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The MediENT® Middle Turbinate Implant is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. 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.

The MediENT® Middle Turbinate Implant is a tack made of an absorbable copolymer that is designed to hold the middle turbinate away from the lateral nasal wall. The sterile, single-use implant is delivered using standard surqical instruments, such as Alligator grasper, Pediatric Blakesly, MediENT® Grasper or similar. The implant provides temporary fixation and can be expected to start degrading approximately 2 to 3 months post-implantation. The MediENT® Middle Turbinate Implant is packaged and provided sterile for single use only.

Acceptance Criteria and Device Performance for MediENT® Middle Turbinate Implant (K130354)

The MediENT® Middle Turbinate Implant is intended to provide temporary fixation of the middle turbinate to the nasal septum to separate it from the lateral nasal wall during the post-surgical healing phase, thereby minimizing the risk of adherence (synechia) and lateralization. The device's performance was evaluated through a clinical study against a predicate device, MeroPack™.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria (e.g., "Synechia rate must be less than X%"). Instead, the acceptance criterion for substantial equivalence was qualitative: to demonstrate that the MediENT® device is "as good as" the predicate device, MeroPack™, in preventing synechia and lateralization of the middle turbinate, and that its placement and implantation are safe.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 60 patients.
• Data Provenance: Prospective, randomized, multi-center randomized trial conducted at five U.S. centers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• The summary mentions that "synechia was evaluated by a blinded reviewer." It does not specify the exact number of experts (it implies one primary blinded reviewer) or their qualifications (e.g., radiologist, ENT surgeon, experience level).

4. Adjudication Method for the Test Set

• The summary states that "synechia was evaluated by a blinded reviewer." This suggests a single blinded reviewer for this particular outcome. There is no mention of an adjudication method like 2+1 or 3+1, which implies that a consensus process involving multiple reviewers was not explicitly used for the final determination of synechia in the clinical trial description. Other elements like edema and infection were "endoscopically examined to rate" by unspecified personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of comparing human readers' performance with and without AI assistance. This device is an implantable medical device, not an AI-powered diagnostic or assistive tool for human interpretation.

6. If a Standalone Performance Study Was Done

• Yes, a standalone clinical performance study was done for the MediENT® device, but it was a comparative effectiveness study against a predicate device, not a "standalone" in the sense of an algorithm-only review for AI systems. The device itself (the implant) was evaluated directly in human subjects, functioning as intended without constant human intervention after placement.

7. The Type of Ground Truth Used

• The ground truth for the clinical study was based on clinical observation and assessment by a "blinded reviewer," specifically for synechia, and also included endoscopic examination for edema and infection, as well as turbinate position. This is a form of expert clinical assessment serving as the reference standard.

8. The Sample Size for the Training Set

• This question is not applicable in the context of this traditional medical device submission. The MediENT® Middle Turbinate Implant is a physical implant, not a software algorithm or AI model that requires a "training set" in the machine learning sense. The "training" for such a device would involve bench testing, cadaveric studies, and usability testing, all focused on its physical and mechanical properties and surgical delivery.

9. How the Ground Truth for the Training Set Was Established

• As mentioned above, this question is not applicable. For a physical device, the "ground truth" during development (analogous to training) would be established through engineering specifications, biomechanical testing standards, and preclinical feedback from surgeons on usability and performance in cadaveric models. These activities are designed to optimize the device design to meet performance requirements rather than to train an algorithm.

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