(181 days)
Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair
Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction
Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction
Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair
Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement
The PEEK Knotless Anchors are single-use devices.
The PEEK Knotless Anchors are soft tissue anchors available in four diameters and comprised of PEEK-Optima® polymer.
The provided text describes a 510(k) premarket notification for "PEEK Knotless Anchors" by Biomet Sports Medicine, Inc. As such, it focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria for a new device and proving its attainment through a dedicated study.
Therefore, many of the requested elements (acceptance criteria, study details, expert involvement, specific ground truth methods, sample sizes for training/test sets, MRMC study details) are not applicable or not explicitly provided in this type of regulatory submission.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating that the new device's technological characteristics are "similar or identical" to predicate devices, and that non-clinical testing showed it to be "functional within its intended use."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional within intended use | Non-clinical testing indicated the devices were functional within their intended use. |
| Similar/Identical technological characteristics (material, design, sizing, indications) to predicate devices | "The technological characteristics (material, design, sizing, indications) of the PEEK Knotless Anchors are similar or identical to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. The submission states "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence." This refers to bench testing, not clinical studies with a 'test set' of patient data. The number of samples for the non-clinical tests is not specified.
- Data Provenance: Not applicable. This was non-clinical laboratory testing, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set or human ground truth was established, as it was non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or human adjudication was involved.
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 is not an AI-based device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (suture anchors), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" implicitly refers to established engineering and biomechanical principles and design specifications to demonstrate functionality and equivalence. No human-based "ground truth" (like pathology or expert consensus) was used.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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.