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510(k) Data Aggregation
(17 days)
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(96 days)
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(267 days)
Estremo Fibular Nail is intended for use in the fixation of fibula fractures and osteotomies.
Estremo Fibular Nail includes all implants and instruments required for the fixation of fibula fractures and osteotomies. Estremo Fibular Nail includes the nails, screws, end caps and related instruments. Estremo Fibular Nail differs from traditional nails or rods as it utilizes a "Diapason wings deployment" mechanism at the proximal end of the rod to allow for proximal fixation with a screw. The implants are composed of 316L stainless steel per ASTM F138 and are provided sterile.
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(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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(106 days)
The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.
The T2 Alpha Humerus Nailing System is an intramedullary humerus fracture nailing system consisting of sterile implants (Nails, End Caps, Compression Screw, and Washer) and non-sterile indication-specific instrumentation. The Nails, End Caps, Compression Screw, and Washer are made of titanium alloy as per ASTM F136. The T2 Alpha Humerus Nailing System will be used with the existing Locking Screws and Advanced Locking Screws of the IMN Screws System.
The IMN Screws System includes bone screws (Locking Screws and Advanced Locking Screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are sterile and made of titanium alloy (Ti6Al4V ELI) per ASTM F136.
The T2 Humeral Nail System is an intramedullary nailing system that allows antegrade and retrograde humeral nailing. The nails, end caps, compression screw, and washer are provided sterile and made of titanium alloy as per ASTM F136.
The provided FDA 510(k) clearance letter (K251400) does not concern an AI/software device. Instead, it pertains to a physical medical device: the Stryker T2 Alpha Humerus Nailing System, IMN Screws System, and T2 Nailing System, which are intramedullary fixation rods and bone screws used for treating humerus fractures.
Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/software performance metrics (e.g., accuracy, sensitivity, specificity, F1-score, expert consensus, MRMC studies) are not applicable to this submission.
The document discusses non-clinical performance testing for the physical device, focusing on mechanical properties, sterilization, packaging, and biocompatibility, to demonstrate substantial equivalence to previously cleared predicate devices.
Key points from the document regarding "performance":
- Non-Clinical Performance: This section details various engineering and material tests performed on the physical implants, such as dynamic and static bending, torsional stiffness, targeting accuracy, insertion torque, pull-out force, MRI assessment (magnetically induced displacement/torque, RF-induced heating, image artifacts), packaging tests, and biocompatibility evaluation. All these tests are standard for orthopedic implants.
- Clinical Performance: The document explicitly states: "Clinical data were not needed for the subject devices to demonstrate substantial equivalence to the predicate devices." This is a common situation for 510(k) submissions of physical devices where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.
Since the request asks for information relevant to AI/software device performance, and this document is for a physical orthopedic device, I cannot extract the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) because it is not present and not relevant to this specific biological device 510(k) submission.
In summary, there is no AI/software component in this device clearance that would require the types of performance statistics and study methodologies described in the prompt.
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(204 days)
The indications for use of these internal fixation devices include:
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures and tumor resections
- Supracondylar fractures, including those with intraarticular extension
- Fractures involving osteopenic and osteoporotic bone
- Fractures distal to a total hip prosthesis
- Periprosthetic fractures
- Nonunions and malunions
The struts of the T2 Alpha Femur Retrograde Nailing System are intended to be used only with the nails of this system; they are not to be used as stand-alone devices.
T2 Alpha Femur Retrograde Nailing System, previously cleared in K203819, consists of sterile implants (intramedullary nails in various diameter and sizes, compression screw and end caps), as well as nonsterile instruments (targeting devices).
The subject of this 510(k) submission is to introduce new devices of the T2 Alpha Femur Retrograde Nailing System. This line extension consists of anatomically pre-contoured struts and interlinking dowels designed to be used in combination with the existing nails of the T2 Alpha Femur Retrograde System for the treatment of complex fractures of the distal femur.
All struts are manufactured from Ti6Al4V ELI (Type II anodization) and are available in different sizes and left/right versions; these will be provided both non-sterile and sterile packaged. Interlinking dowels to the femoral nail are manufactured from CoCr and will be provided sterile packaged.
