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The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The ConMed Linvatec Paladin Suture Anchor is a bioabsorbable screw-in suture anchor that is preloaded on a disposable inserter device with two nonabsorbable, braided, polyethylene sutures. The ConMed Linvatec Paladin Suture Anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The copolymer is inert and non-collagenous through the absorption process. The device will be available in 5.0mm - 6.5mm in size with colorant D&C violet #2.

This document is a 510(k) summary for a medical device called the "ConMed Linvatec Paladin, Preloaded with two #2 Hi-Fi® Sutures." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria through a clinical study.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets them, as it is related to a clinical performance study. The document focuses on showing substantial equivalence based on design, materials, intended use, and technical characteristics to previously cleared devices (K042966 and K053561).

To elaborate on why the requested information is not present:

• Acceptance Criteria & Reported Device Performance: This document does not establish new performance acceptance criteria for clinical outcomes. Instead, it argues that the new device's technical characteristics and intended use are similar enough to existing cleared devices, implying similar performance.
• Sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set: All these points relate to the design and execution of a clinical performance study, which is not required or presented in a 510(k) submission for substantial equivalence based on the provided text.

The information provided outlines:

• The device name, common name, and classification.
• The predicate devices used for comparison.
• A description of the device (bioabsorbable screw-in suture anchor made from Self-Reinforced (96L/4D) PLA Copolymer, preloaded with two nonabsorbable sutures).
• Its intended use (reattaching soft tissue to bone in arthroscopic or open surgical procedures).
• A statement of substantial equivalence to the predicate devices in design, manufacturing, materials, intended use, principles of operation, and technical characteristics.

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