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The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency.

The device provides heated and humidified gas to the patient.

The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways bypassed are included.

The High Flow mode has a flow range from 1 to 60 lpm.

The HFT750U is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician.

It is not intended for life support.

This HFT750U is a Continuous Ventilator, intended to provide the patient with a high flow of gas that contains a constant amount of oxygen in a non-invasive method, thereby assisting or regulating the patient's respiration use in a hospital or medical institutions.

It can be used by the upper airways bypassed patients. Equipped with various alarm and safety functions, High flow (HF), the Continuous Positive Airflow Pressure (CPAP) and Bilevel Positive Airway Pressure (bilevel) modes regulate the patient's respiration, but for correct diagnosis it should be used together with clinical information.

The provided FDA 510(k) clearance letter for the HFT750U Continuous Ventilator does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

The document is primarily a clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and safety and performance standards. It lists types of performance testing conducted (e.g., Software Verification, Performance of Ventilation Modes), but it does not provide:

• Specific quantifiable acceptance criteria for device performance.
• Reported device performance data against those criteria.
• Details about the test set (sample size, provenance).
• Information on expert involvement in ground truth establishment or adjudication for performance studies.
• Details of any MRMC studies, standalone AI performance, or ground truth types used in specific performance evaluations.
• Training set information for any AI/ML component (which isn't explicitly mentioned as a core feature of this ventilator model, but could be implied by "Software Verification").

Given the limitations of the provided text, I will answer what can be inferred and highlight what information is missing.

Inferred Acceptance Criteria and Reported Device Performance (Table)

Based on the general nature of a continuous ventilator and the standards it claims to comply with, the acceptance criteria would revolve around meeting the specifications and a lack of hazardous function or failure. However, specific numerical acceptance criteria and direct performance metrics are not explicitly stated in the provided text.

The document implies that the device met acceptance criteria because it was cleared by the FDA and states "The sponsor has demonstrated through performance testing, design and non-clinical testing that the proposed device and predicates have been found to be substantially equivalent."

Here's an attempt to structure a table based on the types of performance aspects mentioned, acknowledging that specific data and criteria are absent:

Missing Information from the Provided Document:

1. Sample size used for the test set and the data provenance: Not mentioned. The document only lists types of tests, not the datasets or sample sizes for those tests.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This device is a ventilator, not an AI diagnostic tool requiring expert ground truth for image or signal interpretation. Performance is typically assessed against engineering specifications and physiological models.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not mentioned. Adjudication methods are typically used for establishing ground truth in human-in-the-loop or standalone AI studies for diagnostic/interpretive tasks, which is not the primary function of this device's "performance testing" as described.
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 not an AI diagnostic or assistive device in the context of "human readers" interpreting medical images or signals. Its "performance testing" would involve engineering and software validation, not human reader studies.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Performance of Ventilation Modes and Control Settings" and "Software Verification" which are forms of standalone testing for the device's core functionality and software. However, no specific metrics or study design for "standalone performance" (as it relates to AI algorithm performance) are provided.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a ventilator, "ground truth" would typically be established by:
   • Engineering specifications: The device's output (flow, pressure, oxygen concentration) is measured against the design specifications.
   • Standardized test lung models: Simulation of patient physiology (e.g., lung compliance, resistance) to assess how the ventilator responds in different scenarios.
   • Reference measurement devices: Highly accurate external sensors to verify the device's internal measurements and deliveries.
   • Compliance with recognized standards: Adherence to standards like ISO 80601-2-12 for basic safety and essential performance of ventilators.
     The document does not explicitly state the specific "ground truth" methods used, but these are the common practices for such devices.
7. The sample size for the training set: Not applicable/not mentioned. The document describes a traditional medical device (ventilator) and its conformity to engineering and safety standards. There is no indication of a machine learning model that would require a "training set" in the context of an AI/ML device submission. The software verification refers to traditional software development and testing.
8. How the ground truth for the training set was established: Not applicable, for the same reason as point 7.

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When used in NIV mode:
The Airvo 3 NV provides non-invasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lb/30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.

When used in High Flow mode:
The Airvo 3 NIV is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 NVV provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals.

