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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 Knotless AC Repair Devices are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The Knotless AC Repair Devices are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.
The Knotless AC Repair Devices with distal clavicle plate button are intended for use with Arthrex clavicle plates for clavicle indications and may not be used alone.

The subject devices are suture constructs configured with one or two metal buttons made of titanium or stainless steel. The nonabsorbable suture is made of UHMWPE. Some of the subject devices are compatible with the Clavicle Fracture plates cleared under K112437.

The provide FDA 510(k) summary describes the Arthrex Knotless AC Repair Devices, which are indicated as adjuncts in fracture repair and for fixation during syndesmotic trauma. The submission aims to demonstrate substantial equivalence to a predicate device, K052776: Arthrex TightRope Acromioclavicular (AC) Device, and refers to several other devices (K112437, K143139, K123341, K202581, K112990) as reference devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Demonstrated that modifications do not negatively impact mechanical strength compared to the predicate device. This implies specific thresholds for ultimate load and cyclic displacement.	Ultimate load testing and cyclic displacement were performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength. (No specific numerical values or direct acceptance "pass/fail" stated, but the conclusion of non-negative impact implies acceptance.)
   Device meets pyrogen limit specifications.	Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications. (Implies meeting the standard, thus acceptance.)
   Device is safe for use in an MR environment, specifically regarding: magnetic field induced displacement force, radiofrequency induced heating, and image artifact. (Based on standards: FDA guidance, ASTM F2052, ASTM F2119, ASTM F2182).	MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, and ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging. (Implies that the testing demonstrated compliance with these standards, meaning the device met the safety criteria for MRI, thus acceptance.)
   Overall, the device is substantially equivalent to the predicate, with differences being minor and not raising questions concerning safety and effectiveness.	"The Arthrex Knotless AC Repair Devices are substantially equivalent to the predicate in which the basic design features and intended use are the same. Any differences between the subject device and the predicate device are considered minor and do not raise questions concerning safety and effectiveness." (This is the overarching conclusion of the submission.)

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

   • The document mentions "ultimate load testing and cyclic displacement," "bacterial endotoxin" testing, and "MRI force, torque, and image artifact testing." However, it does not specify the sample sizes (e.g., number of devices tested) for any of these tests.
   • Data provenance is not explicitly stated. These are laboratory tests, so the "country of origin of the data" would likely be the location of the testing facility, which is not provided. The tests are prospective in nature, as they are conducted specifically for this submission.

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

   • This document describes mechanical, biocompatibility, and MRI compatibility testing of a medical device, not a diagnostic algorithm that requires expert-established ground truth. Therefore, this information is not applicable to this type of submission.

4. Adjudication method for the test set:

   • Similar to point 3, this is not applicable as the studies are physical/chemical device tests, not involving human interpretation or clinical adjudication.

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. The submission is for a physical medical device (suture button), not an AI-powered diagnostic tool.

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

   • This is not applicable. The device is a physical implant, not a software algorithm.

7. The type of ground truth used:

   • For the mechanical tests, the "ground truth" would be the physical properties and performance characteristics of the predicate device, against which the subject device's mechanical performance is compared. Performance standards (e.g., ISO, ASTM) and established biological limits (e.g., pyrogen limits per EP/USP) serve as the "ground truth" or acceptance criteria for biocompatibility and MRI compatibility. Pathology or outcomes data are not relevant for this type of testing.

8. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is a physical device, not an AI/machine learning model.

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

   • This is not applicable as there is no training set.

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