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The Arthrex TightRope II devices are intended to be used for fixation of 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 devices for ACL/ PCL repair and reconstruction for the adult and pediatric patient population; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction.

The proposed Arthrex 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 hole s to permit suture passage and assembly with Arthrex sutures.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for the Arthrex TightRope II device, which outlines the device's indications for use, technological characteristics, and comparison to predicate devices.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, or the number/qualifications of experts used to establish ground truth.
• Information on adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Information on standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets or how their ground truth was established.

The "Performance Data" section briefly states that "Based on cyclic displacement/load displacement testing, the proposed Arthrex TightRope II device is equivalent to the Arthrex TightRope II device predicate device." This indicates that some performance testing was done, but it does not provide the specific criteria or detailed study results. The document focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting detailed performance study data against defined acceptance criteria.

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The Arthrex TightRope II devices are intended to be used for fixation of 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 devices for ACL/PCL repair and reconstruction for the adult and pediatric patient population; and MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population only.

The Arthrex 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.

This document is a 510(k) premarket notification for a medical device called the "Arthrex TightRope II". It details the submission to the FDA for expanding the indications for use of this device.

Here's an analysis of the provided text in relation to your request about acceptance criteria and supporting studies:

Crucially, the provided document DOES NOT contain the type of detailed information typically found for the evaluation of AI/ML-based medical devices or diagnostic tools. This document is for a mechanical fixation device (a bone/soft tissue fastener). Therefore, the questions about "AI vs without AI assistance," "standalone algorithm performance," "ground truth establishment by experts" etc., are not applicable to this type of device submission.

The "Performance Data" section in the document clearly states: "Based on cyclic displacement and strength testing, the proposed Arthrex TightRope II device is equivalent to the predicate Zimmer-Biomet ToggleLoc™ device." This indicates the device's performance was evaluated through mechanical testing, not through clinical studies involving expert interpretation of images or AI algorithm performance.

Given this context, I will address the relevant parts of your request based on the information available in the provided document and explicitly state where the requested information is not applicable.

Device Name: Arthrex TightRope II
Type of Device: Smooth or Threaded Metallic Bone Fixation Fastener
Purpose of Submission: Expand device indications for use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a mechanical fixation device, the "acceptance criteria" are related to mechanical properties and equivalence to a predicate device, not diagnostic performance metrics.

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

• Sample Size: Not specified in terms of number of devices tested, but the evaluation methods are described as "cyclic displacement and strength testing." This implies testing a sufficient number of physical devices or components to establish mechanical properties.
• Data Provenance: The tests were conducted internally by Arthrex Inc. or a contracted lab. No specific country of origin for data (as in patient data) is relevant here, as it's a mechanical device study. It's a proprietary test conducted by the manufacturer to support the 510(k) submission.

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

• Not Applicable. This is a mechanical device, not a diagnostic or AI device requiring expert interpretation for ground truth. The "ground truth" here is the established mechanical performance standards and equivalence to the predicate device, determined through material science and engineering testing.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Mechanical testing does not involve adjudication.

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

• No. This type of study is relevant for diagnostic imaging systems evaluated with human readers, often with AI assistance. It is not applicable to a mechanical bone fixation fastener.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This refers to the standalone performance of an AI algorithm. It is not applicable to this mechanical device.

7. The Type of Ground Truth Used

• Mechanical Performance Standards & Predicate Equivalence: The "ground truth" for this device's performance evaluation is its mechanical behavior (e.g., strength, displacement under load) as measured against engineering standards and in comparison to the well-established predicate device (Zimmer-Biomet ToggleLoc™).

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of AI/machine learning. Its design and validation rely on engineering principles, materials science, and mechanical testing, not data-driven model training.

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

• Not Applicable. See point 8.

