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510(k) Data Aggregation
(118 days)
Intended to stabilize shaft fractures between the proximal and distal third of the tibia. Indications include transverse, comminuted, spiral, oblique, and segmental fractures. The Tibial Nail may also be used for treatment of mal-unions as well as prophylactic nailings of impending pathological fractures.
The DGIMED Ortho DISTALOCK™ Tibial Intramedullary Nail System permits an intramedullary approach for fixation of fractures of the tibia: The DISTALOCK™ Tibial Naillis a closed section, cannulated, curved intramedullary fixation device containing four proximal (three static and one dynamic) and three distal holes to accept locking screws which thread transversely though the proximal and distal third of the tibia. The DISTALOCK™ Tibia Intramedullary Nail System includes the following components: DISTALOCK™ Tibial Intramedullary nails, locking screws and end caps made of titanium alloy. The DISTALOCK™ Tibial Ancillary Instrumentation includes the DISTALOCK™ Tibial Drill and other disposable and reusable instruments needed for accessing the tibial medullary canal; preparing the bone for placement and installation of the nail and locking screws, and removal of the nail and locking screws if required.
The provided text describes a medical device, the DISTALOCK™ Tibial Intramedullary Nail System, and its clearance process. However, it does not contain any information regarding clinical studies, acceptance criteria, or performance metrics in the context of AI/ML device evaluation.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing (bench testing, cadaver testing, material biocompatibility, and human factors analysis). It explicitly states: "No new risks or efficacy concerns other than those identified with the predicate device were raised. Results of non-clinical testing demonstrated that the DISTALOCK™ Tibial Intramedullary Nail System is safe and effective for its intended use."
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text, as this information is not present. The document focuses on demonstrating substantial equivalence through engineering and material testing, not on clinical performance metrics or an AI/ML component.
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(75 days)
The DISTALOCK™ Femoral Intramedullary Nail System is indicated for use in orthopedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.
The DISTALOCK™ Femoral Intramedullary (IM) Nail System permits an antegrade intramedullary approach for fixation of fractures of the femur. The DISTALOCK™ Femoral Intramedullary Nail is a closed section, cannulated, thick walled, mirror finished, curved intramedullary fixation device containing two proximal and two distal holes to accept locking screws which thread transversely though the proximal and distal third of the femur. The DISTALOCK™ Femoral IM Nail System includes the following components: DISTALOCK™ IM standard entry and trochanteric nails, locking screws and end caps made of titanium allov. The DISTALOCK™ Ancillary Instrumentation includes the DISTALOCK™ drill, the DISTALOCK™ Control System (which includes the control box, drill motor assembly and hand controller) and other disposable and reusable instruments.
The provided document is a 510(k) summary for the DISTALOCK™ Femoral Intramedullary Nail System, which is a medical device. This type of document is relevant for demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving a device meets those criteria in the way a diagnostic AI/ML device submission would.
Therefore, many of the requested categories (such as sample size, ground truth, expert qualifications, MRMC studies, standalone performance, and training set information) are not applicable to this type of device and submission.
However, I can extract the information that is present:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Acceptance Criteria Category | Description | Reported Device Performance | Study Type |
|---|---|---|---|
| Biocompatibility | Selection of materials demonstrating appropriate levels of biocompatibility. | Achieved through selection of appropriate materials. | Biological Safety testing |
| Human Factors | Acceptable human factors features in device functioning and labeling. | Concluded as acceptable. | Human Factor Analysis |
| Performance & Safety | Device performs as intended, is safe, and is substantially equivalent to predicate device. | Bench testing and cadaver testing demonstrated performance and safety, confirming substantial equivalence. | Bench Testing, Cadaver Testing |
| Risk Assessment | No new risks or efficacy concerns compared to the predicate device. | Confirmed no new questions of safety or effectiveness. | Risk Assessment |
| Design Verification & Validation | Device system as modified is as safe as the predicate device. | Results demonstrate the modified device is as safe as the predicate. | Design Verification & Validation Testing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical medical device (intramedullary nail), and the "test set" would refer to physical devices or cadavers, not a data set in the AI/ML sense. The document does not specify sample sizes for bench or cadaver testing. Data provenance such as country of origin or retrospective/prospective is not relevant in this context.
