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The XO Button with continuos loop is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral collateral ligament.

The XO Button without continuos loop is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts or bone tendon grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.

The ConMed Linvatec XO Button™ is a sterile, single use, implant for fixation of soft tissue to bone in orthopedic procedures. The XO Button™ is designed with both a continuous loop for fixation of soft tissue to bone and without a continuous loop. The body of the implant is composed of titanium (TI-6AL-4V-ELI) with the following dimensions: length from12 to 18mm and width 4.5 ± .1mm. The continuous loop ranges in size from 10 to 60mm.

Here's an analysis of the provided text regarding the ConMed Linvatec XO Button™:

Based on the provided 510(k) summary for the ConMed Linvatec XO Button™, it appears no specific acceptance criteria or a study demonstrating the device meets those criteria are included in this document.

This 510(k) submission is for a medical device that gains market clearance through a demonstration of substantial equivalence to existing legally marketed predicate devices, rather than through meeting specific performance criteria established by clinical studies for novel devices.

Therefore, many of the requested categories of information cannot be extracted from this document, as they are not relevant to a 510(k) substantial equivalence determination.

Here's a breakdown of what can be inferred or explicitly stated from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. The 510(k) summary does not mention a "test set" in the context of performance testing for the XO Button™. The determination is based on comparison to predicate devices.

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

• Not applicable. There is no mention of a "test set" and thus no ground truth established by experts for performance evaluation of the XO Button™ itself.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or related adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size:

• No. This document does not describe an MRMC comparative effectiveness study. The medical device in question (a fixation button) is unlikely to be evaluated using MRMC studies, which are typically for diagnostic imaging devices where human interpretation is a key component.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• No. This device is a surgical implant, not an algorithm, so this concept is not applicable.

7. The Type of Ground Truth Used:

• Not applicable. For a substantial equivalence submission, the "ground truth" is effectively the established safety and effectiveness of the predicate devices. The new device is compared to these predicates.

8. The Sample Size for the Training Set:

• Not applicable. The device is not an AI/ML algorithm or a diagnostic tool that would require a "training set."

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

• Not applicable. As above, no training set or ground truth establishment for a training set is relevant to this device's submission.

Summary of the Study that "Proves" the Device Meets Acceptance Criteria (in the context of a 510(k)):

The "study" or evidence used in this 510(k) is a comparison study demonstrating substantial equivalence to legally marketed predicate devices. The ConMed Linvatec XO Button™ is deemed substantially equivalent to the following:

• Endobutton Continuous Loop (Smith and Nephew, K980155)
• RetroButton (Arthrex, K062747)
• Tightrope Acromioclavicular (AC) Device (Arthrex, K052776)

The justification for substantial equivalence is based on similarities in:

• Intended Use: The XO Button™ (with and without continuous loop) has intended uses that align with soft tissue to bone fixation for ligament/tendon repair or reconstruction, similar to the predicates.
• Technology/Design: The XO Button™, Endobutton Continuous Loop, and RetroButton have similar designs and are used for fixating soft tissue ligaments. They share similar components and suture lengths. The XO Button™ and the TightRope Acromioclavicular (AC) Device have similar indications and design, with the primary difference being the XO Button™ only involves one sized metal button.
• Materials: The body of the implant is composed of titanium (TI-6AL-4V-ELI), which is a common material for such implants.
• Sterility and Usage: All are sterile, single-use devices.

The submission states that "Any differences between the XO Button™ and the identified predicate devices are considered minor and do not raise questions concerning safety and effectiveness."

This type of submission does not involve clinical trials or performance studies against predefined acceptance criteria for the new device, but rather a direct comparison to already cleared devices based on their established safety and effectiveness.

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