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The Hummingbird™ Tympanostomy Tube System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.

The Hummingbird™ Tympanostomy Tube System (TTS) which includes a tympanostomy tube inserter (TTI) with a preloaded ventilation tube, is a single-use, sterile manual surgical instrument which is used to create a myringotomy in the tympanic membrane and place a ventilation tube. The TTS includes a handle with one or more tip assemblies which contain a sterile tympanostomy tube. Each tip assembly can be removably attached to the handle and includes a positioning rod and a ventilation tube pre-loaded inside the distal end of a sharpened sheath. Attaching the tip assembly to the handle also connects the sheath and actuator, allowing the user to retract the sheath by manually scrolling an actuator located on the handle. The user manually advances the sharpened sheath to create a myringotomy and simultaneously positions the ventilation tube within the myringotomy, always under direct visualization. The user then manually retracts the sharpened sheath away from the myringotomy using the manual actuator located on the handle. The retraction of the sheath releases the tube within the myringotomy. A first tip assembly can then be removed from the handle and replaced with a second preloaded tip assembly for bilateral

The provided document describes the Preceptis Medical, Inc. Hummingbird™ Tympanostomy Tube System (TTS) and its regulatory review (K142282), but it does not contain a table of acceptance criteria or a study that specifically addresses acceptance criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures typically associated with AI/algorithm-based devices.

The document details the device's function as a surgical instrument and predominantly focuses on its safety and successful delivery of tympanostomy tubes in a clinical setting. It also makes a statement about a "comparison between the TTS and predicate device shows that the devices are identical." This suggests the primary "acceptance criterion" for this 510(k) submission and the study conducted was likely demonstrating substantial equivalence to a predicate device, particularly regarding safety and the successful placement of tubes.

However, based on the information provided, here's an attempt to answer your questions by interpreting what could be considered "acceptance criteria" and "reported device performance" for this type of medical device, and then addressing the other points:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit quantitative acceptance criteria (e.g., "Sensitivity > X%") are not present in the document. For a surgical instrument like the Hummingbird™ TTS, acceptance criteria would typically revolve around its ability to perform its intended function safely and effectively. Based on the "Performance Data" section, the key performance indicator was the successful placement of ventilation tubes and the absence of certain adverse events.

2. Sample Size and Data Provenance

• Test set sample size: A total of 69 children (136 ears) across two studies (an initial feasibility study followed by a multi-site study).
• Data provenance: The document does not explicitly state the country of origin, but given the FDA submission context, it is highly likely the studies were conducted in the USA. The studies were prospective clinical studies involving human subjects undergoing tympanostomy procedures.

3. Number of Experts and Qualifications for Ground Truth

• Number of experts: Not explicitly stated how many surgeons or anesthesiologists participated, but the studies involved multiple sites, implying multiple medical professionals.
• Qualifications of experts: The document refers to "surgeons" and "anesthesiologists" who determined the moderate sedation regimen and performed the procedures. It can be inferred they are qualified medical professionals in their respective fields, likely board-certified or similarly qualified, with experience in pediatric ENT procedures and anesthesia. No specific years of experience or sub-specialty details are provided.

4. Adjudication Method for the Test Set

• Adjudication method: Not explicitly mentioned. For a surgical procedure, the "ground truth" (successful tube placement, adverse events) is typically determined and documented by the operating surgeon and/or the attending medical staff at the time of the procedure, possibly reviewed by an independent clinical monitor or study coordinator. There's no indication of a formal 2+1 or 3+1 adjudication process as would be common for subjective image interpretation.

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

• MRMC study: No. This device is a surgical instrument, not an AI/imaging diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess human reader improvement with AI assistance is not applicable and was not performed.

6. Standalone (Algorithm Only) Performance Study

• Standalone study: No. This device is a manual surgical instrument and does not incorporate an algorithm or AI component. Therefore, no standalone algorithm performance study was done.

7. Type of Ground Truth Used

• Type of ground truth: The ground truth was based on clinical outcomes and observations during surgical procedures. This includes:
  • Direct observation of successful tube placement.
  • Documentation of intra-operative and unanticipated adverse events by medical personnel.
  • Assessment of sedation levels and conversions.

8. Sample Size for the Training Set

• Training set sample size: Not applicable. As a manual surgical instrument, there is no "training set" in the context of machine learning or AI algorithms. The development of the device would involve engineering, bench testing, potentially cadaver studies, and iterative design improvements, but not a data-driven training set in the AI sense.

9. How Ground Truth for the Training Set Was Established

• How ground truth for the training set was established: Not applicable. Since there is no training set for an AI algorithm, there is no method for establishing its ground truth. Device development would rely on engineering specifications, preclinical testing results, and established surgical principles.

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