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The Solo+ Tympanostomy Tube Device 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 patients 6 months and older.

The Solo+ Tympanostomy Tube Device (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.

To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation (blue) button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.

The provided text describes the 510(k) clearance for the Solo+ Tympanostomy Tube Device (TTD). While it details the device's characteristics, comparison to predicate devices, and general non-clinical testing, the clinical study information focuses on comparative effectiveness and patient safety/success, rather than specific acceptance criteria for performance metrics that would typically be seen in a study evaluating an AI device or a device with quantifiable performance outputs like accuracy, sensitivity, or specificity.

The Solo+ TTD is a surgical instrument, and its "performance" in this context is primarily related to its ability to successfully place a tympanostomy tube and maintain patient safety. Therefore, the "acceptance criteria" discussed here are related to the success rate of tube placement and the absence of serious adverse events.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance Study

The provided document describes a clinical study to support the substantial equivalence of the Solo+ TTD for an expanded patient population (pediatric patients 6 months and older) compared to its primary predicate (K232702, which was indicated for patients 6-24 months) and a secondary predicate (K221254, which already covered patients 6 months and older). The "acceptance criteria" are implicitly derived from the successful outcomes observed in the study and their comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.

The Solo+ Tympanostomy Tube Device 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 6-24 months old.

The Solo+ Tympanostomy Tube Device TTD (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.

To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.

The provided text describes the Solo+ Tympanostomy Tube Device (TTD) and its substantial equivalence determination. However, it does not contain information about studies proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance, as typically seen in submissions for AI-powered devices. The device described, the Solo+ TTD, is a physical medical device for placing tympanostomy tubes, not an AI/software device.

Therefore, many of the requested points in your prompt are not applicable to the provided document. I can, however, extract the relevant information regarding the clinical study performed to demonstrate the device's safety and effectiveness compared to a predicate device.

Here's the closest possible answer based on the provided text, focusing on the clinical study conducted for the physical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The study conducted for the Solo+ Tympanostomy Tube Device (TTD) was a multi-site clinical study designed to demonstrate substantial equivalence to its predicate device, the Preceptis Hummingbird TTS, for in-office tympanostomy procedures in pediatric patients.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents the "acceptance criteria" (though not explicitly labeled as such, these are the primary outcomes measured for comparison of substantial equivalence) as clinical outcomes compared between the Solo+ TTD and the predicate device.

2. Sample Size and Data Provenance:

• Test Set Sample Size: A total of 20 patients (40 ears).
• Data Provenance: Conducted in a multi-site study across 2 sites. The country of origin is not explicitly stated, but the applicant company is based in Ireland. The study was a clinical study, implying a prospective design for the purpose of demonstrating substantial equivalence.

3. Number of Experts and Qualifications: Not applicable. This was a clinical study involving patients and the mechanical placement of a device, not an AI/image-based diagnosis requiring expert readers for ground truth establishment.

4. Adjudication Method: Not applicable. (See #3)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This was not a study evaluating human reader performance with or without AI assistance but rather the performance of a physical surgical device.

6. Standalone (Algorithm Only) Performance: Not applicable. This is a physical device, not an algorithm.

7. Type of Ground Truth Used: The "ground truth" for this study was the observed clinical outcome of the tympanostomy tube placement (i.e., whether the tube was successfully placed and if additional instruments were needed). This is essentially outcomes data directly observed during the procedure and initial follow-up.

8. Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How Ground Truth for Training Set was Established: Not applicable. (See #8)

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• 1 ) Chronic otitis media with effusion characterize as either serous, mucoid, or purulent.
• 2. Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies.
• 3. A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistent or recurrent otalgia, persistent or recurrent vertigo and/or timitus.
• 4. Atelectasis recurrent form retraction pocket of the tympanic membrane or eustachian tube dysfunction.

The Grace Medical, Inc. ETFE (Fluoroplastic) Ventilation Tubes are intended to ventilate the middle ear subsequent to otitis media. The placement of the tympanic membrane provides the means for any fluid buildup in the middle ear while creating an avenue of the passage of air to equalize pressure on either side of the drum. These ventilation tubes will be made from ETFE (fluoroplastic). ETFE has been used as a material for ventilation tubes and other middle ear application for many years.

This document describes an FDA 510(k) premarket notification for a medical device, specifically a Tympanostomy Tube. The submission aims to demonstrate "substantial equivalence" to previously cleared devices rather than providing clinical performance data with acceptance criteria for a new AI application.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI device is not applicable to this document.

