Search Results

The SandShark Injectable Anchor (SIA) System is intended to be an accessory to the stimulator component of the Stimwave Freedom Spinal Cord Stimulator (SCS) System to secure the stimulator to the fascia or interspinous/supra-spinous ligament.

The Stimwave Technologies Incorporated (Stimwave) SandShark Injectable Anchor (SIA) System is used to fixate the Stimwave Freedom Stimulator to surrounding tissue. The System is comprised of a carbothane anchor (SandShark Anchor) that is transferred onto the deployment handle (SandShark Injectroducer) with the Loading Rod and Loading Base. The SIA System is provided sterile. The SandShark Injectroducer is used to deploy the SandShark Anchor onto the Stimulator.

The provided text describes the Stimwave SandShark Injectable Anchor (SIA) System and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with numerical performance values relevant to AI/ML devices.

The document is a 510(k) summary for a medical device (an anchor system for spinal cord stimulators), not an AI/ML device. Therefore, the questions related to AI/ML performance metrics, sample sizes for AI/ML models, expert ground truth adjudication, MRMC studies, and standalone AI performance are not applicable to the content of this document.

The document focuses on demonstrating substantial equivalence to predicate devices through:

• Intended Use and Technological Characteristics Comparison: Showing that the SIA System has the same intended use and similar technological characteristics as existing legally marketed devices.
• Biocompatibility Data: Confirming that the materials meet biological safety and compatibility requirements (ISO 10993-1:2009).
• Non-Clinical Performance Data: Verifying that the device meets system design requirements and applicable voluntary standards for physical performance (e.g., protection from temperature change, atmospheric pressure change as per AAMI ANSI ISO 14708-3:2008).

Since the device is not an AI/ML system, the requested information in the prompt, which is tailored for AI/ML device evaluations (e.g., sensitivity, specificity, expert ground truth, training/test sets, etc.), cannot be extracted from this document.

Therefore, I am unable to provide a table of acceptance criteria and reported device performance, or details about studies proving device performance with respect to AI/ML metrics, as this information is not present in the provided text.

Ask a specific question about this device