Search Results

The inspired™ VHB20 Heated 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 inspired TM VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.

The subject device, inspired™ VHB20 Heated Humidifier, is indicated to add humidity and heat to the breathing gasses delivered to patients requiring mechanical ventilation or positive pressure breathing assistance.

It consists of an electrically powered heat controlled with a microprocessor to provide software control of the heating element that transfers heat to the water in a chamber.

Breathing tubes enable the humidified gas to be transported to the patient which may also be electrically heated (if connected), by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. A passive electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit. Over-current protection is provided by the SMPS inside the inspired™ VHB20 Heated Humidifier, which incorporates an over-current protection that will be triggered (cut-out) if output power of the SMPS reaches 110% of the rating (100W). The SMPS will recover automatically after fault condition is removed, while the humidifier will restart. This safety feature protects the humidifier from short-circuits in the DC part of the circuit, and prevents voltage and current transients on the heater-wire.

The inspired™ VHB20 Heated Humidifier provides heated and humidified gas with flow rates of 5 to 60 lpm (invasive) and 5 to 120 lpm (non-invasive).

The inspired™ VHB20 Heated Humidifier is a mains powered device that complies with ES60601-1, IEC 60601-1-2, ISO 80601-2-74 and AIM 7351731.

The provided text describes a 510(k) premarket notification for a medical device, the "inspired™ VHB20 Heated Humidifier." This document focuses on demonstrating substantial equivalence to a predicate device, the Fisher & Paykel MR850 Respiratory Humidifier. The information provided is primarily for regulatory clearance based on equivalence, not a clinical study proving specific performance metrics against acceptance criteria in the way one might see for a novel AI/ML device.

Therefore, many of the requested items related to Acceptance Criteria and Study Design (e.g., sample size for test sets, ground truth establishment by experts, MRMC studies, standalone performance with effect sizes) are not applicable to this type of regulatory submission for a respiratory gas humidifier. The "acceptance criteria" here are based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through bench testing comparing its performance specifications.

However, I can extract the relevant "acceptance criteria" (which are performance specifications) and the "reported device performance" from the provided Table 1, and comment on other requested points based on the available information.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this type of device are generally its performance specifications that demonstrate it operates within safe and effective parameters, comparable to a predicate device. The "reported device performance" is the measured performance of the proposed device.

Here's a table comparing the subject device's reported performance against the predicate's, which implicitly serves as the "acceptance criteria" for substantial equivalence:

Ask a specific question about this device

ConchaTherm Neptune Heated Humidifier: The ConchaTherm® Neptune TM is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal cannula or face masks to adult, pediatric, infant and neonatal patients. This system may be used with either conventional (non-heated wire) breathing circuits or compatible (21-volt) Hudson Respiratory Care Incorporated (RCI) heated-wire circuits. The ConchaTherm® NeptuneTM can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or nonflammable anesthesia gases to help maintain patient body temperature.

ConchaSmart Column: When used with the Hudson RCI ConchaTherm Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.

Comfort Flo Humidification System: To provide a continuous flow of heated and humidified gas to spontaneously breathing patients.

The ConchaTherm Neptune Heated Humidifier is an active heated humidifier designed to provide heat and moisture to the medical gases delivered to a patient through continuous flow, invasive ventilation or non-invasive ventilation. The ConchaSmart Column is an accessory to the ConchaTherm Neptune Heated Humidifier. It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the ConchaTherm Neptune. The Comfort Flo Humidification System is intended to deliver heated and humidified respiratory gases to spontaneously breathing patients. The Comfort Flo Humidification System is designed to be used in conjunction with the ConchaTherm Neptune Heated Humidifier for neonate/infant, pediatric, and adult populations. The Comfort Flo Humidification System includes a Heated Wire Breathing Circuit, a ConchaSmart Column, and various Class I exempt accessories.

The provided document is a 510(k) summary for a medical device (Teleflex Medical's ConchaTherm Neptune Heated Humidifier, ConchaSmart Column, and Comfort Flo Humidification System). It focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and performance data related to safety standards.

