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The indications for use for the modified devices described in this submission are the same as those for the previously cleared SWIFT Anterior Cervical Plate System. The indications are as follows:

The SWIFT™ Plus Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as pain with degeneration of the disc discogenic confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.

The SWIFT Plus Anterior Cervical Plate System consists of an assortment of plates and screws.

The SWIFT Plus Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

It looks like the text provided is a 510(k) summary for a medical device called the SWIFT™ Plus Anterior Cervical Plate System. This document outlines the device description, intended use, and materials.

However, the provided text does not contain any information regarding acceptance criteria, device performance metrics (numerical or otherwise), sample sizes for testing or training, data provenance, expert information, adjudication methods, or different types of studies (MRMC, standalone).

The "PERFORMANCE DATA:" section is present, but it only states "Performance data were submitted to characterize the SWIFT Plus Anterior Cervical Plate System." without providing any specifics. Medical device submissions like 510(k)s typically include detailed performance data, but this specific excerpt is lacking that information.

Therefore, I cannot fulfill your request for the tables and detailed information about acceptance criteria and study designs based solely on the text provided. To answer your questions, I would need a section that explicitly details the performance testing results, acceptance criteria, test methodologies, and clinical study information.

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