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The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical ventilation and who are intubated with endotracheal tube including cuff in the ICU, OR and for intra-hospital transport.

The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical ventilation and who are intubated with endotracheal tube including cuff in the ICU, OR and for intra-hospital transport.

It is used by health professionals (doctor or nurse) specifically trained in this tool.

The CuffGuard has a pressure sensor and software that can monitor and automatically adjust the cuff pressure.

The accessories associated include:

• Connection tube with filter
• Power supply
• Micro USB connection cable
• Fixation clamp and its tilt block)

The FDA 510(k) clearance letter for CuffGuard specifies the device's technical characteristics and performance data to support its substantial equivalence to a predicate device. However, it does not include a detailed study proving the device meets specific acceptance criteria in a clinical context with human readers or standalone performance metrics. The provided document focuses on bench testing and software validation.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

Description of Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the comparison to the predicate device, the Hamilton Medical Intellicuff, and compliance with relevant electrical safety and software standards. The "reported device performance" is largely presented as a comparison to the predicate's specifications and confirmation of standard compliance.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document states: "The following performance data were provided in support of the substantial equivalence determination." These data primarily consist of:

• Electrical safety and electromagnetic compatibility (EMC) testing: Conducted on the CuffGuard device, confirming compliance with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-1-2 standards.
• Software Verification and Validation Testing: Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." The software documentation level for CuffGuard is "enhanced."
• Evaluation of Pressure Range Difference: The difference in pressure range (CuffGuard: 5-40 cmH2O vs. Predicate: 5-50 cmH2O) was "evaluated on the SW verification and validation." The justification states this difference is "not clinically significant" as 40 cmH2O is a "realistic physiological limit and common clinical practice."

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

The document does not mention any clinical test set sample size, data provenance, or whether data was retrospective or prospective. The performance evaluation described is entirely non-clinical (bench testing and software validation).

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

This information is not applicable as no clinical test set using expert ground truth is described in the provided document.

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

This information is not applicable as no clinical test set requiring adjudication 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The CuffGuard is described as an "endotracheal tube cuff controller," a hardware device with embedded software for automatic pressure adjustment, not an AI-assisted diagnostic tool that human readers would interpret. The document explicitly states: "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate, nor its safety and effectiveness."

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

A standalone performance evaluation (bench testing) was performed for the device's technical specifications and software functionality, but not in the context of an AI-driven "algorithm only" performance study. The device's core function is automatic pressure control, which is inherently "standalone" in its operation once user-defined parameters are set. The reported performance metrics (e.g., pressure accuracy, alarm functions) reflect this standalone operational capability.

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

The ground truth for the technical performance was based on engineering specifications, compliance with international standards (IEC 60601 series), and the established performance of the predicate device. For the software, the ground truth was derived from the requirements defined during the software development life cycle, validated through verification and validation testing against these requirements.

8. The sample size for the training set

This information is not applicable as the device is a cuff controller based on established physical principles and software logic, not a machine learning model that requires a "training set" for its core function as described.

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

This information is not applicable as no training set for a machine learning model is mentioned or relevant to the described device. The "ground truth" for the device's functional performance was established through engineering design, compliance with regulatory standards, and validation against specification requirements.

Ask a specific question about this device

The CuffTrek is intended to measure and regulate the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supractottic airways). The device is intended for single patient use from pediatric to adult, under medical supervision in hospitals, prehospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated. It is for disposable single patient use.

The device is a battery-operated cuff pressure-controlling device intended to be used with ventilation tubes (ETT, Tracheostomy, LMA). It is a single patient-use, non-sterile device designed to be used continuously for up to 7 days. The device is connected to the pilot balloon of airways with inflatable air-filled cuffs via the device's extension line. The operating range of the device is 0-99 cmH2O. The device body houses the active pressure monitoring mechanism, which displays the cuff pressure on the digital screen. An indicator light provides an additional visual aid to indicate whether the cuff pressure is at the correct pressure or if the pressure is out of the set range of 20-30 cmH2O (red).

The provided text is a 510(k) summary for the device "CuffTrek," an inflatable tracheal tube cuff pressure regulator. It outlines the device's characteristics, indications for use, comparison to predicate devices, and performance testing.

However, the document primarily focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, rather than detailing a clinical study with a rigorously defined acceptance criteria table and performance study results as requested in the prompt. The document explicitly states "Clinical Study: Not applicable."

