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510(k) Data Aggregation
(258 days)
The Versalock Periprosthetic Femur Plates is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the femur, including:
- · Periprosthetic fractures
- Comminuted fractures
- Supracondylar fractures
- Trochanteric fractures
- · Fractures in normal and osteopenic bone
- Non-unions and Malunions.
The purpose of this submission is to obtain marketing clearance for the Versalock Periprosthetic Femur Plates System which is composed of plates, screws and, a cerclage cable and related device.
The subject devices are designed for the treatment of femur fractures, particularly, periprosthetic femur fractures. The plates are available in the following design-types to be used according to the fracture location: Proximal and Distal Femur Periprosthetic Plates, Trochanteric Periprosthetic Plates and Condylar Femur Plates.
The plates are for use with the subject device screws to fix them to the bone. The following compatible screws are available for this purpose: Cortical Screws, Versalock Variable Angle Locking Screws, Versalock Variable Angle Screws, Versalock Variable Angle Cannulated Screws and Versalock Variable Angle Periprosthetic Screw. The Trochanteric Plate Fastening Screw is to connect one plate to another when a Trochanteric Periprosthetic Plates is used. The Versalock Spacer Screw is threaded into the plate hole prior to plate insertion to act as a spacer providing no contact between the plate and the bone surface.
The Gama Cable is a cerclage cable indicated to provide fixation and/or stabilization of the bone when it is not possible the usage of any screw. The Gama Cable related devices are the Gama Cable Lock and the Versalock Connector Screw. During the installation of the Gama Cable Lock is crimped to lock the movement of the cable, maintaining the tensioning applied while the Versalock Connector Screw , which holds the cable to the plate and set the proper cable routing position. The Gama Cable and related devices are used in conjunction with the Proximal or Distal Femur Periprosthetic Plates, or Condylar Femur Plates
The subject devices are made of made of titanium alloy (ASTM F136) with exception of the Gama Cable Lock which it is made of commercially pure titanium (ASTM F67). All the subject devices are coloredanodized.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.
The provided document is a 510(k) summary for the Versalock Periprosthetic Femur Plates System - GMReis. This document outlines the regulatory submission for a medical device and, as such, does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Therefore, many of the requested sections related to clinical studies, sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance will not be available in this document.
Here's a breakdown of the information that can be extracted or inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of explicit acceptance criteria with specific numerical targets. Instead, it states that performance was demonstrated through mechanical testing according to established ASTM standards. The "performance" in this context refers to the device's mechanical integrity and functionality, rather than a clinical outcome.
| Acceptance Criteria (Standard Adherence) | Reported Device Performance (Demonstrated Adherence) |
|---|---|
| Adherence to ASTM F382 for plates (static and dynamic testing) | Performance of subject device plates was demonstrated through static and dynamic testing according to ASTM F382. |
| Adherence to ASTM F543 for screws (mechanical testing) | Performance of subject screws was demonstrated through mechanical testing according to ASTM F543. |
| Adherence to ASTM F2180 for cerclage cable (mechanical testing) | Performance of the cerclage cable was demonstrated through mechanical testing according to ASTM F2180. |
| System construct testing for cerclage cable | Performance of the cerclage cable was demonstrated through system construct testing. |
| Biocompatibility established via risk assessment following ISO 10993-1 | Biocompatibility was established through a risk assessment following ISO 10993-1. |
| Equivalence in indications for use, design principles, materials, physical dimensions, and sterilization method to predicate device | The subject and predicate devices have equivalent intended use and equivalent technological characteristics. The subject and predicate devices are all manufactured from identical or equivalent materials and share equivalent design characteristics. The subject and predicate devices encompass equivalent physical dimensions and are to be sterilized by identical or equivalent method. |
| No new issues of safety or efficacy raised by technological differences | Any difference in the technological characteristics do not raise new issues of safety or efficacy. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This document describes mechanical testing of physical device components, not a study involving patient data or a "test set" in the context of AI/diagnostic device performance. The sample sizes would refer to the number of plates, screws, and cables tested in the lab. This specific number is not provided, though it would typically be defined by the ASTM standards.
- Data Provenance: Not applicable. The data comes from internal mechanical testing, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically defined for diagnostic AI/clinical studies (e.g., expert consensus on images, pathology results) is not relevant to this type of device submission. The "ground truth" here is the adherence to mechanical engineering standards, which is determined by test procedures and measurement against those standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the reasons stated above.
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:
- No. This is not a diagnostic AI device, and therefore, an MRMC study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical implant device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance (mechanical testing), the "ground truth" is adherence to established engineering standards (ASTM F382, ASTM F543, ASTM F2180) and a risk assessment based on biocompatibility standards (ISO 10993-1).
- For the substantial equivalence claim, the "ground truth" is the characteristics of the predicate device, which the subject device is compared against.
8. The sample size for the training set:
- Not applicable. There is no training set mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set.
