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The device 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, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.

The GraftMax™ Button, ALB (Adjustable Loop Button) with Button Cradle and GraftMax™ Button, BTB (Bone-Tendon-Bone) with Button Cradle are sterile, single use devices. The button and cradle used together measure 21mm in length and 6mm in width. The devices are oval shaped and manufactured of titanium alloy. The devices are designed with five (5) holes that sutures can be threaded through.

This document is a 510(k) premarket notification for a medical device called the GraftMax™ Button, ALB with Cradle and GraftMax™ Button, BTB with Cradle. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence for regulatory approval.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" alongside specific numerical "reported device performance" values for parameters like ultimate fixation strength or cyclic testing. Instead, it lists the types of performance data collected to support substantial equivalence. The implication is that the performance of the new device was compared against existing standards or the predicate device's performance, and found to be acceptable. Without specific numerical criteria or results, a direct "acceptance criteria vs. reported performance" table cannot be fully constructed.

However, based on the provided text, the types of tests performed indicate the areas where performance was evaluated.

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

The document does not specify the sample sizes used for any of the performance tests (Reliability, Packaging, Ultimate Fixation Strength, Cyclic, Sterilization, Verification Testing, Transportation, Biocompatibility, User Validation, Shelf-life).

The data provenance is also not explicitly stated. It can be inferred that the testing was conducted by or for CONMED Corporation in support of their 510(k) submission to the FDA, but details like country of origin of the data or whether it was retrospective or prospective are not provided. Given the nature of a 510(k) submission for a physical device, these would typically be laboratory or in-vitro tests, likely prospective experiments designed to evaluate the new device.

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

This information is not applicable and therefore not provided in the document. The device is a physical fastener for surgical use, not an AI/software device that requires ground truth established by experts for classification or diagnosis. The "ground truth" for this device's performance would be objective measurements obtained through engineering and material science testing.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1 consensus) are typically used in studies involving expert review or interpretation, which is not the case for the performance testing of this mechanical device.

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 and therefore not provided. An MRMC study is relevant for diagnostic or interpretive AI systems. The GraftMax™ Button is a physical surgical implant, not an AI-assisted diagnostic tool.

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

This information is not applicable and therefore not provided. "Standalone" performance testing for an algorithm is irrelevant to a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For a physical device like the GraftMax™ Button, the "ground truth" for performance evaluations typically comes from objective, quantitative measurements obtained through standardized engineering and material science testing. For example:

• Ultimate Fixation Strength: Measured numerically (e.g., in Newtons) under specified load conditions.
• Cyclic Testing: Number of cycles to failure under defined load parameters.
• Biocompatibility: Results from cell culture or in-vivo animal tests adhering to ISO standards.
• Sterilization: Microbiological testing to confirm sterility assurance levels.

The document implicitly refers to these types of objective data as the basis for performance evaluation.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The concept of a "training set" pertains to machine learning algorithms. This document describes a physical medical device that does not involve artificial intelligence or machine learning.

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

This information is not applicable and therefore not provided, as there is no training set for a physical medical device.

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