Therefore, I cannot extract the information required for a comprehensive answer regarding acceptance criteria and a study proving the device meets them via a clinical study. The document describes non-clinical performance testing.

If the request refers to non-clinical acceptance criteria and performance data, I can extract information related to accuracy, response time, and the types of tests conducted. Based on the provided text, here's what can be extracted for non-clinical performance:

Non-Clinical Performance Criteria and Reported Device Performance

Regarding the other points of the prompt, based on the provided text:

2. Sample sizes used for the test set and the data provenance:

   • The document mentions "Performance Testing" and "Non-Clinical Study" but does not specify the sample sizes (e.g., number of devices, number of measurements) for these tests.
   • Data provenance: Not explicitly stated, but implies laboratory testing of the device. Given the manufacturer's address in Shanghai, China, the testing could have occurred there or elsewhere. It is non-clinical performance data, not patient data (retrospective or prospective).

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

   • Not applicable as this was a non-clinical device performance study, not a study involving expert human interpretation or ground truth establishment from patient data.

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

   • Not applicable as this was a non-clinical device performance study, not a study involving expert human interpretation.

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 MRMC study was not done. The document explicitly states "Clinical Study: Not applicable." This device is a measurement and regulation device, not an AI diagnostic tool requiring human reader studies.

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

   • Yes, performance testing of the device itself (analogous to "standalone" for a physical device) was done. This includes tests like accuracy, response time, fluid leakage, etc. The results are summarized in the table above where specific values are mentioned (e.g., accuracy ±2 cmH2O). The document states that "Non-clinical tests were conducted to verify that the proposed devices met all design specifications."

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

   • For the non-clinical performance tests, the "ground truth" would be established by calibrated laboratory standards and measurement equipment, comparing the device's output to known inputs or reference measurements. For example, for pressure accuracy, the device's reading would be compared against a high-accuracy reference pressure meter.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning/AI model that requires a "training set." It is a physical medical device.

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

   • Not applicable, as there is no "training set" for this physical device.

Ask a specific question about this device

The TrachCuff Cuff Controller is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation.

The TrachCuff Cuff Controller can be used with any mechanical ventilator.

The TrachCuff Cuff Controller is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT, in the following areas:

• In the intensive care ward by Respiratory Therapist
  Prescription use only.

The TrachCuff Cuff Controller is an automatic cuff pressure controller specified for use in professional healthcare environments. The device provides the operator with the means to set and control the pressure for cuffed endotracheal tubes and cuffed tracheostomy tubes during mechanical ventilation, and continuous monitoring of the set cuff pressure with alarms.

The TrachCuff Cuff Controller is mains powered via a Mains to DC power adapter, and the enclosure may be mounted on a bed rail by means of an optional mounting bracket.

The TrachCuff Cuff Controller is provided in an enclosure with touch screen operator panel.

It is designed for immediate use; no calibration or maintenance is required. A largescale display and convenient and intuitive interaction buttons maximize safe use and visibility of all important data.

The associated accessories include:

• Disposable Tubing Set with Filter .
• Device Mount Solution Bedside Mounting Bracket. .

The provided document describes the TrachCuff Cuff Controller, a medical device intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a structured comparison for each criterion. Instead, it lists the standards and types of testing performed and then states that the device "met acceptance criteria."

However, based on the Comparison of Technological Features to Predicate Devices table (page 5-6), we can infer some key performance aspects and their comparison to the predicate device. The primary performance criteria revolve around pressure control and accuracy, and usability.

Inferred Acceptance Criteria and Reported Performance:

Study Details

The document describes non-clinical testing for the TrachCuff Cuff Controller.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a distinct "test set" in terms of patient data or a specific number of units for performance testing. Instead, it refers to laboratory testing and usability studies. For durability testing, "the device" was evaluated. For usability, it mentions a "representative population of USA clinical users," but no specific number.
   • Data Provenance: The testing was conducted in a laboratory setting ("The TrachCuff Cuff Controller was laboratory tested"). Usability testing involved "USA clinical users," suggesting prospective data collection for that specific aspect. These are non-clinical studies.

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

   • This information is not provided as the studies are primarily non-clinical engineering and usability tests against predefined standards and specifications, rather than clinical studies requiring expert ground truth for diagnostic or therapeutic accuracy. For usability, "USA clinical users" participated, implying healthcare professionals, but no specific number or detailed qualifications are given.