It does not contain any information about acceptance criteria and studies related to AI/algorithm performance, human reader studies, ground truth establishment, or sample sizes for training/test sets for an AI device. The document is for a physical medical device (humidifier) and not an AI/ML software device.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The Transcend Heated Humidifier is indicated for the humidification of the air delivered from a compatible Transcend positive airway pressure therapy device. The Humidifier is intended for single patient re-use in the home environment and in a hospital/institutional environment. The Humidifier is for use only as recommended by a physician.

The Transcend Heated Humidifier is a humidifier that is designed to humidify the air delivered to the airway during positive airway pressure (PAP) therapy with a compatible Transcend PAP device.

The provided document describes the acceptance criteria and supporting studies for the Transcend Heated Humidifier, a medical device for humidifying air during positive airway pressure (PAP) therapy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Transcend Heated Humidifier are primarily based on compliance with recognized consensus standards and direct comparison to a predicate device (ResMed HumidAire 2i™). The document presents a comparison of various characteristics, some of which serve as performance criteria.

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

The document does not detail specific sample sizes for particular performance tests. The studies conducted are described as "Device design was qualified through the following tests and assessments" which implies these were bench and lab-based tests, not human studies. Therefore, typical "sample sizes" (as in patient data) and "data provenance" (e.g., country of origin, retrospective/prospective) are not applicable in the context of this device's premarket submission, which focuses on engineering, safety, and performance characteristics rather than clinical diagnostic accuracy. The studies performed are:

• Electrical Safety
• Electromagnetic Compatibility
• Biocompatibility Assessment
• Cleaning Validation
• Software Validation
• Packaging and Shipping
• Performance: physical (cycling), resistance to flow, spillage, flow sensing, sound power level, humidification output, out of water shutdown, temperature, runtime, warm-up duration, and reservoir gas leak

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

This section is not applicable. The device relies on physical and electrical performance data, and compliance with engineering standards (e.g., ISO 8185, IEC 60601-1). Ground truth is established by the specifications defined in these standards and by direct laboratory measurements, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts evaluate ambiguous cases to reach a consensus for ground truth. This submission focuses on engineering and performance testing, where outcomes are determined by objective measurements against predefined criteria.

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. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance with and without AI assistance is compared. The Transcend Heated Humidifier is a therapeutic accessory, not a diagnostic device involving human interpretation of complex data.

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

This section is not applicable in the typical sense of AI algorithms. The "device" itself operates "standalone" in its function as a humidifier, based on its internal programming and hardware. However, it's not an AI algorithm in the context of data analysis or diagnostic support where a "human-in-the-loop" would be relevant. The software validation mentioned ensures the device's internal algorithms and controls function correctly, which is a standalone performance test.

7. The Type of Ground Truth Used

The ground truth for the device's performance is based on:

• Engineering Standards and Specifications: Metrics defined by standards such as ISO 8185 (e.g., maximum output humidity, pressure drop, gas leak, sound power level, temperatures).
• Predicate Device Characteristics: Direct comparison of physical, functional, and safety attributes against a legally marketed predicate device.
• Laboratory Measurements: Objective measurements of the device's performance against the specified criteria (e.g., humidification output, temperature, water capacity).

8. The Sample Size for the Training Set

This section is not applicable. This device is not an AI/machine learning model where a "training set" of data would be used to develop an algorithm. Its design and validation are based on traditional engineering principles and testing.

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

This section is not applicable as there is no "training set" in the context of this device.

Ask a specific question about this device

The VEGA CPAP System/Heated Humidifier, models CP-03 delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only. The device is intended for use in the home or hospital/institutional environment on adult patients.

The VEGA CPAP System/Heated Humidifier, models CP-03 is a smaller and lighter AC -powered, micro processor-controlled, and blower-based system that generates positive airway pressure from 3 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface(mask). The CPAP device may also be used with VEGA Heated Humidifier that has been designed to be compatible with the CPAP and controlled from the CPAP. The basic functional and performance characteristics of the VEGA CPAP System/Heated Humidifier are completely similar to the predicate device, the Respironics REMstar Plus CPAP System/REMstar Heated Humidifier(K010263).

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of a medical device's performance characteristics or clinical outcomes. Instead, it describes a 510(k) summary for a CPAP system and heated humidifier, focusing on its substantial equivalence to a predicate device, technical specifications, and non-clinical verification activities.

