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The Opus Magnum Implant is intended for fixation of tendon to bone using a "silky" II Polydek® non-absorbable braided polyester or FiberWire® braided polyblend USP size #2 suture for the indications listed below. The Magnum system consists of a fixation device pre-loaded with suture snares in an inserter handle. The Magnum Implant is a knotless fixation device whereby surgical knots are not necessary for fixation. Bone stock must be adequate to allow proper placement.

Indications:

(1) Shoulder 1) Rotator Cuff Repair

The Magnum system consists of a fixation device pre-loaded with suture snares in an inserter handle. The Magnum Implant is a knotless fixation device whereby surgical knots are not necessary for fixation.

This document is a 510(k) clearance letter from the FDA for the Opus Magnum™ Implant System. It does not contain any information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, or study methodologies (like MRMC or standalone performance studies).

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. There is no performance data, clinical study information, or details of a study proving the device meets acceptance criteria provided in this document.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the provided text.

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