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Found 3 results
510(k) Data Aggregation
(27 days)
DynaNail Mini Tapered Hybrid
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.
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(59 days)
Dynanail Mini Hybrid
The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.
The proposed DynaNail Mini Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an additional 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 DynaNail Mini Hybrid™ is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail Mini Hybrid™ is implanted with a driver/ deployment frame and fixation screws. 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.
The provided text describes a medical device, the DynaNail Mini HybridTM, and its 510(k) premarket notification to the FDA. The information focuses on the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.
Based on the provided text, the device is a Smooth or threaded metallic bone fixation fastener / Orthopedic Nail. The acceptance criteria and the study that proves the device meets them are described in the context of establishing substantial equivalence to a predicate device, not in the typical sense of AI/algorithm performance.
Here's a breakdown of the requested information based on the provided document:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Tests) | Reported Device Performance |
|---|---|
| Static Torsion test per ASTM F543 | Test results and analysis demonstrate substantial equivalent performance to the predicate device. |
| Static Axial Strain test per ASTM F2516 | Test results and analysis demonstrate substantial equivalent performance to the predicate device. |
| Fatigue Strain test per ASTM E606 | Test results and analysis demonstrate substantial equivalent performance to the predicate device. |
| Pyrogenicity testing per ANSI/AAMI ST72 (worst-case largest DynaNail™ system) | Confirms the most loaded device scenario meets the limit of 20EU. |
| Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011 (R2016) | Confirms the most loaded device scenario meets the limit of 20EU. |
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the mechanical tests (Static Torsion, Static Axial Strain, Fatigue Strain, Pyrogenicity, BET). These tests are typically performed on a limited number of device samples, not patient data. The provenance of this data is from engineering analysis and laboratory testing, not patient-derived data from specific countries or study designs (retrospective/prospective). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable (N/A). The evaluation is based on engineering and material performance specifications of the device itself, not on expert interpretations of medical images or patient outcomes. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This concept is for clinical trials or diagnostic performance studies involving human interpretation. The reported studies are mechanical and biocompatibility tests. -
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
N/A. This is a medical device (bone fixation fastener), not an AI diagnostic or assistance tool. Therefore, MRMC studies are not relevant. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a hardware medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by validated engineering standards (ASTM F543, ASTM F2516, ASTM E606) and biocompatibility standards (ANSI/AAMI ST72). The ground truth for performance is the ability of the device to meet the specified performance criteria set by these standards, demonstrating substantial equivalence to the predicate device. -
The sample size for the training set
N/A. This medical device does not involve a "training set" in the context of machine learning or AI. -
How the ground truth for the training set was established
N/A. As there is no training set, this question is not applicable.
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(141 days)
DynaNail Mini
The DynaNail™ Mini Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.
The proposed DynaNail™ Mini is a sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. The DynaNail™ Mini's 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 DynaNail™ Mini is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail™ Mini is implanted with a deployment frame and fixation screws. 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.
This is a 510(k) premarket notification for a medical device (DynaNail Mini) and therefore does not include detailed information about clinical studies, acceptance criteria, or ground truth establishment for AI/ML device performance. This document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, materials, and mechanical performance testing, rather than reporting on a study demonstrating clinical performance against acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred from the document:
1. A table of acceptance criteria and the reported device performance:
The document mentions "Engineering analysis and mechanical performance testing (Pull-out per ASTM F543) was performed." and "The test results and analysis demonstrate substantial equivalent performance to the predicate devices." It also states "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 20EU. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011."
However, the specific acceptance criteria (e.g., "pull-out strength X N or greater") and the exact reported performance values are not provided in the text. The only specific acceptance criterion mentioned is for pyrogenicity: "confirmi[ng] the most loaded device scenario meets the limit of 20EU."
2. Sample size used for the test set and the data provenance: Not applicable. This document describes a mechanical device, not an AI/ML system tested on a dataset of patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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.
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): Not applicable. The "ground truth" for this device would be its mechanical properties and biological compatibility, which are assessed through engineering analysis and laboratory testing (e.g., ASTM F543, ANSI/AAMI ST72), not clinical data from patients.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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