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The Hummingbird® Tympanostomy Tube System (HTTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6 months and older.

The Hummingbird® Tympanostomy Tube System (HTTS), which includes 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 surgeon 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.

The provided text does not describe an AI/ML device but rather a medical device called the "Hummingbird® Tympanostomy Tube System (HTTS)". Therefore, the information requested regarding acceptance criteria and study proving device meets acceptance criteria, specifically for an AI/ML device, cannot be extracted from this document.

However, I can extract the information relevant to the clinical performance of the HTTS device itself, based on the provided text, using the structure you've requested. Please note that terms like "test set," "training set," "experts," and "ground truth" are typical for AI/ML studies and may not perfectly align with how a traditional medical device's clinical study is described, but I will interpret them to the best of my ability based on the provided clinical data.

Device: Hummingbird® Tympanostomy Tube System (HTTS)

Device Type: Medical Device (Tympanostomy Tube Inserter with pre-loaded ventilation tube) - Not an AI/ML device.

Acceptance Criteria (Interpreted as Clinical Performance Endpoints) and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

1. Sample Size and Data Provenance:

   • Test Set (Clinical Study Population): A total of 48 children (74 ears) for the "2-17 years old" study.
   • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be a multi-site study in an ENT office setting.
   • Retrospective or Prospective: Implied to be prospective, as it describes a multi-site study where procedures were performed and results collected.

2. Number of Experts and Qualifications:

   • The study involved ENT specialists performing the procedures and evaluating outcomes. Specific numbers or detailed qualifications (e.g., years of experience) beyond "ENT" are not provided. The recovery of the child was evaluated by the "ENT and staff."

3. Adjudication Method for the Test Set:

   • No formal adjudication method (like 2+1 or 3+1 used in imaging studies) is described. Clinical outcomes were presumably determined by the treating ENT and staff, and adverse events were recorded.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC study was not done, as this is not an AI/ML diagnostic or assistive device. The study evaluates the effectiveness and safety of a surgical device performed by human operators.

5. Standalone Performance:

   • This concept is not directly applicable. The device (HTTS) is a manual surgical instrument. Its "performance" is inherently tied to its use by a human operator. The study provides data on its performance when used in a clinical setting by an ENT.

6. Type of Ground Truth Used:

   • The "ground truth" for clinical outcomes (successful procedure completion, efficacy of tube delivery, safety/AEs) was established through direct observation, medical records, and clinical assessment by the treating physicians and staff during and after the procedure. Parent surveys were also collected for satisfaction.

7. Sample Size for the Training Set:

   • This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device design and previous predicate device (K200952) serve as the foundation for this iteration.

8. How Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no AI/ML training set. The device's design and previous version (K200952) are based on traditional engineering and medical device development processes, which include preclinical testing and clinical data from previous iterations. The present study for K221254 uses clinical data from the identical device (as the predicate) to demonstrate substantial equivalence for an expanded age group.

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The Hummingbird® Tympanostomy Tube System (HTTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic of the patient and is indicated to be used in office settings for children 6-24 months old.

The Hummingbird® Tympanostomy Tube System (HTTS), which includes a preloaded ventilation tube, is a single-use, sterile manual surgical instrument. The HTTS is used to create a myringotomy in the tympanic membrane and place a ventilation tube. The surgeon manually advances the sharpened sheath to create a myringotomy and simultaneously positions the ventilation tube within the myringotomy, always under direct visualization. The surgeon 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.

The provided text describes the Hummingbird® Tympanostomy Tube System (HTTS) and its performance data, particularly in an office setting for children. Here's a breakdown based on the categories you provided:

1. A table of acceptance criteria and the reported device performance

While the document doesn't explicitly list "acceptance criteria" in a separate table, it presents several performance metrics from a clinical study, implicitly serving as the basis for evaluating the device's acceptability for its intended use. The comparison to a predicate device's performance also highlights what might be considered acceptable thresholds.

2. Sample size used for the test set and the data provenance

• Sample Size: 180 children (360 ears) underwent tympanostomy procedures in an ENT office using the HTTS.
• Data Provenance: The study was a "multi-site clinical study." While specific countries are not mentioned, the FDA clearance suggests it was likely
  conducted, at least in part, within the United States. The data is prospective, collected specifically for this clinical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: The document states "A committee of clinicians with ENT and/or pediatric specialty independently reviewed 18 procedure videos". The exact number of clinicians on this committee is not specified, but it was more than one due to the phrasing "each of the reviewers".
• Qualifications of Experts: Clinicians with "ENT and/or pediatric specialty". No specific years of experience are mentioned.

4. Adjudication method for the test set

• For the video review of child tolerance, it appears experts reviewed independently, and the aggregated results (bar graph tabulation) indicate a consensus was reached, as "In all 18 cases, each of the reviewers deemed that the child tolerated the procedure acceptably." This suggests either unanimous agreement or a very strong majority for acceptability. No specific formal adjudication such as 2+1 or 3+1 is detailed for the video review, but the reported outcome implies a high level of agreement.
• For the core clinical endpoints (success rate, AE rate), these are typically based on observed events and objective measures, not multi-reader adjudication of images.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance for human readers was not done. The device is a surgical instrument (Tympanostomy Tube System), not an AI-powered diagnostic or assistive tool for human interpretation of data. The study focuses on the device's performance outcomes (efficacy, safety, procedural characteristics) during its use.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable. The device is a physical surgical instrument, not an algorithm. Its performance is inherently tied to its use by a human operator (surgeon) in real-world clinical settings, making "standalone" algorithm-only performance irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance relies on several types of data:

• Clinical Outcomes Data: This includes direct measurements of success rates (tube delivery, completion in office), adverse event rates, procedure times, early extrusion rates, and plugging rates.
• Expert Observational Consensus: For the child's tolerance during the procedure, a committee of ENT/pediatric clinicians reviewed videos and made judgments (see point 3 & 4).
• Patient/Parent Reported Outcomes: Parent surveys provided data on satisfaction and willingness to recommend.

8. The sample size for the training set

• This question is not applicable to the information provided. The "training set" concept is relevant for machine learning algorithms. This document describes the clinical evaluation of a medical device (surgical instrument), not an AI system. The study described is a clinical validation study, not a dataset for training.

9. How the ground truth for the training set was established

• This question is not applicable for the same reasons as point 8.

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