(82 days)
The Opus® Magnum™ PI bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The Opus Magnum™ PI device is a bone anchor with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
The provided text is a 510(k) summary for the ArthroCare Corporation Opus Magnum PI Knotless Fixation Device. It's a regulatory document for premarket notification of a medical device, not a study report or clinical trial. Therefore, it does not contain the detailed information typically found in a study describing acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Here's what can be inferred and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., tensile strength thresholds, pull-out force, success rates). The acceptance criterion implicitly is that the device is "as safe and effective" as the predicate devices, despite the change in material.
Reported Device Performance: No specific performance metrics or data (e.g., experimental results, clinical outcomes) are reported. The document states: "The differences between the Opus® Magnum™ PI and the predicate devices do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices." This is a declarative statement of equivalence, not a presentation of performance data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| As safe and effective as predicate devices | Declared "as safe and effective as predicate devices" based on substantial equivalence to existing devices (Opus® Magnum™ Knotless Fixation Device and Opus® LabraLock™ P Knotless Fixation Device) with well-characterized materials. No specific performance metrics or test results are provided. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for the Test Set: Not applicable/Not provided. This document does not describe a clinical or performance test with a "test set" in the traditional sense of a study. The demonstration of equivalence is based on comparing the new device's characteristics to already-cleared predicate devices.
- Data Provenance: Not applicable. No new data (clinical or experimental) is described in this summary to have specific provenance. The basis for safety and effectiveness relies on the prior clearance of predicate devices and the known characteristics of the PEEK material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable/Not provided. Ground truth establishment for a test set is not part of this 510(k) summary. The regulatory process for substantial equivalence to predicate devices typically involves a review of scientific data and rationales by FDA experts, but this is distinct from establishing ground truth for a study's test set.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. There is no described "test set" or adjudication method.
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 medical device for bone/soft tissue fixation, not an image analysis or AI-driven diagnostic device. Therefore, an MRMC study or AI-assisted performance evaluation is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. As noted above, this device is not an algorithm or AI system.
7. The Type of Ground Truth Used
- Not applicable/Not provided. The concept of "ground truth" for experimental or clinical data is not directly relevant to this submission, which relies on substantial equivalence. The "truth" in this context is that the predicate devices are considered safe and effective by the FDA.
8. The Sample Size for the Training Set
- Not applicable/Not provided. Training sets are typically associated with machine learning models and are not relevant to this type of mechanical medical device submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. As above, training sets and their ground truth are not relevant to this submission.
§ 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.