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To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

The Biomet Sports Medicine TunneLoc™ Tibial Fixation Device is a non-resorbable intratunnel implant intended to aid in arthroscopic ACL and/or PCL reconstructions. The inserter instrument provides a means to apply and hold tension to the soft tissue, align and drive the PEEK implant. A nitinol quide wire instrument is provided to aid in implant placement. The TunneLoc™ Tibial Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.

This document describes the TunneLoc™ Tibial Fixation Device, a non-resorbable intratunnel implant for ACL and/or PCL reconstructions. The device is intended for soft tissue fixation within the tibial tunnel.

Here is an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size (number of devices, test repetitions) for the non-clinical pullout tests.

• Data Provenance: The tests were conducted using porcine tibia and bovine tendon test medium. This indicates an in vitro or ex vivo setting, not human data. The country of origin of the data is not specified, but the applicant is based in Indiana, USA. The testing is retrospective in the sense that it evaluates the device after its design, but not on human patients.

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

• This information is not provided. Non-clinical mechanical tests typically rely on established engineering standards and methodologies for "ground truth" (e.g., force transducers, load cells, material properties testing machines), rather than human expert consensus.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments. Mechanical testing follows predefined protocols and measurements.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

• This question is not applicable. The TunneLoc™ Tibial Fixation Device is a medical implant, not an algorithm or AI system. Its performance is evaluated through mechanical testing, not algorithmic output.

7. The Type of Ground Truth Used

• The ground truth for the non-clinical testing was established through objective measurement of pullout strength using force testing equipment. This relies on the physical properties of the materials and the mechanical forces applied, rather than expert consensus, pathology, or outcomes data, which are relevant for clinical studies or diagnostic devices.

8. The Sample Size for the Training Set

• This question is not applicable. This is a medical device, not an AI or machine learning system that requires a "training set."

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

• This question is not applicable as there is no training set for this device.

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