Specifically:

• The document mentions "Performance Compliance Test for CPAP according to ISO 17510-1" and "Performance Compliance Test for heated humidifier according to ISO 17510-1" as non-clinical tests conducted by the manufacturer. However, it does not specify what the acceptance criteria for these tests were (e.g., specific pressure accuracy ranges, flow rate tolerances, temperature stability) nor does it report the device's performance against any such criteria.
• It explicitly states: "No any Clinical Test is conducted for the VEGA CPAP System/Heated Humidifier." This means there is no clinical study to demonstrate effectiveness or patient outcomes, which would typically be associated with acceptance criteria for device performance in a clinical setting.
• The document primarily relies on "substantial equivalence" to a predicate device (Respironics REMstar Plus CPAP System/REMstar Heated Humidifier, K010263) based on similar intended use and technological characteristics, and verification/validation tests for electrical safety and EMC.

Therefore, I cannot provide the requested table or answer most of the questions because the necessary information (acceptance criteria, reported performance against those criteria, details of a performance study, sample sizes, ground truth, expert qualifications, etc.) is not present in the provided 510(k) summary.

In summary, the document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial or a detailed performance validation report would.

Ask a specific question about this device

The Smiths Medical Thera-Heat™ Heated Humidifier is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases. The Smiths Medical Thera-Heat™ Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers.

A Neonate Ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.

A Neonate Heated Wire Ventilator Breathing Circuit is intended to warm breathing gases before they enter a patient's airway and to warm the breathing gases on return from the patient to the ventilator when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.

The Thera-Heat™ Heated Humidifier system is a respiratory gas humidificr according to a 21 CFR §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm and add humidity to the breathing gases that are administered to the patient. The Thera-Heat™ Heated Humidifier system warms and adds water vapor to the inspired gas by heating water within the humidification chamber as the dry gas passes over the warmed water. The humidification chamber is an auto-fill style. The water supply (liquid reservoir) is a prefilled sterile water reservoir that connects to a filling port on the humidification chamber. When the liquid reservoir is empty, the caregiver will exchange it with a new one. After the gas is warmed and humidified it is channeled to the breathing tube for delivery to the patient.

The system can be operated using a conventional breathing tube (non-heated Adult versions only) in both limbs, or a heated breathing tube in the inspiratory limb only (Adult and Neonate versions), or a heated breathing tube in both limbs (Adult and Neonate versions). The purpose of the heated breathing tube is to regulate the gas temperature from the humidification chamber to the patient thereby reducing condensation and pooling of water and controlling the relative humidity. Thera-Heat™ Heated Humidifier sets and controls the heating of the humidification chamber and the breathing tube. The caregiver first sets the unit to the desired patient temperature and then sets a humidity value that is scaled by the controller based on the desired patient temperature. Thera-Heat™ Heated Humidifier will maintain the selected temperature at the patient and the humidification chamber output temperature based on the humidity value.

Accessories for the Thera-Heat™ Heated Humidifier include the humidification (water) chambers, temperature probes, interface cables and brackets.

A Heated Wire Ventilator Breathing Circuit is a disposable device compromised of 10 mm corrugated plastic tubing, 22 mm plastic tube connectors, and an electrical heaterwire harness subassembly. After the gas is warmed and humidified in the water chamber it is delivered through the inspiratory limb of the breathing circuit to the patient. Heating of the breathing tube is provided and controlled by the Thera-Heat™ Heated Humidifier. The breathing circuits may be comprised of a dual limb (Adult and Neonate versions) or single limb circuit (Adult versions only). The purpose of the heated wire ventilator breathing circuits is to maintain or raise the gas temperature to or above the dew point reducing or eliminating water condensation and/or pooling of water in the breathing circuit. Other accessories such as water traps, etc. can be added in to the overall assembly creating different product variations.

The provided text describes the Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuits. It outlines functional performance, safety standards, and electromagnetic compliance. However, it does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance specific to a new AI/medical device's performance metrics (like sensitivity, specificity, or accuracy) and a study that proves it meets said criteria.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the given text. The document states that the Thera-Heat™ Heated Humidifier meets safety and performance standards like UL60601-1/IEC 60601-1, CAN/CSA C22.2 No. 60601.1, IEC60601-1-2, IEC60601-1-4, ASTM F1690 (USA), and ISO8185. It also mentions that the device "meets the safety requirements" and "complies with the performance and safety standards." However, it does not present specific quantitative acceptance criteria (e.g., "temperature output must be within +/- 0.5°C") and then report the device's measured performance against those criteria.

