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Maxon** and Maxon CV** sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue, where growth is expected to occur, and in peripheral vascular tissue.

Maxon** and Maxon CV** monofilament synthetic absorbable sutures (clear or green) are prepared from a copolymer of glycolic acid and trimethylene carbonate. The sutures are sterile, inert, noncollagenous and nonantigenic.

The provided text is a 510(k) summary for a surgical suture and does not contain information about acceptance criteria or specific study results that would typically be reported for a device meeting acceptance criteria. Instead, it focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request to describe acceptance criteria and associated study results. The document does not provide the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information about a standalone (algorithm only) performance study.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

This document primarily serves to:

• Identify the device (Maxon Synthetic, Absorbable Surgical Suture).
• State its intended use.
• Establish substantial equivalence to predicate devices for regulatory clearance.
• Outline regulatory classifications and requirements for its marketing.

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