The Airvo 3 NIV provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 NIV is not intended to provide total ventilatory requirements and is not intended for use during field transport.

AirSpiral NIV tube and chamber kit (900PT573):
For use with noninvasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lbs./30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.

The subject device, F&P Airvo 3 NIV is a respiratory support device for the delivery of High Flow and NIV (Non-Invasive Ventilation) therapy intended to treat spontaneously breathing patients who would benefit from receiving High Flow or respiratory pressure support. The Airvo 3 NIV is NOT to be used for life-supporting or life-sustaining purposes.

The Airvo 3 NIV is a non-implantable, prescription-only device, provided in a non-sterile state, and intended to be used by healthcare professionals, namely respiratory therapists, doctors and nurses in hospitals. When used in High Flow mode, the Airvo 3 NIV delivers gas at flow rates of between 2-70 L/min. The Airvo 3 NIV also has three non-invasive ventilation therapy modes: CPAP, Bi-Level S/T and Bi-Level PCV.

The AirSpiral NIV Tube and Chamber Kit is a single limb circuit kit designed for use with the Airvo 3 NIV device, for non- ventilator dependent, spontaneously breathing adult patients with respiratory insufficiency.

The provided text is a 510(k) Summary for the F&P Airvo 3 NIV device. It focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this document as it does not describe an AI/ML device or a study of its clinical performance against specific acceptance criteria for such an algorithm.

However, I can extract information related to performance testing from the "PERFORMANCE DATA VII." section, which includes "Bench / Performance Testing."

Here's an attempt to answer your request based on the provided document, noting the limitations due to the nature of the submission:

Acceptance Criteria and Study for F&P Airvo 3 NIV (K233643)

The F&P Airvo 3 NIV is a respiratory support device and not an AI/ML driven diagnostic or therapeutic device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing performed to establish substantial equivalence to predicate devices and ensure general safety and effectiveness in line with recognized medical device standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance testing conducted but does not explicitly state numerical acceptance criteria or reported device performance values in a table format. Instead, it states that the testing "demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device" and that "The testing demonstrated the appropriate biocompatibility profile for the device" and "The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 and AIM Standard 7351731 Rev. 3.00 2017-02-23" as well as "Alarms testing was performed in accordance with ANSI AAMI IEC 60601-1-8:2006 and A1:2012." For reprocessing, "The acceptance criteria and endpoints used are based on the following standard: AAMI TIR30:2011". For comparative performance, it states "Comparative performance testing was performed to demonstrate substantial equivalence."

Given the information, a table with specific numerical acceptance criteria and performance values cannot be fully populated as requested for items like blending accuracy, flow rate accuracy, etc. The document implies compliance with relevant standards as the "acceptance criteria."

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

• Not applicable for an AI/ML context. This device is hardware with embedded software, thus performance testing involves engineering verification and validation, not a test set of patient data for an algorithm. The testing described focuses on functional aspects of the device, not an algorithm's performance on a dataset.

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

• Not applicable for an AI/ML context. Ground truth, in the sense of clinical expert assessment of data, is not mentioned in relation to the device's technical performance testing.

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

• Not applicable for an AI/ML context. This type of adjudication is relevant for resolving discrepancies in expert interpretations of clinical data, which is not described here.

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

• Not applicable. This device is not an AI-assisted tool for human readers.

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

• Not applicable. This device does not feature a standalone algorithm performing a diagnostic or therapeutic task.

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

• For engineering and performance testing described (electrical safety, EMC, flow rate accuracy, etc.), the "ground truth" would be established physical and engineering principles, international standards, and measurements from calibrated reference instruments. It is not clinical "ground truth" as typically defined for AI/ML performance.

8. The sample size for the training set:

• Not applicable. There is no mention of an AI/ML training set. Software verification and validation refer to standard software engineering practices.

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

• Not applicable. There is no mention of an AI/ML training set or its associated ground truth establishment.

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Servo-air Lite Ventilator System is an assist ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring.

Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above.

Servo-air Lite Ventilator System is to be used only by healthcare professionals.

