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Found 2 results
510(k) Data Aggregation
(65 days)
Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT
Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical
The SLIM LOC Anterior Cervical Plate System and SKYLINE Anterior Cervical Plate System are indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, traumatic kyphosis or lordosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems and the EAGLE Plus Micro Anterior Cervical Plate System are also indicated for treatment of spinal stenosis.
The PULSE Anterior Cervical Plate System is indication of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The SWIFT™ Plus Anterior Cervical Plate System is manufactured from titanium alloy and consists of segmented plates that allow up to 2mm of controlled graft settling between each of the segments. The plates are available with two to six screw hole pairs, in various lengths and two configurations, discectomy and corpectomy. The screws are available in various sizes and screw-tip geometries. A graft screw is available for use in the corpectomy plates and can be used in the SWIFT Plus system.
The EAGLE™ Plus Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available with two to six screw hole pairs in various lengths. The screws are available in various sizes and screw-tip geometries.
The EAGLE Plus Micro Anterior Cervical Plate System is designed for use alone or adjacent to a previously implanted anterior cervical plate. The EAGLE Plus Micro Anterior Cervical Plate System consists of an assortment of titanium alloy single-level plates and uses EAGLE Plus screws. The anterior cervical plates are available in various lengths to accommodate varying patient anatomy.
The DePuy PULSE™ Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to four screw-hole pairs in various lengths. The screws are available in various sizes and screw-tip geometries, including self drilling and blunt tip to create a semi-constrained construct.
The SKYLINE" Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to six screw hole pairs in various lengths. The screws are available in various sizes and screwtip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.
The SLIM LOC® Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available in lengths ranging from 22-111mm in configurations with 2, 3, 4, 5 or 6 pairs of screw holes. The SLIMLOC screws are available in 4.5mm in diameter and are available as self-drilling in even length sizes ranging from 10-18mm or self-tapping in even length sizes ranging from 10-26mm. Larger diameter screws (4.8mm) are available in 12, 14, and 16mm lengths.
The UNIPLATE® and UNIPLATE® 2 Anterior Cervical Plate Systems consist of an assortment of titanium alloy plates and screws. The anterior cervical plates are available in various lengths to accommodate one to two segments of fixation. The screws are available in various sizes and tip geometries.
Here's an analysis of the provided text regarding the acceptance criteria and study for the medical devices, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from referenced standards) | Reported Device Performance |
|---|---|---|
| MR Safety: Heating | Defined by ASTM F2182-11a: "Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging" | Not explicitly detailed, but stated that testing was conducted and results supported MR conditional labeling. |
| MR Safety: Torque | Defined by ASTM F2213-06: "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment" | Not explicitly detailed, but stated that testing was conducted and results supported MR conditional labeling. |
| MR Safety: Displacement | Defined by ASTM F2052-15: "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment" | Not explicitly detailed, but stated that testing was conducted and results supported MR conditional labeling. |
| MR Safety: Image Artifacts | Defined by ASTM F2119-07: "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants" | Not explicitly detailed, but stated that testing was conducted and results supported MR conditional labeling. |
Study Details for Device Acceptance:
This submission is for MR Conditional Labeling for existing devices. The primary purpose is to demonstrate that the devices are safe for use in an MRI environment under specific conditions.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of devices or components tested. It generally refers to "tests and analyses were conducted."
- Data Provenance: The data is from non-clinical testing (bench testing) performed by the manufacturer (Medos International, SARL). The location of the testing is not explicitly stated, but the manufacturer is based in Switzerland. This is prospective testing, specifically conducted to support the MR conditional claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth for MR compatibility is established by adherence to recognized international standards (ASTM).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The assessment relies on objective measurements against the criteria defined by the ASTM standards, rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This submission does not involve a multi-reader multi-case comparative effectiveness study. It is focused on the inherent MR compatibility properties of the devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: Yes, in a sense. The "performance" being evaluated is the physical interaction of the medical device with an MRI system. This is an objective measurement of the device's physical properties in an MRI environment, without human interpretation or intervention in the measurement process. The results directly reflect the device's inherent characteristics.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth is based on objective physical measurements and adherence to established international standards (ASTM) for MRI safety and compatibility. The FDA Guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, December 11, 2014" also serves as a guiding framework.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. These are physical medical devices, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable.
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(25 days)
SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM
The indications for use for the modified devices described in this submission are the same as those for the previously cleared SWIFT Anterior Cervical Plate System. The indications are as follows:
The SWIFT™ Plus Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as pain with degeneration of the disc discogenic confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
The SWIFT Plus Anterior Cervical Plate System consists of an assortment of plates and screws.
The SWIFT Plus Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
It looks like the text provided is a 510(k) summary for a medical device called the SWIFT™ Plus Anterior Cervical Plate System. This document outlines the device description, intended use, and materials.
However, the provided text does not contain any information regarding acceptance criteria, device performance metrics (numerical or otherwise), sample sizes for testing or training, data provenance, expert information, adjudication methods, or different types of studies (MRMC, standalone).
The "PERFORMANCE DATA:" section is present, but it only states "Performance data were submitted to characterize the SWIFT Plus Anterior Cervical Plate System." without providing any specifics. Medical device submissions like 510(k)s typically include detailed performance data, but this specific excerpt is lacking that information.
Therefore, I cannot fulfill your request for the tables and detailed information about acceptance criteria and study designs based solely on the text provided. To answer your questions, I would need a section that explicitly details the performance testing results, acceptance criteria, test methodologies, and clinical study information.
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