This appears to be a 510(k) clearance letter for an orthopedic implant, not an AI/Software as a Medical Device (SaMD). The document describes the "T2 Alpha Femur Retrograde Nailing System," which is a physical device used for internal fixation of femoral fractures.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert ground truth, MRMC studies, standalone performance, and training/test set provenance does not apply to this clearance document. These criteria are typically evaluated for AI/SaMD products, where algorithmic performance and human-AI interaction are critical.
The provided document details:
- Device Type: Intramedullary fixation rod (physical implant).
- Performance Data: Non-clinical bench testing (fatigue strength, cut-out performance, stiffness, shear-off, pull-out, insertion, static bending, fretting corrosion, targeting accuracy, MR assessment, packaging) and references to clinical evidence from peer-reviewed scientific literature.
- Comparison to Predicate Devices: Focuses on material, manufacturing, intended use, and mechanical performance equivalence.
No mention of AI, algorithms, or software performance evaluation is present.
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(160 days)
The Succession™ Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications:
- Failed ankle replacement
- Arthritis of ankle and subtalar joint
- Correcting neuromuscular imbalance of hindfoot, where bone fusion is required
- Revision of failed ankle and/or subtalar fusion
- Revision of failed Tibiotalocalcaneal (TTC) fusion
- Talar Avascular Necrosis (AVN)
- Charcot
- Trauma
- Neuroarthropathy
- Pseudoarthrosis
- Rheumatoid arthritis
The Succession™ AFN System is comprised of a set of straight 10mm, 11mm, and 12 mm diameter cannulated nails, 12.5mm diameter end caps, 5mm and 6mm diameter cortical screws, and accessory instrumentation. All implants are composed of Titanium (Ti-6Al-4V ELI) and provided to the user sterile packed with a combination of both sterile and non-sterile accessory instrumentation to assist in implantation. Each of the accessory instruments provided with the subject device contain substantially equivalent materials to the Oxford™ Ankle Fusion Nail System predicate device instrumentation, including stainless steel (ASTM F899 and ASTM F138 / ISO 5832-1) and Fluorinated Ethylene Propylene direct contacting materials.
During the procedure, following preparation of the tibial intramedullary canal (using the device accessory instrumentation) and placement of the intramedullary fixation nail, the provided 5mm screws are inserted into the medial to lateral (M/L) slots of the implant, allowing for fixation in the tibia, talus, and calcaneus. In both the talus and calcaneus, dynamic compression slots are included in the nail and are to be used with the internal and/or external methods of compression across the tibiotalar and subtalar joints. In addition, a 6mm screw is placed through the only angled posterior to anterior (P/A) slot located at the distal end of the nail implant, allowing for additional fixation between the calcaneus and talus. Following the placement of all screws, the end caps are implanted to add stability to the distal end of the nail and prevent excess bony ingrowth from occurring within the nail cannulation. Overall, the Succession™ Ankle Fusion Nail is intended to effectively fuse the tibiotalar and subtalar joints together, providing stability in the hindfoot region to facilitate tibiotalocalcaneal arthrodesis.
Based on the provided FDA 510(k) Clearance Letter, the Succession™ AFN System is an intramedullary fixation rod, and the clearance is primarily based on substantial equivalence to predicate devices. This means the device is demonstrated to be as safe and effective as a legally marketed device, not necessarily by proving it meets specific quantitative performance acceptance criteria for an AI/machine learning device.
The document provided does not contain information about an AI/ML-driven device's acceptance criteria or a study proving its performance. The "Non-Clinical and/or Clinical Tests Summary" in the document describes mechanical testing of the physical device (nails, screws, and accessories) for properties like torsional yield strength, driving torque, pullout strength, self-tapping force, cyclic fatigue, bending strength, torsional strength, and corrosion resistance.
Therefore, I cannot provide the requested information for an AI/ML device based on this document. The provided text is solely about the substantial equivalence of a physical orthopedic implant.
If this were a document about an AI/ML device, the sections you requested would typically be found in a "Performance Benchmarking" or "Clinical Study" section, detailing the AI's accuracy, sensitivity, specificity, or impact on human performance, along with the study methodology.
