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The AlRvance™ Bone Screw System is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring. The AlRvance™ Bone Screw System is also suitable for the performance of a hyoid suspension procedure which can be used in combination with other procedures for the treatment of obstructive sleep apnea (OSA). It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.

The AlRvance™ Bone Screw System consists of three main components: a bone screw attached to surgical suture material, a bone screw inserter, and a suture passer. The AlRvance™ bone screw is a sharp tipped, small diameter titanium screw with polypropylene monofilament no. 1 suture crimped into its base. The AlRvance™ Bone Screw Inserter is a disposable, battery operated, single use device. The AlRvance™ Suture Passer is designed to assist in passing the suture through the floor of the tongue base advancement procedure or through the neck during a hyoid suspension procedure.

This 510(k) summary (K122391) for the AIRvance™ Bone Screw System indicates that the device is substantially equivalent to a predicate device (Repose™ Bone Screw System (K981677)) and did not involve a standalone study or a comparative effectiveness study with human readers assisted by AI.

The submission states: "No additional nonclinical tests were conducted in support of this submission. The current device is identical to the predicate." and further, "Because the new device is physically identical to the predicate device, justifying no new nonclinical testing, along with the evolution of upper airway surgery and the factors reqarding the method of treatment identified in the clinical information, we conclude that this new device is safe and effective for its intended use and performs as well or better than the predicate device."

Therefore, the acceptance criteria and the study that proves the device meets the acceptance criteria are based on its substantial equivalence to the predicate device and existing literature, rather than a new standalone performance study for this specific device.

Here's an attempt to structure the information based on your request, acknowledging the limitations due to the nature of this 510(k) submission:

Acceptance Criteria and Device Performance for AIRvance™ Bone Screw System (K122391)

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) relies on substantial equivalence to a predicate device and existing clinical literature for similar procedures, there are no specific quantitative acceptance criteria or reported performance metrics derived from a new study of the AIRvance™ Bone Screw System itself.

Instead, the "acceptance criteria" can be inferred as the demonstration of substantial equivalence to the predicate device (Repose™ Bone Screw System (K981677)) and the established effectiveness of the underlying surgical procedures (hyoid suspension, tongue base suspension) as supported by peer-reviewed literature.

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

• Sample Size for Test Set: Not applicable. No new test set data was generated for this 510(k) submission for the AIRvance™ Bone Screw System, as its performance was established through substantial equivalence to the predicate and existing literature.
• Data Provenance: The "Clinical Information" section refers to a "summary of clinical studies involving hyoid suspension published in the peer-review literature." The specific countries of origin or whether these were retrospective/prospective studies are not detailed in this summary.

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

• Number of Experts: Not applicable. No new clinical "ground truth" for a test set was established for the specific AIRvance™ Bone Screw System as part of this submission. The "clinical conclusion" is based on the general understanding of hyoid suspension procedures from published literature, implying general consensus among the medical community.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no new test set requiring adjudication in this submission for the AIRvance™ Bone Screw System.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. This submission does not mention or present the results of an MRMC study.
• Effect size of human readers with vs. without AI assistance: Not applicable, as no MRMC study or AI assistance component is described for this device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Was a standalone study done? No. This submission explicitly states: "No additional nonclinical tests were conducted in support of this submission. The current device is identical to the predicate." Therefore, no standalone performance study was conducted for the AIRvance™ Bone Screw System.

7. Type of Ground Truth Used

• Type of Ground Truth: For the purpose of establishing safety and effectiveness, the "ground truth" relied upon is the established clinical efficacy of hyoid suspension procedures as demonstrated in peer-reviewed medical literature and the documented safety and performance of the predicate device (Repose™ Bone Screw System). This is a form of expert consensus and outcomes data at the procedural level, rather than specific performance data for the new device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm requiring a training set. The substantial equivalence argument relies on the physical and technological identity to the predicate device and the clinical understanding of the surgical procedures for which it is used.

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

• How Ground Truth for Training Set Established: Not applicable, as there is no training set for this device.

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