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The dynaMXTM Compression Plate is indicated for fixation of small fragments, osteolomics, atthrodeses, replantations, and reconstructions of small bones and small fragments.

The dynaMX™ Compression Plate provides a means of fixation for small bones and small fragments. The dynaMÄ™ Compression Plate is made of biocompatible Nitinol. The bridge of the implant is designed to exhibit superelastic properties at room temperature.

I apologize, but the provided text is a 510(k) summary for a medical device (dynaMX™ Compression Plate) and primarily focuses on establishing substantial equivalence to predicate devices through laboratory bench testing.

Therefore, the input document does not contain any information regarding clinical studies, acceptance criteria related to clinical performance, or the involvement of human readers or experts for ground truth establishment.

The document describes bench tests conducted to verify suitability and substantial equivalence, such as:

• Elastic Static Bending Testing
• Bending Fatigue Testing
• Cyclic Potentiodynamic Polarization Corrosion Testing
• Galvanic Corrosion Testing
• Compressive Force Performance
• Transformation Temperature Determination
• Package Seal Strength Verification

It also mentions testing for locking screws, including:

• Insertion and Removal Torque
• Torsional Strength
• Pullout Strength

Without information about clinical performance acceptance criteria and studies linked to human or algorithm performance, and ground truth establishment, I cannot fulfill your request for the specific details you've asked for.

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The dynaMX™ Nitinol Compression Screw is indicated for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The implants are intended for single use only.

The dynaMX™ Nitinol Compression Screw is a cannulated self-drilling / self-tapping screw with a threaded head which can be countersunk into the bone. The screw is available in a range of lengths from 16mm to 40mm in 2mm increments. The screw is manufactured from biocompatible superelastic Nitinol is fully transformed at room temperature and requires no external heating. Screws are shipped pre-elongated (i.e., stretched). An internal retaining pin maintains the screw in the stretched condition. Following implantation of the screw, removal of the internal retaining pin causes the screw to want shorten to its original un-stretched length. This action generates compression across the fracture site.

This document describes a 510(k) premarket notification for the dynaMX™ Nitinol Compression Screw. The submission aims to demonstrate substantial equivalence to a predicate device, the Synthes (USA) 3.0mm Headless Compression Screw [K050636].

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists the following laboratory studies (bench tests) conducted to verify the suitability of the dynaMX™ Nitinol Compression Screw and establish substantial equivalence. While specific numerical acceptance criteria are not explicitly stated in this summary, the tests themselves represent the criteria used for evaluation. The "reported device performance" is implied to have met these criteria, leading to the conclusion of substantial equivalence.

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

The document does not explicitly state the sample sizes used for each specific bench test. It generally refers to "a series of laboratory studies (bench tests)". The data provenance is from bench testing, meaning it's in-vitro/ex-vivo laboratory data, not human patient data. There is no information regarding country of origin, retrospective or prospective nature, as it pertains to laboratory testing.

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

This information is not applicable as the studies are bench tests, not clinical studies requiring expert ground truth for patient outcomes. The "ground truth" for these tests would be established through engineering specifications, material science principles, and relevant industry standards.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are bench tests and do not involve human interpretation or adjudication in the context of clinical outcomes. The results of the bench tests would be measured and analyzed objectively against pre-defined specifications or predicate device performance.

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. The device is a physical medical device (compression screw), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

This information is not applicable. The device is a physical medical device and does not involve any algorithm or AI component that would be evaluated in a standalone manner.

7. The Type of Ground Truth Used

The ground truth for the bench tests would be based on:

• Engineering Specifications: Pre-defined mechanical and material properties (e.g., strength, torque values, compression force).
• Material Science Principles: Properties of Nitinol (e.g., transformation temperature).
• Industry Standards: Relevant ASTM or ISO standards for testing medical devices and bone fixation fasteners.
• Predicate Device Performance: Comparative data derived from the Synthes (USA) 3.0mm Headless Compression Screw, which serves as the established "truth" for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design, manufacturing, and testing processes are based on engineering principles and established medical device development guidelines.

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

This information is not applicable for the same reasons as point 8.