3. Adjudication method for the test set:

   • This information is not applicable as the studies are non-clinical engineering and usability tests against predefined standards. There is no mention of adjudication for discrepancies in expert assessments.

4. 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, an MRMC comparative effectiveness study was not done. This device is a medical device for controlling cuff pressure, not an AI diagnostic or assistive tool, so such a study would not be relevant.

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

   • The document implies standalone non-clinical performance testing of the device's technical specifications (pressure accuracy, electrical safety, etc.) against established standards. The device itself operates automatically to maintain cuff pressure once set by a user, so its core function is "algorithm only" in terms of maintaining the set pressure. The usability evaluation, however, involves human interaction.

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

   • For technical performance, the "ground truth" is defined by established engineering and medical device standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, ISTA 3A, IEC 62366), device specifications (e.g., pressure range, accuracy), and manufacturer's technical files (for biocompatibility). There is no "pathology" or "outcomes data" ground truth as this is not a diagnostic device.

7. The sample size for the training set:

   • This information is not applicable/not provided. This device is a hardware-based cuff controller with embedded software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software development followed IEC 62304 (software lifecycle process) rather than an AI/ML model training paradigm.

8. How the ground truth for the training set was established:

   • This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

Ask a specific question about this device

The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation.

1. When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user.
2. When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff.
3. When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the tube's cuff.

The AG100s system is comprised of the following main components:

• The AG100s control unit
• The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit.
  Additional device components include cart, secretions canister (Trap Bottle), rinsing fluid (saline) bag and antibacterial air filter.
  When the AG100s, is connected to AG ETT, it monitors leaks between endotracheal cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the AG ETT). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.
  The AG100s also performs cuff pressure monitoring and control in standard FDA cleared TTs and ETTs; depending on the tube type, the system may also perform secretions removal.

The provided text is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence of a modified medical device (AG100s) to a previously cleared predicate device. This type of document typically does not contain detailed acceptance criteria and performance data in the format of a clinical study report with specific statistical outcomes, sample sizes, and expert qualifications.

However, I can extract the types of performance evaluations mentioned and general statements about the device's functionality.

Based on the provided document, here is an attempt to address your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating that the modified device (AG100s) functions equivalently to its predicate. The "performance data" section lists the types of tests conducted to support this claim.

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

The document does not specify quantitative sample sizes (e.g., number of patients, number of devices) for any of the tests mentioned (Comparative AG100s Cuff pressure control + suction performance, Software System V&V Test, Usability Validation).

Regarding data provenance: The studies were conducted by Hospitech Respiration Ltd., which is based in Israel. The nature of the studies ("Comparative," "V&V Test," "Usability Validation") suggests they are prospective validation and verification tests conducted specifically for this submission, likely involving laboratory or simulated environments, and potentially human factors evaluations. There is no mention of retrospective clinical data from patients.

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

The document does not provide this information. Given the nature of the tests (performance, software V&V, usability), "ground truth" would likely be established by engineering specifications, validated test methods, and human factors validation protocols rather than expert consensus on medical images or diagnoses. For usability, experts in human factors might be involved, but their number and qualifications are not specified.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. Adjudication is typically used in clinical studies when there's uncertainty in ground truth or to resolve discrepancies among multiple readers. For the verification and validation tests described, results would likely be directly compared against predefined engineering specifications or performance metrics rather than requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. MRMC studies are typically clinical studies evaluating the performance of AI-assisted human readers compared to unassisted readers, especially in diagnostic imaging. This document describes technical verification and validation studies to demonstrate substantial equivalence of a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is an automated system for monitoring and controlling cuff pressures and evacuating secretions. Its core function is inherently "standalone" in that it performs these tasks without immediate human intervention for each action, although it is designed for use by trained medical professionals who would set initial parameters and manage the patient. The performance tests described (cuff pressure control, suction performance, CO2 monitoring functionality, software V&V) inherently evaluate the device's standalone technical performance. There isn't a separate "algorithm only" evaluation as described for, for example, an AI diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests would be based on:

• Engineering Specifications: For parameters like cuff pressure control range (10-50 mmHg), suction pressure range (-20 to -120 mmHg), and flow rate (0-12 L/min).
• Validated Test Methods: Using calibrated equipment to measure and verify the device's outputs against its intended specifications.
• Functional Requirements: Demonstrating that features like CO2 monitoring leading to cuff pressure adjustment, and secretion evacuation, work as designed.
• User Needs/Human Factors Data: For the usability validation.

