(87 days)
The HEALIX ADVANCE™ PEEK Anchor is indicated for:
Shoulder: Rotator Cuff Repair, 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;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular repair, Acetabular Labral Repair.
The HEALIX ADVANCE PEEK Anchor is non-absorbable threaded suture anchor manufactured of PEEK material. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size 2 suture to bone. The suture options may include needles to facilitate suture passage through tissue. HEALIX ADVANCE PEEK Anchor is provided sterile and is for single patient, use only.
The provided text describes a 510(k) premarket notification for a medical device called the HEALIX ADVANCE™ PEEK Anchor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial to establish new safety and effectiveness.
Therefore, the study described is a non-clinical, design verification study. The information required for an AI/CADe medical device, such as expert consensus, MRMC studies, or training set details, is not applicable to this type of device and submission.
Here's an analysis of the provided information within the context of a non-clinical device:
1. Table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Anchor Torque | Pre-defined acceptance criteria (not specified) | Demonstrated suitability for intended use (meets criteria) |
| Anchor Pull Out | Pre-defined acceptance criteria (not specified) | Demonstrated suitability for intended use (meets criteria) |
Explanation: The document states, "Design verification activities, such as Anchor Torque and Anchor Pull Out were performed against pre-defined acceptance criteria according to the indicated use. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." However, the specific numerical acceptance criteria and the quantitative results of these tests are not provided in this summary. These details would typically be found in the full test reports submitted to the FDA, not in the 510(k) summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests. The description implies multiple anchors were tested for design verification.
- Data Provenance: Not applicable in the context of human data. These are laboratory-based, non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: For non-clinical tests like anchor torque and pull-out strength, "ground truth" is established by engineering specifications and objective measurements, not expert human interpretation.
4. Adjudication method for the test set:
- Not Applicable: No human interpretation or adjudication is involved in these types of physical performance tests.
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 surgical anchor and not an AI/CADe device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is a physical surgical anchor and not an algorithm.
7. The type of ground truth used:
- Engineering Specifications/Objective Measurements: For mechanical tests like torque and pull-out, the "ground truth" is derived from relevant engineering standards, material properties, and mechanical test methodologies. These tests objectively measure the physical properties of the anchor.
8. The sample size for the training set:
- Not Applicable: This is a non-clinical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable: This is a non-clinical device, not an AI/ML algorithm that requires a training set and corresponding ground truth.
In summary: The K120449 PEEK Anchor submission relies on non-clinical, mechanical design verification tests to demonstrate substantial equivalence to a predicate device. The information requested pertaining to AI/CADe devices (such as expert reads, MRMC studies, and training set details) is not relevant to this type of medical device submission.
§ 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.