Servo-air Lite Ventilator System is to be used only in professional health care facilities and for transport within these facilities. It is not intended for transport between health care facilities.

The Servo-air Lite Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.

The Servo-air Lite Ventilator System is based on the cleared reference device Servo-air Ventilator System (K192604), with additions based on reference device Servo-u Ventilator System (K201874).

The ventilator delivers controlled or supported breaths to the patient, with constant pressure, using a set oxygen concentration. The ventilator can also deliver High Flow therapy with a constant flow.

Servo-air Lite contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard).

Accessories for CO2 monitoring are available as options.

The Servo-air Lite Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings.

The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.

The provided text describes a 510(k) submission for the Servo-air Lite Ventilator System, which is a medical device and not an AI/ML-based device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable in the context of an AI/ML device.

The document discusses non-clinical testing and performance for the ventilator system, focusing on:

• Software: Code review, static code analysis, unit tests, and integration tests.
• Performance: System testing, regression testing, free user testing, and waveform testing.
• Biocompatibility: Volatile Organic Compounds, Particulate Testing, Leachable testing.
• Human Factors Validation Testing.
• Compliance with various product standards (e.g., ANSI/AAMI ES 60601-1, IEC 60601-1-2) and biocompatibility standards (AAMI/ANSI/ISO 10993-1).

The conclusion states that the device is substantially equivalent to the predicate device (Respironics V60 K102985) based on equivalent indications for use and that no new questions of safety and effectiveness are raised. They have conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output meets the design input requirements and appropriate product standards.

However, the document does not provide specific acceptance criteria in a table or detailed results of these tests that would typically be presented for an AI/ML device's performance metrics like sensitivity, specificity, or AUC.

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The Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospital-type facilities, and in-hospital transportation by qualified and trained users under the directions of a physician.

The NKV-330 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for pediatric through adult patients. The NKV-330 design is comprised of two major components, a Breath Delivery Unit (BDU) and a Graphic User Interface (GUI). The GUI allows clinicians to set ventilator control parameters such as PEEP and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, and to view waveforms. The BDU assembly contains a blower and the electronics required to perform breath delivery. Ambient air is taken into the blower and mixed with oxygen which is flow rate controlled by a proportional valve. The mixed gas is provided to the patient. The microprocessor controls the blower and the proportional valve to deliver the pressure and oxygen concentration which are set by the user. It also provides various alarms and other design features to maximize patient safety.

The provided document is a 510(k) summary for the Nihon Kohden NKV-330 Ventilator System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study or detailed performance metrics.

Therefore, the document does not contain the specific acceptance criteria, reported device performance in those terms, details of a specific study proving it, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details as requested.

The document primarily states that the device's technical characteristics are "substantially equivalent" to a predicate device (Philips/Respironics V60 Ventilator) and lists various non-clinical performance data and standards compliance to support this claim. It explicitly states "Clinical performance data was not required to demonstrate substantial equivalence."

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The Fisher & Paykel Healthcare single patient use masks are intended for use as an accessory to ventilators to enable noninvasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.

The Nivairo™ RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version (referred as RT047) is a vented hospital full face mask with an anti-asphyxiation valve for use with single limb circuits. The RT047 is a single use device intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as passively vented non-invasive ventilation system. The RT047 is a prescription only device, provided in a non-sterile state.

This document is a 510(k) Premarket Notification from the FDA regarding the F&P Nivairo™ RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version. It does not contain information about a study that tests the device's performance against acceptance criteria in the context of an AI/human reader study.

Instead, the document focuses on demonstrating substantial equivalence of the RT047 mask to a previously cleared predicate device (RT045) based on non-clinical performance data and technological characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria for an AI-related context because this document pertains to a medical device that is not an AI/ML-enabled product. The device is a full face mask, an accessory to ventilators.

The document explicitly states:

• "Clinical performance testing was not required to demonstrate substantial equivalence for the RT047." (Page 5)

It also does not mention any AI component, human readers, ground truth establishment by experts, or MRMC studies.

