(86 days)
The Opus SpeedLock Knotless Fixation Device 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 SpeedLock Knotless Fixation 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 Opus SpeedLock Knotless Fixation Device. It asserts substantial equivalence to a predicate device (Opus LabraLock P Knotless Fixation Device, K061349). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Instead, the submission focuses on:
- Description of the new device and its intended use.
- Identification of an existing predicate device the new device is substantially equivalent to.
- A statement of substantial equivalence, asserting that the differences do not raise new questions of safety or effectiveness.
- Regulatory information such as classification, product code, and contact details.
Therefore, I cannot populate the table or answer most of your detailed questions because the necessary information about performance studies, acceptance criteria, sample sizes, ground truth, or expert involvement is not present in the provided document. The 510(k) process for this type of device typically relies on demonstrating equivalence to a legally marketed predicate, rather than extensive de novo clinical studies with specific performance metrics.
Here's what I can extract based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified. The submission relies on substantial equivalence to a predicate device, implying that the safety and effectiveness are inferred from the predicate's known performance, rather than new performance data specific to the Opus SpeedLock device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new test set or ground truth establishment is described in this 510(k) summary.
4. Adjudication method for the test set:
- Not applicable. No new test set or adjudication process 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 or imaging device that would involve human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a bone anchor, not an algorithm.
7. The type of ground truth used:
- Not applicable. No new ground truth is described. The basis for clearance is substantial equivalence to a predicate device.
8. The sample size for the training set:
- Not applicable. This is not an AI device, and no training set is mentioned.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.