(105 days)
The Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications:
Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction
Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction
Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis
Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction
Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females
The device described in this submission is designed with a corkscrew style thread and will be made available initially in a 5.0 mm nominal diameters, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axva Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 5000 Bio-Albsorbable Bone Anchor is prethreaded with USP polypropylene monofilament, USP nylon, JJSP braided polyester and USP braided polyethylene suture materials.
The Model 5000 Bio-Absorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.
The Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor's acceptance criteria and the study proving it meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device performance) | Reported Device Performance (Axya Model 5000 AxyaLoop™) |
|---|---|
| Anchor pull-out strength comparable to predicate device. | Compared favorably with the predicate device of similar corkscrew geometry. |
| Failure mode consistent with predicate device. | Predominately the same as that of the predicate anchor. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "in vitro studies" and "the data presented" without specifying the exact number of anchors tested.
- Data Provenance: The studies were "in vitro studies" conducted to evaluate anchor pull-out strength. The country of origin is not specified, but the submission is to the FDA in the US, suggesting the testing was likely conducted by or for the manufacturer, Axya Medical, Inc. (located in Beverly, MA, USA). The studies were retrospective in the sense that they were performed to demonstrate substantial equivalence to already cleared predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study was an in vitro mechanical performance test, not a study involving human interpretation or clinical outcomes requiring expert ground truth.
4. Adjudication method for the test set:
This is not applicable as the study involved in vitro mechanical testing, not a process requiring adjudication of observations or interpretations.
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. This device is a bio-absorbable bone anchor, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.
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 medical implant, not an algorithm. The testing focused on its physical mechanical properties.
7. The type of ground truth used:
The ground truth for the in vitro studies was the mechanical performance (specifically anchor pull-out strength and failure mode) of the predicate devices. The goal was to show that the Axya device performed comparably to these established devices.
8. The sample size for the training set:
This is not applicable. The device is a physical implant, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
§ 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.