(130 days)
TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue .
The TAPESTRY® Biointegrative Implant device is composed of collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. TAPESTRY® is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. TAPESTRY® is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 25mm to 70mm x 50mm. TAPESTRY® is available with or without a co-packaged polyethylene Insertion Sleeve, which is used to maintain the implant's orientation and to facilitate easy application onto the tendon. The Insertion Sleeve is discarded after use and not implanted. TAPESTRY® is designed for stand-alone use. At the discretion of the surgeon, TAPESTRY® may be hydrated with sterile isotonic solution.
The provided text describes a 510(k) premarket notification for the TAPESTRY® Biointegrative Implant, a Class II surgical mesh. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for an AI-powered diagnostic device with specific acceptance criteria and performance metrics typically associated with AI.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/diagnostic device.
The text discusses:
- The device (TAPESTRY® Biointegrative Implant) and its intended use (management and protection of tendon injuries).
- Comparison of technological characteristics with a predicate device (Rotation Medical Inc. Collagen Tendon Sheet).
- Preclinical studies (in vivo animal study) to evaluate tissue response, systemic toxicity, and device resorption, not performance metrics of an AI diagnostic tool.
- Biocompatibility testing against ISO 10993-1 standards.
It is a submission for a surgical implant, not an AI-powered diagnostic tool. Hence, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" as they apply to diagnostic accuracy (e.g., sensitivity, specificity, AUC) for an AI model are not present in this document. There's no mention of:
- A table of acceptance criteria with reported device performance for an AI/diagnostic task.
- Sample sizes for test sets in an AI context.
- Number of experts or their qualifications for ground truth.
- Adjudication methods for test sets.
- MRMC studies or effect sizes for human reader improvement.
- Standalone AI performance.
- Type of ground truth (e.g., pathology, outcomes data in an AI context).
- Sample size for a training set or how its ground truth was established.
In summary, this document is entirely unrelated to the type of AI/diagnostic device evaluation you are asking about.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.