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The Riverpoint Medical IDEAL Ziploop is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

The Riverpoint Medical IDEAL Ziploop adjustable button loop is comprised of an ultrahigh molecular weight polyethylene (UHMWPE) loop combined with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate or as a single titanium (Ti-6Al-4V ELI per ASTM F136) plate. Additional non-absorbable sutures consisting of UHMWPE looped through the titanium plate to aide in assembly of the device and passing the plate through the intended void. The UHMWPE is available undyed (white), dyed blue, or dyed black. A titanium (Ti-6Al-4V ELI per ASTM F136) plate or button is affixed to the loop during the procedure for configurations where the button is not pre-attached to the loop. For models that come with a pre-attached titanium plate, the procedure is the same except the titanium plate is passed through the void. In both configurations, additional sutures are used to pass the loop and titanium plate (if pre-attached) parallel through the bone tunnel and secure into place.

The device is sterilized by ethylene oxide gas and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The classification for the IDEAL Ziploop is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.

The provided document is a 510(k) premarket notification for a medical device called the IDEAL Ziploop. This type of regulatory submission in the United States focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific (quantitative) acceptance criteria through novel clinical studies.

Therefore, the document does not contain the information requested regarding acceptance criteria for device performance, the study design (test set sample size, data provenance, expert consensus details, adjudication methods, MRMC studies, standalone performance), or training set details typically found in submissions for novel AI/ML-based medical devices or devices requiring de novo clearance with specific performance targets.

Instead, the document highlights:

• Substantial Equivalence: The primary method of demonstrating safety and effectiveness is by showing the IDEAL Ziploop is substantially equivalent to a predicate device (Riverpoint Medical OrthoButton AL K171060 and K230212).
• Performance Data (Non-Clinical): Performance data is primarily non-clinical, focusing on:
  • Suture requirements (USP tensile strength)
  • Sterilization adoption validation
  • Biocompatibility testing (ISO10993-1:2018)
  • Product packaging validation (ISO 11607-1:2006)
  • Usability engineering validation with simulated use in cadaveric models (EN62366: 2015)
  • LAL and rabbit pyrogenicity testing
  • Non-clinical mechanical testing: Specifically, cyclic testing to verify fixation strength was performed as compared to the predicate device.
• Conclusion: The device "performed comparably to the predicate device and the validations performed demonstrated that the IDEAL Ziploop met all requirements for its intended use."

In summary, this document is a 510(k) for a hardware medical device (a bone fixation fastener), not an AI/ML-driven device or one requiring extensive clinical performance studies against defined acceptance criteria. Therefore, the specific details requested about acceptance criteria, test set, expert involvement, MRMC studies, and training set information (which are common for AI/ML device submissions) are not present.

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