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Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.

It is supplied sterile.

It is intended for one-time use.

Colorado Therapeutics Xenograft Implant is a sterile implant consisting of porcine pericardium. It is glutaraldehyde cross-linked, sterilized by ethylene oxide (EO) and packaged dry with no rinsing or rehydration required. The Colorado Therapeutics proprietary process produces a uniquely thin, dry, and durable xenograft implant, which makes possible an advantageous xenograft product.

The only change in this Special 510(k) Notification is the addition of two sizes: 02x03cm and 04x04cm. These sizes are both outside the 36cm² and 90cm² sizes in K160181. This change represents a notification to the original device, K160181, and changes in dimensions are considered appropriate for review as a Special 510(k).

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the Colorado Therapeutics Xenograft Implant. It is not a study report for an AI/ML algorithm or a diagnostic device. Therefore, the requested information about acceptance criteria for an algorithm, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is not available in this document.

The document discusses a physical medical device (surgical mesh) and its substantial equivalence to a predicate device. The change being reviewed is simply the addition of two new sizes for the existing device.

The relevant section {4} and {5} state:

• "The only change in this Special 510(k) Notification is the addition of two sizes: 02x03cm and 04x04cm. These sizes are both outside the 36cm² and 90cm² sizes in K160181."
• "Clinical Tests Submitted: Not Applicable; no clinical tests are submitted for this 510(k)."

Given this information, I cannot provide the requested details because they pertain to a different type of medical device evaluation (e.g., AI/ML, diagnostic accuracy) than what is described in this 510(k) submission.

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