There is no mention of pathology, expert consensus on clinical cases, or outcomes data in humans presented in this summary to establish ground truth.

8. The Sample Size for the Training Set

This document is for a modified physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable here. The device's operation is governed by pre-programmed logic, not by a machine learning model trained on data.

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

As stated above, the concept of a "training set" is not applicable to this device.

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The CPM is intended to continuously measure and automatically maintain the cuff pressure of an endotracheal tube or tracheostomy tube that has been set by the user/clinician during mechanical ventilation. The CPM is intended for use with adult and pediatric patients during mechanical ventilation in the listed areas:

Intensive care unit (ICU)
Recovery room
Emergency medical care
Medical emergency vehicles when the patient is being transported
During transport within and outside of the hospital

The Puritan Bennett™ Cuff Pressure Manager (CPM) continuously measures and automatically maintains cuff pressure during ventilation of patients using a cuffed endotracheal tube or tracheostomy tube. It is an integrated and continuous cuff pressure control solution that secures airway management in intensive care units, recovery room and during interhospital and intrahospital transport.

It operates in range of 5-50 cm H2O of user-set cuff pressures for various cuffed endotracheal tubes to provide suitable solutions for various clinical patient situations. The Puritan Bennett™ Cuff Pressure Manager introduces some new small features and convenient user interface to maximize safe use and usability. Both manual adjusting and one-click inflation function are provided alternatively for user's preference to start inflation. Measure mode allows user to observe the cuff pressure without device intervening before taking actions. Auto Key-lock feature help to avoid mis-operation when there's no user intervene for a long time. For inflation, room air is used and no contact to the respiratory gas system of a patient occurs. It is not intended to connect with ventilator.

The cuff pressure manager is designed with closed loop mechanism which is Pl controlled, and the software level of concern is Class C/Major concern.

The Puritan Bennett™ Cuff Pressure Manager is provided non-sterile and no re-processing is required. A sterile extension tube is equipped with the Puritan Bennett™ Cuff Pressure Manager for inflating/deflating or measuring cuff pressure. The associated accessories include:

• Extension Tube with filter Rechargeable Li-ion Battery Mounting Rack AC/DC Adaptor

The provided document describes the Puritan Bennett™ Cuff Pressure Manager (CPM) and its substantial equivalence to a predicate device (IntelliCuff Cuff Pressure Controller, K150893). The information mainly focuses on technical specifications, safety, and performance evaluations, primarily through bench testing against recognized standards. There is no mention of a study involving human or animal subjects, ground truth, expert adjudication, or multi-reader multi-case studies in the provided text.

Based on the available information, the acceptance criteria and device performance relate to technical specifications and compliance with various international standards for medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the specified technical characteristics and compliance with the referenced industry standards. The reported device performance is indicated by its adherence to these specifications and successful completion of the described tests.

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

The document does not specify a "test set" in the context of clinical data or human-derived data. The testing described is primarily bench testing of the device's hardware and software components. For these types of tests, samples would refer to the number of devices or components tested. This information is not provided in the document.

Data provenance is not applicable in the sense of country of origin of patient data, as no clinical or patient data was used. All described tests are non-clinical, likely performed by the manufacturer, Covidien llc, in China or its designated testing facilities. The tests are retrospective in the sense that they are conducted on manufactured devices before market release.

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

This is not applicable as there is no "test set" requiring expert ground truth in the context of clinical images or patient data. The ground truth for the technical performance tests is established by the engineering specifications and recognized international standards themselves.

4. Adjudication method for the test set

This is not applicable as there is no clinical test set requiring expert adjudication.

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 MRMC comparative effectiveness study was done as the device is a cuff pressure manager, not an AI-assisted diagnostic or interpretative tool for human readers.

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

This concept is not directly applicable to this device in the traditional sense of an "algorithm only" performance study for image analysis or diagnosis. The device itself is an automated system for managing cuff pressure, and its performance is inherently a "standalone" evaluation of its functional accuracy and safety. The performance tests ("Function and performance Test-Cuff Pressure Manager") demonstrate the algorithm (closed-loop PI control) and device's ability to maintain pressure automatically without human intervention.