Here's an analysis of the provided information from the perspective of the document's content:

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

   • The document lists several non-clinical tests performed (e.g., Dead Space Testing, Pressure Drop and Resistance to Flow Testing, CO2 Testing, Venting Leak Rate, Biocompatibility testing). However, it does not explicitly provide a "table of acceptance criteria" with specific numerical targets and the device's reported performance against each. It states that these tests demonstrate "substantial equivalence" and that "device design changes, compared to the predicate do not raise new questions of safety or effectiveness." This implies the device met the expected performance within these tests, likely by being comparable to the predicate or within established safety limits, but the specific criteria and results are not detailed in this summary.

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

   • This information is not provided in the document. The non-clinical tests are described generically without details on sample sizes or data provenance.

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):

   • This is not applicable as the document does not describe a study involving expert establishment of ground truth.

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

   • This is not applicable.

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:

   • This is not applicable. The device is a physical medical mask, not an AI system.

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

   • This is not applicable.

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

   • This is not applicable. The document refers to non-clinical performance data for substantial equivalence, not ground truth for an AI task.

8. The sample size for the training set:

   • This is not applicable as there is no AI component or a "training set" mentioned.

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

   • This is not applicable.

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The Fisher & Paykel Healthcare single patient use masks are intended for use as an accessory to ventilators to enable noninvasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (>30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.

The Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve (herein referred to as RT045) is a non-vented hospital full face mask with anti-asphyxiation valve for use with single limb circuits. The RT045 is a single use device intended to deliver noninvasive positive pressure ventilation (NPPV) to a patient as part of a passively vented noninvasive ventilation system.

The RT045 is an oronasal full face mask intended to be used in a hospital/institutional environment by trained medical staff with patient monitoring systems in place. It connects to a single limb breathing circuit via a 22mm female swivel adaptor to receive pressurized breathing gases from an external flow source or ventilator (CPAP or Bi-Level).

The RT045 mask is a prescription only device, provided in a non-sterile state.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve). This document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data.

The document states: "Clinical performance testing was not required to demonstrate substantial equivalence for the RT045."

Therefore, I cannot provide information on:

• Acceptance criteria and device performance based on a study of the device's effectiveness in clinical use. The document does not describe such a study.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The document does mention that non-clinical performance data was conducted to demonstrate substantial equivalence. It refers to:

• Performance testing of the RT045 compared to the RT040 (predicate device).
• Evaluations against standards:
  • ISO 5356-1:2004 Anaesthetic and respiratory equipment- Conical connectors: Part 1: Cones and sockets.
  • ISO 10993-1:2009 Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
  • Clauses 5.3 and 5.5 of ISO 17510-2:2007 Sleep Apnoea Breathing Therapy- Part 2: Masks and Application Accessories.

However, the specific "acceptance criteria" and "reported device performance" in relation to these non-clinical tests are not detailed in the provided text in a way that would allow for a table similar to what you requested for clinical studies. The document only states that "These data demonstrates substantial equivalence of the RT045 to the RT040. The results of the comparative bench testing do not raise any new questions regarding safety or effectiveness for the RT045."

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The device is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb / 13 kg and above) with respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea. The device is for non-invasive use, or invasive use (with the use of the ResMed Leak Valve). Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.

The Stellar 150 is a pressure controlled ventilator using a single limb vented circuit, product code MNT, and is substantially equivalent to the already marketed Stellar 150 device (K113640). The device contains a microprocessor controlled blower that generates the required airway pressure. CPAP and Bi-level modes are implemented and the device is suitable for patients weighing above 30 lbs (13 kg) for CPAP and Bi-level modes. The device also includes a volume assured pressure support mode (iVAPS), indicated for patients above 66 lbs (30 kg).

This submission updates the Stellar 150 to include a new Remote Alarm (optional) accessory. The Remote Alarm generates an audible and visual signal when an alarm is triggered on the ventilator. For the connection of this new Remote Alarm, the Stellar 150 requires an additional connector on the back of the device as well as electronics and software support for this additional port. This new Remote Alarm triggers this 510[k].

