Search Results

Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of auto- and allografts.

The MectaScrew Extension includes implantable devices used for the tibial and the femoral fixation of the graft in reconstructive treatment of knee ligament ruptures. They have been developed to provide interference between a ligament graft and a bone tunnel in the ligament reconstruction surgery.

The MectaScrew Extension implants includes MectaScrew C, a composite interference screw made of RESOMER® Composite LR 706S B-TCP, a mixture of 70 % RESOMER® LR 706 S and 30 % B-TCP.

MectaScrew C is available in 19 different configurations ranging from 6 to 12 mm in diameter and 15 to 35 mm in length.

The provided text is a 510(k) summary for a medical device called "MectaScrew Extension." This document outlines the device's characteristics, its intended use, and its comparison to predicate devices to establish substantial equivalence.

Crucially, the document states: "No clinical studies were conducted." This means there is no study evaluating the device's performance against pre-defined acceptance criteria with human subjects or actual clinical outcomes in the format you've requested.

Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance (as no clinical performance criteria or results are given).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications used to establish ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or its effect size.
• Standalone performance.
• Type of ground truth used (as no clinical ground truth was established from a study).
• Sample size for the training set (no AI/ML component described).
• How ground truth for the training set was established (no AI/ML component described).

The document focuses on non-clinical studies (design validation, performance testing like torque resistance and pull-out strength, MR safety, pyrogenicity, and biocompatibility) to demonstrate substantial equivalence to predicate devices. These non-clinical tests would have their own internal acceptance criteria, but these are not for the "device performance" in the clinical sense you are asking for.

In summary, based on the provided text, the MectaScrew Extension did not undergo a clinical study to prove its performance against acceptance criteria in human use. Its clearance was based on demonstrating substantial equivalence through non-clinical data and comparison to existing legally marketed devices.

Ask a specific question about this device

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.

Ask a specific question about this device