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The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.

The purpose of this 510(k) is to notify the FDA of a modification to the Opus Magnum® Implant System wherein a new suture, MagnumWire™, will be added as an option to provide convenience to the user. MagnumWire™ is substantially equivalent to FiberWire® USP braided polyester suture size #2 originally cleared under 510(k) 031083. The intended use and indications for use are the same as the predicate device. The addition of the use of MagnumWire™ with the Opus Magnum® Implant System does not alter the fundamental technology of the Opus Magnum® Implant System.

This document is a 510(k) summary for the Opus Magnum® Anchor with Inserter, focusing on a modification to include a new suture, MagnumWire™. The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) is primarily concerned with demonstrating substantial equivalence to a predicate device (the existing Opus Magnum® Implant Set with FiberWire® suture) for the purpose of regulatory clearance, not with presenting performance studies against predefined acceptance criteria for a new AI/software device.

Therefore, I cannot provide the requested information, as it is not present in the provided text.

The document details:

• Manufacturer, contact, and date prepared.
• Device information: Trade Name, Common Name, Classification Name, Classification, and Product Code.
• Substantial Equivalence claim: States the new device (with MagnumWire™) is substantially equivalent to the previously cleared Opus Magnum® Implant Set (with FiberWire®).
• Indications For Use: Rotator cuff repair in the shoulder.
• Reason for 510(k) Notification: To add MagnumWire™ as an option, stating it is substantially equivalent to the previously cleared FiberWire®.
• FDA Clearance Letter: Confirms the device's substantial equivalence and clearance for marketing.

To answer your specific questions, information about acceptance criteria, performance studies, sample sizes, ground truth establishment, expert involvement, or MRMC studies would need to be present in a different section of the 510(k) submission, typically a more detailed performance data section, which is not included in the provided summary.

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The Opus Magnum® Anchor and Instrument Set is intended for the fixation of soft tissue to bone for the following indications: - (1) SHOULDER 1.) Rotator Cuff Repair

The Opus Magnum Instrument Set consists of an Inserter squeeze handle tool with a stainless steel nosepiece. The Instrument Set is supplied non-sterile.

This submission (K030172) does not include a study with acceptance criteria and device performance as described in the request. Instead, it is a 510(k) Premarket Notification for a medical device (Opus Magnum® Instrument Set).

Here's why the requested information cannot be provided from the given document:

• Substantial Equivalence: The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to perform a de novo study with acceptance criteria and a detailed performance evaluation in the way requested for AI/software devices.
• Device Type: The Opus Magnum® Instrument Set is a physical surgical instrument (an "Inserter squeeze handle tool with a stainless steel nosepiece") used for soft tissue to bone fixation. It is not an AI/software device. The questions regarding AI assistance, ground truth establishment, training sets, test sets, expert consensus, etc., are usually applicable to software-as-a-medical-device (SaMD) or AI-powered devices, not mechanical instruments.
• Content of the Document: The provided text primarily focuses on:
  • Identifying the company and contact.
  • Describing the device and its intended use (fixation of soft tissue to bone for rotator cuff repair).
  • Stating that the device has "the same technological characteristics" as a predicate device (K012125).
  • The FDA's letter confirming substantial equivalence.
  • The Indications for Use statement for the device.

Therefore, the requested information fields would be "Not applicable" or "Not provided" for this specific submission.

Summary of why the requested information is not available:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. Performance is demonstrated by substantial equivalence to a predicate device, not through a de nouveau study with defined acceptance criteria in this submission.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No test set as understood for AI/software devices was used.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/software device is not relevant for this mechanical instrument.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical surgical instrument, not an AI-assisted device for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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The Opus Magnum Anchor and Inserter is intended for the fixation of soft tissue to bone for the following indications: SHOULDER (l) 1.) Rotator Cuff Repair

Not Found

The provided text is a 510(k) premarket notification approval letter from the FDA for a medical device called the "Opus Magnum Anchor and Inserter." This type of document declares that a device is substantially equivalent to a predicate device and can be marketed, but it does not contain information about acceptance criteria or specific study results showing the device meets those criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided document. The document describes the regulatory approval process but does not include the detailed technical and clinical study data that would inform such criteria and performance reports.

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