This is a 510(k) premarket notification for a minor modification (addition of a remote alarm accessory) to an existing medical device, the Stellar 150 ventilator. The submission primarily relies on demonstrating substantial equivalence to predicate devices rather than conducting extensive new clinical studies to establish novel performance metrics. As a result, many of the requested elements for a study proving device acceptance criteria in a typical AI/diagnostic device context are not directly applicable or explicitly detailed in this document.

However, I can extract and infer information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the Stellar 150 ventilator itself, the acceptance criteria are implicitly that it performs as well as the prior cleared Stellar 150 (K113640) and meets applicable standards. For the new Remote Alarm accessory and its integration, the acceptance criteria are implicitly that it performs as well as the predicate Respironics Trilogy series Remote Alarm (K111610) and functions correctly with the Stellar 150. Specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not presented as this is not a diagnostic device and the submission focuses on safety and performance equivalence.

• "Design and system verification testing in regards to mechanical and environmental testing according to IEC 60601-1-11:2010, electrical safety testing according to IEC 60601-1:2005, EMC testing according to IEC 60601-1-2:200, etc. was performed."
• "A regression analysis identified the features which were changed and which test cases needed to be repeated. End-to-end testing on the appropriate test cases has been performed."
• "The tests as well as the existing data from the K113640 submission, demonstrate that the Stellar 150 meets the predetermined acceptance criteria and is substantially equivalent to the predicate device (K113640)." |
  | Remote Alarm | Perform comparably to the Respironics Trilogy series Remote Alarm (K111610).
  Interoperate safely and effectively with the Stellar 150. | - "The Remote Alarm was compared to the Respironics Trilogy series Remote Alarm (K111610). The result of this comparison is that the Remote Alarm is substantially equivalent to the Trilogy Remote Alarm (K111610)."
• "The compatibility of Stellar 150 with the Remote Alarm was tested and confirmed."
• "In addition verification testing for the Remote Alarm was performed and demonstrated that it met the predetermined acceptance criteria." |

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

The document does not specify a "sample size" in terms of patient data for a test set. This submission relies on engineering verification and validation testing (e.g., mechanical, electrical safety, EMC, software regression testing) rather than a clinical study with patient data. Therefore, the concept of data provenance (country of origin, retrospective/prospective) related to patient data is not applicable here.

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

Not applicable. Ground truth in the context of this submission would refer to the expected performance of the device under various engineering tests, which is established by engineering specifications, regulatory standards (like IEC 60601-1), and comparison to predicate device performance, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human adjudication process for interpreting test results. Device performance is determined by meeting pre-defined engineering and regulatory standards during verification and validation testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic or imaging device, and no MRMC study was performed.

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

The Stellar 150 is a medical device, not an algorithm in the AI sense. Performance testing was done on the device (and its new accessory) as a standalone system to ensure it met its specifications and regulatory standards. The "standalone" performance here refers to the device itself operating as intended, independent of direct interaction during the test, but it's not "algorithm-only" performance as one might see in AI/ML submissions.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is established through:

• Engineering specifications and design requirements: Derived from the predicate device and relevant standards.
• Regulatory standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11.
• Performance of the predicate devices: The Stellar 150 (K113640) for the main device and the Respironics Trilogy series Remote Alarm (K111610) for the new accessory.
• Functional tests: Ensuring the device and accessory perform their intended functions (e.g., alarm triggers correctly, connectivity works).

There is no mention of pathology, expert consensus on clinical cases, or outcomes data as the primary ground truth for this technical verification and validation.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable, as no training set was used.

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The BiPAP A40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adulate and pediatric weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA), Respiratory Insufficiency, or Respiratory Failure. It is intended to be used in the home, institutional/hospital, and portable applications such as wheelchairs and gurneys.

The Respironics BiPAP A40 Ventilatory Support System is a microprocessor controlled blower and valve based positive pressure ventilatory system. The device can provide non-invasive or invasive ventilation. The device augments patient breathing by supplying pressurized air through a patient circuit. It senses the patients breathing effort by monitoring airflow in the patient circuit and adjusts its output to assist in inhalation and exhalation. This therapy is known as Bi-level ventilation. Bi-level ventilation provides a higher pressure, known as IPAP (Inspiratory Positive Airway Pressure), when you inhale, and a lower pressure, known as EPAP (Expiratory Positive Airway Pressure), when you exhale. The higher pressure makes it easier for you to inhale, and the lower pressure makes it easier for you to exhale. This device can also provide a single pressure level, known as CPAP (Continuous Positive Airway Pressure).

