Search Results
Found 1 results
510(k) Data Aggregation
(133 days)
The MedShape PEEK Interference Screw is intended for soft tissue to bone reattachment in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically;
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (Basal Thumb Joint Arthroplasty), Carpal Ligament Reconstructions and Repairs, Tendon Transfer in the Hand/Wrist
The proposed Helical Ridge Bone Anchor is a sterile, single use, orthopedic implant intended to be used for fixation of soft tissue to bone.
The Helical Ridge Bone Anchor is comprised of PEEK. The anchor is provided sterile and pre-loaded on a disposable driver handle.
The provided document is a 510(k) premarket notification for the MedShape Helical Ridge Bone Anchor (also referred to as MedShape PEEK Interference Screw). This type of submission is for medical devices and does not typically involve AI/ML components or software. Therefore, the questions related to AI/ML study design, such as sample size for test and training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable to this document.
However, I can extract information related to the device's acceptance criteria and the studies performed to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrates Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material: Comprised of implant grade PEEK. | The Helical Ridge Bone Anchor is comprised of PEEK. |
| Indications for Use: Same as predicate devices. | The Helical Ridge Bone Anchor has the same indications for use as the predicate devices. |
| Functional Performance: Monotonic soft tissue fixation strength in Sawbone® bone analogue must be comparable to predicate devices. | Analysis of the results (including monotonic soft tissue fixation strength) supports the conclusion that the proposed device is substantially equivalent to the predicate devices. |
| Dimensional Verification: Product samples must meet specified dimensional requirements. | Dimensional verification testing for product samples was performed. |
| Material Safety: Must demonstrate biocompatibility and MRI compatibility. | Material safety testing (both biocompatibility and MRI compatibility) was performed. |
2. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are primarily bench testing (e.g., in Sawbone® models) rather than clinical studies with human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of AI/ML or clinical expert review is not relevant here. The "ground truth" for this device's performance would be the physical properties and mechanical strength of the anchor, measured objectively.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical trials or expert review for AI/ML performance, not for bench testing of physical devices.
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 physical bone anchor, not an AI/ML diagnostic tool.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing (e.g., monotonic soft tissue fixation strength, dimensional verification, material safety), the "ground truth" refers to objective measurements and established standards for mechanical properties and material safety.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Ask a specific question about this device
Page 1 of 1