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TurbAlign is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with sinus surgery (e.g., endoscopic sinus surgery, FESS). The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral nasal wall.

TurbAlign™ is a bioabsorbable, polydioxanone implant designed to hold the middle turbinate away from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. The implant includes self-anchoring features (e.g., one "distal anchor" and multiple "proximal anchors") which enable attachment to the middle turbinates for short-term fixation of the middle turbinate to the nasal septum.

TurbAlign includes an attached surgical needle which is inserted into the lateral aspect of the middle turbinate. It is then passed through the nasal septum and then through the contralateral middle turbinate. The implant is then pulled through all three structures until the distal anchor feature is embedded in the first middle turbinate at which time the turbinate is medialized to the septum. The contralateral turbinate is then medialized to the opposite side of the septum using a freer or equivalent and held into place via the proximal anchor. The excess portion of the implant is trimmed off.

The sterile, single-use implant is delivered using standard surgical instruments, such as needle drivers. The implant provides temporary fixation and is fully resorbed over 180 days.

This document is a 510(k) Pre-market Notification for a medical device called TurbAlign. It does not describe a study based on analyzing medical images or clinical data for AI/ML device approval. Instead, it describes hardware device attributes and physical performance tests.

Therefore, the requested information regarding acceptance criteria, reported performance for an AI/ML device, sample size for test/training sets, experts, adjudication methods, MRMC studies, or specific types of ground truth cannot be extracted from this document, as it pertains to a different type of medical device submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for an intranasal splint based on:

1. Biocompatibility Testing: Ensuring the materials are safe for human contact.
2. Distribution, Packaging, and Shelf-Life Testing: Verifying sterile barrier integrity and device performance over time.
3. Performance Testing – Bench: Evaluating mechanical integrity, anchoring features, and usability by ENT physicians in cadaver specimens.

The closest this document comes to "performance criteria" is the statement that "Mechanical integrity testing of the implant and needle properties was performed and demonstrated that the physical and functional requirements were met" and "Comparative testing... demonstrated equivalent performance of the device's anchoring features in the relevant tissue." For usability, it states that "the physicians graded the turbinate position post-TurbAlign placement and confirmed both turbinates were medialized and did not contact the lateral wall." However, these are not quantitative acceptance criteria in the format requested for an AI/ML study.

Summary of missing information for an AI/ML device:

• Table of acceptance criteria and reported device performance: Not applicable; no AI/ML performance metrics are mentioned.
• Sample size for test set and data provenance: No test set of data (images, etc.) is mentioned.
• Number of experts and qualifications: Experts (ENT physicians) were used for usability testing of the physical implant in cadavers, not for establishing ground truth on a data set.
• Adjudication method: Not applicable.
• Multi Read Multi Case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable; this is a physical device.
• Type of ground truth used: Not applicable for an AI/ML context. The closest is the physical observation of turbinate medialization by physicians in cadavers.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

This 510(k) pertains to a traditional, non-AI medical device.

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