The BiPAP A40 Ventilator is compatible with the System One Heated Humidifier. The System One heated humidifier, previously cleared for use in K113053, is an accessory for the Philips Respironics A Series therapy devices to provide moisture to the circuit.

The BiPAP A40 ventilator introduces a new therapy mode called AVAPS-AE. This therapy mode combines an improved AVAPS algorithm with an auto-back up to treat hypoventilation. An auto-EPAP algorithm runs simultaneously with the bi-level therapy to deliver the pressure support at the optimal PEEP. Additionally the ventilator can be operated using AC power, a detachable battery, or an external battery.

A Graphical user interface displays device data and device settings.

The BIPAP A40 Ventilatory Support System is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable,

Like its predicates, the BiPAP A40 Ventilatory Support System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask or trach). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen tubing, an exhalation device, and a patient interface device.

This document describes the BiPAP A40 Ventilatory Support System, a continuous ventilator intended for invasive and non-invasive ventilatory support in both adult and pediatric patients weighing over 10 kg. It's meant for use in various settings, including home, hospital, and portable applications.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing that confirmed the product met "predetermined acceptance criteria" (Page 5). However, specific numerical acceptance criteria (e.g., "Pressure Accuracy: +/- X cmH2O") are not explicitly listed in a table format alongside specific numerical performance results. Instead, the document generally states that "All tests confirmed the product met the predetermined acceptance criteria."

The closest information to acceptance criteria is found in the "Technological Characteristic" table on page 3, which lists specifications for pressure accuracy and alarm indicators. The document then states that "Performance testing comprises pressure performance, trigger and cycling, as well as volume assured pressure support ventilation" and "All tests confirmed the product met the predetermined acceptance criteria." This implies that the device's performance aligned with these listed characteristics.

The "Pressure Accuracy" is stated as "+/- 2.5 cmH2O of the setting". The document does not provide a separate table of specific acceptance criteria values versus reported performance values with numerical results for each test. It simply states that the device "passing all test protocols" and "All tests confirmed the product met the predetermined acceptance criteria."

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

The document describes "bench testing" and "non-clinical tests" (Page 4, 5, 6, 7). No specific sample size (e.g., number of patients or patient data sets) for a test set is provided. The testing appears to be primarily focused on the device's functional performance in a laboratory setting, rather than with a human patient test set.

The data provenance is from non-clinical bench testing rather than human subject data. There is no mention of country of origin of data or whether it was retrospective or prospective, as it pertains to bench testing.

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

This information is not applicable as the testing described is non-clinical bench testing, not involving human experts for ground truth establishment of a medical condition. The "ground truth" for the device's performance was established by its design input specifications and engineering verification.

4. Adjudication Method for the Test Set

This information is not applicable as the testing was non-clinical bench testing and did not involve expert adjudication of results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes "comparative testing" (Page 5) and "side-by-side bench testing methodologies" (Page 6) with predicate devices to demonstrate substantial equivalence, but this refers to comparing the device's technical performance against other devices, not a study involving human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The testing described is primarily standalone in nature for the device itself (algorithm only without human-in-the-loop performance in a clinical context). The device is a ventilatory support system, not an AI diagnostic tool requiring human interpretation. The "algorithms" mentioned (AVAPS, AVAPS-AE, Trigger Type Options) are intrinsic to the device's operation. The bench testing verified their functional performance.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical testing was based on design input specifications, engineering principles, and validated test protocols for ventilator performance (e.g., pressure accuracy, breath rates, tidal volume delivery). For the algorithms, the ground truth was their ability to perform to these specifications, to "safely change pressure support to maintain a target tidal volume" and "safely adjust the EPAP setting" under varying conditions (Page 6).

8. The Sample Size for the Training Set

The document does not describe a training set in the context of machine learning. The device's algorithms (like AVAPS-AE) appear to be rule-based or control-loop systems, rather than trained machine learning models requiring a distinct "training set." Therefore, this information is not applicable in the conventional sense of machine learning.

