Search Results

Components of the Signature Orthopaedics range of soft tissue fixation devices are intended to reattach ligament, tendon or soft tissue to bone. Specifically, the BI-ON Screw and Anchor, BI-ON Bio-screw and Bio-anchor, Vector Knotted, ATOK, Vortex Anchor, Dynaloc Anchor and Shoulder Suture Anchor are indicated for use in the shoulder, including:

Shoulder

• Capsular stabilization
  • Bankart Repair
  • Anterior shoulder instability
  • SLAP lesion repairs
  • Capsular shift or capsulolabral reconstructions
• Acromioclavicular separation repairs
• Deltoid repairs
• Rotator cuff tear repairs
• Biceps tenodesis

The Shoulder Soft Tissue Anchor System consists of a range of implants for soft tissue fixation to bone in the shoulder joint. The soft tissue anchors are manufactured from PEEK OPTIMA LT1 (ASTM F2026) or a PEEK/Hydroxyapatite composite and are available as knotted and knotless variants. Several of the soft tissue anchor variants are supplied preloaded with sutures and preassembled onto a driver. The UHMWPE (HS fibre) sutures are finished devices externally supplied by RiverPoint Medical and previously cleared through 510(k) K10006. All components are intended for single use only.

The following variants are included in the range of Shoulder Soft Tissue Anchors:

• Turbine Anchor
• Mini Incision Anchor
• Turbine OP Anchor
• Vortex Anchor
• Vector Anchor
• DynaLoc Anchor
• BI-ON Bio Anchor
• Arthroscopic Transosseous Knotless (ATOK) Anchor

The provided 510(k) clearance letter is for a medical device (Shoulder Soft Tissue Anchors), not an AI/software device. Therefore, the questions regarding acceptance criteria, study design for AI models, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance do not apply to this document.

This document describes the process for clearing a physical medical device (soft tissue anchors) through the FDA's 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing.

However, based on the information provided, I can extract the following relevant details about the device and its testing:

1. Acceptance Criteria and Reported Device Performance:

The document states that the "results of non-clinical testing show that the strength of the Signature Orthopaedics Shoulder Soft Tissue Anchor System is sufficient for their intended use and substantially equivalent to legally marketed predicate devices."

While specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons) and corresponding reported performance values are not detailed in this public clearance letter, the overall conclusion indicates that the device met the established performance thresholds for mechanical strength. The "acceptance criteria" for a physical device like this would typically be defined as meeting or exceeding the performance of the predicate device(s) or generally accepted engineering standards for comparable devices, often expressed as quantitative values for specific mechanical tests.

The relevant performance tests conducted were:

• Anchor insertion testing
• Anchor pull-out testing
• Anchor torque to failure testing
• Anchor fatigue testing

These tests were performed using ASTM F543 as a guide. This ASTM standard provides guidance for "Standard Practice for Metallic Medical Bone Screws," which would be appropriately adapted for bone anchors.

Therefore, a table of specific numerical acceptance criteria and reported device performance cannot be generated solely from this document. The document only provides the conclusion that the device met these criteria through testing.

The remaining questions are not applicable to the content of this 510(k) clearance letter for a physical implantable device.

Ask a specific question about this device