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

The "ground truth" for the device's performance is established by:

• Technical Specifications: The design parameters and target performance values set by the manufacturer.
• International Standards: Compliance with recognized standards like IEC 60601 series for electrical safety, EMC, alarms, usability, and software, as well as ISO standards for sterilization, biological evaluation, and connectors.
• Benchmark Testing: Comparison against the predicate device's known performance characteristics (though the specific "ground truth" for this comparison is the predicate's established performance).

8. The sample size for the training set

This is not applicable as the device is not an AI/ML model that requires a training set of data in the typical sense. Its control mechanism is a PI controller, a traditional engineering control system, not a learned AI model.

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

This is not applicable as there is no training set for an AI/ML model. The "ground truth" for the device's control logic is based on engineering and physiological principles for maintaining appropriate cuff pressure.

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The Cuffix is intended to measure and regulate, through passive control, the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.

The Cuffix is a battery-operated cuff pressure controlling device which is intended to be used with ventilation tubes (ETT, Tracheostomy, LMA) It is a single patient-use, non-sterile device designed to be used continuously for up to 14 days. The device is connected to the pilot balloon of airways with inflatable air-filled cuffs via the device's extension line. The operating range of the Cuffix is 0-99 cmH2O. The device body houses the passive pressure mechanism component as well as the active pressure monitoring mechanism which displays the cuff pressure on the digital screen. An indicator light provides an additional visual aid to indicate whether the cuff pressure is at the correct pressure (green) or is the pressure is out of the set range (red). The elastic band hanger allows to attach the Cuffix as needed (e.g., to the ventilation circuit, the patient bed rail, etc.).

This document is a 510(k) Pre-market Notification for the Cuffix device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with human-in-the-loop or standalone AI performance. Therefore, many of the requested details, particularly those related to AI algorithm validation (like MRMC studies, training/test set sample sizes for AI, expert adjudication, etc.), are not present in this document.

However, based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table format. Instead, it describes performance characteristics and compares them to predicate devices. The closest to acceptance criteria are the "Accuracy" and "Cuff pressure intended use range" specifications.

Note: The table above is constructed from the comparative table provided in the document. The "Acceptance Criteria (Implied)" column reflects what the Cuffix device aims to achieve, as demonstrated by its own specifications.

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

The document states: "Animal and clinical performance data was not included." This implies there was no "test set" in the context of clinical data for performance evaluation in human subjects. The comparative testing mentioned appears to be non-clinical (e.g., bench testing, laboratory evaluations).

Therefore, information on sample size for a clinical test set and data provenance (country, retrospective/prospective) is not available in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no clinical test set or human-in-the-loop study involving interpretations (e.g., radiology images) was performed, there were no experts used to establish ground truth in the context of diagnostic or clinical assessment.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was described.

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

No MRMC study was done. This is a device for measuring and regulating tracheal tube cuff pressure, not an image-based diagnostic AI device. The comparison is primarily against predicate devices based on technical specifications and non-clinical performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The Cuffix is a hardware device with an active pressure monitoring and passive pressure regulation mechanism. It is not an AI algorithm in the sense of a standalone diagnostic or predictive AI. Its "performance" is based on its physical properties and mechanical/electronic accuracy.

7. Type of Ground Truth Used

The "ground truth" for the Cuffix device's performance would have been established through:

• Bench testing: Using calibrated pressure sensors/manometers as a reference standard to verify the Cuffix's pressure measurement accuracy.
• Engineering specifications and tests: For characteristics like battery life, response time, kinking resistance, etc.

It is not expert consensus, pathology, or outcomes data in the clinical sense, as the evaluation is primarily focused on the device's physical and functional performance, not its diagnostic or clinical interpretation capabilities.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that involves a "training set" for an algorithm.

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

Not applicable, as this is not an AI/machine learning device.

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To provide visual indication of the pressure within an inflatable tracheal tube cuff, which is a device, used to provide an airtight seal between a tracheal tube and a patient's trachea.

