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510(k) Data Aggregation
(193 days)
The DynaNail TTC Fusion System is intended for use in tibiotalocalcaneal fusions:
- Post-traumatic and degenerative arthritis.
- Post-traumatic or primary arthrosis involving both ankle and subtalar joints.
- Revision after failed ankle arthrodesis with subtalar involvement.
- Failed total ankle arthroplasty.
- Non-union ankle arthrodesis.
- Rheumatoid hindfoot.
- Absent Talus (requiring tibiocalcaneal arthrodesis).
- Avascular necrosis of the talus.
- Neuroarthropathy or neuropathic ankle deformity.
- Neuromuscular disease and severe deformity.
- Osteoarthritis.
- Charcot Foot.
- Previously infected arthrosis, second degree.
The DynaNail TTC Fusion System consists of the following components: the DynaNail TTC Fusion Nail, DynaNail End Cap, DynaNail Screws, and the DynaNail Deployment Frame. The DynaNail TTC Fusion Nail, DynaNail End Cap, and the DynaNail Screws are implanted into the medullary canal of the tibia, talus and calcaneus using the DynaNail Deployment Frame and Ancillary Surgical Instruments.
The DynaNail TTC Fusion Nail is manufactured from nitinol and titanium alloy (Ti 6Al-4V ELI) and is available in multiple diameters and lengths. The DynaNail End Cap is manufactured from titanium alloy (Ti-6AI-4V ELI). The DynaNail Screws are manufactured from titanium alloy (Ti 6Al- 4V ELI) and are available in a range of lengths.
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(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.
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(151 days)
-Fracture, osteotomy fixation and joint arthrodesis of the hand and foot.
-Fixation of proximal tibial metaphysis osteotomy.
-Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula, and sternum.
The proposed MedShape DynaClip® Bone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site. The DynaClip® Bone Staple is intended to be used for fracture and osteotomy fixation, including joint arthrodesis, and fixation of small bone fragments, and is comprised of Nickel Titanium alloy commonly referred to as NiTiNOL (reference ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical lmplants). The staple is provided pre-loaded on a disposable inserter.
The provided FDA 510(k) summary for the MedShape DynaClip® Bone Staple (K220812) does not contain information related to a study involving image analysis, AI, or human reader performance.
Instead, this document describes a bone staple, which is a physical medical device intended for fracture and osteotomy fixation. The acceptance criteria and the study proving the device meets these criteria are based on mechanical testing, material characterization, and biocompatibility assessments, not on performance in interpreting medical images or improving human interpretation.
Therefore, I cannot populate the requested table and answer the questions related to acceptance criteria and studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) as they pertain to image analysis or AI/human-in-the-loop performance, because this information is not present in the provided text.
The closest relevant information, regarding performance testing to support substantial equivalence, is listed as:
- Corrosion resistance testing per ASTM F2129
- Transformation temperature thermal analysis testing per ASTM F2004-17
- Bacterial endotoxin testing per ANSI/AAMI ST72:2011
- Mechanical comparison via Finite Element Analysis
The document explicitly states: "No clinical data was collected, as it was deemed unnecessary to support the assertion of safety." This further confirms that no studies involving human or AI interpretation of images were conducted or are described here.
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(391 days)
The MedShape DynaFuse Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The proposed MedShape DynaFuse Fixation System is a sterile, single use orthopedic implant system consisting of a threaded bone fastener and washer. The DynaFuse Fixation System is designed to apply compression across a target fracture or fusion site and is intended to be used for fracture and osteotomy fixation, including joint arthrodesis. The devices provided sterile, intended for single use, and are comprised of titanium alloy and nickel-titanium.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any clinical study details such as sample size, data provenance, expert ground truth, or adjudication methods in the context of an AI/algorithm-enabled medical device.
The provided document is a 510(k) premarket notification for the DynaFuse Fixation System, which is a physical orthopedic implant system (a threaded bone fastener and washer). The tests mentioned (Static Torsion Test, Static Strain Test, Fatigue Strain Test, Bacterial endotoxin testing) are engineering and biocompatibility tests for physical medical devices and are not related to the performance of an AI or software algorithm.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets them for an AI/algorithm-based device from this document.
