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510(k) Data Aggregation
(86 days)
Preceptis Medical, Inc.
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:
| Acceptance Criteria (Clinical Endpoint) | Reported Device Performance (2-17 years old study) | Pediatric Office Study, 6-24 months (K200952, for comparison) |
|---|---|---|
| Successful procedure completion in-office | 95.8% | 98.9% |
| Efficacy endpoint (HTTS delivery of tube) | 97.3% | 96.9% |
| Safety endpoint (procedural AE rate) | 0.0% | 0.56% |
Study Proving Device Meets Acceptance Criteria:
-
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.
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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."
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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.
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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.
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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.
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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.
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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.
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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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(57 days)
Preceptis Medical, Inc
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.
| Clinical Metric | Reported Device Performance (HTTS Pediatric Office Study) | Implicit Acceptance Criteria (based on predicate or good clinical outcome) |
|---|---|---|
| Successful rate in office or under sedation | 98.9% | High success rate (e.g., >88.3% of predicate) |
| Efficacy endpoint (HTTS delivery of tube) | 96.9% | High efficacy (e.g., >92% of predicate) |
| Safety endpoint (procedural Adverse Event rate) | 0.56% (2/360 ears) | Low procedural AE rate (ideally comparable to or lower than predicate, though predicate reported 0.0%) |
| % ears completed in one surgical pass | 84.5% | High percentage of single-pass completion (e.g., >82% of predicate) |
| Child's tolerance of procedure (clinician review) | "In all 18 cases, each of the reviewers deemed that the child tolerated the procedure acceptably." | Acceptable tolerance by child in office setting. |
| Parent satisfaction (alternative to GA) | 93.1% strongly agree/agree | High parent satisfaction. |
| Parent recommendation | 93.1% strongly agree/agree | High parent recommendation. |
| Bi-lateral procedure time | Median 5:00 (range 2:00-15:32) | Efficient procedure time for office setting. |
| Recovery (calm/no inappropriate crying before leaving) | 98.3% (177/180 children) | High rate of calm recovery. |
| Tube delivery using additional instruments | 7 ears | Minimal need for additional instruments. |
| Passes required: >2 passes | 2.3% | Low rate of multiple passes. |
| Early extrusion rate | 3.0% | Comparable to or lower than predicate (predicate 3.2%). |
| Plugging rate | 11.3% | Comparable to or lower than predicate (predicate 12.3%). |
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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(77 days)
PRECEPTIS MEDICAL
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | The tympanostomy tube met all performance acceptance criteria. (General statement; no specific metrics provided.) |
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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(251 days)
PRECEPTIS MEDICAL
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.
| Acceptance Criterion (Inferred from study findings) | Reported Device Performance |
|---|---|
| 1. Successful placement of ventilation tubes as planned. | 100% of children received ventilation tubes as planned. |
| 2. Absence of intra-operative adverse events. | No intra-operative adverse events. |
| 3. Absence of unanticipated adverse events. | No unanticipated adverse events. |
| 4. Adverse event rates to be within peer-reviewed literature rates. | Adverse event rates were well within peer-reviewed literature reported rates. |
| 5. Ability to complete procedure under moderate sedation. | Procedure performed under moderate sedation with local anesthetic. (Note: Some conversions to general anesthesia occurred, but overall aim was moderate sedation completion.) |
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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(242 days)
PRECEPTIS MEDICAL
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: No safety issues associated with the TTS. | An independent otolaryngologist reviewed the results of the trial and determined that there were no safety issues associated with the TTS. There was one case of recurrent infection not associated with the TTS and three occluded tubes, but these were not deemed safety issues directly attributable to the device. |
| Performance (Success Rate): 100% success rate in performing tympanostomy procedures. | The success rate in performing the tympanostomy procedures was 100%. Tympanostomy tubes were successfully delivered in all 25 patients (50 ears). |
| Performance (Use of TTI): TTI used as the sole instrument for the tympanostomy procedure. | In 40/50 ears (80%), only the TTI was used for the tympanostomy procedure. In 10/50 ears (20%), either a pick or alligator clip was used for additional adjustment of the tympanostomy tube. In all cases, only a single TTI was used for each ear. |
| Performance (Tube Retention): 100% tube retention at follow-up (15-60 days post-surgery). | At follow-up, between 15 and 60 days post-surgery, tube retention was 100%. |
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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