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Found 6 results
510(k) Data Aggregation
(244 days)
Femoral Trochanteric Nail System Neonail
The Femoral Trochanteric Nail System - Neonail 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 and shaft regions of the femur.
An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Femoral Trochanteric Nail System – Neonail consists of metal rods, bone screws, and end caps. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.
I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them with the level of detail requested. The document is an FDA 510(k) clearance letter for a medical device (Femoral Trochanteric Nail System - Neonail), which primarily focuses on demonstrating substantial equivalence to a predicate device.
Here's why I cannot fulfill your request completely:
- No acceptance criteria are explicitly stated in a tabular format. The document describes a comparison to a predicate device to establish substantial equivalence, not a set of specific performance acceptance criteria for the new device.
- The document states "Clinical data were not submitted in this premarket notification." This means there was no clinical study conducted on the device to prove it meets clinical acceptance criteria. Instead, the submission relies on non-clinical data (engineering analysis, dimensional analysis, and mechanical testing) to show substantial equivalence.
Therefore, I cannot provide information on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set or data provenance for a clinical study.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone performance study based on clinical data.
- The type of ground truth used from a clinical study.
- Sample size for a training set (as no AI/machine learning component is mentioned or evaluated).
- How ground truth for a training set was established.
However, I can extract the following relevant information regarding the non-clinical data used for demonstrating substantial equivalence:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical)
While not in your requested format, the device's performance was evaluated against standards applicable to intramedullary fixation devices. The "acceptance criteria" here are implicitly meeting the requirements of these standards and demonstrating equivalence to the predicate device.
| Acceptance Criteria (Implied by Standards and Substantial Equivalence Claim) | Reported Device Performance (Based on Non-Clinical Testing) |
|---|---|
| Conformance to ASTM F1264 for Intramedullary Fixation Devices: Static Four-Point Bending | The "worst case nail" was subjected to static four-point bending and the "worst case screws" to static four-point bending according to ASTM F1264. (Implied successful conformance for substantial equivalence). |
| Conformance to ASTM F1264 for Intramedullary Fixation Devices: Static Torsion | The "worst case nail" was subjected to static torsion according to ASTM F1264. (Implied successful conformance for substantial equivalence). |
| Conformance to ASTM F1264 for Intramedullary Fixation Devices: Bending Fatigue | The "worst case nail" was subjected to bending fatigue and the "worst case screws" to bending fatigue according to ASTM F1264. (Implied successful conformance for substantial equivalence). |
| Conformance to ASTM F384-17 for Metallic Angled Orthopedic Fracture Fixation Devices: Static Bending | The "worst case nail" was subjected to static bending according to ASTM F384-17. (Implied successful conformance for substantial equivalence). |
| Conformance to ASTM F384-17 for Metallic Angled Orthopedic Fracture Fixation Devices: Bending Fatigue | Tthe "worst case nail" was subjected to bending fatigue according to ASTM F384-17. (Implied successful conformance for substantial equivalence). |
| Conformance to ASTM F543 for Metallic Bone Screws: Torsional Properties, Driving Torque, Axial Pullout Strength, Self-Tapping Performance | The "worst case screws" were subjected to torsional properties, driving torque, axial pullout strength, and self-tapping performance according to ASTM F543. (Implied successful conformance for substantial equivalence). |
| Cut-out Resistance Performance (for Trochanteric Nail/Trochanteric Sliding Screw construct) | Cut-out testing was performed for the Trochanteric Nail/Trochanteric Sliding Screw construct based on the article by SOMMERS et al., 2004. (Implied successful conformance for substantial equivalence, specifically focusing on this critical mechanical aspect for trochanteric nails). |
| Substantial Equivalence to Predicate Device (K200869) in Indications, Design, Dimensions, Operating Principle, Materials, and Packaging | The submission claims the device has equivalent indications, design, dimensions, operating principle, basic design, materials, and similar packaging to the predicate device. Differences (lack of "U-Blade Lag Screw" and specific osteoporotic/osteopenic bone indication) were deemed not to raise new safety/effectiveness concerns, with the subject device's indications being a subset of the predicate's. This is the overarching "performance" demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Non-clinical): The document refers to "worst case nail" and "worst case screws" being subjected to testing. It doesn't specify the exact number of nails or screws tested beyond referencing "worst case." The data provenance is from non-clinical mechanical testing conducted by the manufacturer (Neoortho Produtos Ortopédicos SA). It is prospective in the sense that the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. This information pertains to clinical studies, which were explicitly stated as "not submitted."
