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510(k) Data Aggregation
(89 days)
The M-Fix™ Acromioclavicular Device is intended to provide fixation during the healing process following syndesmotic trauma such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
The M-Fix™ Acromioclavicular Device (M-Fix™) is a suture band system designed to provide reduction and stabilization of the acromioclavicular joint following syndesmotic disruptions. The M-Fix is a polyethylene terephthalate (PET) band that may be tensioned and secured with the integrated, low-profile Connector/Button which is made of titanium or stainless steel.
The one-time use band with connector is provided sterile. Additional accessory instruments, including a Counter Traction Tool and a Punch Tool for securing the Connector/Button are single use devices provided sterile for use during the orthopedic procedure.
This document describes a medical device called the M-Fix™ Acromioclavicular Device, which is a suture band system intended to provide fixation during the healing process following syndesmotic trauma such as acromioclavicular separations. The document is an FDA 510(k) premarket notification summary.
Based on the provided text, the device described is a physical medical device, not a software device or an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria based on metrics like sensitivity, specificity, F1-score, sample sizes for training/test sets, ground truth establishment methods, expert qualifications, and MRMC studies, are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering performance tests for a physical medical device to demonstrate substantial equivalence to predicate devices, rather than clinical performance or diagnostic accuracy.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Ultimate Tensile Testing | The M-Fix™ device must demonstrate mechanical strength and integrity comparable to, or better than, the predicate devices (Arthrex TightRope™, Surgicraft Lockdown™, Dallen Medical Tensyn™ Band) for its intended use in fixing acromioclavicular separations. Specific quantitative values are not provided in this summary but are implied to be established through engineering comparisons. | "Ultimate Tensile and Cyclic Tests were performed." The outcome indicated "the M-Fix™ Acromioclavicular Device is substantially equivalent to the predicate devices." Specific numerical results are not detailed in this summary. |
| Cyclic Testing | The M-Fix™ device must maintain its structural integrity and functional performance over repeated loads, simulating the physiological stresses the device would experience post-implantation. This demonstrates durability and resistance to fatigue. Specific quantitative values are not provided, but comparison to predicate devices is key. | "Ultimate Tensile and Cyclic Tests were performed." The outcome indicated "the M-Fix™ Acromioclavicular Device is substantially equivalent to the predicate devices." Specific numerical results are not detailed in this summary. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. The phrase "bench studies" typically refers to in-vitro testing where multiple samples of the device are tested.
- Data Provenance: The studies are "bench studies," meaning they were conducted in a laboratory setting. This is not clinical data, so country of origin or retrospective/prospective is not applicable.
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 question is not applicable as the device is a physical medical device and the studies performed are mechanical bench tests, not involving expert interpretation or clinical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as the device is a physical medical device and the studies performed are mechanical bench tests, not involving human adjudication of clinical outcomes or images.
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:
- This question is not applicable as the device is a physical medical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these bench tests is the established mechanical properties of the predicate devices and general engineering standards for material strength and fatigue life. It is not clinical "ground truth" derived from patient data.
8. The sample size for the training set:
- This question is not applicable as the device is a physical medical device and there is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
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