Search Results

The Spirair Nasal Septal Strap is used to support and straighten in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

The Spirair Nasal Septal Strap is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. The Nasal Septal Strap is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. The Nasal Septal Strap is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle attachment to the tissue which is trimmed off after use. The Nasal Septal Strap is provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.

This document is a 510(k) summary for the Spirair Nasal Septal Strap, detailing its regulatory review and substantial equivalence to a predicate device. It primarily focuses on the device's technological characteristics, indications for use, and performance data required for regulatory clearance. It does not describe a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device, as the Spirair Nasal Septal Strap is a physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device, because the provided text is for a physical medical device and lacks any mention of AI, algorithms, or complex performance metrics typical of AI/ML systems.

The document discusses performance data related to:

• Biocompatibility Testing: According to ISO 10993-1 and FDA Guidance, assessing cytotoxicity, sensitization, irritation, implantation, and chemical characterization.
• Distribution, Packaging, and Shelf-Life Testing: Successful completion of accelerated aging and integrity of sterile barrier.
• Performance Testing - Bench: Demonstrating physical and functional requirements, including mechanical properties, material properties, migration of implant, and in vitro degradation.
• Performance Testing - Animal: A GLP animal study for safety, degradation, and biocompatibility.
• Performance Testing - Clinical: Interim safety data from a prospective, multi-center, multi-cohort, early feasibility clinical study in the US.

These tests are designed to demonstrate the safety and effectiveness of a physical implantable device, not an AI/ML algorithm.

Ask a specific question about this device