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The Care Cycle Connect software application is intended for use with Trilogy Series ventilators by both caregivers and clinicians. The application pairs with the Trilogy device via a Bluetooth connection. The application provides the caregiver remote patient monitoring, and alarm surveillance. Alarm surveillance consists of both an audible tone and a visible alert if an alarm condition exists. The application provides the clinician with the ability to view, collect and store patient ventilator usage data. Care Cycle Connect also provides educational information on ventilator use to both caregivers and clinicians. It is intended to be used in the home, and hospital/ institutional settings. The Care Cycle connect application is intended to supplement and not replace any part of the current device monitoring procedures.

The Care Cycle Connect application is an accessory to a continuous ventilator (product code MOD). Care Cycle Connect is intended for use with the Trilogy Series of Ventilators cleared by the US FDA under K083526, K093416, K093905, and K111610. Care Cycle Connect (CCC) is a mobile software application designed to provide features and functions related to respiratory care in the home, hospital and institutional healthcare settings. The application provides the caregiver remote patient monitoring and alarm surveillance. The CCC application has been designed with two users in mind, the caregiver and the clinician. The functionality of the application is tailored to the different needs of these users and is configured when the application is installed. At the initial start-up of the application, users are asked to choose either careqiver (for patients and their in-home caregivers) or clinician mode. Functionality is based on the configuration selected. Once this choice is made, users cannot switch back and forth between the two configurations. The primary users expected to interact with Care Cycle Connect in the context of patient care in the home (the main use scenario) are caregivers and respiratory therapists (clinicians). CCC may also be used if the patient is in a hospital or institutional environment (sub-acute care facility). Caregivers are not expected to use CCC in a hospital or institutional setting. Care Cycle Connect provides constant feedback to the caregiver while the app is connected to the ventilator. This feedback is displayed via the Manometer Display feature within the application. This constant display provides data on the patient's use of the ventilator, ensuring that the ventilator is providing therapy. Care Cycle Connect will also provide educational information on the use of the ventilator to the caregiver or clinician, independent of being connected to the ventilator. The respiratory therapist will use the app when connected to a patient ventilator while on a home visit to gather ventilator data. It provides an interface for keeping patient information. When the app is not connected to the patient ventilator, the clinician can review stored data, such as appointments, journal, and vent check records. In the hospital or institutional environment. CCC may be used by clinicians to schedule and perform vent checks, which would be completed in the patient's room. Care Cycle Connect is an application that can be loaded onto an Apple device (iPad) that uses iOS 8.0 or more recent. The application relies on a Bluetooth Class 1 radio connection to a Trilogy ventilator. With the exception of low level communication protocol information (i.e., handshake connection), the Trilogy device does not accept any data, commands, or controls from the CCC Application. The Trilogy device functionality is not changed in any manner by connecting to the CCC Application. The Trilogy device simply sends information to the CCC Application on a periodic basis.

The provided text describes the acceptance criteria and study information for the "Care Cycle Connect" software application.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test set used in "Software Verification and Validation Testing" or "Usability Testing." It mentions "complete system level testing" and "usability testing was completed," implying a sufficient set of tests were performed.

• Data Provenance: Not explicitly stated as retrospective or prospective patient data. The testing appears to be primarily laboratory/bench testing and simulated use, as it focuses on software verification, validation, and usability with the device itself, rather than clinical patient outcomes. The origin is implicitly related to the manufacturer's testing facilities (Respironics Inc., USA).

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The ground truth for the testing described seems to be based on compliance with international standards (IEC, ISO) and the device's functional design specifications, rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set. The testing described focuses on discrete pass/fail criteria against engineering requirements and established standards.

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

No. The document explicitly states: "Clinical tests were not required to demonstrate the substantial equivalence of Care Cycle Connect. Product functionality has been adequately assessed by non-clinical tests." Therefore, an MRMC comparative effectiveness study was not performed.

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

Yes, a standalone performance assessment was effectively done. The "Software Verification and Validation Testing" and "Non-Clinical Tests" describe the evaluation of the Care Cycle Connect application's functionality, adherence to software life cycle processes, alarm system compliance, and usability independent of a clinical human-in-the-loop study. These tests evaluate the algorithm's (software's) performance against its design requirements and relevant standards.

7. Type of Ground Truth Used

The ground truth used for the testing of Care Cycle Connect appears to be:

• Compliance with International Standards: e.g., IEC 62304, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 62366, ISO 14971.
• Product Requirements/Design Specifications: The software was tested against "product requirements" and various listed functionalities (device pairing, login, information display, alarm signals, etc.).
• Guidance Documents: Adherence to FDA guidance documents (e.g., for software, human factors, mobile medical apps, cybersecurity, wireless technology, home use devices).

Essentially, the "ground truth" is a combination of regulatory compliance, engineering specifications, and validated functional behavior.

8. Sample size for the Training Set

Not applicable. The document describes the verification and validation of a software application for remote monitoring and data display for a medical device. It does not mention any machine learning or AI components that would require a dedicated "training set." The software appears to be rule-based or deterministic, rather than data-driven in a way that requires a training set.

