(317 days)
The Aevumed PHANTOM™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral Repair
The Aevumed PHANTOM™ Sutures Anchor with HS Fiber™ suture is a suture anchor manufactured from polyetheretherketone (PEEK) material and are preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM™ Suture Anchors are available in diameter sizes: 3.5mm and 4.5mm. They are offered sterile and are for single use only.
The document provided is an FDA 510(k) clearance letter for the Aevumed PHANTOM Suture Anchors. This type of device (a bone fixation fastener) is a physical implant and not an AI/ML-driven diagnostic or assistive technology. Therefore, the questions related to AI/ML device performance (such as acceptance criteria for AI performance, sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training and test sets, and training set size) are not applicable to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Aevumed RAPID Suture Anchors, K223878) based on non-clinical performance and material characteristics, rather than diagnostic accuracy or AI effectiveness.
Here's an analysis based on the information provided, tailored to a medical device clearance:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General for Suture Anchors) | Reported Device Performance (Aevumed PHANTOM Suture Anchor) |
|---|---|
| Mechanical Performance: | Maximum Pullout Strength: Demonstrated significantly higher pullout strength compared to the predicate RAPID™ Anchor (K223878). |
| - Adequate pullout strength | |
| - Cyclic tensile strength | Tested. No specific values provided, but implied to be acceptable and comparable or superior to predicate. |
| - Static tensile strength | Tested. No specific values provided, but implied to be acceptable and comparable or superior to predicate. |
| Material: | Manufactured from Polyetheretherketone (PEEK). Identical to predicate. |
| - Biocompatibility | Deemed identical to the predicate device (Aevumed RAPID™ Suture Anchor, K223878). |
| Sterilization: | Identical to the predicate device. |
| Packaging: | Identical to the predicate device. |
| Pyrogenicity/Endotoxin Monitoring: | Identical to the predicate device. |
| Shelf Life: | Identical to the predicate device. |
| Intended Use/Indications: | Identical to predicate for suture or tissue fixation in various anatomical locations (shoulder, foot/ankle, knee, hand/wrist, elbow, hip) |
| Operational Principle: | Identical to predicate. |
| Geometric Design: | Similar to predicate. Minor differences do not raise new questions of safety and effectiveness. Available in 3.5mm and 4.5mm diameters. |
Study Proving Device Meets Acceptance Criteria:
The study conducted was a non-clinical mechanical testing study. This involved direct comparative testing of the Aevumed PHANTOM™ Suture Anchor against its primary predicate device, the Aevumed RAPID™ Suture Anchor (K223878).
- Tests performed: Insertion testing, cyclic tensile testing, and static tensile testing.
- Key finding: The Aevumed PHANTOM™ Suture Anchor demonstrated "significantly higher pullout strength" in comparison to the predicate RAPID™ Anchor.
- Conclusion drawn: The data supports the relative safety of the device and demonstrates that it performs as intended and comparably (or superiorly in key mechanical aspects) to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact number of devices (suture anchors) used in the non-clinical mechanical tests. These tests typically involve a statistically significant number of samples to ensure repeatability and reliability of the results.
- Data Provenance: The data is generated from laboratory-based non-clinical mechanical testing. This means the "data provenance" isn't in terms of patient population (e.g., country of origin, retrospective/prospective) but rather controlled experimental conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. For a physical medical device like a suture anchor, "ground truth" for non-clinical mechanical testing is established by engineering standards and validated testing methodologies, not by expert interpretation of patient data or images. The "ground truth" would be the measured physical properties (e.g., pullout strength).
4. Adjudication Method for the Test Set:
- Not Applicable. As mentioned above, this device does not involve human interpretation of data for its primary evaluation for 510(k) clearance. Mechanical tests have quantitative outputs, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC effectiveness study is relevant for diagnostic imaging or AI-assisted diagnostic devices where human readers interpret cases. This is not applicable to a physical implantable device like a suture anchor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not Applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
- The "ground truth" for demonstrating substantial equivalence for this device is based on objective engineering and mechanical performance data (e.g., measured pullout strength, tensile strength, and material properties) obtained from non-clinical laboratory testing, alongside adherence to established standards for biocompatibility and sterilization.
8. The Sample Size for the Training Set:
- Not Applicable. This device is not an AI/ML 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.