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510(k) Data Aggregation
(114 days)
MicroLink All-Suture Button Fixation System (Radiopaque)
Intended Use
The MicroLink™ All-Suture Button Fixation System, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Indications for Use
The CONMED MicroLink All-Suture Button Fixation System is indicated for fixation of bone-to-bone as an adjunct in the following orthopedic surgical procedures:
Procedure: Carpometacarpal Suspension
Anatomic Location: Hand
The MicroLinkTM All-Suture Button Fixation System (Radiopaque) is an all-suture suspension device with one strand of #2 (5 metric) Hi-Fi® suture, a radiopaque flat braid Hi-Fi® Suture Button and a radiopaque flat braid Hi-Fi® suture Backstop threaded on a Loader. A suture passing drill is provided with a nitinol loop for passing. A trapezium pin is provided to facilitate manipulation of the trapezium during trapeziectomy. All four catalog numbers are provided sterile, intended for single-use.
The provided document is a 510(k) summary for a medical device called the "MicroLink™ All-Suture Button Fixation System (Radiopaque)". This document is a regulatory submission to the FDA for medical device clearance, indicating that the device is a physical product, not a software algorithm. Therefore, the questions related to AI/software aspects such as acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.
The document discusses performance testing for the physical device to demonstrate its equivalence to a predicate device.
Here's the relevant information that can be extracted from the provided text regarding device performance:
1. A table of acceptance criteria and the reported device performance
The document lists types of performance testing completed, but does not provide specific acceptance criteria or quantitative performance results in a table format. It generally states that the device "performs as intended and is substantially equivalent to the predicate device" and "met the endotoxin limits."
| Performance Test | Reported Device Performance |
|---|---|
| Bacterial Endotoxin Testing | Met the endotoxin limits. |
| Sterilization | Completed (implies met standards). |
| Reliability | Completed (implies met standards). |
| Pyrogen | Completed (implies met standards). |
| Ultimate Fixation Strength | Completed (implies met standards and comparable to predicate). |
| Cyclic | Completed (implies met standards and comparable to predicate). |
| Biocompatibility | Completed (implies met standards). |
| Shelf-life | Completed (implies met standards). |
| User Validation | Completed (implies met standards). |
| Packaging | Completed (implies met standards). |
| Transportation | Completed (implies met standards). |
| Side-by-Side Testing | Completed (implies comparable to predicate). |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes a physical medical device, and the testing mentioned (e.g., sterilization, biocompatibility, fixation strength) would typically involve laboratory or bench testing on device samples, not patient data sets.
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 information is not applicable and not provided. The device is a physical implant, not an diagnostic imaging or AI tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for subjective assessments, typically in clinical trials or AI performance evaluations, not for the physical performance testing described.
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 information is not applicable and not provided. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. This device is a physical surgical implant, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and not provided in the context of ground truth for an AI system. For the physical device, performance criteria are likely based on engineering standards, biomechanical principles, and regulatory requirements for medical devices of its type.
8. The sample size for the training set
This information is not applicable and not provided. This device is a physical surgical implant, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This device is a physical surgical implant, not a machine learning model.
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