The PYLANT MONITOR is used by personnel trained in pulmonary resuscitation and airway management (ex. anesthesiologists, RN, respiratory therapists, EMT, paramedics) used to measure the trachael cuff pressure of an endotrachael tube or tracheotomy tube by measuring the external pilot line port of the tube. The Pylant Monitor (PM) is a medical device intended to indicate changes inside an endotracheal tube (ETT) cuff. One end of the PM is fabricated to fit into the "pilot balloon" (international standard for all types of intra-tracheal tubes with a cuff) of the ETT cuff. The other end is fabricated to accept a medical syringe (international standard for all intravenous syringes) for adding or removing air from inside the ETT cuff and altering the volume of air and therefore the pressure inside the ETT cuff. The syringe end of the PM has a one way air tight valve that is open when the syringe is connected. When the syringe is not connected the valve is closed and air is trapped within the ETT cuff and the PM creating the seal between the trachea and cuff. In between the two ends of the PM is a silicone diaphragm that expands and contacts with pressure. As pressure rises the more the diaphragm expands and as pressure falls the diaphragm contracts. Attached to the center of the diaphragm is and indicator arrow/needle. The diaphragm and arrow/needle is housed inside a designed case. The case acts as a protector of the silicone diaphragm arrow needle assembly and is labeled, color coded and calibrated to indicate pressure ranges from 20 cm H2O to 30 cm H2O. The PM is designed to remain connected to the ETT pilot balloon and continuously monitor the pressure or monitor pressure intermittently. Pressure changes within the ETT when connected to the PM are indicated by expansion or contraction of the silicone diaphragm causing calibrated movement of the arrow/needle and indicated on the color coded label.

Acceptance Criteria and Device Performance for PYLANT MONITOR

The provided documentation describes the Pylant Monitor, a device intended to provide a visual indication of pressure within an inflatable tracheal tube cuff. The acceptance criteria for this device and its performance are detailed below, along with information about the study conducted.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 120 randomly selected production Pylant Monitors were used for the bench testing.
• Data Provenance: The study was a bench test conducted by the manufacturer (Kal-Med, LLC). The document does not specify the country of origin of the data beyond the manufacturer being in the United States. It is an in-vitro (bench) study and therefore neither retrospective nor prospective in the clinical sense.

3. Number of Experts and their Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth for the test set was established using a calibrated instrument rather than expert human interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was determined by a calibrated PYTON regulator, which provided a known pressure of 25 cm H2O. The device's reading was then compared against this known value.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study was a bench test evaluating the physical performance of the device against a known pressure.
• Effect Size: Not applicable as no MRMC study was conducted.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was conducted. The Pylant Monitor's ability to accurately indicate pressure was tested directly against a calibrated pressure source (PYTON regulator). The device's visual indication was the sole output evaluated.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was established by a calibrated instrument. Specifically, a calibrated PYTON regulator was used to pressurize the ETT cuff to a known 25 cm H2O.

8. Sample Size for the Training Set

• Sample Size: Not applicable. The Pylant Monitor is a mechanical device that indicates pressure changes. It does not employ an algorithm or AI that would require a "training set" in the conventional sense of machine learning. Its design and calibration are based on established physical principles.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of mechanical device. The device's calibration is inherent in its design and manufacturing to visually represent specific pressure ranges.

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The Accucuff Cuff Pressure Indicator is intended to monitor intra-cuff pressures of endotracheal, supraglottic airways or tracheostomy tubes. The device is indicated for the patients from pediatric to adult who have an artificial airway and for which the user would like to monitor cuff pressure.

The Accucuff™ Cuff Pressure Indicator is intended to monitor the cuff pressure of endotracheal, supraglottic airways or tracheostomy tubes. It is designed with different color coded zones to indicate the normal, negative and positive pressure. The black marker on the device will be moved when the cuff pressure is changed. The device is available in 10-20 cmH2O, 20-29 cmH2O and 40-60 cmH2O three different models to accommodate the intended populations from pediatric to adult.

The provided text describes the Accucuff Cuff Pressure Indicator, a device intended to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the acceptance criteria and study information, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal "acceptance criteria" table from a study, but rather a comparison table (Table 1) outlining the proposed device's specifications against predicate devices, and then details of non-clinical tests performed. We can extract the relevant performance metrics and the proposed device's performance from these sections.

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

The document describes non-clinical tests, not human subject clinical trials. Therefore, there is no "test set" in the context of patient data (e.g., medical images, patient records). The samples used would be individual units of the Accucuff Cuff Pressure Indicator device. The specific number of devices tested for each non-clinical test (e.g., how many units for pressure accuracy, how many for biocompatibility) is not provided.

There is no data provenance related to country of origin of data or retrospective/prospective nature, as this was not a clinical study.

