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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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