(53 days)
The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:
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" Anchor with Permacord™ suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone. Healix Advance Anchors are available in absorbable BR and non-absorbable PEEK materials. Permacord suture is a non-absorbable suture that conforms to USP, except for oversized diameter. Healix Advance Anchors with Permacord are provided sterile and is for single use only.
The provided text describes the Healix Advance™ Anchor with Permacord™ suture and its substantial equivalence to predicate devices, but it does not detail specific acceptance criteria or a study proving the device meets those criteria in the typical format you've requested for AI/software-based medical devices.
Instead, the submission focuses on demonstrating safety and effectiveness through substantial equivalence to already legally marketed devices, which is a common pathway for predicate-based medical devices. The "study" here refers to non-clinical testing performed to show that the new device performs comparably to its predicates.
Here's an interpretation based on the provided text, formatted to align with your request where possible, but with clear indications where the information is not present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Pull out testing adequate | Performed (results not detailed) |
| Insertion torque adequate | Performed (results not detailed) |
| Failure torque adequate | Performed (results not detailed) |
| In-vitro testing successful | Performed (results not detailed) |
| Suture testing per USP | Performed (results not detailed) |
| Material Equivalence: | |
| Anchor materials same as predicates (K120078, K120449) | Confirmed: "The proposed Healix Advance Anchors with Permacord suture have the same anchor materials and design as predicate Healix Advance Anchors (K120078, K120449)." |
| Permacord suture materials same as Force Fiber suture (K070673, K092533, K100506) | Confirmed: "The Permacord suture has the same design and materials as Teleflex's Force Fiber suture (K070673, K092533, K100506), and conforms to USP, except for oversized diameter." |
| Design Equivalence: | |
| Anchor design same as predicates (K120078, K120449) | Confirmed: "The proposed Healix Advance Anchors with Permacord suture have the same anchor materials and design as predicate Healix Advance Anchors (K120078, K120449)." |
| Permacord suture design same as Force Fiber suture | Confirmed: "The Permacord suture has the same design and materials as Teleflex's Force Fiber suture..." |
| Functional Equivalence: | |
| Principal operation same as predicates (K120078, K120449, K100012) | Confirmed: "The proposed device principal operation is the same as predicate Healix Advance Anchors (K120078. K120449) and Gryphon™ BR (K100012) anchors." |
| Intended Use: | |
| Suitable for intended use | Confirmed: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." |
| Sterility: | |
| Provided sterile | Confirmed: "Healix Advance Anchors with Permacord are provided sterile and is for single use only." |
| Biocompatibility: | Not explicitly mentioned, but typically covered by material equivalence to predicates or standard biocompatibility testing for new materials. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Verification activities were performed on the implant and / or its predicates" and "Testing assessments include pull out testing, insertion and failure torque, in-vitro testing and suture testing per USP." This implies engineering bench testing, which would involve a certain number of samples, but the exact count is not provided.
- Data Provenance: The testing appears to be internal lab testing ("Verification activities were performed"), not necessarily in a country of origin context. It is non-clinical/bench testing. It is retrospective in the sense that it's evaluating a final design against pre-defined performance metrics, but the data itself is generated prospectively for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is a medical device for physical implantation, not an AI/software device that requires human expert review for "ground truth" labels. The "ground truth" for this device's performance is established by engineering specifications and material standards (like USP) as well as the performance of predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. As this is not an AI/software device requiring human judgment for data labeling, there is no adjudication method in the context described. Performance is measured against engineering and material specifications.
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 a physical medical device (suture anchor), not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used
- For this type of device, the "ground truth" is defined by:
- Engineering Specifications: Specific quantifiable values for pull-out strength, torque, etc.
- Material Specifications: Adherence to established standards such as USP (United States Pharmacopeia) for sutures.
- Predicate Device Performance: The demonstrated safe and effective performance of the predicate devices. The new device is shown to be substantially equivalent to these devices.
8. The Sample Size for the Training Set
- Not applicable. This product is a physical medical 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 product is a physical medical device, not an AI/ML algorithm that requires a training set and associated ground truth establishment.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.