This document focuses on:

• Device: Grace Medical, Inc. ETFE Tympanostomy Tube (K232059)
• Predicate Devices: Grace Medical, Inc. PTFE Tympanostomy Tube (K062385) and Micromedic, Inc. ETFE Tympanostomy Tube (K830228)
• Primary Change: Material change from PTFE to ETFE for the Grace Medical device.
• Demonstration of Substantial Equivalence: By comparing technological characteristics, indications for use, and presenting non-clinical bench testing, biocompatibility, sterility, and packaging testing data.

There is no mention of an AI component or software in this document.

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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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Indicated where chronic Eustachian tube dysfunction does not respond to conventional therapy.

The tympanostomy tube is a silicone tube that is intended to provide ventilation and drainage to the middle ear.

The provided document is a 510(k) summary for the Preceptis Medical Hummingbird Tympanostomy Tube. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not available in this document. The document explicitly states: "The tympanostomy tube met all performance acceptance criteria," but it does not elaborate on what those criteria were or how they were met beyond general statements about equivalence to the predicate device.

Here's a breakdown of the available information based on your request:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available. The document does not describe a clinical study or a test set involving human subjects. The evaluation appears to be based on an engineering comparison and material properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not available. No human experts are mentioned as establishing ground truth for a test set in this 510(k) submission, as there is no described clinical or performance study with such a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not available. No test set or adjudication method is described.

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. This is a medical device for implantation, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This device is a physical medical implant, not an algorithm.

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

• Not applicable/Not available. For the "Performance Data" stated as "The tympanostomy tube met all performance acceptance criteria," the document implies that the ground truth for performance was likely established through engineering tests and material characterization to demonstrate that the device meets its design specifications and characteristics similar to the predicate device. No clinical outcomes data or pathology is referenced as ground truth for this submission, which focuses on substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device; therefore, there is no training set in the conventional sense.

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

• Not applicable. See point 8.

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When inserted through a myringotomy, a ventilation tube provides a passageway for movement of air between the auditory canal and the middle ear. The unobstructed passageway may also allow a means of drainage of fluids resulting from acute or chronic otitis media from the middle ear into the auditory canal. In addition, surgical placement of ventilation tubes also provides a means of equalizing air pressures between the outer ear and the middle ear and continued ventilation to prevent fluid accumulation within the middle ear.

The surgeon must use medical judgment and consider the patient's medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but not limited to:

• Chronic otitis media with effusion characterized as serous, mucoid, or purulent
• Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies
• A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus
• Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction

Medtronic® Xomed® Ventilation (tympanostomy) Tubes are small tubular implants available in a variety of biocompatible materials including silicone elastomer, fluoroplastic. C-FLEX® TPE. stainless steel and titanium. Numerous designs and sizes are available with single or multiple flanges to satisfy various surgical techniques for insertion and to facilitate short or long-term communication of the auditory canal with the middle ear. Some tubes are fitted with semi-permeable membranes intended to allow free passage of air while preventing movement of fluids into the middle ear.

The provided text describes a 510(k) premarket notification for "Ventilation (Tympanostomy) Tubes" by Medtronic Xomed, Inc. This submission is for consolidating previously cleared and preamendment ventilation tubes and claims substantial equivalence to predicate devices. As such, it does not contain information about a study to prove acceptance criteria for a new device or algorithm performance.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this document. This submission relies on the existing clearance and established performance of the predicate devices.

Here's a breakdown of what can be extracted and what cannot:

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

• Not Applicable. This submission is for devices that have already been cleared or were preamendment devices, meaning their performance and safety were established previously. No new performance acceptance criteria or study results are presented in this document. The document asserts "same" for all comparative characteristics with existing predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No new test set or data provenance is mentioned as no new performance testing was conducted for this 510(k). The document states, "The Ventilation (Tympanostomy) Tubes did not undergo any design changes as a result of this submission. Therefore no additional bench, animal or clinical testing is required."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No test set or ground truth establishment relevant to the performance of a new device is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or related adjudication method is mentioned.

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

• Not Applicable. This is not an AI device, and no MRMC study was conducted or referenced for this submission.

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

• Not Applicable. This is not an AI/algorithm device.

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

• Not Applicable. No new ground truth for performance evaluation is mentioned. The clearance is based on substantial equivalence to predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/algorithm device and thus has no training set.

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

• Not Applicable. This is not an AI/algorithm device and thus has no training set or associated ground truth establishment.

