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The AirLife DuoTherm™ Heated Humidifier is intended to add moisture to, and warm, the breathing gases for administration to a patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. This product is non-sterile, reusable, and intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients ranging from neonates to adults using a heated humidifier. The product is a single use device, nonsterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Neonate Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Neonate Heated-Wire Circuits are used with a pediatric population, specifically the neonate (birth to 28 days) and infant (29 days to 2 years) pediatric subgroups with an ideal body weight of 0.5 to 8kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Neonate Heated-Wire Circuits are used for flow rates greater than 1 LPM. The product is single patient use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Pediatric Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Pediatric Heated-Wire Circuits are used with the pediation, specifically infant (29 days to 2 years) and children (2 years) with an ideal body weight of 6 to 42kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Pediatric Heated-Wire Circuits are used for flow rates greater than 2 LPM. The product is single use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Adult Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire Circuits are used with the adult population and pediation, specifically those with an ideal body weight of 30kg or above, that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Adult Heated-Wire Circuits are used for flow rates greater than 3 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Adult Heated-Wire NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire NV Circuit is used with the spontaneously breathing adult population (>21 years), specifically those with an ideal body weight of 30kg or above, that benefit from high flow therapy. The Adult Heated-Wire NIV Circuits are used for flow rates greater than 5 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Humidification System is used to deliver heated, humidified breathing gases to a patient's airway when he/she is mechanically ventilated, receiving continuous noninvasive (NIV) positive airway pressure or high-flow oxygen therapy. The system is intended for use in a standard hospital or professional health care environment.

The AirLife DuoTherm™ Humidification System consists of:

• A heated humidifier, which includes reusable temperature probes, heated wire adapters, and a power cord,
• A humidification chamber, and
• . Heated wire circuits, which include neonate, pediatric, and adult single and dual limb circuits, as well as an adult heated wire NIV circuit.

Based on the provided text, the document is a 510(k) Premarket Notification for the AirLife DuoTherm™ Humidification System. This type of submission aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and efficacy from scratch through extensive clinical trials. Therefore, the information provided focuses on non-clinical performance testing and comparison to predicate devices, rather than a traditional clinical study with human data.

There is no clinical study data provided in this document that would define acceptance criteria for AI model performance (e.g., accuracy, sensitivity, specificity) against a ground truth established by experts using a test set, nor does it describe an MRMC study.

The document explicitly states:
"There was no clinical testing required to support the AirLife DuoTherm™ Humidification System, as the intended use and indications for use are equivalent to the primary predicate and reference devices. These types of devices, including the primary predicate device, have been on the market with a proven safety and efficacy record for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the AirLife DuoTherm™ Humidification System, and its safety and effectiveness."

Therefore, I cannot provide the requested information regarding acceptance criteria, training/test sets, expert adjudication, or MRMC studies as these were not part of the demonstrated substantial equivalence for this particular device.

However, I can summarize the non-clinical performance testing and the basis for the substantial equivalence claim as described in the document.

Summary of Acceptance Criteria and Device Performance (Non-Clinical):

The acceptance criteria for the AirLife DuoTherm™ Humidification System were met by demonstrating compliance with various national and international consensus standards for medical electrical equipment, respiratory humidifying equipment, biocompatibility, and software. The device performance is deemed acceptable because it met the requirements of these standards and was shown to be substantially equivalent to existing predicate devices with a proven safety and efficacy record.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Regarding the specific questions about an AI/Algorithm performance study:

1. A table of acceptance criteria and the reported device performance: As explained above, for the AirLife DuoTherm™ Humidification System, this refers to compliance with performance and safety standards for medical devices and demonstration of substantial equivalence to predicate devices, not AI performance metrics.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set for an AI algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts for an AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. No MRMC study was conducted or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. No training set for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this FDA 510(k) submission pertains to a physical medical device (a humidification system) and its components, demonstrating substantial equivalence to existing devices through non-clinical testing and comparison of fundamental characteristics. It does not involve AI or an algorithm whose diagnostic or prognostic performance would be evaluated through the types of studies described in the prompt.

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The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation.

