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Properly used, this system is interior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The PREMIER™ Anterior Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The PREMIER™ Anterior Cervical Plate System features a sliding washer that covers the heads of the bone screws to prevent screw back-out. The sliding washer is fixed into place with a set screw. The sliding washer and set screw come pre-assembled to the plate. Associated instruments are available to facilitate the implantation of the device.

The PREMIER™ Anterior Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136 or ISO 5832-3. This material is not compatible with other metal alloys. Do not use any of the PREMIER™ Anterior Cervical Plate System components with the components from any other system or manufacturer. MEDTRONIC SOFAMOR DANEK expressly warrants that these devices are fabricated from the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

The provided text is a 510(k) summary for the PREMIER™ Anterior Cervical Plate System. It describes the device, its indications for use, and a substantial equivalence claim to itself. However, it does not contain any information about acceptance criteria, device performance testing, clinical studies, sample sizes, ground truth establishment, or expert reviews.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document.

The document only states:

• Device Name: PREMIER™ Anterior Cervical Plate System
• Description: A system of bone plates and screws for anterior interbody screw fixation of the cervical spine, featuring a sliding washer to prevent screw back-out. Made from titanium alloy.
• Indications for Use: Temporary stabilization of the anterior spine during cervical spinal fusions in patients with degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, and/or failed previous fusions.
• Substantial Equivalence: Claimed to be substantially equivalent to itself, implying it's a modification or resubmission of a previously cleared device, or that the previous predicate was also this same device. This typically means performance testing against specific criteria would have been done for the original device or is considered sufficiently similar to not warrant new, extensive clinical trials for this resubmission.

To answer your specific questions, information regarding performance testing and acceptance criteria would typically be found in a separate section of a 510(k) submission, not usually included in the public 510(k) summary provided here.

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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.

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.

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