(143 days)
The Knotless Suture Fixation System is intended to secure soft tissue to bone of: The Shoulder, Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Rotator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radia! Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Ankle/Foot Indications: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction
Knotless Suture Fixation System includes threaded anchors used to facilitate fixation of soft tissue to bone. This is a knotless suture anchor for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder and other joints. The implant is constructed of Polyetheretherketone (PEEK) which is widely used for products in the product code.
The provided text describes a 510(k) summary for the "Knotless Suture Fixation System" by Core Essence Orthopaedics, Inc. This document focuses on demonstrating substantial equivalence to predicate devices for market clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical or analytical setting with defined endpoints like accuracy, sensitivity, or specificity.
Here's a breakdown of the information based on your request, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pullout force | Met acceptance criteria |
| Suture retention | Met acceptance criteria |
| (Specific numerical criteria or thresholds are NOT provided in the document) | (Specific numerical results are NOT provided in the document) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "The following tests were performed to demonstrate that the Knotless Suture Fixation System is substantially equivalent to other predicate devices: Pullout force Suture retention".
- Sample Size for Test Set: Not specified. The document only states that tests were performed to demonstrate equivalence.
- Data Provenance: Not specified. It's implicitly laboratory testing, but details like country of origin or whether the data is retrospective/prospective are not relevant for these types of mechanical tests and are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are mechanical (pullout force and suture retention), not diagnostic or clinical tests requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. Mechanical tests do not typically involve adjudication methods for ground truth, as the measurements are objective.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical tests were performed." Therefore, no MRMC study was conducted.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a physical medical device (suture fixation system), not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for the "pullout force" and "suture retention" mechanical tests would be the measured physical properties themselves, determined by standardized testing protocols (e.g., ASTM standards). The document indicates that the tests showed the device "met the acceptance criteria," implying there were objectively measurable thresholds.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Summary of the Study and Acceptance Criteria:
The "study" described is a set of nonclinical mechanical tests (pullout force and suture retention) designed to demonstrate that the Knotless Suture Fixation System is substantially equivalent to existing predicate devices. The acceptance criteria for these tests were met, confirming the device's mechanical integrity for its intended use. However, the document does not provide the specific numerical values for these acceptance criteria nor the detailed results or sample sizes from these tests. It only states that the criteria were met. No clinical studies were conducted or presented as part of this 510(k) submission.
§ 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.