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(146 days)
The MedShape DynaClip Bone Staple is intended to be used for the following:
- Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- Fixation of proximal tibial metaphysis osteotomy.
- Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
The proposed MedShape DynaClip Bone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site. The DynaClip Bone Staple is intended to be used for fracture and osteotomy fixation, including joint arthrodesis, and fixation of small bone fragments, and is comprised of Nickel Titanium alloy commonly referred to as NiTiNOL (reference ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The staple is provided pre-loaded on a disposable inserter.
The provided text is a 510(k) summary for the MedShape DynaClip Bone Staple. This document describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. It does not describe an AI/ML powered medical device, nor does it contain information typically found in studies related to AI/ML device acceptance criteria.
Specifically, the document focuses on bench testing for a physical orthopedic implant. Therefore, the questions regarding acceptance criteria and studies that prove an AI device meets acceptance criteria (such as sample sizes for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details, etc.) are not applicable to this document.
The document states: "No clinical data was collected, as it was deemed unnecessary to support the assertion of safety and effectiveness." This further reinforces that there was no study involving human readers or AI algorithms as would be expected for an AI/ML device.
Therefore, an answer based on the provided text cannot fulfill the user's request, as the request is predicated on the assumption of an AI-powered device, which the MedShape DynaClip Bone Staple is not.
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(141 days)
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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(125 days)
The MedShape DynaClip™ Bone Staple is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
The proposed MedShape DynaClip Bone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site. The DynaClip Bone Staple is intended to be implanted in the bones of the hand or foot and is comprised of Nickel Titanium alloy commonly referred to as NiTiNOL (reference ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The staple is provided pre-loaded on a disposable inserter.
The provided text describes a 510(k) premarket notification for the MedShape DynaClip™ Bone Staple, a medical device for bone fixation. It details the device's characteristics, indications for use, and a comparison to a predicate device, focusing on the rationale for substantial equivalence.
However, the document does not contain any information about an AI/algorithm-based device, human reader studies, or the establishment of ground truth by expert consensus or other methods. It describes a traditional medical device (bone staple) that undergoes mechanical and material testing, not a diagnostic or AI-driven system.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies that prove an AI/algorithm device meets those criteria based on the provided text. The questions you posed are relevant to AI-based medical devices, which this document does not cover.
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(176 days)
The DynaNail™ TTC Fusion System is intended for tibio-talo-calcaneal fusions:
- Post-traumatic and degenerative arthritis.
- Post-traumatic or primary arthrosis involving both ankle and subtalar joints.
- Revision after failed ankle arthrodesis with subtalar involvement.
- Failed total ankle arthroplasty.
- Non-union ankle arthrodesis.
- Rheumatoid hindfoot.
- Absent Talus (requiring tibiocalcaneal arthrodesis).
- Avascular necrosis of the talus.
- Neuroarthropathy or neuropathic ankle deformity.
- Neuromuscular disease and severe deformity.
- Osteoarthritis.
- Charcot Foot.
- Previously infected arthrosis, second degree.
The proposed DynaNail™ is a sterile, single use titanium device with an additional internal Nitinol compressive element for use in tibiotalocalcaneal fusions. The DynaNail™'s titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the ankle and subtalar joints postoperatively.
The DynaNail™ is available in 10, 11, and 12mm diameters and lengths of 180mm, 220mm, 260mm, and 300mm. The DynaNail™ is implanted with a deployment frame and fixation screws. The fixation screws are single use 5mm titanium headed and headless screws. The screws are available in lengths that range from 20 to 110mm.
The provided text is a 510(k) Summary for the DynaNail TTC Fusion System, and it describes a medical device, not an AI/ML powered device. Therefore, the information requested in the prompt, which is primarily relevant to the evaluation and validation of AI/ML devices (e.g., acceptance criteria for algorithm performance, sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance), is not applicable and cannot be extracted from this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through design, function, intended use, and adherence to relevant standards like ASTM F 1264-03 for functional performance and ANSI/AAMI ST72 for pyrogenicity.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert qualifications, adjudication methods, or AI/MRMC studies, as these concepts are not part of the described medical device evaluation in this 510(k) summary.
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