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DynaMatrix™ is intended for use to aid in guided tissue regeneration and guided bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain and prevent migration of graft material. The device is provided sterile and intended for one-time use.

DynaMatrix™ is a bioabsorbable, extracellular collagen membrane matrix that is identical to the predicate SURGISIS® Periodontal Membrane (K010952), also manufactured by Cook Biotech Incorporated. This premarket notification is being submitted to expand the indications for use and to introduce a new product name.

The provided text is a 510(k) summary for a medical device called DynaMatrix™. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a comparative study with a strict set of performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Instead, the submission focuses on establishing substantial equivalence based on:

• Device Description: DynaMatrix™ is described as a bioabsorbable, extracellular collagen membrane matrix that is identical to a previously cleared predicate device, SURGISIS® Periodontal Membrane (K010952).
• Intended Use: The intended uses are provided, which expand upon those of the predicate device while maintaining the same design principles. These uses include guided tissue regeneration, guided bone regeneration, healing of periodontal defects, gingival augmentation, maintaining/enhancing alveolar ridges, and containing/preventing graft material migration.
• Equivalence to Marketed Device: The core of the 510(k) is the claim that DynaMatrix™ is substantially equivalent in indications and design principles to existing predicate devices. This implies that the safety and effectiveness are established by the predicate devices, rather than through new performance studies against specific acceptance criteria.

In summary, the document states that the device is substantially equivalent to a predicate device, which allows it to be marketed. It does not provide the details of a study with acceptance criteria and measured performance as requested.

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