Summary of the study that proves the device meets acceptance criteria:

The study proving the device meets its acceptance criteria involved mechanical testing, specifically "cyclic displacement and strength testing." The goal was to establish "equivalence" of the proposed Arthrex TightRope II device to the predicate device, Zimmer-Biomet ToggleLoc™. This type of testing assesses the physical properties and performance characteristics of the implantable medical device under simulated physiological conditions. The manufacturer, Arthrex Inc., performed these tests to demonstrate that the expanded indications for use (MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population) are supported by the device's equivalent mechanical performance to a device already cleared for similar applications.

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The Arthrex TightRope II is intended to be used for fixation of 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 these for ACL/PCL Repair and Reconstruction.

The Arthrex TightRope II is suture and button construct comprised of a titanium button and nonabsorable suture intended to be used for the purpose ACL/PCL repair and reconstruction.

This is a 510(k) summary for a medical device, which means it describes the device and its equivalence to a predicate device, but it does not contain information about an AI/ML-driven medical device or a clinical study proving its performance against acceptance criteria in the way a diagnostic AI would.

The document describes the Arthrex TightRope II, which is a mechanical device (suture and button construct) for bone and soft tissue fixation, specifically for ACL/PCL repair and reconstruction.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, data provenance, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract the relevant information regarding acceptance criteria and performance for this type of mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance

For the Arthrex TightRope II, the "acceptance criteria" are implied by demonstrating that modifications to the device (compared to its predicate) do not negatively impact its mechanical strength and that it meets pyrogen limits and MR compatibility standards.

• ASTM F2052 (Magnetically Induced Displacement Force)
• ASTM F2119 (MR Image Artifacts)
• ASTM F2182 (Radio Frequency Induced Heating)
• ASTM F2213 (Magnetically Induced Torque)
  (Results are not quantified but are implied to show MR conditional labeling is appropriate and safe.) |

Explanation of the Study Proving Device Meets Acceptance Criteria:

The study involved various bench tests and laboratory analyses comparing the Arthrex TightRope II to its predicate device (K112990) and assessing its compliance with relevant regulatory standards. These tests covered:

• Mechanical Performance: Ultimate load testing and cyclic displacement testing to ensure the device's structural integrity and durability were not compromised by design modifications.
• Biocompatibility/Pyrogenicity: Bacterial endotoxin testing to confirm the device is non-pyrogenic.
• MR Compatibility: A series of tests adhering to FDA guidance and ASTM standards (F2052, F2119, F2182, F2213) to evaluate magnetic force, torque, radiofrequency-induced heating, and image artifacts, leading to an "MR conditional" label.

The conclusion states that these "performance data" demonstrate that the device modifications are minor and "do not raise different questions concerning safety or effectiveness," thereby supporting its substantial equivalence to the predicate device.

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 for Test Set: This document does not specify the number of individual devices or test runs for each mechanical or biological test. These are typically standard laboratory tests, not clinical studies with patient data.
• Data Provenance: The data would originate from laboratory bench testing and analysis conducted by the manufacturer (Arthrex Inc.) or a contracted testing facility, likely in the US, as Arthrex Inc. is based in Naples, FL, USA. It is essentially prospective testing against predefined engineering and material standards.

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

• Not Applicable. For a mechanical fixation device, "ground truth" is established by adherence to engineering specifications, material science principles, and regulatory standards, not by expert medical review of patient data. The "experts" involved would be engineers, material scientists, and quality assurance specialists performing the tests and comparing results to established benchmarks.

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

• Not Applicable. This is not a diagnostic AI study requiring adjudication of expert opinions. Device performance is determined by quantitative measurements against objective criteria.

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

• Not Applicable. This is a mechanical surgical device, not an AI-driven diagnostic or assistive tool for human readers.

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

• Not Applicable. This device is a mechanical construct, not an algorithm. Its performance is inherent in its physical and material properties.

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

• Ground Truth Type: For mechanical performance, the "ground truth" is defined by engineering specifications, material properties, and established industry standards (e.g., maximum load, displacement limits, pyrogen limits, MR safety thresholds from ASTM standards).

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this mechanical device.

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

• Not Applicable. As there is no training set, this question does not apply.

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