(84 days)
The PREMIER™ Anterior Cervical Plate 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 during the development of cervical spinal fusions 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
The PREMIER™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (slide washers and set screws are preassembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and may be supplied either sterile or non-sterile.
The provided text describes a 510(k) submission for the PREMIER™ Anterior Cervical Plate System, focusing on its substantial equivalence to previously marketed devices. This type of submission relies on demonstrating equivalence through comparison to legally marketed predicate devices, often using mechanical test data, rather than clinical studies with explicit acceptance criteria related to device performance in an AI or diagnostic context.
Therefore, the sections of your request related to AI/diagnostic performance, such as sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, are not applicable to the information provided in the K992110 510(k) summary.
Acceptance Criteria and Device Performance (Based on the provided text):
The primary acceptance criteria for a 510(k) submission are related to demonstrating substantial equivalence to a predicate device. The performance is assessed through mechanical testing to show the device functions similarly and safely.
| Acceptance Criteria Category | Specific Criteria (Implicit for 510(k)) | Reported Device Performance (Summary from text) |
|---|---|---|
| Material Composition | Device materials are biocompatible and meet established standards. | Components made from titanium alloy as described by ASTM F-136. |
| Mechanical Strength & Durability | Device demonstrates similar mechanical properties (e.g., strength, fatigue resistance) to predicate devices. | "Mechanical test data were provided in support of this notification." (Specific metrics like tensile strength, torsional strength, fatigue life are not detailed in this summary.) |
| Intended Use & Indications | Device's intended use and indications for use are within the scope of or comparable to predicate devices. | Intended for anterior interbody screw fixation of the cervical spine. Indicated for temporary stabilization during cervical spinal fusions in patients with degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, and/or failed previous fusions. (Matches predicate device indications implicitly). |
| Safety & Effectiveness | Device is as safe and effective as the predicate device(s). | Demonstrated substantial equivalence to commercially available cervical plating systems, implying comparable safety and effectiveness where no new safety concerns arise. |
Irrelevant/Not Applicable Information for this 510(k) Summary:
The following requested information is not relevant to a 510(k) submission for a non-AI medical device and is therefore not present in the provided text:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for mechanical testing or a non-clinical 510(k) submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/diagnostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/diagnostic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of device performance as one might for a diagnostic claim. Ground truth for mechanical testing would involve engineering standards and measurements.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.