Search Results

The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.

The Saffron Fixation System consists of a single-use disposable Saffron Fixation Tool (delivery tool) and implantable tissue fixation Saffron Anchors (packaged and sold separately) made of polysulfone that are intended to be compatible with commercially available sutures up to size 0 (not provided as a part of the system). The delivery tool facilitates anchor placement with or without direct visualization and may be used to implant multiple anchors in a single patient as needed by the surgeon. The fixation anchors are multi-barbed hooks that provide permanent fixation points for suture attachment to the sacrospinous ligament.

The provided text describes the Saffron™ Fixation System, a medical device for attaching sutures to pelvic floor ligaments. The document does not contain information about acceptance criteria for a study or a study proving the device meets these criteria in the context of an AI/ML powered device.

Instead, the document details a 510(k) premarket notification for a traditional medical device, focusing on demonstrating substantial equivalence to a predicate device based on non-clinical performance data (biocompatibility, mechanical/performance testing, sterilization, and packaging).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets these criteria, as the input document does not pertain to an AI/ML powered device or a clinical study with detailed acceptance criteria of that nature.

Here's why the provided text cannot answer your questions and what it does contain:

• No mention of AI or ML: The Saffron™ Fixation System is a mechanical device, not an AI/ML powered device. Therefore, questions about "human readers improve with AI vs without AI assistance" or "standalone (algorithm only without human-in-the-loop performance)" are irrelevant.
• No clinical study for effectiveness: The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This means there's no clinical trial data to establish effectiveness in a human population.
• Focus on Substantial Equivalence via Non-Clinical Data: The FDA clearance for this device is based on demonstrating that it is "substantially equivalent" to an existing legally marketed device (predicate device). This is primarily achieved through showing similar technological characteristics and non-clinical performance data (e.g., strength, material safety, sterility) rather than a clinical effectiveness study against predefined acceptance criteria.
• "Acceptance Criteria" in this context refers to regulatory compliance: The "acceptance criteria" for this device are broadly the standards and test results that show it meets its intended function safely and effectively, and is comparable to the predicate device, as outlined in the various ISO standards and FDA guidances cited. They are not framed as specific performance metrics from a clinical study.
• Ground Truth: For a traditional mechanical device like this, "ground truth" for training or testing isn't applicable in the same way it is for AI. Performance is assessed through engineering tests (e.g., tensile strength, penetration force).

If you were expecting information on an AI/ML powered device, please provide a different document.

Ask a specific question about this device