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

Not applicable, as there is no mention of a training set for machine learning/AI.

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The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation.

The iVAPS mode is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air is directed to the patient via one of three ventilator breathing circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the main turbine. The device provides both therapeutic alarms (e.g. tidal volume) and technical alarms (e.g. system fault), and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery.

The Astral is capable of providing the following types of ventilatory support:

• -Assist/Control and SIMV with either volume or pressure control
• -Continuous Spontaneous Ventilation in either Pressure Support or CPAP
• -Volume Assurance and Apnea Ventilation

The provided document is a 510(k) premarket notification for a medical device (ventilator). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria for AI or a new diagnostic tool.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance derived from a test set, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, training set information, or how ground truth was established for a new AI/diagnostic device.

The document discusses:

• Device Name: Astral 100/150
• Regulation Name: Continuous Ventilator
• Predicate Device: ResMed Astral 100/150 (K133868)
• Reference Device: Respironics Trilogy 200 (K093416)
• Reason for Submission: New device (specifically, the addition of the iVAPS therapy mode).
• Non-Clinical Performance Data: Stated that design and verification activities were performed, including accuracy of ventilation, volume & pressure controls and monitoring, waveform performance, accuracy and repeatability of triggering and cycling, endurance and environmental testing, and alarm verification. It explicitly states, "All tests confirmed the product met the predetermined acceptance criteria." However, it does not list these specific acceptance criteria in a table or provide quantitative performance results against them. It also mentions side-by-side performance testing for the new therapy mode (iVAPS) and electrical changes testing.
• Conclusion: The device is substantially equivalent to the predicate and reference devices based on intended use, technological characteristics, and principles of operation. Clinical testing was not required for this submission.

In summary, this document is a 510(k) submission for a ventilator, focusing on substantial equivalence to a predicate device and not a study validating a new AI/diagnostic device with the specific criteria you've outlined.

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This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs (>10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight.

The Simple T Pediatric Nasal Mask is intended to be used with positive airway pressure devices. For use of this mask with a CPAP therapy device, the patient population is limited by the intended use of the device (e.g. > 30 kg). In other words, this mask can be used with a variety of therapy devices which may have their own limitations on patient population. If the therapy device itself is limited to patients greater than 10 kg (e.g. 30 kg), then the use of this mask does not expand the intended use of that therapy device.

The mask provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with a fabric frame and an adjustable headgear. The cushion contains an adjustment dial that can be engaged to reduce minor leaks around the nose. The mask may be cleaned in the home (single-patient use) or reprocessed by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).

This document is a 510(k) Summary for the Simple T Pediatric Nasal Mask (K151120). It details the substantial equivalence of the new device to previously cleared predicate devices. Unfortunately, the document does not contain specific acceptance criteria or study data in the format requested for AI/ML device testing.

The document discusses performance testing, but this refers to engineering tests on the physical mask (e.g., intentional leak, total mask leak, CO2 rebreathing, cleaning validation), not to the performance of an AI model. There is no mention of an algorithm or AI component in this device.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance for an algorithm.
2. Sample size for a test set, data provenance, number of experts, or adjudication method for an AI/ML model.
3. Multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance effect size.
4. Standalone (algorithm only) performance.
5. Type of ground truth (expert consensus, pathology, outcomes data) for an AI/ML model.
6. Sample size for the training set or how ground truth for the training set was established.

This document is for a physical medical device (a nasal mask) and outlines its substantial equivalence based on material, design, and non-clinical performance testing. It explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the Simple T Pediatric Nasal Mask. Product functionality has been adequately assessed by non-clinical tests." This further confirms the absence of AI/ML or clinical efficacy studies as would be required for such devices.

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PerforMax Pediatric EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bilevel system. The mask is for multi-patient use in the hospital / institutional environment only. The mask is to be used on patients 1 year or older (> 7 kg) for whom positive airway pressure therapy has been prescribed.

PerforMax Pediatric EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bi-level system. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable bonnet headgear. It may be cleaned by the professional in the hospital/institutional environment through a thermal high-level disinfection process or a chemical high-level disinfection process for multi-patient use.

The PerforMax Pediatric EE Total Face Mask consists of a faceplate with a bonded silicone seal for the face and an elbow with an integral entrainment valve. The mask features an interchangeable elbow hub which accepts an EE Leak 1 and EE Leak 2 elbow. The EE Leak 2 elbow includes built-in exhalation, an entrainment valve, a flexible tube, and a 22 mm connection. The EE Leak 1 elbow includes an entrainment valve and a 22 mm connection. The 22 mm elbow is used to conventional air delivery hose between the mask and the positive airway pressure source. The bonnet headgear is connected to the mask through slots in the upper part of the frame and clips that attach to the lower part of the frame. The mask is designed in such a way that it can be easily disassembled for disinfection or to replace several of the mask components, such as the headgear and elbow.