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(28 days)
The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
- Post-traumatic or degenerative arthritis
- Previously infected arthrosis
- Revision of failed ankle arthrodesis
- Revision of failed total ankle arthroplasty
- Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
- Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
- Rheumatoid arthritis
- Osteoarthritis
- Nonunions or pseudarthrosis of hindfoot and distal tibia
- Trauma (severe or malunited tibial pilon fracture)
- Charcot foot (neuroarthropathy)
- Severe end-stage degenerative arthritis
- Instability and skeletal defects after tumor resection
- Pantalar arthrodesis
- Severe foot/ankle deformity
Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The subject Phantom® Hindfoot TTC Trauma Nails are offered in a variety of sizes and lengths to accommodate variations in patient anatomy. The Phantom® TTC/TC screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.
I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Phantom® Hindfoot TTC/TC Nail System) and does not contain the specific information you are requesting about acceptance criteria, study details, expert qualifications, or ground truth establishment for a diagnostic or AI-based device.
This document is a regulatory approval notice that states the device is substantially equivalent to a previously cleared predicate device. It confirms the device's indications for use, its classification, and mentions that "engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices." However, it does not elaborate on:
- A specific table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results or effect sizes.
- Stand-alone algorithm performance (as this is not an AI/diagnostic device).
- Type of ground truth used.
- Training set sample size.
- How ground truth for the training set was established.
The document discusses "performance testing" and "engineering analysis" to demonstrate substantial equivalence, but it does not detail these tests in the way you've outlined for a diagnostic or AI study. The "device" in question is a surgical implant system, not a diagnostic tool or an AI algorithm that would typically have the kind of performance metrics you are seeking.
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(107 days)
The GMReis Fibula Nail System is intended for fixation of fractures and osteotomies of the fibula.
The GMReis Fibula Nail System is a system of locked intramedullary nails for osteosynthesis of fibular fractures. It has multiple lengths (110mm to 180mm) and diameters (3.0mm and 3.6mm). The arrangement of the holes in the intramedullary nails allows the surgeon to block the implant in different planes. The screws have a specific profile that reduces the risk of skin prominence and have threaded locking in the nail holes. GMReis Fibula Nail System are manufactured with titanium alloy, are for single use and the devices are provided non-sterile and must be properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.
The provided FDA 510(k) Clearance Letter for the "GMReis Fibula Nail System" (K250559) establishes substantial equivalence based on mechanical performance data, not clinical performance or AI/software-driven insights. Therefore, many of the requested points regarding acceptance criteria, study design, ground truth establishment, and expert involvement for an AI/software-based device cannot be extracted from this document.
The clearance is for a mechanical medical device (an intramedullary fixation rod), not a software or AI device. The type of acceptance criteria and study design are fundamentally different for a mechanical device versus a software/AI device.
However, I can extract the information relevant to this specific device's clearance process from the provided document:
Acceptance Criteria and Device Performance for GMReis Fibula Nail System (K250559) - A Mechanical Device
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|---|
| Mechanical Performance | Demonstrated equivalent mechanical properties to the predicate device for fibula fracture fixation. | "The performance of the subject devices are demonstrated through mechanical testing according to ASTM F1264 and ASTM F543, respectively. Based on submitted testing data, the subject device is equivalent to the predicate device." |
| Material Equivalence | Material composition to be suitable for implantation and consistent with the predicate device. | "GMReis Fibula Nail System are manufactured with titanium alloy... All of the subject device final finished components are manufactured... using identical materials... as used for the previously cleared reference devices in K201728, K223114 and K232829." Predicate also had titanium, with an option for stainless steel. |
| Biocompatibility | Biologically compatible for human implantation. | "substantially equivalent with regard to materials, packaging and biocompatibility" (stated in comparison to predicate/reference devices). |
| Sterilization | Suitable for sterilization. | "are for single use and the devices are provided non-sterile and must be properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use." "are to be sterilized by the same methods" (as predicate). |
| Dimensions/Fit for Use | Appropriate lengths and diameters for fibula fixation, comparable to predicate devices in function. | Minor differences in length and diameter compared to the predicate (predicate has longer, smaller, and larger diameter nails). These differences are deemed "minor and do not affect the safety and effectiveness of the subject device." Predicate's additional stainless steel option is also noted as a minor difference. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices tested, but implicitly refers to a sufficient number of samples to satisfy the requirements of the ASTM standards (ASTM F1264 for Intramedullary Fixation Rods and ASTM F543 for Metallic Medical Bone Screws). These standards outline specific testing configurations and sample numbers for mechanical characterization.
- Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in Brazil. The data is retrospective in the sense that it's generated for a regulatory submission rather than a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device. "Ground truth" in the context of expert consensus or clinical outcomes is not relevant for the primary evidence of substantial equivalence for this type of device. The "ground truth" here is the physical properties demonstrated by mechanical testing, measured by calibrated equipment.
4. Adjudication method for the test set:
- Not Applicable. As this is mechanical testing to specific ASTM standards, there is no expert adjudication process in the sense of reviewing images or clinical data. The results are quantitative measurements against predefined engineering specifications.
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. This is a mechanical implant device, not an AI or software product. MRMC studies are for evaluating diagnostic or interpretive AI systems with human-in-the-loop.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical implant device, not an AI algorithm.
7. The type of ground truth used:
- Quantitative Mechanical Properties: The "ground truth" for this device are the quantifiable mechanical properties (e.g., stiffness, strength, fatigue life) as determined by standardized laboratory tests (ASTM F1264 and ASTM F543).
8. The sample size for the training set:
- Not Applicable. This is a mechanical device, so there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8)
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(265 days)
ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).
ARIX Femur Nail System (Nail, Lag Screw, Interlocking Screw, Set Screw, and End Cap) is made of Titanium Alloy which meets ASTM F136. ARIX Femur Nail System is provided Sterile or Non-Sterile.
The provided text is an FDA 510(k) Clearance Letter for the ARIX Femur Nail System. This type of document is for a physical medical device (an intramedullary fixation rod), not a software or AI-powered device. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and AI-specific metrics (like human improvement with AI assistance) are not applicable to the information given in this document.
For medical devices like the ARIX Femur Nail System, "acceptance criteria" are generally tied to meeting established industry standards for performance, material properties, and biocompatibility, rather than diagnostic accuracy or algorithmic performance. The "study that proves the device meets the acceptance criteria" refers to bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.
Here's a breakdown of the information that is available based on your request, with an explanation of why other points are not applicable:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Bench Tests) | Reported Device Performance (Summary) |
|---|---|
| ASTM F1264-16: Standard Specification and Test Methods for Intramedullary Fixation Devices | |
| - 4-Point Bending Test | The test results demonstrated that the subject device complies with these standards. |
| - 4-Point Bending Fatigue Test | The test results demonstrated that the subject device complies with these standards. |
| - Torsional Test | The test results demonstrated that the subject device complies with these standards. |
| ASTM F384-17: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices | |
| - Full Construction Static Test | The test results demonstrated that the subject device complies with these standards. |
| - Full Construction Fatigue Test | The test results demonstrated that the subject device complies with these standards. |
| ASTM F543-23: Standard Specification and Test Methods for Metallic Medical Bone Screws | |
| - Torsional Strength Test | The test results demonstrated that the subject device complies with these standards. |
| - Driving Torque Test | The test results demonstrated that the subject device complies with these standards. |
| - Axial Pull-out Load Test | The test results demonstrated that the subject device complies with these standards. |
| Other: Cut-out Performance Test | The test results demonstrated that the subject device complies with this standard. |
| Overall Conclusion: The ARIX Femur Nail System is equivalent to the predicate device in terms of performance, safety, and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in a 510(k) summary for bench testing. The "test set" in this context refers to the physical samples of the device components manufactured for the specified mechanical and material tests. The document does not specify the number of samples tested for each benchmark. There is no patient data involved, as no clinical studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. "Ground truth" in this context would refer to the established pass/fail criteria for mechanical and material tests, which are defined by the ASTM standards themselves. These are engineering specifications, not expert interpretations of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This refers to methods for reconciling discordant expert opinions in clinical studies, which were not conducted.
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. This is not an AI-powered device, and no MRMC studies or clinical studies were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is established by the specified ASTM (American Society for Testing and Materials) standards. These are internationally recognized engineering standards that define the methods and criteria for evaluating the mechanical properties and performance of medical implants.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve machine learning or a training set.
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