Summary of Relevant Information from the Document:

The document focuses on demonstrating substantial equivalence to existing predicate devices. The key argument is that the proposed Ventilation (Tympanostomy) Tubes are identical in intended use, indications for use, technological characteristics, and principle of operation to 12 previously cleared predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" appear to be meeting the characteristics of the predicate devices, thereby establishing substantial equivalence. The reported "performance" is implicitly that these devices function identically to the legally marketed predicates.

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

The Preceptis 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 TTI comprises 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 procedures.

Here's a breakdown of the acceptance criteria and study details for the Preceptis Tympanostomy Tube System (TTS), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states: "The Preceptis TTS met the study safety and performance criteria."

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: 25 pediatric patients, involving a total of 50 ears.
• Data Provenance: Prospective, treatment-only multicenter clinical study. The document does not explicitly state the country of origin, but given the FDA submission and the language used, it's highly likely to be the United States.

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

• Number of Experts: 1
• Qualifications of Experts: An independent otolaryngologist. No specific years of experience are provided, but the title suggests a qualified medical professional specializing in ear, nose, and throat.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The evaluation appears to be based on direct observation during the procedures by the 6 investigators, and the post-procedure safety review by a single independent otolaryngologist.

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

No, an MRMC comparative effectiveness study was not done. This study solely evaluated the performance and safety of the TTS device in a treatment-only context. It did not compare the device's performance against human readers or assess improvement with AI assistance (as the device itself is a manual surgical instrument, not an AI diagnostic tool).

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only) performance study was not done. The device is a manual surgical instrument, not an algorithm, and its performance is inherently tied to its use by a human surgeon.

7. Type of Ground Truth Used

The ground truth used was primarily clinical observation and outcomes data:

• Procedure Success: Directly observed by the 6 investigators during the surgery (whether the tympanostomy tube was successfully delivered and positioned).
• Safety: Evaluated by an independent otolaryngologist based on clinical results and adverse events.
• Tube Retention: Assessed at follow-up clinical visits.

8. Sample Size for the Training Set

The document does not mention a training set as this is a clinical study for a medical device (surgical instrument), not an AI/machine learning model.

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

Not applicable, as there was no training set for an AI/machine learning model.

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The Tympanostomy Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Paparella type tympanostomy tube.
Conditions for which tympanostomy tubes are indicated include:
Chronic otitis media with effusion (serous, mucoid, or purulent)
Recurrent otitis media that fails to respond to conventional medical treatment
A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.
Retraction pocket of the tympanic membrane.

The Tympanostomy Tube Delivery System is a device that penetrates the tympanic membrane and inserts the Acclarent Tympanostomy Tube with a button controlled activation.
The Tympanostomy Tube Delivery System is a mechanical device that can create a myringotomy and deliver the Acclarent Tympanostomy Tube. The Acclarent Tympanostomy Tube is provided pre-loaded in the subject device.

The Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System is a mechanical device designed to create a myringotomy and deliver a preloaded tympanostomy tube.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 101 ears enrolled from 53 pediatric subjects.
• Data Provenance: The study was a prospective, multi-center, single-arm clinical study conducted across 4 study sites. The country of origin is not specified but implied to be the US given the FDA submission.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on evaluating the device's technical performance and patient outcomes, rather than diagnostic accuracy requiring expert consensus on a ground truth label. Procedures were performed by 4 investigators (presumably surgeons).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing a ground truth for the test set, as the study primarily evaluated objective device performance metrics (success rate, tube retention) directly observed during or after surgical procedures.

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

No MRMC comparative effectiveness study was mentioned. The study was a single-arm clinical study evaluating the device's performance directly.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The clinical study evaluated the performance and safety of the Acclarent TTDS device for the placement of the Acclarent Tympanostomy Tube. The success rates and retention rates are standalone performance metrics.

7. Type of Ground Truth Used

The "ground truth" in this context refers to directly observed clinical outcomes and device functionality.

• Device Success: Based on the observed ability of the device to fully deploy tubes across the tympanic membranes. Failures were directly observed (e.g., device not fully deploying the tube).
• Tube Retention: Observed during the one-week post-procedure follow-up.
• Indicated Treatment Received: Direct observation that all enrolled ears received the intended tympanostomy tube placement, even if manual intervention was required after device failure.

8. Sample Size for the Training Set

The document does not mention any "training set" in the context of an algorithm or AI model development. The study described is a clinical performance study of a mechanical device, not an AI/ML-based device.

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

Not applicable, as no training set for an AI/ML model was utilized.

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