The provided document is a 510(k) summary for the PerforMax Pediatric EE Total Face Mask. It describes the device, its intended use, and compares its technological characteristics to predicate devices. It also outlines the non-clinical testing performed to demonstrate safety and efficacy.

However, this document does not contain information on "acceptance criteria" for a study in the context of device performance metrics (e.g., sensitivity, specificity, accuracy, etc.) nor does it describe a study that proves the device meets such criteria in the way typically associated with AI/software devices.

This submission is for a medical device (a face mask) and the "study" referred to is primarily bench testing to demonstrate performance and functionality under various conditions, particularly after cleaning and disinfection processes, and against established material safety standards.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and submission described in the input.

Here's an attempt to answer the questions based only on the provided text, flagging where information is not present or not applicable:

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

The document does not explicitly present a table of "acceptance criteria" with specific numerical targets for performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly stated as meeting "performance specifications" and raising "no new issues of safety or effectiveness."

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. The testing described is "bench testing," meaning physical tests on the device itself, not on a human or animal population.
• Data provenance: Not applicable in the context of clinical data for this type of bench testing. The testing was performed pre and post institutional cleaning and disinfection treatments.

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. Ground truth as typically understood for diagnostic algorithms (e.g., expert consensus on images) is not relevant for this physical device's bench testing. The "ground truth" would be the established engineering and safety standards/specifications.

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

Not applicable. Adjudication methods are used in clinical studies, particularly for interpreting ambiguous findings or assessing reader agreement, which is not relevant for the bench testing of a medical mask.

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. An MRMC study is not mentioned and is not applicable to the evaluation of a non-AI medical mask. The document explicitly states: "Use of face masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the PerforMax Pediatric EE Total Face Mask, as was the case with the predicate devices."

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

This refers to an algorithm's performance. The device is a physical face mask, not an algorithm. Therefore, this question is not applicable.

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

Not applicable. The "ground truth" for this device would be its ability to meet specified engineering performance metrics (e.g., mask leak, resistance) and material safety standards when subjected to various environmental and cleaning conditions. It is based on engineering specifications and established regulatory standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth established in that context.

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The PerforMax Pediatric SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for multi-patient use in the hospital/institutional environment only. The mask is to be used on patients 1 year or older (> 7 kg) who are appropriate candidates for noninvasive ventilation.

The PerforMax Pediatric SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation when used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable bonnet headgear. It may be cleaned by the professional in the hospital/institutional environment through a thermal high-level disinfection process or a chemical highlevel disinfection process for multi-patient use.

The PerforMax Pediatric SE Total Face Mask consists of a faceplate with a bonded silicone seal for the face. A 22 mm standard elbow is connected to the elbow hub on the faceplate. The 22 mm elbow is used to connect a conventional air delivery hose between the mask and the positive airway pressure source. The bonnet headgear is connected to the mask through slots in the upper part of the frame and clips that attach to the lower part of the frame. The mask is designed in such a way that it can be easily disassembled for disinfection or to replace several of the mask components, such as the headgear and elbow.

This document describes the PerforMax Pediatric SE Total Face Mask, a patient interface for noninvasive ventilation. The submission declares that the device is substantially equivalent to predicate devices based on non-clinical performance testing.

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

Acceptance Criteria and Reported Device Performance

The submission does not explicitly list acceptance criteria in a table format with corresponding performance metrics. Instead, it states that "extensive performance testing was completed" to demonstrate functionality was unaffected by changes from predicate devices. The overarching acceptance criterion implicitly is that the device "meets its performance specifications" and "raises no new issues of safety or effectiveness."

Implicit Acceptance Criteria and Performance:

Study Details

Based on the provided text, this submission relies on non-clinical bench testing rather than clinical studies involving human subjects or AI algorithms. As such, many of the requested fields are not applicable to this type of regulatory submission.

1. 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 quantitatively. The document refers to "extensive performance testing" but does not give specific numbers of masks or test cycles.
   • Data Provenance: Not specified. The testing was likely conducted in a lab environment by the manufacturer (Respironics, Inc. based in Murrysville, PA). The testing appears to be prospective as it was performed specifically for this 510(k) submission.

2. 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. This was a non-clinical bench test. "Ground truth" would refer to established engineering and material science standards, and the expertise would be in test engineers and quality assurance personnel rather than medical experts for clinical ground truth.

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

   • Not applicable. This relates to clinical studies and expert review for ground truth establishment.

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:

   • Not applicable. This is a medical device for ventilation, not an AI-assisted diagnostic or imaging device. No AI component is mentioned.

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

   • Not applicable. No AI algorithm is involved.

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

   • For the non-clinical tests, the "ground truth" was established by recognized industry standards and FDA guidance documents for medical device performance, disinfection, and biocompatibility. Examples cited include AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), FDA CDRH guidance on sterilants/disinfectants, and ISO 10993-1 for biocompatibility.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning device; therefore, there is no "training set."

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

   • Not applicable. There is no training set.

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