The operating flow range is 5 to 120L/min depending on the patient interface.

The HC550 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional.

The Fisher & Paykel Healthcare HC550 System is designed to condition gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.

The HC550 System consists of the following components:

• . HC550 Respiratory Humidifier
• . Accessories:
  • a) Breathing circuit (compatible adult breathing circuits as cleared in K983112, K020332, K034026, K103767, K122432)
  • b) Humidification Chamber (as cleared in K9341401 and K913368)
  • c) Heaterwire Adaptor (as cleared in K073706)
  • d) Temperature/Flow Probe (as cleared in K983112)
  • RT008 Air Entrainer (optional oxygen therapy accessory) (as cleared in K953711) e)

The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a humidification chamber.

A dryline tube (part of the breathing circuit) transports respiratory gases from a flow source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.

The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube may be electrically heated by means of a heater-wire placed internally to the tube, which is controlled by the HC550 respiratory humidifier.

The expiratory limb of the breathing circuit transports expired gas from patient. In the case of a dual-heated breathing circuit, this limb may also be heated in the same manner as the inspiratory limb.

If a heated breathing circuit is used, the heaterwire adaptor provides electrical energy from the respiratory humidifier to the heaterwire in the breathing circuit.

Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.

HC550 System Acceptance Criteria and Study Details

This document describes the acceptance criteria and corresponding study results for the HC550 System, a respiratory gas humidifier. The information is extracted from the provided 510(k) Notification K132017.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HC550 System are based on compliance with the ISO 8185:2007 standard for humidification systems. The device's performance is compared to these requirements.

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The Fisher & Paykel MR810 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases, when using a continuous or 'intermittent non-invasive ventilator system or a continuous gas flow system.

The MR810 System is intended for non-invasive therapies only. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through non-invasive ventilation is beneficial to prevent drying of the patient airways.

The MR810 System is designed for use in hospitals, long term care facilities and homes under the prescription of a qualified medical professional.

The Fisher & Paykel Healthcare MR810 System is designed to condition respiratory gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.

The MR810 System consists of the following components:

• . MR810 Respiratory Humidifier
• Accessories: .
  • O Breathing circuit (i.e. 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit)

Note: The 900MR810 and 900MR810E breathing circuits have identical heated inspiratory limbs, however the 900MR810E also includes an expiratory limb (unheated) and a Y-piece (which connects the inspiratory and expiratory limbs).

• O Humidification chamber (as cleared in K934140 and K913368).
  The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element which transfer heat to the water in a humidification chamber and control power to the heated inspiratory limb of the breathing circuit.

A dryline tube (part of the breathing circuit) transports respiratory gases from a gas source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.

The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube of the 900MR810 and 900MR810E breathing circuits is electrically heated by means of a heaterwire placed internally to the tube, which is controlled by the MR810 respiratory humidifier.

The MR810 respiratory humidifier also includes a built-in heaterwire adaptor. The heaterwire adaptor makes an electrical connection with the heated inspiratory limb of the breathing circuit for the purpose of powering the heated limb. The heater wire adaptor incorporates an ambient (room) temperature sensor and a chamber temperature sensor. The heaterwire adaptor also includes an embedded LED to visually indicate that the heated breathing circuit has been connected correctly.

The expiratory limb of the breathing circuit transports expired gas from the patient when a return flow of expired gases from the patient to the gas source is required (the 900MR810E Adult Dual Limb Breathing Circuit should be used as it includes an expiratory limb).

The Fisher & Paykel Healthcare MR810 System is a respiratory gas humidifier designed to condition respiratory gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.

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

1. Table of Acceptance Criteria and Reported Device Performance

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The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11lbs.), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
• Assist Control, SIMV, or CPAP modes of ventilation. -

The ventilator is suitable for use in institutional, home, or transport settings.

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
• Assist/Control, SIMV, or CPAP modes of ventilation. .
• Breath types including Volume, Pressure Control and Pressure Support. .

