(60 days)
The Opus Magnum X bone anchor with inserter is indicated for use in fixation of soft tissue to bone for rotator cuff repair.
The Opus Magnum X device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
This 510(k) submission (K081497) for the Opus Magnum X Knotless Fixation Device is a notification of a proposed modification to an existing product, the Opus Magnum2 Knotless Fixation Device (K042914). The submission primarily relies on the concept of substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not applicable or available within the provided documentation. The FDA's clearance is based on the new device having the "same intended use and technical characteristics as the predicate device," or "the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device."
Here's a breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Same intended use as predicate device (K042914) | "Indicated for use in fixation of soft tissue to bone for rotator cuff repair." (Matches predicate) |
| Safe and effective as predicate device (K042914) | "The proposed device, as designed, is as safe and effective as predicate devices." |
| No new questions raised regarding safety and effectiveness due to modifications | "The differences between the Opus Magnum X and the predicate device do not raise any questions regarding the safety and effectiveness of the implant." |
| Materials are well characterized and used in similar predicate devices | "Furthermore, the materials are well characterized and have been used in predicate devices with similar indications." |
| Specific quantitative performance metrics (e.g., tensile strength, pull-out force, etc.) are not explicitly detailed in this summary for the new device, but would have been assessed in comparison to the predicate device. | Specific quantitative performance metrics are not detailed in this summary. |
Study That Proves the Device Meets Acceptance Criteria:
The "study" in this context is a substantial equivalence comparison to the predicate device (Opus Magnum2 Knotless Fixation Device, K042914). The documentation asserts substantial equivalence based on a comparison of intended use, technological characteristics, and safety/effectiveness profile. It explicitly states: "The Opus Magnum X design and technology is substantially equivalent to the existing Opus Magnum2 Knotless Fixation Device cleared by the Food & Drug Administration [K042914]."
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission is based on substantial equivalence to a predicate device, not on a new clinical study with a distinct "test set" of patient data as might be found in a de novo premarket submission or a PMA. The "test" for substantial equivalence is a comparison of design, materials, and intended use against the predicate.
- Data Provenance: Not applicable. No new patient data (e.g., from a specific country or retrospective/prospective study) is presented for the Opus Magnum X device itself in this summary. The "data" relevant here would be the design specifications, material properties, and performance data used to establish the safety and effectiveness of the predicate device, which are not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No "ground truth" derived from expert consensus on a test set of data is described in this substantial equivalence summary. Clinical outcomes with the predicate device would have informed its clearance, but this isn't a new clinical study.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No "test set" requiring adjudication by experts is described for this substantial equivalence submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is not mentioned or required for this substantial equivalence submission. An MRMC study is typically used to assess the effectiveness of an AI system's performance in a diagnostic context, often comparing human readers with and without AI assistance. This device is a surgical fixation device.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: No. This refers to the performance of an AI algorithm on its own. This device is a medical implant, not an AI algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of a new clinical study for this device. The "ground truth" for the predicate device's safety and effectiveness would have been established through a combination of design validation, bench testing, potentially animal studies, and/or clinical experience, but these details are not provided for the predicate in this summary. For the Opus Magnum X, the "ground truth" is its equivalence to the already cleared predicate.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no AI model or training set described for this device.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no AI model or training set.
§ 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.