Search Results

The Dunamis Force DFX Tensile Tape Sutures are indicated for use in approximation and/or ligation of soft tissues including use of allograft tissue for orthopaedic surgeries".

The Dunamis Force DFX Tensile Tape Sutures are sterile single use sutures used in approximation and/or ligation of soft tissues, including use in allograft tissue for orthopaedic surgeries. Force DFX Tensile Tape suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force DFX Tensile Tape suture is flat in shape and differs from USP requirements (not USP). It is available in 1.5mm, 2mm, tape width sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE). Force DFX Tensile Tape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.

This document describes a 510(k) premarket notification for the "Dunamis Force DFX Tensile Tape Sutures". It compares the new device to a legally marketed predicate device, the "Teleflex Force Fiber OrthoTape Polyethylene Non-Absorbable Surgical Sutures (K150438)".

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets in this document. Instead, the document claims that the Dunamis device's performance is "identical to the Teleflex device characteristics" and meets "USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture." The reported performance for the Dunamis device is that it meets these requirements.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions that "Dunamis LLc. has established a contract manufactured product specifications that has been accepted by Teleflex Medical which documents and secures the product configuration and required test methods to assure the device is equivalent in performance and to all the elements of Teleflex 510k K150438." This suggests that the testing likely followed the same or similar protocols as the predicate device, but specific details are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a medical device submission focused on physical and mechanical properties, not diagnostic accuracy requiring expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device submission focused on physical and mechanical properties.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical decision support systems where human interpretation is a key factor. This submission concerns the physical properties and performance of a surgical suture.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device submission for a physical surgical suture, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria appears to be established by:

• USP (United States Pharmacopeia) standards: Specifically, "USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture."
• Predicate device characteristics: The Dunamis device claims to have "identical" characteristics and "risk profile identical" to the Teleflex Force Fiber OrthoTape (K150438). This implies that the performance established for the predicate device serves as the benchmark.

8. The Sample Size for the Training Set

Not applicable. This is a medical device submission for a physical surgical suture, not a machine learning algorithm 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.

Ask a specific question about this device