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

As there is no mention of a training set for machine learning, this information is not applicable. The "ground truth" for the device's operational parameters would have been established through engineering design, physiological models, and clinical requirements and specifications for ventilator performance.

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The device is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb / 13 kg and above) with respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea. The device is for non-invasive use, or invasive use (with the use of the ResMed Leak Valve). Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.

The Stellar 150 is a pressure controlled ventilator using a single limb vented circuit, product code MNT and is substantially equivalent to the already marketed Stellar 150 device (K103167). For both devices as they are substantial equivalent, it is essential that a microprocessor controlled blower generates the required airway pressure. CPAP and Bi-level modes are implemented. With ongoing technological progress, the device is further suitable to include a population above 30 lbs (13 kg) for CPAP and Bilevel modes. The device also includes a volume assured pressure support mode (iVAPS), indicated for patients above 66 lbs (30 kg). The Stellar 150 in combination with the new developed ResMed Leak Valve supports the invasive use therapy. The ResMed Leak Valve incorporates a leak port as well as an integrated anti-asphyxia valve.

The provided document describes a 510(k) submission for the ResMed Stellar 150 ventilator, focusing on a change in the indication for use to include invasive therapy with a new ResMed Leak Valve. The submission asserts substantial equivalence to a previously cleared device (K103167).

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

1. Table of Acceptance Criteria and Reported Device Performance

• ISO 5356-1 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
• ASTM F 1246-91 Specification for Electrically Powered Home Care Ventilators, Part 1 - Positive-Pressure Ventilators and Ventilator Circuits |
  | System Verification (Stellar 150 + Leak Valve): | "System verification testing was performed as well as bench testing. The side-by-side testing demonstrated that there is no significant difference in delivering invasive therapy using the new ResMed Leak Valve (leak port with integrated anti-asphyxia valve) and therefore the Stellar 150 is Substantially Equivalent to the predicate device."
  "Performance and side-by-side testing demonstrated that there is no significant difference in [safety and effectiveness] between the ResMed Leak Valve and the new ResMed Leak Valve (leak port with integrated anti-asphyxia valve)." (likely a typo, intended to compare the new system to the predicate or non-invasive system) |

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

• Sample Size: Not explicitly stated. The document mentions "performance testing," "system verification testing," and "bench testing," but does not provide specific numbers of units tested, test runs, or patient data (as this appears to be a device performance and safety study, not a clinical trial with patient data).
• Data Provenance: Not explicitly stated. Given it's a submission for regulatory clearance of a medical device, the studies are typically conducted by the manufacturer (ResMed) in a controlled environment. The nature of the tests (bench and system verification) suggests laboratory-based testing rather than patient data from a specific country. This is retrospective in the sense that it relies on previously established performance for the core device and new testing for the new component.

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

• The document does not describe a ground truth established by human experts for a test set in the context of diagnostic accuracy. This submission is for a ventilator, and the performance criteria are based on engineering standards (ISO, ASTM) and functional comparisons, not expert interpretation of diagnostic output.

4. Adjudication Method for the Test Set

• Not applicable as there is no "test set" requiring expert adjudication in the context of diagnostic accuracy. The performance is assessed against engineering standards and functional equivalence.

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 comparative effectiveness study was not done. This is a regulatory submission for a continuous ventilator, not an AI-powered diagnostic tool. The concept of "human readers" and "AI assistance" is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is not an algorithm-only device. The device itself (ventilator) operates as a standalone unit in delivering therapy. The performance tests described (ISO, ASTM, bench testing) are standalone in the sense that they evaluate the device's functional attributes, not human interaction with an algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for the performance evaluation of the new ResMed Leak Valve and the combined system is based on:
  • Engineering Standards: Compliance with ISO 5356-1 and ASTM F 1246-91.
  • Functional Equivalence: Demonstrated "no significant difference" in delivering invasive therapy when compared side-by-side to the predicate device/system.
  • Predetermined Acceptance Criteria: The core Stellar 150 device already met these from its prior clearance (K103167).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device 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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