Search Results

The TLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopaedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.

The TLS® Fixation System is composed of the following elements:

• The TLS® screw, used for the fixation of the TLS® tape to the bone. -
• The TLS®+ tendon fixation tape kit, for the ACL and PCL reconstruction, to which the tendon graft is attached.
  This kit is composed of:
• = 1 non-absorbable tape : implantable,
• · 2 passing wires: non implantable, to be used to pass the tape and the attached graft through the bone tunnel,
• · 1 tape support: non implantable, to be used for the preparation of the graft.

This document describes the TLS® Fixation System and its substantial equivalence to predicate devices, focusing on the mechanical properties rather than AI/ML performance. Therefore, many of the requested criteria related to AI/ML studies are not applicable.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Tensile Strength
• Stiffness
• Cyclic Fatigue Testing | "The TLS® Fixation System was tested against the EndoButton to determine if it was equivalent in strength. Tensile Strength, Stiffness and Cyclic Fatigue Testing were examined. After the testing was completed, it was determined that the TLS® Fixation System is as strong as the currently marketed EndoButton™." |
  | Substantial equivalence in:
• Materials
• Intended Use
• Performances
• Safety
• Effectiveness | "The TLS® Fixation System ... are substantially equivalent to the selected predicate devices in terms of materials, intended use, performances, safety and effectiveness." (Based on comparison tables for TLS® tape vs. ENDOBUTTON™ CL/TENOLIG®, and TLS® screw vs. Rci™ screw, which show similar characteristics). |
  | Addresses risks to health | "Risk to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations." |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Tensile Strength, Stiffness and Cyclic Fatigue Testing" but does not specify the sample size for these tests. The provenance of the data is from F.H. Industrie (Fournitures Hospitalières Industrie), located in Quimper, France. The study appears to be prospective testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a medical device (fixation system for ACL/PCL reconstruction), not an AI/ML diagnostic tool. Therefore, there are no "experts used to establish the ground truth" in the context of image interpretation or similar AI applications. The "ground truth" for this device relates to its mechanical performance, which is established through physical testing and comparison to predicate devices, not expert consensus on medical images.

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

Not applicable. This is not an AI/ML study involving human readers' assessments that would require an adjudication method.

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 medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a medical device, not an AI algorithm.

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

The "ground truth" for this medical device is established through:

• Mechanical Testing: Tensile strength, stiffness, and cyclic fatigue testing results comparing the TLS® Fixation System directly against the predicate device (EndoButton™).
• Predicate Device Characteristics: The established safety and effectiveness of the legally marketed predicate devices (EndoButton™ Continuous Loop, Tenolig®, and RCi™ screw) served as the benchmark for substantial equivalence comparisons in terms of materials, indications for use, and performance characteristics.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/ML system that utilizes a training set.

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

Not applicable. There is no training set for this type of medical device.

Ask a specific question about this device