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

Not applicable. As this was a non-clinical device performance study, there was no "ground truth" to be established by human experts in a diagnostic or clinical context. The "ground truth" for the device's performance relies on objective measurements against established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set:

Not applicable, as there was no test set requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission."

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

Not applicable. The Accucuff Cuff Pressure Indicator is a mechanical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply. The non-clinical tests evaluated the device's inherent mechanical performance.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests was established through:

• Established engineering and performance standards: Such as ISO 594-1 for conical fittings.
• Biocompatibility standards: ISO 10993 series for cytotoxicity, irritation, and skin sensitization.
• Packaging standards: ASTM F88/F88M-15 and ASTM F1929-15 for seal strength and leak detection.
• Internal design specifications: For characteristics like pressure range and accuracy, evaluated against the specified values.
• Reference measurements: The "Pressure Accuracy Test" and "Repeatability Pressure Accuracy Test" would have involved comparing the device's readings against a calibrated reference pressure measurement device.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

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

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AG 100s is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

The AG100s system is comprised of the following main components:

• The AG100s control unit
• The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit.
• The AnapnoGuard endotracheal tube (ETT) or another FDA cleared cuffed Airway.
• Accessories: including cart, secretions canister (Trap Bottle), ● rinsing fluid (saline) bag and antibacterial air filter.

AG100s, including its three components, monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user).

Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period.

The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.

The provided text describes the Hospitech Respiration Ltd. AG100s device, an airway management system. The document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria and reported device performance from a test set. Instead, it compares the characteristics of the AG100s system to its predicate device, the AnapnoGuard 100 System (K150157). The "Comparison" column in the table on pages 6-7 serves to highlight similarities and differences, and performance tests are mentioned to support substantial equivalence where differences exist.

Below is a summary of the performance-related comparison provided in the document:

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The VORTRAN® Cuff Inflator (VCI) is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laryngeal Mask Airways (LMAs). The VORTRAN® Cuff Inflator (VCI) is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics, where a patient may be intubated.

The VORTRAN® Cuff Inflator (VCI) is a disposable, hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.

The provided text describes the VORTRAN® Cuff Inflator (VCI) and its substantial equivalence determination by the FDA. However, it does not detail a study that defines acceptance criteria and then proves the device meets those criteria in the way typically seen for AI/ML-driven medical devices (e.g., involving AI model performance metrics like sensitivity, specificity, AUC).

This document is a 510(k) summary for a mechanical device, a cuff inflator, not an AI/ML-driven device. Therefore, many of the requested criteria in your prompt (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone AI performance) are not applicable to the information provided in this document.

The "Performance Data" section (Section VIII) states: "Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks. The performance testing includes a comparison between the VORTRAN® Cuff Inflator (VCI) and its predicate and reference devices, Posey Cufflator and Hospitech AG Cuffill."

Based solely on the provided document, here's an attempt to answer your questions, acknowledging the limitations for a non-AI/ML device:

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

The document provides "Pressure Accuracy and Range" as key performance characteristics. While not explicitly stated as "acceptance criteria" with pass/fail thresholds in the provided text, these are the performance targets the new device aims to match or be equivalent to.

Note: The document states for "Pressure Range": "(1) range has no significant difference, in comparison to its predicate or reference devices, and does not raise different questions of safety and effectiveness." This indicates the 0-60 cm-H2O range was deemed acceptable relative to the predicate/reference devices.

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

• Sample Size: Not specified in the document. The performance testing is described generally ("Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks.").
• Data Provenance: Not specified. Given it's a technical performance test, it's likely lab-based and conducted by the manufacturer.
• Retrospective/Prospective: Not applicable in the context of device performance testing in this document.

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 specified. The ground truth for manometer accuracy, inflation/deflation function, and leak absence would be established by calibrated instruments and engineering measurements, not human expert consensus, for a mechanical device.

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

• Not applicable. This is not a human-reader study requiring adjudication.

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 MRMC study was done, as this is a mechanical device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical device. Its performance is its standalone performance. There is no "algorithm" in the AI sense.

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

• For the performance characteristics mentioned (manometer accuracy, inflation/deflation, leaks), the ground truth would be established by calibrated reference standards and engineering measurements. For example, manometer accuracy would be verified against a highly accurate master pressure gauge.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not applicable.

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