(30 days)
The X-Twist PEEK Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
The X-Twist PEEK Suture Anchor consists of an implantable anchor and anchor tip that are provided assembled to a driver. Retention suture(s) or suture tapes(s) are preloaded through the driver cannulation to secure the anchor tip onto the driver shaft. The anchor tip can be loaded with additional suture(s) or suture tapes(s) if needed for the intended surgical procedure. Clockwise rotation of the driver allows for advancement of the fully threaded anchor and anchor tip into the prepared bone socket to serve as the point of fixation for soft tissue repair.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: X-Twist PEEK Suture Anchor
Type of Study: Non-clinical (benchtop) testing and bacterial endotoxin testing. No clinical study was performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Benchtop Testing | Met defined acceptance criteria, demonstrated substantial equivalency for design and performance when assessed against predicate devices. | The results of the testing met the defined acceptance criteria and were assessed against the results obtained with the predicate devices to determine substantial equivalency for design and performance. (Specific numerical values not provided in the summary) |
| - Cycle loading and elongation | Not explicitly defined in this section, but implied to be comparable to predicate. | Met defined acceptance criteria. |
| - Insertion torque | Not explicitly defined in this section, but implied to be comparable to predicate. | Met defined acceptance criteria. |
| - Anchor pullout force | Not explicitly defined in this section, but implied to be comparable to predicate. | Met defined acceptance criteria. |
| Bacterial Endotoxin Testing (USP ) | Standard Curve Correlation Coefficient: ≥0.98 | |
| Neg. Control Onset Time: Onset time > lowest Cal Standard | ||
| PPC: 50-200% | ||
| Test Article Endotoxin Concentration: ≤20 EU/device | Standard Curve Correlation Coefficient: 1.00 | |
| Neg. Control Onset Time: >6000 seconds | ||
| PPC: 58% | ||
| Test Article Endotoxin Concentration: and ). |
4. Adjudication Method for the Test Set
- Not applicable. As this is non-clinical benchtop and laboratory testing, there is no adjudication method involving human interpretation to establish ground truth for a test set. The results are quantitative measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical medical implant (suture anchor), not an algorithm or AI-powered system, so the concept of "standalone performance" in the context of AI does not apply. The performance evaluated is the physical and biological characteristics of the device itself.
7. Type of Ground Truth Used
- Benchtop Testing: Engineering performance metrics (e.g., force, torque, elongation) compared against established design specifications and predicate device performance.
- Bacterial Endotoxin Testing: Quantitative measurement of endotoxin levels against a regulatory standard (USP and ).
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms. While the device's design might have involved iterative testing and refinement, this is not documented as a formal "training set" in the context of this submission. The "training" in a broad sense would be the development process and previous predicate device data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As no formal "training set" (in the AI/ML sense) was used, this question is not relevant. The "ground truth" for the device's development would likely be established through biomechanical principles, material science, and the performance characteristics of previously cleared predicate devices.
§ 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.