(186 days)
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.