4. Adjudication Method for the Test Set:
- Not applicable. This information pertains to retrospective clinical studies or expert consensus processes, neither of which were performed for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study involves human readers interpreting cases, often with and without AI assistance, and was not performed.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- No. This device is a physical medical implant, not an algorithm. The standalone performance refers to the device's mechanical integrity as tested against industry standards.
7. The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is established by engineering and mechanical testing standards (e.g., ASTM F1264, ASTM F384-17, ASTM F543) and a referenced scientific article for cut-out testing (SOMMERS et al., 2004). The "truth" is whether the device meets the physical requirements and behaviors defined by these standards.
8. The Sample Size for the Training Set:
- Not applicable. No training set is mentioned as this is a physical device, not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set is involved.
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(253 days)
The Progen Trochanteric Nail System
The Progen™ short trochanteric nail is indicated for fixation of various types of stable and unstable neck, intertrochanteric, and peritrochanteric fractures.
The Progen™ long trochanteric nail is intended for fixation of stable femoral fractures occurring from the base of the femoral neck extending distally to a point approximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, and revisions.
The Progen™ long trochanteric nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, malunion, and revisions.
The Progen™ Trochanteric Nail System consists of temporary fixation intramedullary nails and their accompanying instrumentation designed for fracture fixation and stabilization of the femur. The implants are available in various lengths and diameters to accommodate a range of patient anatomy. Each of the intramedullary nails is secured by a sequence of screws that transect through holes in the proximal and distal sections of each nail.
The Progen™ Trochanteric Nail System consists of single-use intramedullary nails for stable and unstable neck, intertrochanteric, pertrochanteric, and subtrochanteric fractures and combinations of these fractures. The system consists of Nail, Lag Screw, Secondary Screw, Lag Cap, Locking Screws, Set Screws, and Nail End Cap. The nails and accompanying components are manufactured from titanium alloy (Ti-6Al-4V ELI). Additionally, the Nails and Lag Screws have a Type II anodized surface treatments.
The provided text describes the Progen™ Trochanteric Nail System, an intramedullary fixation rod system, and its substantial equivalence with predicate devices. However, this document does not contain information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.
The information provided relates to a traditional medical device (an intramedullary nail system), and the performance data section focuses on sterilization, shelf-life, biocompatibility, and mechanical testing in accordance with ISO and ASTM standards. There is no mention of an AI/ML component, clinical testing, or any metrics related to AI/ML device performance such as sensitivity, specificity, or accuracy.
Therefore, I cannot provide the requested table or answer the questions related to AI/ML device performance, ground truth, expert qualifications, or MRMC studies based on the provided text.
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(30 days)
AOS Galileo Trochanteric Nail System
The AOS Galileo™ Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.
The AOS Galileo™ Trochanteric Nail System is a single-use, open reduction and internal fixation device, comprised of the Trochanteric Intermedullary Nail, Telescoping Lag Screws, Anti Rotation Screw, Cortical Locking Bone Screws, and their dedicated accessories, and sterilization trays. The trochanteric nail is a side specific cannulated femoral intramedullary nail with a proximal bend that is designed to enter through the greater trochanter, for the treatment of fractures to the femur, including peritrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations thereof. The device is meant to be used as a load sharing device, and it may be removed once the fracture is healed.