The modification intended to be cleared by this submission is:

The addition of commercially available heated wire breathing circuit inspiratory/expiratory limbs manufactured and distributed by Allegiance Healthcare Corporation (K000697), as an option to the ventilator breathing circuits specified for use

This 510(k) submission (K040790) describes a modification to the LTV 1000 Ventilator, specifically the addition of commercially available heated wire breathing circuits. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel device requiring extensive performance testing against acceptance criteria in the traditional sense. Therefore, the details requested regarding a specific "study that proves the device meets the acceptance criteria" and related metrics are not explicitly provided in this document as it pertains to a new device.

However, based on the provided text, we can infer the implicit "acceptance criteria" and "device performance" in terms of establishing substantial equivalence and the testing methods typically involved for such modifications.

Inferred Acceptance Criteria and Reported Device Performance (Table 1)

Given that this is a 510(k) for a modification focused on incorporating existing, cleared components (heated wire breathing circuits) into a cleared ventilator system, the primary "acceptance criterion" is demonstating that the modified system maintains the safety and effectiveness of the predicate device and the added components when integrated. This is typically achieved through:

• Substantial Equivalence: The modified device performs as intended and is as safe and effective as the predicate device(s).
• Performance Testing: Verification of critical ventilator parameters and circuit performance within established engineering specifications and relevant standards. This might involve pressure, flow, volume delivery, temperature control (for the heated circuits), and alarm functionality.
• Biocompatibility: Ensuring that the materials of the new breathing circuits are biocompatible with patient contact.
• Electrical Safety and EMC: Compliance with relevant electrical safety and electromagnetic compatibility standards.

Since the document is a summary for a 510(k), explicit, detailed acceptance criteria values (e.g., "flow rate must be within ±5% of set value") are not laid out, nor are specific performance testing results presented as a report. Instead, the "reported device performance" is implied by the statement of substantial equivalence and the expectation that the combined system meets the performance of its cleared predicate components.

Detailed Study Information (Based on 510(k) Modification Context)

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

   • Test Set Sample Size: The document does not specify a "test set" sample size in terms of patient data. For a 510(k) modification focused on component integration and substantial equivalence, testing would involve engineering verification and validation (V&V) on a sufficient number of device units (physical ventilators with the new circuits) to demonstrate performance against specifications and compliance with standards. The specific number of units tested is not provided in this summary.
   • Data Provenance: The data provenance would primarily be from internal engineering and quality testing conducted by Pulmonetic Systems, Inc. on their modified LTV 1000 Ventilator system. Additionally, the pre-existing clearance (K000697) of the Allegiance Airlife Heated Ventilator Breathing Circuits would draw upon its original test data. This is prospective testing related to the manufacturing and verification of the modified device before market entry. Country of origin for testing is implied to be the US (Minneapolis, Minnesota for Pulmonetic Systems, Inc.).

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

   • This question is largely not applicable in the context of this 510(k) modification. "Ground truth" established by external experts (like radiologists for imaging) is relevant for diagnostic devices or AI algorithms where clinical accuracy is being assessed. For a ventilator modification, the "ground truth" for performance is established by engineering specifications, international standards (e.g., ISO for ventilators), and existing predicate device performance. Device validation would be performed by qualified engineers and technicians, not typically by external clinical "experts" establishing a "ground truth" for a test set in the way this question implies. Clinical experts would inform requirements and user needs, but they wouldn't perform ground truth adjudication on device performance data in this manner.

3. Adjudication method for the test set:

   • Not Applicable in the sense of clinical adjudication. Device performance testing against specifications typically involves defined measurement protocols, acceptance criteria, and verification by qualified test personnel. Discrepancies would be resolved through standard engineering and quality assurance processes, not a multi-reader, multi-case adjudication method.

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 ventilator device, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant to this submission.

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

   • Not Applicable. This is a hardware modification for a ventilator, not an algorithm or AI system.

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

   • The "ground truth" in this context is based on engineering specifications, compliance with recognized national and international standards for medical devices (specifically ventilators and breathing circuits), and the established safety and performance profile of the predicate devices. This includes physical and functional performance measurements, material biocompatibility, electrical safety, and electromagnetic compatibility.

