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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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The Michelangelo Bunion System is intended for the following surgical indication: To assist in the correction of hallux valgus deformities by providing reduction of the 1st intermetatarsal angle.

The Instratek Michelangelo Bunion System is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st. intermetatarsal angle. Like the predicate device, the Michelangelo Bunion System is intended to assist in the correction of hallux valgus deformities by providing reduction of 1st intermetatarsal angles up to and including 16 degrees. The Michelangelo Bunion System may eliminate the necessity of a traditional osteotomy in the correction of Hallux Valgus deformities within the indicated criteria. The implanted device consists of three components: Medial Plate, Lateral Plate, Suture. There are 6 accessories required to implant the device: suture lasso, kwire, cannulated drill bit, kwire guide, plate bender, suture scissor.

The provided document is a 510(k) summary for the Michelangelo Bunion System and does not contain detailed information about acceptance criteria or a comprehensive study demonstrating direct device performance against such criteria. The document states that performance tests included "knot pull testing," but no specific acceptance criteria or results from this testing are provided.

Instead of a study proving the device meets acceptance criteria, the submission concludes that the device is "substantially equivalent" to predicate devices (HAV-Lok Bunion Correction System, K082384, and Arthrex Mini-Tightrope, K061925) based on similar technological characteristics and intended use. The core of the submission relies on this substantial equivalence argument rather than presenting a standalone study with defined acceptance metrics.

Therefore, most of the requested information cannot be extracted from this specific document.

However, based on the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document only mentions "knot pull testing" was performed, but no number of samples or tested units is provided.
• Data Provenance: Not specified. The document does not indicate the country of origin of any test data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not provided. The study mentioned (knot pull testing) is a mechanical performance test, not one requiring expert human interpretation or ground truth establishment in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. Adjudication methods are typically associated with clinical studies involving human readers or expert consensus, which is not the nature of the "knot pull testing" mentioned.

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 is not applicable as the Michelangelo Bunion System is a surgical device, not an AI-based diagnostic or assistive technology for human readers. No MRMC study was done, and therefore, no effect size related to AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable for this device. The device is a surgical implant and associated accessories, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the "knot pull testing," the ground truth would be the objectively measured force at which the knot failed. This is a physical measurement, not a clinical ground truth like pathology or expert consensus. No specific measurement data is provided.

8. The sample size for the training set

• Not applicable/Not provided. As this is a 510(k) submission for a physical device relying on substantial equivalence, there is no mention of a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Not applicable/Not provided for the same reasons as above.

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The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:

1. Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
2. Tarsometatarsal (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 Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Mini TightRope is designed as either two metal buttons with a pre-threaded FiberWire suture or as one metal button, one bioabsorbable suture anchor with one pre-threaded FiberWire suture.

The provided text is a 510(k) summary for the Arthrex Mini TightRope device. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance and does not contain information about acceptance criteria or specific study results to prove device performance in the context of AI/machine learning.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and study results, as this type of data is not present in the provided document. The document describes a medical device, its intended use, and its substantial equivalence to other devices, which is a regulatory and functional description rather than a performance evaluation with quantifiable metrics against acceptance criteria.

The information you are asking for, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are characteristic of studies evaluating AI/machine learning medical devices, which this document does not describe.

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