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The DTAD is intended for cutting, coagulation, and removal of tissue in general ENT procedures. Specific indications include: Tonsillectomy and Adenoidectomy.

The DTAD (Disposable Tonsil and Adenoid Device) is a disposable microdebrider blade with a built-in motor that will plug into the users electrosurgical generator. The sole energy application mode is Monopolar coagulation. The monopolar use will require a return electrode for the generator. The cutting performance is the same as the current Gyrus ACMI Diego® tonsil and adenoid blades cleared under K034004, with the addition of monopolar coagulation. The monopolar effect is completely dependent upon the generator used and its settings, which is the same as the other monopolar predicates. The device will be a single-use battery operated microdebrider with monopolar capability. A button will activate the blade oscillation and the standard OR electrosurgical unit footswitch will power the monopolar effect. A nosecone will allow the tip to rotate 90° left or right. The blade will be provided at a 40° bend for adenoids with the capability of being reduced to 15° for tonsillectomies. The blade angle is flexible, and the design allows the blade to be bent between 0° and 50°. The microdebrider device will include a monopolar cable that connects to a separate standard operating room electrosurgical generator. A standard suction tube will be attached to the suction port and a clip will attach the tubing to the cable. Two batteries, provided with a three year shelf life from the manufacturer, will be provided in the DTAD cable to power the blade oscillation. The battery leads connect internally to the PCB in the housing which connects to the oscillation switch and motor. When the handpiece button is pressed, power is sent to the motor which oscillates a gear which in turn oscillates the inner blade gear at approximately 3500 rpm. The monopolar lead from the cable is connected directly to the outer blade and is powered by the electrosurgical generator footswitch. For user convenience the package will also include a disposable stylet for declogging if needed.

The Gyrus ACMI DTAD is a disposable microdebrider blade with a built-in motor and monopolar coagulation capability. Its intended use is for cutting, coagulation, and removal of tissue in general ENT procedures, specifically tonsillectomy and adenoidectomy.

Here's the breakdown of its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "sample size" for the test set in terms of a number of cases or patients. Instead, it describes:

• Non-clinical/Preclinical Performance:
  • Bench tissue: Evaluated ex vivo using bovine tissue. The number of bovine tissue samples is not specified.
  • Animal: Evaluated in vivo using porcine models. The number of porcine models is not specified.
• Data Provenance: The preclinical studies used animal (porcine) and ex vivo (bovine) tissue, suggesting laboratory-based testing rather than human clinical data. The exact country of origin for these animal models or tissue is not specified.
• Retrospective or Prospective: These were prospective studies conducted specifically for the device's evaluation.

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

The document does not mention the use of human experts to establish "ground truth" for the test set in the way one might for diagnostic imaging or a subjective clinical assessment. The performance evaluations were based on objective measurements and observations in bench and animal studies. Therefore, no specific number or qualification of experts establishing ground truth is provided.

4. Adjudication Method for the Test Set

Not applicable. The performance testing described (non-clinical and preclinical) does not involve subjective human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document explicitly states: "No clinical testing was conducted." The evaluation was based on non-clinical and preclinical performance, and substantial equivalence to predicates.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies conducted were standalone in the sense that they evaluated the device's technical performance and its ability to cut, coagulate, and remove tissue without human-in-the-loop real-time performance interaction being measured as the primary outcome. The studies focused on the intrinsic capabilities of the DTAD.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established scientific and engineering principles for functional performance, direct physical measurement of device characteristics, and the observed effects on biological tissue. It includes:

• Objective Measurements: For mechanical, electrical, and functional performance (e.g., tip vibration, pull force, battery endurance, torque).
• Observed Biological Effects: For cutting efficiency, coagulation effectiveness, thermal impact, and tissue removal in ex vivo bovine and in vivo porcine models.
• Comparison to Predicate Devices: The performance of the DTAD was compared to the established safe and effective performance of predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a surgical instrument, not an AI/ML algorithm that requires a "training set" of data. Its design and performance are based on engineering principles, material science, and established medical device functionality, not on learning from a data set.

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

Not applicable, as there is no training set for this type of medical device.

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