The only specific performance detail mentioned is an exception: "Clause 51.6.2 the Thera-Heat™ generates a high priority alarm in the event that the airway temperature is at or above 41℃. This event does cause the Thera-Heat™ to generate an alarm and stops the heating of the humidification chamber and the heated circuit." This describes a safety mechanism, not a general performance metric.

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. The document states "Non-clinical testing of the Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuits have been conducted including mechanical, electrical, and software for functional performance, temperature accuracy under environmental conditions, and test standards for electromagnetic immunity." It does not specify the sample sizes (e.g., number of units tested, number of test runs) or the nature of the data (e.g., laboratory simulations, animal studies, human data). It also does not mention 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 information is not provided. This section is typically relevant for studies involving human interpretation or expert consensus for ground truth establishment (e.g., in diagnostic AI). For a hardware device like a humidifier, "ground truth" would likely refer to measurements from calibrated instruments, not expert consensus on interpretations.

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

This information is not provided. Adjudication methods are usually relevant for studies where there's subjectivity in ground truth determination, often involving multiple experts (e.g., in medical image analysis). This is not applicable to the type of non-clinical testing described.

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

This information is not provided. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks. The Thera-Heat™ device is a humidifier, not a diagnostic AI system, so this type of study is not applicable.

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

This information is not applicable/provided in the requested context. The device is a physical humidifier with software control. Its "standalone performance" is what the non-clinical testing already assesses (mechanical, electrical, software for functional performance). There isn't an "algorithm only" component separate from the device's function in the way an AI diagnostic algorithm would be.

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

For this device, the "ground truth" for the non-clinical testing would have been established through objective measurements using calibrated instruments and reference standards. For example, temperature accuracy would be compared against a known, accurate temperature measurement device. Electromagnetic compliance would be verified against established test standards (e.g., IEC60601-1-2). Functional performance would be assessed against engineering specifications. The document doesn't explicitly state "calibrated instruments" but this is the implied method for such device testing.

8. The sample size for the training set:

This information is not provided. "Training set" is primarily relevant for machine learning algorithms. While the device has "Software... controlled using a microcontroller," there's no indication that it utilizes machine learning requiring a distinct training set. The software's performance would be validated through traditional software testing and verification methods, not typically a "training set" in the AI sense.

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

This information is not provided/not applicable for the same reasons as point 8.

Ask a specific question about this device

The Respironics REMstar Pro M-Series CPAP & Heated Humidifier System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

The Respironics REMstar Pro M-Series CPAP & Heated Humidifier System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Pro M-Series CPAP & Heated Humidifier System also includes the flex therapy feature cleared in K052110 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. The design of the humidifier has been adapted to be powered from DC. Like its predicate, the REMstar Pro M-Series CPAP & Heated Humidifier System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.

I am sorry, but the provided text does not contain detailed information about specific acceptance criteria, device performance metrics, or the study design (test set size, provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth establishment, or training set size) as requested in your prompt.

The document states:

• "Design verification tests were performed on the Respironics REMstar Pro M-Series CPAP & Heated Humidifier System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, it does not specify what those acceptance criteria were, how the device performed against them, or any of the details about the underlying study that would typically prove these criteria were met. The document focuses on establishing substantial equivalence based on intended use, operating principle, technology, and manufacturing process, and notes that modifications had no impact on safety and effectiveness.

Therefore, I cannot populate the table or provide answers to the specific questions about the study that proves the device meets the acceptance criteria.

Ask a specific question about this device

The Smiths Medical Thera-Heat™ Heated Humidifier device is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases. The Smiths Medical Thera-Heat™ Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers.

Inspiratory heated limb: An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and noninvasive breathing systems.

Inspiratory and Expiratory heated limbs: An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway and to warm the breathing gases on return from the patient to the ventilator when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.

The Thera-Heat™ Heated Humidifier system is a respiratory gas humidifier according to 21 CFR §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to add moisture and if applicable, heat to breathing gases prior to administration to a patient. Indirect heating is used by the Thera-Heat™ to provide an evaporated water content to dry breathing gases.

