(88 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 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. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 3000 Titanium Bone Anchor is prethreaded with size 2/0 USP non-absorbable monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers. The Model 3000 Titanium Bone Anchor is intended for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Axya Model 3000 AxyaLoop™ Titanium Bone Anchor:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: Anchor pull-out strength equal to or better than a predicate device, as specified in FDA Guidance Document for Testing Bone Anchor Devices (April 20, 1996). | The anchor pull-out force of the Axya Model 3000 AxyaLoop Titanium Bone Anchor compared favorably with the predicate device (OBL 2.0 mm Mini Tac). The failure mode observed (anchor pull-out) was the same for both. |
| Material Biocompatibility: Materials have an established history of use in medical applications. | The materials from which the Axya device is fabricated have an established history of use in medical applications. |
| Sterilization: Components are provided sterile, and the sterilization process is equivalent to the original suture manufacturer. | 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 manufacturer. |
| Clinical Equivalence: Safe and effective for specific soft tissue to bone repairs in extremities. | Similar legally marketed bone anchors have been used for the same clinical applications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states an "in vitro study," but it does not specify the sample size (e.g., number of anchors tested, number of repetitions, or types of bone analogues used).
- Data Provenance: The study was an in vitro study. The country of origin for the data is not specified, but given the company's address (Beverly, MA, USA) and the FDA submission, it can be inferred the study was likely conducted in the USA or supervised under US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described study is an in vitro mechanical performance study, not a clinical study involving human expert assessment for ground truth. The "ground truth" here is the physical measurement of pull-out force.
4. Adjudication Method for the Test Set
This is not applicable as the described study is an in vitro mechanical performance study and does not involve human readers or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is a bone anchor, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or AI comparison was done.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical bone anchor, not an algorithm or software.
7. The Type of Ground Truth Used
The ground truth used for the in vitro study was objective mechanical measurement (specifically, pull-out force) following an established FDA guidance document.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" mentioned or implied as this is a physical medical device undergoing mechanical testing, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
§ 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.