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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

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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The SKYLINE Anterior Cervical Plate System is 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: instabliity 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 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, trauma, fracture, post-traumatic kvphosis 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 are also indicated for treatment of spinal stenosis.

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 three segments of fixation. The screws are available in various sizes and tip geometries.

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 screw-tip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.

The provided text is a 510(k) summary for anterior cervical plate systems, focusing on demonstrating substantial equivalence to predicate devices, primarily due to a change in sterilization method. It explicitly states that "Performance data is not provided in this submission." Therefore, the document does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or results of MRMC or standalone studies.

This document is a regulatory submission for a medical device that has undergone a change in manufacturing process (sterilization method). The manufacturer is asserting that this change does not alter the fundamental safety or effectiveness of the device, and therefore, extensive new performance studies are not required. Instead, they are relying on the established performance and safety of the previously cleared predicate devices.

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The SKYLINE® Anterior Cervical Plate System is 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 pseudoarthorosis 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 myleopathy.

The SKYLINE® System consists of cervical plates and screws which are terminally sterilized via gamma radiation. Previously, these devices were commercialized as clean, but non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain screws will be packaged in sterile multi-packs for customer convenience.

This document pertains to a 510(k) premarket notification for the SKYLINE® Anterior Cervical Plate System. The core of this submission is about a change in the sterilization method (from non-sterile to terminally sterilized via gamma radiation) for an already cleared device. Therefore, the information provided focuses on the substantial equivalence to the predicate device based on this change, rather than a clinical study evaluating the device's clinical performance against specific acceptance criteria in the conventional sense of a diagnostic or AI-powered device.

As a result, many of the typical acceptance criteria and study details requested for an AI/diagnostic device (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of submission. This 510(k) is primarily concerned with verifying that the change in sterilization does not alter the fundamental safety, efficacy, or performance characteristics of the device, which is demonstrated through a comparison to a predicate device and assessment of manufacturing processes and materials.

Here's a breakdown based on the provided document, addressing the requested points where applicable and explaining why others are not relevant:

1. A table of acceptance criteria and the reported device performance

For this specific 510(k), acceptance criteria are not in the form of diagnostic performance metrics (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are demonstrating substantial equivalence to the predicate device, particularly regarding the change in sterilization. The key "performance" reported is that the device remains functionally identical.

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 not a study assessing diagnostic performance or clinical outcomes in humans that would require a test set of patient data. The "test" here involves demonstrating that the sterilized product is equivalent to the unsterilized predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. There is no "ground truth" establishment in the context of clinical data for this type of submission. The evaluation is based on engineering, materials science, and regulatory compliance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 3.

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 device is a surgical implant, not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. The "ground truth" for this submission revolves around established engineering standards, material specifications (ASTM F-136), and regulatory requirements for medical devices and sterilization methods, rather than clinical patient data. The primary "ground truth" is that the predicate device itself was previously cleared as safe and effective.

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.

Summary of the Study (as described in K103491):

The "study" or justification demonstrating the device meets the (implied) acceptance criteria is a substantial equivalence comparison to a previously cleared predicate device (SKYLINE® Anterior Cervical Plate System, cleared as the Hybrid Anterior Cervical Plate System, K052552).

• Nature of the Study: This is a regulatory submission demonstrating that a modification (change to terminal gamma sterilization) to an existing device (SKYLINE® Anterior Cervical Plate System) does not alter its fundamental safety, efficacy, or performance compared to its predicate.
• Key Argument: The design, materials (ASTM F-136 implant grade titanium alloy), and technology of the plates and screws remain identical to the predicate systems. The intended use also remains unchanged.
• Biocompatibility: The submission states that the sterile devices do not require biocompatibility testing, implying that either the gamma sterilization is a well-understood process for these materials that does not negatively impact biocompatibility or that prior testing for the predicate already covered relevant considerations.
• Conclusion: The submission concludes that the sterile SKYLINE® devices are as safe, as effective, and perform as well as the predicate device, thus establishing substantial equivalence.

In essence, the "study" is a technical and regulatory argument, based on established knowledge of materials and sterilization, rather than a clinical trial with human subjects and diagnostic performance metrics.

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