Search Results

HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surqical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.

The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for a medical device called "HS Fiber Sutures." This document is not about an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and studies for AI/ML device performance.

The questions are specifically about:

• Table of acceptance criteria and reported device performance (for an AI/ML model)
• Sample size and data provenance for a test set (for an AI/ML model)
• Number and qualifications of experts for ground truth (for an AI/ML model)
• Adjudication method for a test set (for an AI/ML model)
• MRMC comparative effectiveness study (for an AI/ML model)
• Standalone performance (for an AI/ML model)
• Type of ground truth (for an AI/ML model)
• Sample size for training set (for an AI/ML model)
• Ground truth establishment for training set (for an AI/ML model)

Instead, this document describes a traditional medical device (surgical sutures) and demonstrates its substantial equivalence to a predicate device. The performance data mentioned for the HS Fiber Sutures relates to:

• USP performance requirements for needle attachment and tensile strength.
• Biocompatibility (per ISO 10993-1:2018).
• Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments.

The conclusion is that the HS Fiber Suture (K231163) is substantially equivalent to the predicate device (K190817), primarily due to identical intended use, materials, manufacturing processes (sterilization), and meeting established physical performance standards for sutures. There are no mentions of AI, machine learning, algorithms, or any studies involving human readers or expert consensus for image interpretation.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device