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The Opus Magnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone for rotator cuff repair.

Opus Magnum™ Anchor with Inserter

The provided text is a 510(k) premarket notification for a medical device called the "Opus Magnum™ Bone Anchor with Inserter." This document establishes substantial equivalence to an existing device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, the information typically found in such a study (like detailed performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods) is not present in the provided text.

The core of this 510(k) is a claim of substantial equivalence to a previously cleared device. This means the manufacturer is asserting that the modified device is as safe and effective as the predicate device, not that it has independently met specific performance criteria through a new clinical or laboratory study in the way a novel device might.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not describe acceptance criteria for a new device's performance, nor does it report specific performance metrics from a study designed to meet those criteria. The submission is based on substantial equivalence.

2. Sample Sizes Used for the Test Set and Data Provenance

Not applicable. No "test set" in the context of device performance evaluation (e.g., a cohort of patients or a set of images) is mentioned because this is a substantial equivalence submission, not a de novo study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth establishment by experts is described as there is no performance study presented.

4. Adjudication Method

Not applicable. No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study is mentioned. The device is a bone anchor, not an AI or imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical bone anchor and inserter, not an algorithm.

7. Type of Ground Truth Used

Not applicable. No ground truth is described.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set or ground truth established for training.

Summary of Provided Information Relevant to Substantial Equivalence:

• Device Name: Opus Magnum™ Bone Anchor with Inserter
• Manufacturer: Opus Medical, Inc.
• Predicate Device: Opus Magnum™ Anchor with Inserter (cleared under 510(k) K012125)
• Reason for 510(k): Proposed modification to the Magnum™ Bone Anchor.
• Claim of Equivalence: The modified Opus Magnum™ is substantially equivalent to the original, with the same intended use, indications for use, and technology.
• Indications for Use: Fixation of soft tissue to bone for rotator cuff repair.

In essence, this 510(k) notification is a regulatory submission for a minor modification to an already approved device, asserting that the change does not alter its safety or effectiveness compared to the previous version. It does not contain the kind of detailed performance study data you would request for a novel device.

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