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SeptAlign is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

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

The SeptAlign implantis provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. The SeptAlign implant and accessory delivery tool are provided sterile and are intended for single-use only.

I am sorry, but the provided text from the FDA 510(k) notification for the SeptAlign device does not specify acceptance criteria for device performance or describe a study that proves the device meets such criteria in terms of accuracy, sensitivity, or specificity for any diagnostic or prognostic task.

The document primarily focuses on the device's mechanical and material performance, biocompatibility, packaging, and shelf-life. It states that "No animal or clinical performance testing was required to support substantial equivalence." This indicates that the substantial equivalence determination for this device (SeptAlign) was not based on clinical performance studies measuring diagnostic accuracy or reader improvement.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to diagnostic/prognostic metrics.
2. Sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or ground truth types. These are typically associated with studies evaluating AI/diagnostic device performance, which were not required or reported for this submission.

The "Performance Data" section (Pages 4-5) lists the following performance elements:

• Biocompatibility Testing: Confirms materials do not pose a risk of negative interaction. This is about safety, not diagnostic performance.
• Distribution, Packaging and Shelf-Life Testing: Demonstrates integrity of sterile barrier and preservation of performance, related to product stability and safety.
• Performance Testing – Bench: Focuses on the accessory delivery tool's functionality, mechanical integrity, and cannula joint strength. This is about the physical device and its delivery mechanism working as intended, not its ability to detect or diagnose anything.

The acceptance criteria implicitly met are related to these physical and material properties (e.g., passing biocompatibility tests, maintaining sterility, successful mechanical deployment).

In summary, the provided document does not contain the type of information needed to answer your questions regarding acceptance criteria for diagnostic performance or studies proving such performance, as the device is a physical implant (a bioabsorbable ribbon) rather than a diagnostic or AI-powered device.

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