Respiratory gas humidifiers are used by clinicians to raise the water content of gases delivered to patients. Gases available for medical use do not always have sufficient moisture and may damage or irritate the respiratory tract or desiccate tracheobronchial secretions of patients whose airways have been bypassed. The Thera-Heat™ Heated Humidifier system warms and adds water vapor to the inspired gas by heating water within the humidification chamber as the dry gas passes over the warmed water.

The humidification chamber is an auto-fill style that contains an integral float valve at the water filling port. The float valve regulates the water level inside the chamber to maintain a constant water level. The water supply (liquid reservoir) is a pre-filled sterile water reservoir that connects to a filling port on the humidification chamber. When the liquid reservoir is empty, the caregiver will exchange it with a new one. After the gas is warmed and humidified it is channeled to the breathing tube for delivery to the patient.

The system can be operated using a conventional breathing tube (non-heated) in both limbs, or a heated breathing tube in the inspiratory limb only, or a heated breathing tube in both limbs. The heating of the humidification chamber and the power supplied to the heated breathing tube is provided by the controller unit. The purpose of the heated breathing tube is to regulate the gas temperature from the humidification chamber to the patient, reducing condensation and pooling of water, and the means of controlling the relative humidity by maintaining a temperature gradient between the humidification chamber and the delivered airway temperature. The caregiver sets the controller unit to the desired patient airway temperature, and then sets a humidity index value, which is limited in range by the controller based on the desired patient airway temperature. The control unit will maintain the selected temperature for the patient airway and the humidification chamber output temperature based on the humidity index value.

Accessories for the Thera-Heat™ Heated Humidifier include the humidification (water) chambers, temperature probes, interface cables and brackets.

Heated Wire Ventilator Breathing Circuits: A heated Wire Ventilator Breathing Circuit is a disposable device compromised of 22mm corrugated plastic tubing, 22 mm plastic tube connectors, and an electrical heater-wire harness subassembly. After the gas is warmed and humidification chamber it is delivered through the inspiratory limb of the breathing circuit to the patient. Heating of the breathing tube is provided and controlled by the heated humidifier. The heated wire breathing circuits may be comprised of a dual limb or single limb circuit. The purpose of the heated wire ventilator breathing circuits is to maintain or raise the gas temperature to or above the dew point reducing or eliminating water condensation and/or pooling of water in the breathing circuit. Other accessories such as exhalation valves, water traps, etc. can be added in to the overall assembly creating different product variations.

The provided text describes a 510(k) premarket notification for the "Thera-Heat™ Heated Humidifier and Heated Wire Ventilator Breathing Circuits." The focus of this submission is on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment, which are typical for studies validating AI/ML medical devices, is not explicitly detailed or applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not present a formal table of quantitative acceptance criteria for device performance. Instead, it states that the device "complies with the performance and safety standards ASTM F1690 (USA) and ISO 8185 for active humidification" with two noted exceptions. The reported "performance" is primarily compliance with these standards.

   Acceptance Criteria (Standards Compliance)	Reported Device Performance
   IEC60601-1 (Safety)	Complies
   UL60601-1 (Safety)	Complies
   CAN/CSA 22.2 No.60601.1 (Safety)	Complies
   IEC60601-1-2 (Electromagnetic Compliance)	Complies
   IEC60601-1-4 (Software Compliance)	Complies (to the acceptance of Underwriters Laboratories)
   ASTM F1690 (USA) (Active Humidification)	Complies with exceptions:

• Clause 51.6.2: Generates a high priority alarm if airway temperature is $\ge$ 41°C.
• Clause 51.8 part C: Cannot reduce airway temperature sufficiently when airflow is instantaneously increased from minimum to maximum rated flow in a non-heated circuit, allowing airway temperature to exceed 43°C for 30 seconds. An alarm is generated, and heating stops. A warning label and operational manual notice are provided. |
  | ISO 8185 (Active Humidification) | Complies with exceptions:
• Clause 51.6.2: Generates a high priority alarm if airway temperature is $\ge$ 41°C.
• Clause 51.8 part C: Cannot reduce airway temperature sufficiently when airflow is instantaneously increased from minimum to maximum rated flow in a non-heated circuit, allowing airway temperature to exceed 43°C for 30 seconds. An alarm is generated, and heating stops. A warning label and operational manual notice are provided. (As per ASTM F1690, which likely references similar performance metrics). |

2. Sample Size and Data Provenance (for test set):
   The document does not detail specific "test sets" in the context of clinical or performance data for an AI/ML device. The testing conducted was "non-clinical testing...covering mechanical, electrical, and software for functional performance and temperature accuracy under environmental conditions and tests standards." This implies laboratory or bench testing, not patient data.