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. No "ground truth" using human experts in the context of diagnostic performance is described for this physical device. The testing involved engineering, material science, and possibly anatomical cadaver studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations of data, such as images, which is not the primary focus of this device's testing.
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/ML diagnostic device, so MRMC studies and human reader improvement with AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context would be defined by engineering specifications, material science standards, and established biomechanical principles for orthopedic fixation. For cadaver testing, the "ground truth" would be the successful mechanical fixation of fractures as assessed by engineers or orthopedic experts in a controlled setting, potentially comparing against the predicate device's performance. The document doesn't explicitly detail the "type" of ground truth but implies it's based on engineering and biomechanical performance.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this physical device.
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(185 days)
The Revolution Femoral Intramedullary Nail System is indicated for use in orthopaedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.
The Revolution Femoral Intramedullary Nail System permits an antegrade intramedullary approach for fixation of fractures of the femur. The Revolution Femoral Intramedullary Nail is a closed section, cannulated, thick walled, mirror finished, curved intramedullary fixation device containing two proximal and two distal holes to accept locking screws which thread transversely though the proximal and distal third of the femur. The Nail is available in a variety of diameters and lengths.
Locking screws are also included as a component of the Nail system. The locking screws are designed to reduce the likelihood of shortening and rotation of femoral fractures. The locking screws are available in a single diameter and a variety of lengths.
The ancillary instrumentation include standard orthopedic instruments for accessing the femoral medullary canal, preparing the bone for placement and installation of the intramedullary nail and locking screws, and removal of the intramedullary nail and screws, if required.
Here's an analysis of the provided text regarding the Revolution Femoral Intramedullary Nail System, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Premarket Notification for a medical device. It does not contain the detailed study information typically found for AI/ML-based devices regarding acceptance criteria, sample sizes, expert ground truth, or MRMC studies. The device, an intramedullary nail system, is a traditional orthopedic implant, not an AI/ML-powered diagnostic or treatment planning system. Therefore, the questions related to AI/ML device evaluation are not applicable to this submission.
The "studies" described are non-clinical, meaning they involve engineering testing rather than human clinical trials or data analysis.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of quantitative acceptance criteria or detailed reported device performance metrics in the format usually expected for AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, it makes a general statement:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and performance as intended | "Results of testing confirm that the Revolution Femoral Intramedullary Nail System reliably performs as intended." |
| Substantial equivalence to predicate devices | "Revolution Femoral Intramedullary Nail System is substantially equivalent to the currently marketed predicate devices with respect to intended use, materials and technological characteristics." |
| No new questions of safety or effectiveness | "No new questions of safety or effectiveness have been raised." |
| Compliance with non-clinical testing requirements | "The safety and performance... have been substantiated through non-clinical testing." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided for this type of device submission. The device is a physical implant. The "test set" would refer to the number of nails or components tested in non-clinical (e.g., mechanical) studies, which is not detailed here. There is no "data provenance" in the context of clinical images or patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device. There is no "ground truth" established by clinical experts in the context of device performance in non-clinical testing.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device. Adjudication methods are relevant for subjective interpretations of clinical data, which is not the subject of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
This information is not applicable to this device. An MRMC study is relevant for AI-assisted diagnostic or interpretation systems. This is a physical orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not applicable to this device. A standalone study refers to the performance of an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Revolution Femoral Intramedullary Nail System's performance is implicitly defined by engineering specifications, material properties, and comparison to legally marketed predicate devices. The testing would likely involve mechanical stress tests, fatigue tests, and material characterization to ensure the device meets predefined physical and performance standards comparable to existing implants. It is not based on expert consensus, pathology, or outcomes data in the sense of clinical study results for a diagnostic or predictive algorithm.
8. The Sample Size for the Training Set
This information is not applicable to this device. There is no "training set" in the context of machine learning for a physical orthopedic implant.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable to this device.
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