(83 days)
The Opus MiniMagnum™ 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 reattachment 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 MiniMagnum™ Anchor with Inserter is substantially equivalent to the existing Opus Magnum™ Anchor with Inserter and the Mitek Bioknotless Anchor cleared by the Food and Drug Administration. Additionally, the intended use of the Opus MiniMagnum™ Anchor with Inserter is identical and therefore substantially equivalent to the intended use of the existing Mitek BioKnotless Anchor, for fixation of soft tissue to bone. The purpose of this 510(K) is to notify the FDA of the clearance of a new Opus product, the Opus MiniMagnum™ Bone Anchor. The Opus MiniMagnum™ is substantially equivalent to Opus Magnum™ originally cleared under 510(k) 012125, but is smaller in size. The intended use and indications for use are the same as the predicate device, the Mitek BioKnotless Bone Anchor. The fundamental technology of the Opus MiniMagnum™ Bone Anchor System is substantially equivalent to the Opus Magnum™ Bone Anchor.
The provided text is a 510(k) premarket notification for a medical device (Opus MiniMagnum™ Bone Anchor with Inserter). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics. Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for a new clinical trial.
Instead, the document asserts substantial equivalence based on:
- Identical intended use and indications for use to the predicate devices (Opus Magnum™ Anchor with Inserter and Mitek BioKnotless Anchor).
- Similar fundamental technology to the Opus Magnum™ Bone Anchor.
- The MiniMagnum™ is described as being "smaller in size" than its predicate.
To directly answer your specific questions in the context of this 510(k) submission, the following would be the response:
1. Table of acceptance criteria and the reported device performance:
This 510(k) submission does not include a table of acceptance criteria and reported device performance based on a new clinical study. The device's performance is implicit in its substantial equivalence to predicate devices, meaning it is expected to perform similarly to devices already on the market for the same intended use.
2. Sample size used for the test set and the data provenance:
No test set sample size or data provenance is reported, as a new clinical study demonstrating specific performance metrics was not conducted. The submission relies on the established safety and effectiveness of its predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts for a test set is mentioned, as no new clinical study was performed.
4. Adjudication method for the test set:
Not applicable. Since there was no test set or expert ground truth establishment, no adjudication method is described.
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 device is a bone anchor, not an AI-assisted diagnostic tool. Therefore, an MRMC study involving human readers improving with AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical bone anchor, not a software algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used:
Not applicable. Given that no new clinical study with performance metrics was conducted, there is no mention of ground truth derived from expert consensus, pathology, or outcomes data. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set:
Not applicable. No training set is mentioned as this is a physical medical device seeking substantial equivalence, not an AI/ML device requiring a training set for algorithm development.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an algorithm, the method of establishing ground truth for it is not discussed.
§ 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.