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Megaloop Button System - Megaloop Button with Megaloop Adjustable Loop
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.

Megaloop Button System - Megaloop AD Device
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.

Megaloop Button System - Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button
Megaloop FLB Device and Megaloop FLW Device are used for fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

When used in conjunction with the Megaloop FLB Device or Megaloop FLW Device, the Megaloop XL Button is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs.

Megaloop Button System - Megaloop DB Device, Megaloop AC Button with Megaloop Adjustable Loop
The Megaloop DB Device and Megaloop AC Button are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically:

• The Megaloop DB Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

• The Megaloop AC Button is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The Megaloop Button System is a family of titanium buttons for the fixation of bone to bone or soft tissue to bone. The system includes a variety of buttons made of Ti-6AI-4V ELI titanium alloy, with or without pre-assembled nonabsorbable loops, sutures and needles. The loops and sutures are offered in non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) material. The long straight needles are offered in XM-16 stainless steel material. The sutures and needles are not implantable and are discarded after assisting with button placement.

The Megaloop Button System is provided sterile, non-absorbable, for single use only.

The provided text describes a 510(k) premarket notification for the "Megaloop Button System," which is a family of titanium buttons used for fixation of bone or soft tissue to bone. The submission asserts that the device is substantially equivalent to several predicate devices.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are primarily based on comparing the subject device's characteristics and performance to legally marketed predicate devices. The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., minimum pullout strength in Newtons, minimum cycles for fatigue life). Instead, it relies on demonstrating that the subject device's non-clinical test results are comparable to or perform as well as the predicate devices.

Therefore, the table below outlines the general performance aspects evaluated and the reported outcomes:

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

The document explicitly states: "Non-clinical bench tests were conducted in support of the substantial equivalence determination."

• Sample Size: The document does not specify the sample size used for the pullout or fatigue tests, or any other non-clinical bench tests.
• Data Provenance: The nature of "non-clinical bench tests" implies that the data was generated in a controlled laboratory environment, likely by the manufacturer (Suzhou Endophix Co., Ltd.) or a contracted testing facility. There is no information regarding the country of origin of the data beyond the manufacturer's location (China), nor any mention of retrospective or prospective human data. This entire submission relies on bench testing, not human or clinical data.

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

This information is not applicable to this submission. The "ground truth" for the non-clinical bench tests would be the measured physical properties of the materials and devices under specific testing conditions, as determined by laboratory instruments and protocols. There is no mention of human experts establishing a "ground truth" for the test set, as these are mechanical and material property tests.

4. Adjudication Method for the Test Set

This is not applicable. Since the evaluation is based on non-clinical bench tests measuring objective physical properties, there is no need for an adjudication method by human reviewers. The test results are quantitative measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where expert readers evaluate cases. The Megaloop Button System is a surgical implantable device, and its evaluation is based on non-clinical bench testing.

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

This question is not applicable. The Megaloop Button System is a physical surgical implant, not a software algorithm or an AI-powered device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical bench tests consists of:

• Material Specifications: Compliance with established international standards (ISO, ASTM) for the chemical composition and mechanical properties of the materials (titanium alloy, UHMWPE).
• Biocompatibility Standards: Compliance with ISO 10993-1.
• Mechanical Test Results: Measured load-to-failure (pullout) and cycles-to-failure (fatigue) data, which are compared against general performance expectations for such devices and, implicitly, against the predicate device's performance. The "ground truth" here is the objectively measured physical behavior of the device under stress.
• Sterilization Validation: Demonstrated SAL of 10^-8.
• Shelf-life Data: Results from accelerated aging tests.

No pathology, expert consensus, or outcomes data were used for establishing ground truth in this non-clinical submission.

8. The Sample Size for the Training Set

This is not applicable. The Megaloop Button System is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The design and manufacturing process would involve internal testing and iteration, but not "training data" in the AI sense.

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

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

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