Knotless Mini TightRopes are intended to provide fixation during the healing process following:

1. Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;

2. Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and

3. Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal intermetatarsal angle.

The Arthrex Knotless Mini TightRopes, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair.

Specifically, the Arthrex Knotless Mini TightRopes are indicated for Carpal (CMC) joint arthroplasty as an adjunct in the healing process of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis. The Arthrex Knotless Mini TightRopes are also indicated for use as adjuncts in the suspension of the thumb metacarpal during process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Arthrex Knotless Mini TightRopes are suture and button constructs that consist of two buttons, one or more suture strands and various ancillary instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM F136 (Ti-6AL-4V ELI). The sutures are manufactured from UHMWPE, polyester and/or nylon. The devices are sold sterile and are single-use.

This document describes the Arthrex Knotless Mini TightRopes device. It appears to be a 510(k) Summary for a medical device cleared by the FDA, primarily focusing on proving substantial equivalence to predicate devices rather than providing a detailed study of its performance against specific acceptance criteria in a clinical context.

Therefore, many of the requested categories for describing an AI/device performance study and its acceptance criteria are not applicable to this document as it's a submission for a mechanical implant, not an AI or digital health device, and the "performance data" refers to mechanical testing.

However, I can extract the information that is present and indicate where information is not available or not relevant for this type of device submission.

Here's an attempt to answer your request based on the provided text, while noting the limitations:

1. A table of acceptance criteria and the reported device performance

For a mechanical implant, acceptance criteria are typically defined by demonstrating substantial equivalence to a predicate device through mechanical testing. The document states that the new device must perform "statistically equivalent" to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample sizes (e.g., number of devices tested) for the mechanical, MRI, endotoxin, or biocompatibility tests.
• Data Provenance: Not explicitly stated, but these are typically laboratory tests performed by the manufacturer or contracted labs, not clinical data from a specific country or retrospective/prospective clinical studies.

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)

This is not applicable. The ground truth for this device is based on established engineering standards (ASTM, ISO) and comparison to predicate device performance through objective material and mechanical testing, not expert interpretation of clinical data or images.

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

This is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. The described tests are objective laboratory measurements.

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

This is not applicable. This is a physical implant, not an AI or imaging device, and no MRMC study was conducted or is relevant to its clearance.

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

This is not applicable. This is a physical implant.

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

The "ground truth" for this device, in the context of its 510(k) clearance, is primarily defined by:

• Established engineering standards (e.g., ASTM for mechanical properties and MRI safety, ISO for biocompatibility).
• The performance characteristics of the legally marketed predicate devices (K133275 and K061925), which serve as the benchmark for "substantial equivalence."

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this type of mechanical device submission.

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

This is not applicable. See point 8.

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