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(262 days)
Fixation of fractures, osteotomies, and non-unions of the scapula, olecranon, humerus, radius, ulna, distal tibia, and fibula, particularly in osteopenic bone
Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed with bone screws. Bone plates and bone screws are implants. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The LOQTEQ® Small Fragment Set consists of:
- LOQTEQ® Straight Plate 3.5
- LOQTEQ® Reconstruction Plate 3.5
- LOQTEQ® 1/3 Tubular Plate 3.5
- LOQTEQ® Cortical Screw 3.5, T15, self-tapping
- LOQTEQ® Cortical Screw 3.5, small head T15, self-tapping
- Cortical Screw 3.5, self-tapping
- Cortical Screw 3.5, small head, self-tapping
- Set of Instruments, Small Fragment Set
The aap LOQTEQ Small Fragment Set is a medical device used for the internal fixation of bone fractures and other bone injuries. The acceptance criteria and the study proving the device meets these criteria are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by ASTM F382) | Reported Device Performance |
|---|---|
| Mechanical performance, specifically implant fatigue tests with progressive loadings (worst-case scenario for clinical use) | Substantial equivalence to predicate devices (Small Fragment Locking Compression Plate (LCP®) System, Synthes (USA), and Zimmer® Small Fragment Universal Locking System) in mechanical performance. |
| Static and dynamic 4-Point bending tests | Substantial equivalence to predicate devices in mechanical performance. |
| Compliance with pre-defined requirements for safety and effectiveness | The device is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses. |
2. Sample Size Used for the Test Set and Data Provenance
The information provided does not specify a distinct "test set" in the context of typical AI/ML studies. Instead, the performance data discussed is based on non-clinical mechanical tests. Therefore, details like "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the same way they would be for studies involving human subject data or AI model validation. The testing was conducted on the device components themselves, following established ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for this device's performance is established by mechanical testing according to industry standards (ASTM F382), not by expert human interpretation of data in the way an AI model's output would be validated.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" involves physical device testing against established mechanical standards, not human expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the premarket notification (510(k)) for a medical device (bone plates and screws), not an AI/ML diagnostic or prognostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed or discussed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No. This device is a physical implant, not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance evaluated is the mechanical integrity and functionality of the physical device components.
7. The Type of Ground Truth Used
The "ground truth" used for this device is based on established mechanical performance standards and material properties defined by ASTM (American Society for Testing and Materials) standards, specifically ASTM F382. The device's performance is compared against these standards and against the mechanical performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" in the context of AI/ML or statistical modeling. The document describes the mechanical testing of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of device submission. The "ground truth" for the device's performance is derived from compliance with specified mechanical testing protocols and comparison to predicate devices, as described in point 7.
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(226 days)
The Mahe Fixation Plate and Screw System is indicated for fracture fixation and joint fusion in the pelvis, small bones and long bones. Examples include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle hand and middle foot bones; and treatment of the calcaneus. The system is indicated for use in adult patients. All implants are intended for single use only.
Mahe Fixation Plate and Screw System consists of various shape and sizes plates featuring compression and locking or non-locking holes, fullthreaded-cortical, short threaded-cancellous, locking or non-locking, cannulated, self-tapping or non-self-tapping screws, compression and dynamic screws, implantable K-wires, pins, washers, and appropriate instrumentation. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The plates and screws are fabricated from stainless steel and titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in following models available: Tubular Plates, Reconstruction Plates, Cloverleaf Plates, Calcaneus Plates, Anatomical Plates, Clavicula Hook Plates, Small Fragment, Locking Plates, and DHSP/DCSP Screw Plates. The thickness of the plates varies from 1.2mm to 10mm; the length varies from 26mm to 317mm; and the number of the holes varies from 2 to 22. The screw implants are in three different diameter sizes (2.7mm, 3.5mm, and 4.0mm) and the K-wire implants are in various lengths (from 70mm to 310mm) and diameter sizes (from 0.8 to 3mm) available. The system is sold non-sterile, the products have to be sterilized prior to use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance (Summary) |
|---|---|
| ISO 5838 "Implants for surgery - Skeletal pins and wires" | The device demonstrates compliant performance with this standard. |
| ASTM F366-04 "Standard Specification for Fixation Pins and Wires" | The device demonstrates compliant performance with this standard. |
| ASTM F0543-07 "Standard Specification and Test Methods for Metallic Medical Bone Screws" | The device demonstrates compliant performance with this standard. |
| ASTM F 382-99 "Standard Specification and Test Method for Metallic Bone Plates" | The device demonstrates compliant performance with this standard. |
| Biocompatibility | Biocompatibility tests were performed, indicating no new safety concerns. |
| Mechanical Properties (compared to predicate devices) | Functional and mechanical testing demonstrates comparable mechanical properties to the predicate devices. |
| Safety & Effectiveness | The device is deemed safe and effective for its intended use, performing as well as or better than predicate devices, and uses well-researched materials. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance for the non-clinical performance data. It mentions that "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures," suggesting real-world data from Europe, but this is not a formal "test set" in the context of a controlled study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The data presented is primarily non-clinical "performance data" such as testing against industry standards, biocompatibility, and mechanical properties, rather than data requiring expert-established ground truth for a clinical test set.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are non-clinical performance data (e.g., mechanical testing against standards).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance data and a comparison of technological characteristics to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a medical implant (plates, screws, and pins), not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical performance data, the "ground truth" is established by:
- Industry Standards: Compliance with established international and national standards (ISO 5838, ASTM F366-04, ASTM F0543-07, ASTM F 382-99).
- Predicate Device Performance: Direct comparison of functional and mechanical properties against legally marketed predicate devices.
- Biocompatibility Testing: Results of established biocompatibility tests.
There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus) in the context of a clinical study for this 510(k) summary.
8. The Sample Size for the Training Set
This is not applicable as the device is a medical implant, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a medical implant, not an AI or algorithm that requires a training set.
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