(204 days)
The Axya Model 3000 AxyaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture or size 3/0 TephaFLEX™ absorbable suture in repairs of the extremities such as those shown below:
Foot and Ankle
1 Hallux Valgus repairs
2 Medial or lateral instability repairs/reconstructions
3 Achilles tendon repairs/reconstructions
4 Midfoot reconstructions
5 Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist and Hand
1 Scapholunate ligament reconstructions
2 Ulnar and radial collateral ligament reconstructions
3 Lateral epicondylitis repair
4 Biceps tendon reattachment
The device described in this submission is designed with a corkscrew style thread and is available in a 2.0 mm diameter specifically for use in ankle, foot, elbow, wrist and hand repairs and reconstructions. The Axya Bone Anchor is available as a system together with a drill bit, a delivery/extraction handle and a drill guide. These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. The Axya Model 3000 Titanium Bone Anchor is prethreaded with either non-absorbable suture or size 3/0 TephaFLEX™ suture material.
This document is a 510(k) summary for the Axya Medical, Inc. Model 3000 AxyaLoop™ Titanium Bone Anchor. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
This document does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) process for this type of device (a bone anchor) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring performance against specific, pre-defined quantitative acceptance criteria through a clinical study in the way a diagnostic device might.
Therefore, many of the requested items (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or not provided in this type of submission.
Here's a breakdown of what can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: The device performs comparably to predicate devices in mechanical tests (e.g., pull-out strength, fatigue). | "The materials from which the Axya device is fabricated have an established history of use in medical applications, and the devices produced by Axya have been tested in accordance with applicable FDA guidelines." (This implies mechanical testing was done to ensure equivalence, but specific criteria and results are not detailed here.) |
| Material Biocompatibility: Materials are safe for long-term implantation. | "The materials from which the Axya device is fabricated have an established history of use in medical applications..." (Titanium and specified sutures are well-established biocompatible materials.) |
| Sterility: Components are sterile. | "The single-patient-use components of the bone anchor system are provided sterile. The suture material and bone anchors are sterilized by a process equivalent to the process used by the original suture manufacturers." |
| Indications for Use: The device can be safely and effectively used for listed indications. | Demonstrated through substantial equivalence to predicate devices used for similar indications. |
2. Sample sized used for the test set and the data provenance:
- Not applicable / Not provided. This 510(k) summary does not describe a clinical study with a "test set" in the context of diagnostic or AI performance. The "testing" referred to is primarily bench testing for mechanical properties and material equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No clinical "test set" requiring expert ground truthing is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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:
- No. This is a hardware medical device (bone anchor), not an AI diagnostic or assistive device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. For a bone anchor, the "ground truth" for its performance is typically established through biomechanical testing (e.g., tensile strength, pull-out force) and material science, demonstrating equivalence to established devices and safety of materials. Clinical outcomes for equivalence are usually based on the predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not applicable / Not provided. No "training set" in the AI sense is relevant for this device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
Summary of the study/evidence provided in the 510(k) submission:
The submission relies on claims of substantial equivalence to predicate devices (Axya Medical, Inc. Model 3000 AxyaLoop™ Suture Anchor [K022207] and Depuy Mitek QUICKANCHOR Plus Bone Anchor [K041115]).
The evidence provided for this substantial equivalence primarily consists of:
- Material Equivalence: The device is made from materials (Titanium, non-absorbable sutures, TephaFLEX™ absorbable suture) with an "established history of use in medical applications."
- Design and Functionality Equivalence: The corkscrew-style thread and 2.0 mm diameter are presented as suitable for the specified anatomical areas, implying similar biomechanical function to predicates.
- Sterilization Process Equivalence: The sterilization process is stated to be "equivalent to the process used by the original suture manufacturers."
- Testing in accordance with FDA guidelines: While specific results are not provided here, the document states that "the devices produced by Axya have been tested in accordance with applicable FDA guidelines." This typically refers to bench testing for mechanical properties (e.g., pull-out strength) to demonstrate that the device performs equivalently to the predicate devices.
- Indications for Use Equivalence: The specified indications for use (foot, ankle, elbow, wrist, hand repairs) are similar to those for which predicate bone anchors are marketed.
In essence, the "study" proving the device meets criteria is a combination of material characterization, bench testing (mechanical performance), and a comparison of design and indications to already-approved predicate devices to establish substantial equivalence, rather than a clinical trial with acceptance criteria for patient outcomes or diagnostic performance.
§ 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.