MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000

• K Number: K011912
• Device Name: MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
• Manufacturer: AXYA MEDICAL, INC.
• Date Cleared: 2001-08-31 ( 73 days)
• Product Code: MBI
• Regulation Number: 888.3040
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K983818

Intended Use

The Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic monofilament non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 5mm anchor may typically be used to repair rotator cuff injuries. The 3 mm anchor may typically be used to repair recurrent dislocation of the shoulder where the anchor is placed through the metaphyseal cortex such as in the case of a Bankart lesion repair procedure.

Device Description

The device described in this submission is designed with a corkscrew style thread and will be made available initially in two sizes (diameters) specifically for use in shoulder repairs. (i.e. rotator cuff repairs). The Axya Self-Tapping Bone Anchor will be made available as a system together with a bone punch and a delivery/extraction tool. 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 2000 AxyaLoop Self-Tapping Bone Anchor is prethreaded with size 2 USP polypropylene monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers.

The Model 2000 Self-Tapping Bone Anchor is designed to be used in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

AI/ML Overview

The provided text describes the Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor, a Class II device intended for securing non-absorbable suture to bone for shoulder repairs. The submission aimed to prove substantial equivalence to a predicate device, the Mitek Fastin ® RC Suture Anchor.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided information:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device, based on the provided text, is equivalent pull-out strength compared to the predicate device.

Acceptance Criteria	Reported Device Performance
Equivalent anchor pull-out force	"The data presented demonstrate that the anchor pull-out force of the Axya Model 2000 AxyaLoop Self-Tapping Bone Anchor was equivalent to that of the predicate device of similar corkscrew geometry (Mitek Fastin RC)."
Predominately anchor pull-out as failure mode	"The failure mode observed for the both anchors was predominately anchor pull-out."

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not explicitly state the specific numerical sample size (e.g., number of anchors tested, number of bone samples). It only refers to "data presented."
   • Data Provenance: The studies conducted were described as "in vitro studies." This indicates the tests were performed in a lab setting, likely using bone simulants or animal bones, rather than human subjects. The country of origin of the data is not specified, though the company is based in the USA.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • This information is not provided in the document. For an in vitro study evaluating mechanical properties like pull-out strength, "ground truth" would typically be established through standardized testing protocols rather than expert consensus on interpretive data (like imaging). The "ground truth" for the mechanical tests would be the measured pull-out force and observed failure mode.

3. Adjudication Method for the Test Set:

   • This information is not applicable and therefore not provided. Adjudication methods like "2+1" are used for human interpretation of data, often in clinical trials or image-based diagnostics, to resolve discrepancies between readers. For in vitro mechanical testing, measurements are typically quantitative and objective, reducing the need for such adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This type of study focuses on the performance of human readers, sometimes with and without AI assistance, especially in diagnostic imaging. The study described here is an in vitro mechanical test of a bone anchor's physical properties.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, a standalone study was done, though it's not an "algorithm" in the sense of AI. The study evaluated the direct mechanical performance of the Model 2000 AxyaLoop™ Self-Tapping Bone Anchor in a laboratory setting, without human intervention or interpretation as part of the primary outcome measure (pull-out strength). The study assessed the device "only" directly.

6. Type of Ground Truth Used:

   • The ground truth used was mechanical test results (measured pull-out force in Newtons or equivalent units) and direct observation of failure mode (predominately anchor pull-out). This is an objective, quantitative ground truth established through scientific measurement.

7. Sample Size for the Training Set:

   • This information is not applicable and therefore not provided. The described study is an in vitro mechanical test, not an AI or machine learning study, so there is no "training set."

8. How the Ground Truth for the Training Set Was Established:

   • This information is not applicable and therefore not provided, as there was no training set discussed.

Regulation Number and Section

§ 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.