(61 days)
The White Pearl Preferred Angle Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis
The White Pearl Preferred Angle Anterior Cervical Plate consist of cervical plates, locking caps, bone screws, and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6Al-4V ELI). The White Pearl Preferred Angle Anterior Cervical Plate is intended to provide stabilization of the cervical vertebrae for various indications. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and/or self-drilling bone screws using an anterior approach. Bone screws are available for fixed angle or variable angle implantation. The White Pearl Preferred Angle Anterior Cervical Plate is intended to be removed after solid fusion has occurred.
This document is a 510(k) Pre-Market Notification for a medical device called the "White Pearl Preferred Angle Anterior Cervical Plate." It outlines the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
Acceptance Criteria and Reported Device Performance
This document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance acceptance criteria for a novel device with clinical endpoints like sensitivity or specificity. Instead, the acceptance criteria are based on mechanical performance standards to demonstrate that the new device performs as safely and effectively as existing, legally marketed devices.
| Acceptance Criteria (from predicate comparison) | Reported Device Performance (from non-clinical testing) |
|---|---|
| Intended Use: Device should have similar indications for use as predicate devices. | The White Pearl Preferred Angle Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine (C2 to T1), an adjunct to fusion for indications like degenerative disc disease, spondylolisthesis, trauma, tumors, deformity, pseudarthrosis, failed previous fusion, and spinal stenosis. This matches the general scope and indications often associated with predicate anterior cervical plates. |
| Design: Similar design principles and components (plates, locking caps, bone screws). | Consists of cervical plates, locking caps, bone screws, and instruments. Fixation construct with plates attached to vertebral body using self-tapping/self-drilling bone screws, with options for fixed or variable angle. This aligns with standard anterior cervical plate designs. |
| Materials: Similar biocompatible materials (e.g., titanium alloy). | All implant components are made from Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136, a standard material for such implants. |
| Mechanical Safety and Performance: Device should meet recognized mechanical testing standards. | Static and dynamic compression testing per ASTM F1717 performed. Static torsion testing per ASTM F1717 performed. The results indicated substantial equivalence to predicate devices. |
Study Details:
The provided document describes non-clinical testing to support the substantial equivalence claim.
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Sample Size used for the test set and the data provenance:
- The document does not specify the sample size (number of constructs or units) used for the mechanical "test set." It only mentions the types of tests performed.
- Data provenance is not explicitly stated in terms of country of origin. The tests are described as non-clinical (laboratory-based mechanical testing), not involving patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. Mechanical testing of a medical device does not typically involve expert review to establish "ground truth" in the way clinical studies or diagnostic AI algorithms do. The "ground truth" for mechanical testing is defined by the physical loads and deformation measurements under established ASTM standards (ASTM F1717).
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Adjudication method for the test set:
- This question is not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used in clinical studies or for diagnostic image interpretation where there's variability in expert opinion. For mechanical testing, the results are quantitative measurements against predefined standards.
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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:
- No MRMC comparative effectiveness study was done. This document is for a spinal implant, which is a physical medical device, not a diagnostic imaging AI algorithm. Therefore, "human readers" and "AI assistance" are irrelevant in this context.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
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The type of ground truth used:
- For the non-clinical mechanical testing, the "ground truth" is established by the definitions and requirements of the ASTM F1717 standard for static and dynamic compression and static torsion testing. This standard specifies how to conduct the tests and how to measure the mechanical properties of the device.
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The sample size for the training set:
- Not applicable. This document describes the testing of a physical medical device. There is no concept of a "training set" as would be used for machine learning.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
§ 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.