(27 days)
The DynaNail Mini Tapered Hybrid is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.
The proposed DynaNail Mini Tapered Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively.
The proposed DynaNail Mini Tapered Hybrid™ is available in identical diameters and lengths to the predicate device, and to accommodate variations in patient anatomy. The proposed device differs from the predicate device only in the threaded component major diameter, which is tapered. The DynaNail Mini Tapered Hybrid™ is implanted with the same driver/ deployment frame and fixation screws as the predicate. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation identical to the predicate.
This document is a 510(k) Summary for a medical device called the "DynaNail Mini Tapered Hybrid." It details the manufacturer's claim that this new device is substantially equivalent to a previously cleared predicate device.
Based on the provided document, there is NO study information available that proves the device meets acceptance criteria related to AI/software performance or human reader improvement.
The document discusses the substantial equivalence of a physical medical device (an orthopedic nail) to a predicate device. The acceptance criteria and "study" information provided refer to mechanical and material testing of the physical implant, not to the performance of a software or AI algorithm.
Therefore, I cannot fulfill your request for information regarding AI acceptance criteria, data provenance, expert ground truth adjudication, MRMC studies, standalone AI performance, or training set details because this document does not contain information about an AI/software device.
The "studies" conducted and described are non-clinical (mechanical) tests to demonstrate that the physical device performs equivalently to its predicate.
Here's what I can extract related to the physical device's "acceptance criteria" and "performance," as inferred from the mechanical testing, but please note this is not for an AI device:
Acceptance Criteria and Device Performance (for the physical medical device - Orthopedic Nail)
This section outlines the non-clinical (mechanical) testing performed to demonstrate the substantial equivalence of the DynaNail Mini Tapered Hybrid to its predicate device. The "acceptance criteria" are implicitly met if the proposed device's performance is "substantially equivalent" or "superior" to the predicate or relevant standards.
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Test Method (Criteria) | Acceptance Criteria (Inferred) | Reported Device Performance (Results) |
|---|---|---|
| Mechanical Performance Tests | ||
| ASTM F1264-16e, Standard Specification for Intramedullary Fixation Devices - Static Four-Point Bend | Performance must be substantially equivalent to the predicate device (DynaNail Mini Hybrid K203381) | "The four-point bending strength of the proposed device was substantially equivalent to the predicate device" |
| ASTM F1264-16e - Static Torsion Test | Performance must be substantially equivalent to the predicate device | "The static torsion strength of the proposed device was substantially equivalent to the predicate device" |
| ASTM F1264-16e - Bending Fatigue Test | Performance must be substantially equivalent to the predicate device | "The bending fatigue strength of the proposed device was substantially equivalent to the predicate device" |
| US FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway", issued December 2020 (Axial Pullout) | Performance must be substantially equivalent to the predicate device AND/OR superior to the reference value recommended per the US FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway", issued December 2020. | "The axial pull-out strength of the proposed device was substantially equivalent to the predicate device" |
| ASTM F543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws, Annex A3 - Fixation Strength (Axial Pullout) | Performance must be substantially equivalent to the predicate device AND/OR superior to the reference value recommended per the US FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway", issued December 2020. | "The distal and proximal fixation strength of the proposed device was substantially equivalent to the predicate device and / or superior to the reference value recommended per the US FDA Guidance Document 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway', issued December 2020." |
| Sterilization Validation | ||
| ISO/AAMI/ANSI 11137-1:2006, Sterilization of health care products - Radiation - Requirements for development, validation, and routine control of a sterilization process for medical devices | Must meet the VDmax25 requirements for radiation sterilization. | "Pass" |
| Biocompatibility | ||
| (Implicit by material and process equivalence) | Biocompatibility must be acceptable for patient contact. | "Biocompatibility of the predicate device was deemed unnecessary since the material, processes, assembly, packaging, and sterilization of the proposed device are identical to the predicate." |
| Pyrogenicity / Bacterial Endotoxin Testing (BET) | Must meet the limit of 20 EU/device. | "Pyrogenicity testing was conducted per ANSI/AAMI ST72 for the worst case largest DynaNail™ system, confirming the most loaded device scenario meets the limit of 20 EU/device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011 (R2016)." |
Regarding the other points of your request as they apply to an AI device (since this document is not about AI):
- 2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" consists of physical devices subjected to mechanical testing. No patient data or clinical imagery is involved.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical tests is established by published test standards and engineering measurements, not by human experts.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. No human readers or AI assistance involved.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the objective physical measurements obtained according to validated standard test methods (e.g., ASTM standards).
- 8. The sample size for the training set: Not applicable. This is not an AI/software device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a physical orthopedic implant, demonstrating its substantial equivalence through mechanical and material testing, not through AI performance studies.
§ 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.