(42 days)
The Cervical Plating system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Deqenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.
When used and connected to a Life Spine cervical interbody, the Cervical Plating System can only be used to treat cervical degenerative disc disease.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
The Life Spine Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.
The Life Spine Cervical Plating System implant components are made from titanium alloy described by ASTM F136. Stainless steel and titanium implant components must not be used together in a construct.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the components with components from any other system or manufacturer. The Cervical Plating System components should never be reused under any circumstances.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cervical Plating System, specifically noting what information is available and what is not present in the given document.
It's important to understand that the provided text is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report for AI/software devices. Therefore, many of your requested items, particularly those related to AI algorithm performance, human expert evaluation, and training data specifics, will not be found as this is a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured?) | Reported Device Performance (Results) |
|---|---|
| Mechanical Performance: | |
| Dynamic Axial Compression Bending (according to ASTM F1717) | Meets ASTM F1717 standards (Implied by "Performance Data" and "demonstrates the substantial equivalency") |
| Static Axial Compression Bending (according to ASTM F1717) | Meets ASTM F1717 standards (Implied by "Performance Data" and "demonstrates the substantial equivalency") |
| Static Torsion (according to ASTM F1717) | Meets ASTM F1717 standards (Implied by "Performance Data" and "demonstrates the substantial equivalency") |
| Material: | |
| Titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 | The device material is titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 (stated explicitly) |
| Indications for Use Equivalence: | |
| Similar indications for use as predicate devices | Substantially equivalent to predicate devices (K152282, K103423, K190227) in indications (stated explicitly) |
| Design Equivalence: | |
| Similar design as predicate devices | Substantially equivalent to predicate devices in design (stated explicitly) |
| Function Equivalence: | |
| Similar function as predicate devices | Substantially equivalent to predicate devices in function (stated explicitly) |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. For mechanical testing of physical implants, "sample size" would refer to the number of implants tested per configuration. The document does not specify these details or data provenance beyond stating that testing was done according to ASTM F1717.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/provided. This device is a physical implant, not an AI/software device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is the physical properties and mechanical performance determined through standardized experimental testing, not human expert consensus on medical images.
4. Adjudication method for the test set
This information is not applicable/provided. No adjudication method is mentioned as this is not a study involving human interpretation of data for medical diagnosis.
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
This information is not applicable/provided. This document concerns a physical medical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be part of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This document concerns a physical medical implant, not an algorithm, so standalone algorithm performance is irrelevant.
7. The type of ground truth used
The "ground truth" for this device's performance is established through standardized mechanical testing according to ASTM F1717. This provides quantitative data on the device's physical properties and performance under various loads, which is compared against established engineering standards and the performance of predicate devices.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" in the context of this device as it is a physical implant, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable/provided. As there is no training set mentioned, the method of establishing its ground truth is also not relevant.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.