Search Results

The XTREME-LOOP is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.

The XTREME-LOOP fixation device consists of a Ultra High Molecular Weight Polyethylene (UHMWPE) continuous loop captured on a titanium alloy button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The XTREME-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.

The XTREME-LOOP device is a soft tissue fastener used for fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate Ligament (ACL) reconstruction. The device was deemed substantially equivalent to the predicate device, SECURE-LOOP (K151601), based on performance testing. The reported information focuses on the device's physical properties and biological safety rather than clinical performance metrics in the context of diagnostic accuracy or clinical outcomes often seen in AI/ML device submissions.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify a "test set" in the context of patient data or image datasets, as this device is a physical implant. The testing described is pre-clinical engineering and biological safety testing. Therefore, information on sample size and data provenance like country of origin or retrospective/prospective nature is not applicable in the way it would be for AI/ML device studies. The sample sizes would pertain to the number of devices or test samples evaluated in the mechanical and biological tests. These specific numbers are not detailed in the summary.

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. Ground truth, in the context of expert consensus, refers to a human interpretation of data (e.g., medical images). For a physical medical device like the XTREME-LOOP, the "ground truth" for performance is established through standardized laboratory testing and material characterization, not expert human interpretation.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as point 3.

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 XTREME-LOOP is a physical device, not an AI/ML diagnostic or therapeutic aid that would involve human readers or AI assistance.

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

This is not applicable. The XTREME-LOOP is a physical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the device's performance was established through:

• Mechanical Testing: Standardized engineering tests (strength, stiffness, fatigue, functional testing) comparing the XTREME-LOOP to the predicate device, SECURE-LOOP.
• Biological Safety Testing: Adherence to established standards for pyrogenicity, specifically:
  • Turbidimetric Limulus Amoebocyte Lysate (LAL) method in line with ANSI/AAMI ST72:2011 for endotoxins.
  • Rabbit pyrogenicity test per USP, General Chapter .

8. The sample size for the training set:

This is not applicable. The XTREME-LOOP is a physical device, not an AI/ML model that requires a training set.

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

This is not applicable for the same reasons as point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

The Smith & Nephew ENDOBUTTON Continuous Loop is used for fixation of tendons and Iigaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions.

The ENDOBUTTON CL is a machined titanium implant assembled with a continuous loop of polyester tape. It is oblong in shape with four holes through which suture is threaded. The polyester loop is preattached to the center holes. The device is designed to provide cortical fixation in the repair of tendons and ligaments. The design of the ENDOBUTTON allows for the device to be endoscopically delivered from a single access point. The device is available with premeasured loops of tape ranging from 20mm-50mm to accommodate different graft sizes.

The ENDOBUTTON is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. It is oblong in shape with four holes through which suture is threaded. The design of the ENDOBUTTON allows for the device to be endoscopically delivered from a single access point.

This document describes the Endobutton Continuous Loop (CL), a suture retention device used for fixation of tendons and ligaments. The submission is for an indication expansion for this existing device, not for a new device requiring extensive performance testing for novel functionality. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to demonstrating substantial equivalence for the expanded indications to a legally marketed predicate device through performance testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., "tear strength must be X N"). Instead, the acceptance criterion for this 510(k) submission is substantial equivalence to a predicate device for the expanded indications.

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

The document does not provide details on:

• The specific sample size (N-number) used for any mechanical or performance testing.
• The explicit data provenance (e.g., country of origin, retrospective or prospective) of the performance testing data.

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

This type of information is not applicable to this 510(k) submission. "Ground truth" for medical decisions or diagnoses made by experts is typically relevant for AI/ML or diagnostic device submissions where human interpretation is being evaluated or augmented. For a mechanical fixation device, validation relies on engineering and biomechanical testing, not expert consensus on medical images or patient outcomes in the same way.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated in point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. An MRMC study is relevant for diagnostic devices where multiple readers interpret cases. This submission is for a surgical implant (fixation device), not a diagnostic tool requiring human interpretation.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable. This device is a physical surgical implant, not an algorithm or software. Its "performance" is assessed through biomechanical testing, not algorithmic output.

7. Type of Ground Truth Used

Ground truth in this context would implicitly be derived from biomechanical testing standards and engineering principles that simulate the forces and stresses the device would experience in vivo. The performance is compared to the predicate device to show similar mechanical properties for the expanded indications. The document implies performance testing, which would involve quantifiable physical measurements.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This is not applicable for the reasons stated in point 8.

Ask a specific question about this device