(168 days)
The dynaMX™ Intramedullary Fixation Device is indicated to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
The dynaMX™ Intramedullary Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges. The implant is fully cannulated with threads on the distal side and two barbs on the proximal side. The implant is offered in multiple combinations of diameter and length to accommodate various anatomies. The dynaMX™ Intramedullary Implant is made of biocompatible Nitinol. The barbs of the implant are designed to exhibit superelastic properties at room and body temperature. As manufactured, one end of the implant has a screw thread, and the other end a pair of barbs. The screw thread is inserted into a drilled hole in the middle phalange. The barbed end is implanted into a broached canal in the proximal phalange. While inserting the barbed end of the implant, the barbs deflect inward to allow the implant to pass through the broached canal. Once inside the canal, the barbs superelastically return to their flared outward configuration to securely hold the implant in the bone. The dynaMX™ Intramedullary Implant is sold as part of a single use disposable kit. The kit includes an implant, pre-loaded onto a delivery device, a drill bit, a broach and a quide wire.
The provided document is a 510(k) premarket notification for a medical device called the "dynaMX™ Intramedullary Implant." This type of document is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, and it typically does not contain detailed acceptance criteria and study results in the same way a clinical trial report would.
However, based on the information provided, I can infer what constitutes the "acceptance criteria" through the bench and cadaver testing listed and how the device aims to meet these through comparison with predicate devices.
Here's an analysis based on your request, structured as much as possible with the available information:
Key Takeaway: The document outlines a substantial equivalence claim based on laboratory studies (bench and cadaver tests) rather than human clinical trials involving complex statistical criteria for AI performance. Therefore, many of your specific questions related to AI-specific metrics, human reader studies, and large-scale data provenance are not applicable to this type of device and submission.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The acceptance criteria for the dynaMX™ Intramedullary Implant are demonstrated through a series of laboratory studies (bench tests and cadaver tests) designed to verify the suitability of the device for its intended use, establish substantial equivalence with predicate devices, and confirm reproducibility of packaging. The successful completion of these tests, showing comparable performance to predicate devices, serves as the primary evidence for meeting acceptance criteria for this Class II medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Measure/Test | Reported Device Performance (as stated in the document) |
|---|---|---|
| Mechanical Performance / Structural Integrity | Elastic Static Bending Testing | Conducted to verify suitability and establish Substantial Equivalence with predicate devices. (Specific quantitative results or pass/fail thresholds are not detailed in this summary.) |
| Bending Fatigue Testing | Conducted to verify suitability and establish Substantial Equivalence with predicate devices. (Specific quantitative results or pass/fail thresholds are not detailed in this summary.) | |
| Implant Pull-Out Force | Conducted to verify suitability and establish Substantial Equivalence with predicate devices. The device's design, with a screw thread on one end and superelastic barbs on the other, is described to "securely hold the implant in the bone." | |
| Rotational Stability | Conducted to verify suitability and establish Substantial Equivalence with predicate devices. (Specific quantitative results or pass/fail thresholds are not detailed in this summary.) | |
| Biocompatibility | Corrosion Testing | Conducted. (Specific results not detailed, but generally, acceptance would be low/negligible corrosion appropriate for implants.) |
| Transformation Temperature Determination (for Nitinol) | Conducted. (Specific results not detailed, but acceptance would be within a range demonstrating appropriate superelastic properties at body temperature.) | |
| Pyrogenicity | Endotoxin testing conducted to confirm the implant is non-pyrogenic. (Implies successful completion.) | |
| Packaging & Sterilization | Package Seal Strength Verification | Confirmed reproducibility of the packaging. (Implies successful completion.) |
| Shelf Life / Stability | A shelf-life/stability protocol has been designed to support expiry dating of up to 36 months, with an initial proposed shelf-life of 6 months following completion of the initial study. | |
| Material Equivalence | Material Composition | Fabricated from Nitinol per ASTM F2063-12. This is explicitly compared to predicate devices, some also using Nitinol,others using stainless steel or titanium. |
| Functional Equivalence | Stabilize and aid in fixation of phalangeal fractures, fusions, and osteotomies | Demonstrated through laboratory studies and substantial equivalence comparison to predicate devices with similar indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the bench and cadaver tests. It generally states a "series of laboratory studies." For cadaver tests, typically a limited number of cadaveric specimens would be used.
The data provenance is laboratory-based (bench tests) and cadaveric. There is no information regarding country of origin, but it is assumed the tests were conducted within the facilities of Arthrex, Inc. (or MX Orthopedics, Corp.) or their designated testing laboratories. These are effectively retrospective in the sense that they are conducted on inert materials or cadaveric tissue in a controlled lab setting, not in live patients.
3. Number of Experts Used to Establish the Ground Truth For The Test Set and Qualifications of Those Experts
This information is not applicable as the device is an implantable mechanical device, not an AI or diagnostic device that relies on expert ground truth for interpretation of output. The "ground truth" for this device's performance would be the physical properties and mechanical behavior observed in the specified laboratory tests.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication typically refers to expert consensus in interpreting diagnostic results or clinical outcomes. The performance of this device is assessed directly through engineering measurements and established material science principles in laboratory settings.
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. This device is a surgical implant, not a diagnostic or AI-powered system, and therefore, human reader studies with AI assistance are irrelevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical implant; there is no algorithm involved in its direct function for standalone performance evaluation in this context.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily engineering specifications, material science properties, and established biomechanical performance standards for bone fixation devices. This is demonstrated through direct physical measurements and observations during bench and cadaver tests. The comparison to predicate devices also establishes a benchmark for "ground truth" in terms of acceptable clinical performance and safety.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical implant, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" for this type of device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.