This document is a 510(k) summary for the AOS Galileo™ Trochanteric Nail System. It describes the device, its indications for use, and its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided text in the context of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabular format as would typically be seen for AI/software-as-a-medical-device (SaMD) performance. Instead, it describes a comparison to predicate devices for mechanical properties.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate mechanical properties/strength | "The AOS Galileo™ Trochanteric Nail System was subjected to functional testing and strength comparison analysis. The results demonstrate that the Galileo™ Intramedullary Nails and accessories are substantially equivalent to the predicates." |
| Same intended use, patient population, operating principle, risk profile | "The subject AOS Galileo™ Trochanteric Nail System, the predicates... have the same intended use, patient population, operating principle, and risk profile." |
| Identical manufacturing, packaging, sterilization, and shipping | "They have identical manufacturing, packaging, sterilization parameters, and shipping processes, all of which will be conducted under the same quality management system." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of AI/SaMD performance evaluation. The "testing" mentioned is functional and strength comparison analysis of the physical device. Therefore, a sample size for a test set and data provenance for a clinical study are not applicable or provided here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD that requires human expert ground truth for image interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD.
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 document pertains to a physical orthopedic implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical orthopedic implant.
7. The Type of Ground Truth Used
For the functional and strength testing, the "ground truth" would be the established mechanical standards and performance characteristics of the predicate devices, against which the new device was compared. This is based on engineering principles and material science, not clinical outcomes or expert consensus in the typical sense for AI.
8. The Sample Size for the Training Set
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes "functional testing and strength comparison analysis" as the study performed to demonstrate that the AOS Galileo™ Trochanteric Nail System is substantially equivalent to its predicate devices. The study concluded that the new device's performance is substantially equivalent, implying it meets the mechanical and functional requirements of the predicate. This is a non-clinical study focused on the physical device's characteristics rather than a clinical trial measuring patient outcomes or an AI model's diagnostic accuracy.
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(29 days)
EBI TROCHANTERIC NAIL SYSTEM
The EB1® Trochanteric Nail is indicated for the treatment of fractures of the femur including: non-comminuted and comminuted midshaft fracture, subtrochanteric fracture, distal third fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures. The EBI Trochanteric Nail is also indicated for osteotomies, reconstructive procedures following tumor resection, revision procedures where other treatment or devices have failed, and arthrodesis.
The EB10 Trochanteric Nail System is an interlocking intramedullary rod used in the fixation of fractures of the femur. The system consists of five basic components; trochanteric nails, lag screws, cortical screws, end caps, and set screws.
The provided 510(k) summary for the EBI® Trochanteric Nail System (K050118) details a submission based on substantial equivalence to a predicate device, not a de novo clinical study with specific acceptance criteria for performance metrics like sensitivity or specificity. Therefore, many of the requested categories are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted from the provided text, and where the information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical strength equivalent to predicate | "mechanically as strong as the predicate device." |
| Substantially equivalent in: | "substantially equivalent* to the predicate device in regards to indications for use, location, design characteristics, material, mechanical strength, and sterility." |
| Safety and Effectiveness | "is as safe and effective and performs as well as the predicate device" |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission is based on mechanical testing and comparison to a predicate device, not a human-data-based test set for device performance as would be seen in an AI/software device. There is no mention of a "test set" in the context of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As noted above, there is no human-data-based "test set" and thus no ground truth established by experts in this submission.
4. Adjudication Method for the Test Set
Not applicable. There is no human-data-based "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-powered devices to assess the impact on human reader performance, which doesn't apply to an intramedullary nail system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (intramedullary nail system), not an algorithm or software device.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established through mechanical testing standards and comparison to a legally marketed predicate device. The key "ground truth" is that its mechanical properties and functional characteristics are equivalent to the predicate device, which has already established its safety and effectiveness in the market.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm or software that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this type of device.