7. The sample size for the training set:

   • Not Applicable. This is for a hardware modification, not a machine learning or AI algorithm development that requires a training set. The "training" for such a device would be the design and development process adhering to a quality management system.

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

   • Not Applicable. See point 7.

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The Fisher & Paykel Healthcare MR850 humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.

The heated-wire breathing circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of humidified inspired gas, to reduce or prevent condensation and to it are accessories for the Fisher & Paykel Healthcare MR850 Respiratory Gas Humidifier. The RT130 is used for flow rates between 0.3 and 4 L/min, and the RT131 is for flow rates greater than 4 L/min, for neonatal patients.

The MR850 humidifier is a Respiratory Gas Humidifier (heated pass-over type) according to 21 CFR §868.5450. Heat is used to provide evaporated water content to dry breathing gases. Heated or unheated breathing tubes can be used to deliver the humidified gas to the patient. Heated breathing tubes increase operating efficiency and reduce excessive water and heat loss.

The MR850 has a thermoplastic enclosure with dimensions of 140 mm high × 135 mm wide × 173 mm deep, and weighs 2.8 kg. A heater plate is positioned in the top of the unit, where the enclosure rim and finger guard allow a humidification chamber to be added. Temperature probe and heater wire connection sockets are on the right side of the unit. A serial data interface port is located in the underside of the unit, with a mounting bracket at the back of the device.

The unit controls and displays are located on the front panel. Controls consist of power, operating mode and alarm mute buttons. A setup / alarm display indicates if a part of the equipment is incorrectly installed, or type of alarm condition occurring.

Accessories for the MR850 humidification chambers, breathing circuits, electrical adapters and temperature / flow probes.

The chamber slides on to the heater plate and contains the water supply for adding humidity to breathing gases. The breathing circuit transports gases to the patient, and includes sections for connection from yentilator to humidifier, inspiratory limb to the patient, and expiratory limb for return to the ventilator. When used with heated breathing circuits the electrical adapter from the humidifier supplies power to the heated wires. The temperature / flow probe has sensors at the chamber and patient airway ends of the inspiratory section for heater control.

The MR850 humidifier has two operating modes. Invasive Mode is used for patients who have bypassed upper airways, and delivers humidified gas to the patient at 37 ℃ (body temperature). Non-Invasive Mode is used for patients receiving breathing gases via a face mask, and delivers humidified gas to the patient at 31 ℃. The MR850 humidifier monitors temperature, flow parameters and equipment integrity, in order to maintain stable performance conditions. It will also notify the user of high delivered temperature, or incorrect equipment set-up conditions, and when in the invasive mode, of inadequate delivered humidity.

Here's a breakdown of the acceptance criteria and the study descriptions for the Fisher & Paykel MR850 Respiratory Humidifier, as derived from the provided document:

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the clinical verification studies (test set). It only refers to "clinical verification studies" in a general sense.

The provenance of clinical data is not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications. The "clinical verification studies" likely involved medical staff, but specific details are not provided.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set.

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

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device is a respiratory humidifier, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

The device itself is a piece of medical equipment, not an algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable in the typical sense for an AI device. The humidifier operates autonomously to deliver humidified gas, based on its internal controls and sensors, without requiring constant human intervention beyond initial setup and monitoring. The "performance" refers to the device's ability to maintain specific temperature and humidity levels.

7. Type of Ground Truth Used

The ground truth for the performance claims appears to be derived from direct measurements of the device's output (temperature, humidity, flow parameters) during operation, and likely observations of patient outcomes/comfort in clinical settings. The "clinical verification studies" would have assessed the device's ability to achieve intended physiological effects.

8. Sample Size for the Training Set

The concept of a "training set" is not explicitly applicable here, as this is a physical medical device, not an AI model that undergoes a training phase with a distinct dataset. The development process involved engineering, testing, and refinement, but not in the same way an AI model is trained.

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

As explained above, a "training set" in the context of AI models is not applicable. The device's design and engineering would have been informed by established medical standards for respiratory humidification, physiological requirements for patients, and results from initial design verification and validation testing, which serve as the "ground truth" for its functional and performance characteristics.

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