(24 days)
The Axya Model 6500 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing in The Axya Model 0500 AxyaLoop - Blo Fissone in the following applications:
Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular
Shoulder: Rotator curi, Bankart, and OEA: "Tocler." Total 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 Uinar 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 is designed with a corkscrew style thread 6.5 mm in diameter, 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. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 6500 Bio-Absorbable Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material.
The Model 6500 Bio-Absorbable Bone Anchor is designed for use in both standard open
t the Model of the state the limited in (arthreasenia) surgical procedures The Model 6500 Blo-Absorbable Dono Anoner 16 access and in mical procedures.
surgical procedures and in minimally invasive (arthroscopic) surgical procedures.
This is a 510(k) premarket notification for a medical device, the Model 6500 AxyaLoop™ Bio-Absorbable Bone Anchor, and therefore does not contain acceptance criteria or study results in the typical sense of an AI/ML device.
The document is a submission to the FDA demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving performance against specific quantitative acceptance criteria for a novel AI algorithm. The studies mentioned are in vitro studies comparing the device's physical properties to predicate devices, not clinical trials or performance evaluations of an AI model.
Therefore, the requested information elements related to AI/ML device performance (acceptance criteria table, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this document.
However, I can extract the information that is present in the document which relates to the comparison to predicate devices:
1. Table of Acceptance Criteria and Reported Device Performance:
This document describes a comparison to predicate devices, not acceptance criteria for an AI/ML model. The "performance" being evaluated is related to physical properties of the bone anchor.
| Characteristic Evaluated | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Anchor Pull-Out Force | Favorable comparison to predicate devices | "The data presented demonstrate that the anchor pull-out force of the Axya Model 6500 AxyaLoop Bio-Absorbable Bone Anchor compared favorably with the predicate device of similar design." |
| Suture Sterilization | Sterilization by original suture manufacturer | "The single-patient-use components of the bone anchor system are provided sterile. The suture sterilization was performed by the original suture manufacturer." |
| Materials | Materials with established history of biocompatibility | "The materials from which the Axya have been Absorbable Bone Anchor... have an established history of use in accordance with applicable FDA guidelines." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of anchors or tests. The document refers to "in vitro studies."
- Data Provenance: Not specified, but "in vitro studies" implies laboratory testing rather than human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/ML study requiring expert ground truth for image or data interpretation. The "ground truth" for bone anchor performance typically comes from validated mechanical testing procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML study involving human adjudication of performance.
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 not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- For anchor pull-out force: Mechanical testing results (physical measurements).
- For materials: Biocompatibility data conforming to FDA guidance.
- For sterilization: Manufacturing process and testing by the suture manufacturer.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
In summary, this 510(k) document focuses on demonstrating substantial equivalence of a physical medical device (a bone anchor) to existing devices based on "in vitro studies" of its mechanical properties and materials, rather than presenting performance data for an AI/ML algorithm against predefined acceptance criteria.
§ 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.