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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 ACL TightRope and ACL TightRope Double Bundle are to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL repair and reconstruction.

The ACL TightRope consists of an adjustable nonabsorbable suture loop and titanium button. The ACL TightRope Double Bundle consists of nonabsorbable suture loops, titanium button, and a PEEK Femoral Wedge. The ACL TightRope and ACL TightRope Double Bundle is to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.

The provided document K112990 is a 510(k) summary for the Arthrex ACL TightRope and ACL TightRope Double Bundle devices, seeking to expand their indications to include Posterior Cruciate Ligament (PCL) repair and reconstruction. This document does not describe a study involving an algorithm or AI. Instead, it focuses on the substantial equivalence of the subject devices to existing predicate devices based on design and mechanical testing.

Therefore, many of the requested sections regarding AI/algorithm performance and study methodology are not applicable to this submission.

Here's an analysis based on the information available in the document:

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

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

• Sample Size: Not explicitly stated for the "bench testing" mentioned. The document only refers to "tensile load to failure strength of the ACL TightRope devices" without providing specific numbers of samples tested.
• Data Provenance: Not applicable in terms of country of origin of patient data, as this was mechanical bench testing, not a clinical study. The testing was conducted by or for Arthrex, Inc., based in Naples, Florida, USA.
• Retrospective/Prospective: Not applicable. This was mechanical laboratory testing.

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 submission concerns mechanical testing of medical devices, not an AI or diagnostic algorithm requiring expert ground truth for interpretation of images or patient data. The "ground truth" here is the physical measurement of tensile strength.

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

• Not applicable. As described above, this was mechanical testing, not a clinical or diagnostic study requiring adjudication of expert opinions.

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, a multi-reader, multi-case comparative effectiveness study was not done. This submission is for a physical medical device, not an AI or software algorithm.

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

• Not applicable. No algorithm or AI device is being submitted or studied here.

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

• For the tensile load to failure strength testing, the "ground truth" would be the objectively measured physical properties (e.g., maximum load at failure) of the devices under controlled laboratory conditions, according to established mechanical testing standards.

8. The sample size for the training set

• Not applicable. There is no AI or algorithm mentioned, hence no training set.

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

• Not applicable. There is no AI or algorithm mentioned, hence no training set or ground truth establishment for it.

Summary of Device Acceptance Criteria and Study:

The acceptance criteria for Arthrex ACL TightRope and ACL TightRope Double Bundle for expanded PCL indications were based on demonstrating substantial equivalence to existing predicate devices (K100652, K101837, K110123). This means the device, with its expanded indication, must be as safe and effective as the already cleared predicate devices.

The study that proves the device meets these criteria was bench testing. This testing specifically "determined the tensile load to failure strength of the ACL TightRope devices." The report concludes that based on this testing, the subject devices are "substantially equivalent" to predicate devices, implying that their mechanical performance (tensile strength) was comparable and therefore considered safe and effective for the expanded PCL indication. The document does not provide specific numerical results or sample sizes for this bench testing, but the FDA's clearance indicates satisfaction with the presented data.

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Ask a specific question about this device

The ACL TightRope is to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) Repair.

The ACL TightRope consists of an adjustable non-absorbable suture loop and titanium button. The proposed device contains a titanium button and non-absorbable suture which are similar to the predicate devices. The proposed device contains an adjustable suture loop when compared to the predicate devices which contain constant loop lengths.

The provided document describes a 510(k) premarket notification for the Arthrex ACL TightRope device. It does not contain information about an AI/ML powered device, nor does it detail acceptance criteria or a study proving device performance in the context of AI.

The document discusses the substantial equivalence of the ACL TightRope to predicate devices based on mechanical testing. It states: "From the mechanical testing completed the ultimate load and cyclic displacement are substantially equivalent for the proposed device when compared to the predicate devices."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/ML device meets the acceptance criteria, as the input document is about an orthopedic surgical device, not an AI/ML system.

However, based on the information provided, I can infer the general nature of the "acceptance criteria" and "study" for this non-AI device:

Inferred Acceptance Criteria for the Arthrex ACL TightRope (Non-AI Device):

Inferred Study that Proves the Device Meets the Acceptance Criteria (Non-AI Device):

The document mentions "mechanical testing completed" as the basis for determining substantial equivalence. This would have been an in-vitro biomechanical study.

1. Sample size used for the test set and the data provenance: Not explicitly stated in the document. This would typically involve a specific number of test samples of the ACL TightRope and the predicate devices subjected to mechanical loads. Data provenance would be from laboratory testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is typically defined by established engineering standards and measurement accuracy, not expert consensus.
3. Adjudication method for the test set: Not applicable. The results are quantitative measurements interpreted against pre-defined performance metrics or direct comparison to predicate device performance.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable as this is a mechanical device, not a diagnostic AI system with human readers.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
6. The type of ground truth used: Mechanical testing data, specifically ultimate load and cyclic displacement measurements. These are objective engineering measurements.
7. The sample size for the training set: Not applicable. There is no "training set" for this type of mechanical device evaluation.
8. How the ground truth for the training set was established: Not applicable.

Summary for the provided document (non-AI device):

The provided document describes a medical device (ACL TightRope) that is evaluated for substantial equivalence to predicate devices through mechanical testing. The "acceptance criteria" appear to be related to the device's ultimate load and cyclic displacement performance, which were found to be "substantially equivalent" to the predicate devices. The study involved biomechanical testing, not an AI/ML evaluation.

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