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The dynaMXTM Tabbed Staple is indicated for:

· Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,

· Fixation of proximal tibial metaphysis osteotomy.

The dynaMX™ Tabbed Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.

• The dynaMÄ™ Tabbed Staples are made of biocompatible Nitinol. The legs of the . staple are designed to exhibit superelastic properties at room temperature.

The provided text is a 510(k) Summary for the dynaMX™ Tabbed Staple, a medical device for bone fixation. It does NOT describe an AI/ML powered device, nor does it contain information about clinical studies with human readers or AI performance metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI device.

The document focuses on the substantial equivalence of the dynaMX™ Tabbed Staple to predicate devices based on bench testing (laboratory studies), not AI model performance.

Here's a breakdown of the relevant information that IS present, to clarify why your specific questions cannot be answered from this text:

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

• Acceptance Criteria (Implied): The document states that "A series of laboratory studies (bench tests) have been conducted to verify the suitability of the dynaMX™ Tabbed Staple for its intended use, establish Substantial Equivalence with the predicate devices and confirm reproducibility of the packaging." The implied acceptance criteria are that the device performs comparably to the predicate devices in these bench tests.
• Reported Device Performance: The document lists the types of tests performed:
  • Elastic Static Bending Testing
  • Bending Fatigue Testing
  • Staple Pull-Out Force
  • Corrosion Testing
  • Package Seal Strength Verification
  • Transformation Temperature Determination
  • However, it does not provide the numerical results or specific acceptance thresholds for these tests. It only states that these studies were conducted to support substantial equivalence.

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

• No information on sample size or data provenance is provided as these were bench tests, not clinical studies in humans.

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):

• Not applicable. This was a bench test involving physical device properties, not clinical assessment requiring expert interpretation to establish ground truth.

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

• Not applicable. This was a bench test, not a clinical trial requiring adjudication of clinical findings.

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:

• No MRMC study was done, and no AI component is described. This device is a physical bone fixation staple.

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

• Not applicable. This is a physical device, not an algorithm.

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

• Not applicable. The "ground truth" for a physical device in bench testing is typically the actual physical properties measured against engineering specifications or predicate device performance.

8. The sample size for the training set:

• Not applicable. This device does not use a training set as it is not an AI/ML model.

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

• Not applicable. This device does not use a training set.

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The dynaMX™ Compression Staple is indicated for:
Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,
Fixation of proximal tibial metaphysis osteotomy

The dynaMX Compression Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.
The dynaMX Compression Staples are made of biocompatible Nitinol. The legs of the staple are designed to exhibit superelastic properties at room temperature.
Staples with a bridge length of 11mm and longer are designed with a bridge that can be bent to contour to the bone surface.

This document is a 510(k) Premarket Notification from MX Orthopedics, Corp. for their dynaMX™ Compression Staple. It declares substantial equivalence to predicate devices and describes the device, its indications for use, and the studies conducted to support its safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists the types of laboratory studies conducted to "verify the suitability...establish Substantial Equivalence...and confirm reproducibility." The implication is that the device met the internal acceptance criteria for each of these tests to demonstrate substantial equivalence.

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

The document mentions "A series of laboratory studies (bench tests)" but does not specify the sample size for any of these tests. It also does not provide information on the data provenance in terms of country of origin or whether the studies were retrospective or prospective. These are bench tests, so they would not typically involve human data.

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 section is not applicable as the studies conducted were "laboratory studies (bench tests)" on the device itself, not studies involving human interpretation or clinical ground truth.

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

This section is not applicable as the studies were bench tests and did not involve human adjudication for establishing ground truth.

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

There is no mention of an MRMC comparative effectiveness study involving human readers or AI in the provided document. The current submission is for a medical device (compression staple), not an AI diagnostic tool.

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

This section is not applicable as the submission is for a physical medical device, not an algorithm or AI.

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

For the bench tests, the "ground truth" would be the engineering specifications and performance targets defined for each test (e.g., a specific pull-out force, a bending fatigue limit). These are inherent properties measured directly from the device. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific tests.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this submission is for a physical medical device and does not involve machine learning or AI.

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

This section is not applicable for the same reasons as #8.

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