(113 days)
The NEO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusions with degencrative disc disease (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal cord stenosis; deformity or curvatures (i.e. kyphosis. lordosis or scoliosis); tumors; pseudarthrosis; and / or failed previous fusions.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The NEO Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates. screws and screw locking tabs. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The NEO ACPS components will be supplied clean and "NON-STERILE".
Here's an analysis of the provided text regarding the Life Spine, LLC NEOTM Cervical Plating System, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a formal clinical study with strict acceptance criteria for a novel device. Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly detailed in this type of document. The study described is mechanical testing, not a clinical study.
Acceptance Criteria and Device Performance (Based on provided text)
The document primarily discusses mechanical testing to demonstrate substantial equivalence, not clinical performance metrics or specific acceptance criteria for diagnostic accuracy (which would be relevant for devices that process medical images or data).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static Strength (comparable) | Comparable to predicate devices |
| Fatigue Strength (comparable) | Comparable to predicate devices |
Study Details (Based on provided text):
Since this is a 510(k) summary for a spinal implant, the "study" referred to is mechanical bench testing, not a clinical trial evaluating human performance or AI accuracy. Therefore, many of your requested fields are not applicable or cannot be extracted from this document.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for the mechanical testing.
- Data Provenance: Not applicable in the context of mechanical testing of physical implants. The materials are specified as implant grade titanium alloy 6A1-4V ELI per ASTM F-136.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is defined by established engineering standards and measurements, not by expert medical consensus.
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Adjudication method for the test set: Not applicable for mechanical testing.
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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 document is for a spinal implant, not an AI-powered diagnostic device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a spinal implant.
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The type of ground truth used: For the mechanical testing, the ground truth is established physical properties and performance benchmarks derived from standardized testing methods (e.g., ASTM standards) and comparison to the predicate devices.
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The sample size for the training set: Not applicable. This is not an AI/ML device, and no training set is mentioned.
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How the ground truth for the training set was established: Not applicable.
Summary of Device and Approval:
The Life Spine, LLC NEOTM Anterior Cervical Plate System is a medical device for temporary stabilization of the anterior spine from C2 to T1 during cervical spinal fusions. It is indicated for various conditions including degenerative disc disease, trauma, and tumors. The device consists of titanium alloy plates, screws, and locking tabs.
The 510(k) submission (K040844) demonstrated substantial equivalence to two predicate devices: Interpore Cross International Anterior Cervical Plate System (K002592) and Howmedica Osteonics Corporation Reflex Anterior Cervical Plate System (K031702). The primary evidence for this equivalence was mechanical testing (static and fatigue strength) which showed comparable properties to the predicate devices. The FDA reviewed the submission and determined that the device was substantially equivalent, allowing it to be marketed.
§ 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.