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The Medacta Ligament Staple is intended for use in medial collateral ligament (MCL) and lateral collateral ligament (LCL) reconstruction.
Reconstructive treatment of ruptured or damaged MCL and LCL.

Medacta Ligament Staple is a single size (ø11 mm) extra cortical fixation device which is impacted on the Medial Collateral Ligament (MCL) or on the Lateral Ligament (LCL) for soft tissue to bone refixation by means of a dedicated impactor. The device consists of a circular plate with protruding tapered serrated legs, made of titanium alloy (Ti6A14V ELI according to ISO 5832-3 and ASTM F136), and a staple inlay, made of PEEK according to ASTM F2026, for pressing the graft down to the bone, featuring a lower spike patterned surface for increasing soft tissue fixation.

The provided text describes a 510(k) premarket notification for a medical device called "Ligament Staple." This submission focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data. It explicitly states that no clinical studies were conducted.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets those criteria, as the information required for such a description (particularly human-in-the-loop performance, expert ground truth, and clinical efficacy/safety) is not present in the provided document.

The document discusses "design validation" and "characterization testing" but these are within the scope of non-clinical testing (e.g., mechanical properties, biocompatibility, MRI safety). There is no mention of an algorithm, AI, or any form of diagnostic or assistive software that would require the typical acceptance criteria and study design described in your prompt (e.g., MRMC studies, standalone performance, human reader improvement).

To explicitly address the points in your prompt given the inability to provide the direct information:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document details non-clinical tests and their adherence to standards (e.g., ASTM, ISO), but these aren't presented as "acceptance criteria" in the context of clinical performance or AI/software. For example, it mentions "Cyclic and load-to-failure properties" and "MR safety evaluation," implying mechanical and safety performance testing rather than diagnostic or AI performance.
2. Sample sizes used for the test set and the data provenance: Not applicable. There's no "test set" in the sense of clinical images or patient data for an AI/diagnostic device. The "Ligament staple Porcine bone workshop" and "Ligament staple wetlab" suggest in-vitro or ex-vivo testing, but no specific sample sizes for these are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. As no clinical studies or human reader-based evaluations were performed, no experts were needed for establishing ground truth in this context.
4. Adjudication method for the test set: Not applicable. No clinical or image-based test set was used that would require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, explicitly stated "No clinical studies were conducted."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (ligament staple), not an algorithm or software.
7. The type of ground truth used: Not applicable in the context of AI/diagnostic performance. Ground truth would relate to the physical properties and performance of the device in non-clinical settings (e.g., mechanical load, material properties, biocompatibility results).
8. The sample size for the training set: Not applicable. There is no AI/algorithm for which a training set would be required.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document describes a physical medical device and its 510(k) submission based on non-clinical performance data (mechanical testing, biocompatibility, MRI safety). It explicitly states that "No clinical studies were conducted." Therefore, the questions related to AI/software performance, human reader studies, and clinical ground truth are not applicable to this submission.

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The MectaFix CL Fixation Button with Continuous Loop is indicated for use in reconstructive treatment and extracortical femoral fixation of an implanted anterior cruciate ligament reconstruction.

The MectaFix CL Fixation Button with Continuous Loop is an implantable fixation button with a continuous loop used for the femoral fixation of the anterior cruciate ligament (ACL) graft by means of an extra-cortical suspensory fixation. It consists of a metal elongated button (Ti6AI4V ELI), a continuous loop (UHMWPE) ranging in length from 15 mm to 60 mm to be coupled with the graft, and a pulling suture (UHMWPE) to pull the construct through the prepared bone tunnel and to subsequently flip the button after passing the femoral lateral cortex. The MectaFix CL Fixation Button with Continuous Loop implants are provided sterile and are provided in single-use packages.

Here's a breakdown of the acceptance criteria and study information for the MectaFix CL Fixation Button with Continuous Loop, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided 510(k) summary only states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." It does not provide the specific quantitative acceptance criteria or the detailed reported performance results for the mechanical tests (cyclic loading, tensile strength, cadaver testing). These details would be contained within the full 510(k) submission but are not summarized here. For pyrogenicity, it mentions the tests performed and the absence of a "non-pyrogenic" label, implying the tests confirmed acceptable pyrogen levels without claiming complete absence.

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

The document does not explicitly state the sample sizes for the "worst-case implants" used in the non-clinical studies. It also doesn't specify data provenance (country of origin, retrospective/prospective) for any of the test data. These are non-clinical (mechanical and sterility) studies, so clinical data provenance is not applicable here.

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

This information is not applicable. The studies described are non-clinical (mechanical, sterilization, shelf-life, pyrogenicity) and do not involve human subjects or expert assessment for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The studies are non-clinical and do not involve adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This is a submission for a mechanical fixation device, not an imaging or diagnostic AI device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these tests is based on engineering standards and established scientific methods. For example:

• Mechanical properties: Defined by ASTM standards (e.g., ASTM D2256/D2256M-10 for tensile strength).
• Sterilization: Defined by recognized sterilization standards and validation protocols.
• Pyrogenicity: Defined by pharmacopoeial monographs (e.g., European Pharmacopoeia §2.6.14, USP , USP ).
• Cadaver testing: Likely involves biomechanical evaluation against established performance benchmarks for ACL fixation.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device. The non-clinical tests do not involve training sets.

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

This information is not applicable as this is not an AI/machine learning device.

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