3. Number of Experts and Qualifications (for ground truth):
   Not applicable. The ground truth for this device is based on compliance with established engineering and medical device safety standards (IEC, UL, CSA, ASTM, ISO), not expert consensus on diagnostic or clinical outcomes from a test set of data.

4. Adjudication Method:
   Not applicable. No expert adjudication method is mentioned as this is not a study involving human interpretation of data for medical diagnosis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   No. The document explicitly states "Clinical Data: Not required." This indicates that no human-in-the-loop clinical study comparing human performance with and without AI assistance was conducted or deemed necessary for this 510(k) submission.

6. Standalone (Algorithm Only) Performance:
   "Standalone performance" in the context of an AI/ML algorithm is not applicable here. The device is a physical medical device (humidifier and breathing circuits). Its performance was assessed through non-clinical laboratory testing against engineering and safety standards.

7. Type of Ground Truth Used:
   The "ground truth" for this submission is compliance with international and national safety and performance standards for respiratory gas humidifiers and breathing circuits (e.g., IEC60601-1, UL60601-1, CAN/CSA 22.2 No.60601.1, IEC60601-1-2, IEC60601-1-4, ASTM F1690, ISO 8185).

8. Sample Size for the Training Set:
   Not applicable. This is not an AI/ML device that requires a training set. The device is a hardware system.

9. How the Ground Truth for the Training Set Was Established:
   Not applicable. As this is not an AI/ML device, there is no training set or ground truth established in that manner. The "ground truth" for its design and manufacturing is adherence to established engineering principles and regulatory standards.

Ask a specific question about this device

HumidCare Heated Humidifier is for use with Apex Medical Corp.'s CPAP 9S-003 system. It is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat that some people may experience.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "HumidCare Heated Humidifier." This document does not contain information regarding acceptance criteria or a study proving the device meets those criteria. It is a regulatory approval letter that confirms substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information.

Ask a specific question about this device

The Evo Heated Humidifier is intended to warm and add moisture to the breathing gases for administration to a patient. It is used for patients requiring Continuous Positive Airway Pressure (CPAP) therapy for the treatment of Obstructive Sleep Apnea. The addition of heated humidification to this therapy relieves the drying and irritating effects on the patient airways, which may arise from the use of a CPAP system. Use only with RemRest 900 series CPAP devices. It is portable and is intended to be used in the home, hospital, and institutional settings.

The RemRest Heated Humidifier is a simple heated humidifier to be used with a CPAP device to provide heated and humidified air to the patient. It operates by a conductive heating surface warming a water reservoir and air passes over the water. The device has the following basic specifications: Size 13.1" L x 8.4" W x 4.7" H, Weight 2.5 lbs. dry, Water capacity 400 ml (1 2/3 cups), Power 100-240 VAC 50/60Hz or 1.0 A max., Heater setting 1-5 (85°F to 149°F / 29.4°C to 65°C), Humidity Range 30 mg H2O/l @ 25 lpm, Pressure drop 0.5 cm H2O @ 40 lpm.

The provided text is a summary of safety and effectiveness for the RemRest heated humidifier and does not describe acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The PMH Humidifier is intended to add moisture and To warm the breathing gases for administration to a patient. The humidifier is intended for use with flows of 5 liters per Minute or more through the humidifier.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a PMH 5000 Heated Humidifier for Respiratory Therapy. This document is a regulatory approval for a medical device that adds moisture and warms breathing gases for patients.

It does not contain information about acceptance criteria, device performance metrics, or study design for an AI/ML-driven device. The text is a formal letter confirming that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory pathway for hardware-based medical devices.

Therefore, I cannot extract the requested information regarding AI/ML device performance and study details from this document. The questions you've asked are applicable to AI-driven diagnostic or prognostic devices, not a respiratory gas humidifier.

Ask a specific question about this device