Summary of the Study Proving Acceptance Criteria:
The study proving the EBI® Trochanteric Nail System meets its acceptance criteria is a non-clinical mechanical testing study (bench testing) paired with a comparative analysis of technological characteristics against a predicate device.
- Study Design: The non-clinical testing involved mechanical load testing of the EBI® Trochanteric Nail System. This was supplemented by a detailed comparison of its design, materials, indications for use, and manufacturing processes with those of the Biomet Holland Femoral Nail System (K983641), which served as the predicate device.
- Proof of Acceptance: The results of the mechanical tests demonstrated that the EBI® Trochanteric Nail System exhibits equivalent mechanical strength to the predicate device. Furthermore, the submission argues for substantial equivalence across various technological characteristics (indications for use, location, design, material, mechanical strength, and sterility). This combined evidence led to the conclusion that the device is "as safe and effective and performs as well as the predicate device."
- Conclusion by FDA: The FDA's 510(k) clearance letter (K050118) confirms that they found the device "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market. This determination is based on the provided non-clinical testing and comparative analysis.
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(12 days)
TROCHANTERIC NAIL SYSTEM
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.
The Trochanteric Nail System consists of an intramedullary nail, lag screw, end cap, and optional anti-rotation screw, all manufactured from titanium alloy (Ti-6Al-4V ELI), which are used to treat fractures in the proximal portion of the femur. The lag screw provides dynamic compression of the fracture; the anti-rotation screw can be used to prevent the rotation of the bone fracture segments, and the end cap prevents bone ingrowth. It is estimated that the AR screw is required in only five to ten percent of the cases where additional rotational stability of the fracture is required.
This 510(k) summary (K042325) for the DePuy Orthopaedics Trochanteric Nail System does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. It focuses on device description, intended use, and indications, and then asserts substantial equivalence based on similar use, indications, materials, and sterilization processes to previously cleared DePuy Trochanteric Nail predicate devices (K010780 and K013563).
Therefore, I cannot provide the requested information from this document. To answer your questions, I would need a study report that details performance testing and acceptance criteria for the Trochanteric Nail System.
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(62 days)
LONG TROCHANTERIC NAIL SYSTEM
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.
The Trochanteric Long Nail System consists of an intramedullary nail, lag screw, end cap, and optional anti-rotation screw, all manufactured from Titanium (Ti-6Al-4V ELI) which are used to treat fractures of the femur.
The provided text describes a 510(k) premarket notification for a medical device called the "Long Trochanteric Nail System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for the new device.
Therefore, many of the requested elements about acceptance criteria and study design are not available in the provided document. The document explicitly states:
- "No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for intramedullary nails."
- "The Trochanteric Nail System has the same intended use, is manufactured from the same material and has the same design features as the predicate devices and is therefore substantially equivalent."
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. The submission focuses on substantial equivalence based on intended use, materials, and design features compared to predicate devices, not on specific performance metrics or acceptance criteria for a new clinical study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a clinical performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No ground truth establishment is described as there is no clinical performance study in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is described.
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 / Not provided. This device is a bone fixation device (intramedullary nail), not an AI-powered diagnostic or imaging device, so an MRMC study is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth is described.
8. The sample size for the training set
- Not applicable / Not provided. No training set is described for this type of device submission.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No ground truth for a training set is established.
Summary from the document:
The provided 510(k) summary for the "Long Trochanteric Nail System" relies on demonstrating substantial equivalence to existing legally marketed predicate devices for its clearance. This means the manufacturer presented evidence that their new device shares the same intended use, materials (Titanium (Ti-6Al-4V ELI)), and design features as the predicate devices. The listed predicate devices are:
- ACE Trochanteric Nail (K010780)
- ACE AIM Femoral Nail (K871539)
- Synthes Proximal Femoral Nail (K973240)
- Smith & Nephew TriGen Nail (K981529)
The basis for acceptance is this demonstration of substantial equivalence, rather than a clinical study with specific performance criteria for the new device.
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