(90 days)
The Opus Magnum SpeedScrew 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, biccps 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; patcllar ligament and tendon avulsions
The Opus" SpeedScrew™ device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
This 510(k) summary describes a new medical device, the Opus Magnum SpeedScrew Knotless Fixation Device, and seeks to demonstrate its substantial equivalence to previously cleared predicate devices. Since this is a submission for a new product seeking substantial equivalence to existing predicate devices, the provided document does not contain acceptance criteria in the traditional sense of performance targets that the device must meet in a new study. Instead, the "study" demonstrating that the device meets criteria is the argument for substantial equivalence, which primarily relies on comparing its design, technology, and materials to already cleared devices.
Therefore, for many of your requested points, the answer will be "Not applicable" or "No specific study outlined" because the FDA clearance process for devices seeking substantial equivalence often relies on demonstrating similarity to already approved devices rather than requiring new, extensive performance studies with specific numerical acceptance criteria.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in filing. The device aims to demonstrate "substantial equivalence" to predicate devices, meaning it has the same intended use and technical characteristics, or the same intended use and different technological characteristics but is demonstrated to be as safe and effective. | The device's design, technology, and materials are stated to be "substantially equivalent" to the predicate devices (Arthrex PEEK SwiveLock and Opus Magnum PI Knotless Fixation Device). The differences are stated not to "raise any questions regarding the safety and effectiveness of the implant." |
| Indication for use: fixation of soft tissue to bone (as detailed in the "Indications For Use" section). | The Opus® SpeedScrew™ device is indicated for use in fixation of soft tissue to bone, with specific examples provided for shoulder, ankle, foot, elbow, and knee procedures. This matches the intended use of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No specific test set in the context of human data or a statistically powered performance study is described for this 510(k) submission. The evaluation is based on design and material comparison.
- Data Provenance: Not applicable. This submission relies on a comparison to existing devices rather than new human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth establishment by experts for a test set is not described for this type of submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is not mentioned as part of the submission to demonstrate substantial equivalence for this device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study Done: No. This device is a physical bone anchor, not an algorithm or AI system, so "standalone performance" in that context is not applicable. The assessment is of the physical device's characteristics and materials.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. For this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established safety and effectiveness of the predicate devices. The new device argues it is similar enough to those established devices that it does not pose new safety or effectiveness concerns.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. This is not an AI/ML device requiring a training set.
Summary of the "Study" and How It Meets "Acceptance Criteria"
The "study" in this context is the substantiation of equivalence to predicate devices. The "acceptance criteria" are implied by the FDA's requirements for substantial equivalence:
- Same intended use: The Opus Magnum SpeedScrew has the same intended use (fixation of soft tissue to bone) as the predicate devices.
- Same technological characteristics, OR different technological characteristics but demonstrated to be as safe and effective: The submission states that the "Opus Magnum SpeedScrew design and technology is substantially equivalent" to the predicates, and that "The differences...do not raise any questions regarding the safety and effectiveness of the implant." It also notes that "the materials are well characterized and have been used in predicate devices with similar indications."
The FDA's decision to clear the device (as indicated in the letter from Mark N. Melkerson) confirms that the submitter successfully demonstrated that these "acceptance criteria" for substantial equivalence were met based on the information provided in the 510(k) notification.
§ 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.