(60 days)
The Opus® LabraLock™ P 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 Duff 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 Labral.ock™ P device is a bone anchor with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
This 510(k) premarket notification is for the Opus LabraLock P Knotless Fixation Device. The document indicates that the device is substantially equivalent to existing predicate devices, primarily differing in the material used (PEEK instead of stainless steel). This submission focuses on demonstrating equivalence through material characterization and comparison to predicate devices, rather than an extensive clinical study to establish new performance criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is largely not applicable in the context of this specific 510(k) submission, which relies on demonstrating equivalence to previously cleared devices.
However, based on the information provided, here's what can be inferred or stated about the device and its assessment for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) is "substantial equivalence" to predicate devices. This means the device must have the same intended use and technical characteristics as the predicate, or if it has different technological characteristics, it must be demonstrated to be as safe and effective as the predicate. The key characteristic change here is the material (PEEK vs. stainless steel).
- Reported Device Performance: The document states, "The differences between the Opus® LabraLock™ P 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 qualitative statement of performance, asserting equivalence based on material characterization and comparison to predicate devices. No specific quantitative performance metrics (e.g., tensile strength, pull-out force) or their corresponding acceptance criteria are explicitly detailed in the provided text.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This 510(k) notification does not describe a "test set" in the context of a clinical performance study with human or animal subjects for this specific device. The assessment is based on the substantial equivalence principle, relying on existing knowledge of predicate devices and material properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. As no clinical "test set" or ground truth requiring expert consensus is described for this specific device's performance evaluation, this information is not relevant to this submission. Regulatory bodies like the FDA review the submission based on provided data, but "experts" in the sense of adjudicating clinical outcomes are not mentioned here.
4. Adjudication Method:
- Not Applicable. As no clinical "test set" requiring adjudication for performance outcomes is described, this information is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is typically for evaluating the diagnostic or prognostic performance of an imaging or AI device. This device is a bone anchor, a surgical implant, and such a study is not applicable to its regulatory clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This question pertains to AI/algorithm performance. The device is a physical bone anchor, not an algorithm.
7. The Type of Ground Truth Used:
- Substantial Equivalence: The "ground truth" here is the established safety and effectiveness of the predicate devices. The new device's safety and effectiveness are established by demonstrating that its characteristics (primarily the change in material to PEEK) do not raise new questions of safety or effectiveness compared to the already cleared predicate devices. Material characterization and potentially bench testing data (though not detailed here) would support this claim.
8. The Sample Size for the Training Set:
- Not Applicable. As this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As this is not an AI/ML device, this question is not relevant.
In summary: This 510(k) submission for the Opus LabraLock P Knotless Fixation Device primarily relies on demonstrating substantial equivalence to predicate devices, particularly given a material change from stainless steel to PEEK. The regulatory review focuses on whether this change introduces new safety or effectiveness concerns, rather than requiring extensive de novo clinical performance studies that would generate the kind of data requested in your prompt. The provided text confirms the FDA's agreement with the substantial equivalence claim.
§ 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.