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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."

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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Tensyn Plug 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 which have been properly stabilized and which allow stable placement of the Tensyn Plug apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn Plug is used in conjunction with, but not connected to, supplemental fixation. The subject device is 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 Tensyn Plug is intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions; 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle. The Tensyn Plug, 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. Specifically, the Tensyn Plug is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Tensyn Plug is a knotless system for fixation of syndesmosis disruptions, acromio-clavicular repair, tarasometatarsal injury, hallux valgus reconstruction, and carpal metacarpal joint arthroplasty. The Tensyn Plug is a low profile system comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly. The Tensyn Plug is available in stainless steel.

The provided document is a 510(k) summary for the Tensyn™ Plug, a medical device for fixation during healing processes. It discusses the device's indications for use, technical characteristics, and performance data for demonstrating substantial equivalence to predicate devices. However, the document does not include specific acceptance criteria, detailed results of the studies, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about multi-reader multi-case studies.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the provided text.

Here's an overview of what is available and what is missing:

What is present in the document:

• Device Name: Tensyn™ Plug
• Device Description: Knotless system for fixation, comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly, available in stainless steel.
• Indications for Use: Detailed for various conditions (syndesmotic trauma, acromioclavicular separations, fracture repair, Lisfranc injury, Hallux Valgus reconstruction, Carpal Metacarpal (CMC) joint arthroplasty).
• Predicate Devices: Tensyn Band (K141264, K131850), Arthrex, Inc. Mini TightRope Repair Kit (K061925), Arthrex, Inc. CMC Mini TightRope (K140328), Biomet, Inc. ToggleLoc System (K083070).
• Types of Performance Testing: Rotational loading, cyclic loading, ultimate load, load at 3mm, and shear test.
• Conclusion from Testing: "The testing demonstrated that the Tensyn Plug is substantially equivalent to the predicate devices."

What is missing from the document (and therefore cannot be provided in the answer):

1. Table of Acceptance Criteria and Reported Device Performance: While types of tests are listed, the specific quantitative acceptance criteria (e.g., "ultimate load must be > X N") and the numerical results obtained for the Tensyn™ Plug are not provided.
2. Sample Size Used for the Test Set and Data Provenance: No information is given regarding the number of devices or units tested for each performance test, nor the origin or nature (retrospective/prospective) of any clinical data, as this is a mechanical testing report, not a clinical study report.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable, as this involves mechanical testing, not a diagnostic or AI-driven device requiring expert adjudication of ground truth from images or clinical data.
4. Adjudication Method for the Test Set: Not applicable for mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No information is provided about such a study. This is a mechanical device, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: No information is provided about such a study. This is not an algorithm-driven device.
7. Type of Ground Truth Used: For mechanical testing, the "ground truth" would be the measured physical properties or failure points, not expert consensus, pathology, or outcomes data. The document does not detail the specific ground truth metrics or methods used for "ultimate load," "load at 3mm," etc.
8. Sample Size for the Training Set: Not applicable, as this is a mechanical device, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set was Established: Not applicable.

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