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Intended to add moisture to breathing gases for administration to pediatric through adult patients weighing ≥ 10 kg >1 month in homecare, hospital, extended care and hospice.

There are two models of the Hudson RCI Disposable Humidifier. Both models have identical intended uses and modes of operation. One model has a 4 PSI pressure relief valve (referred to as model 3230) and the other has a 6 PSI pressure relief valve (referred to as model 3260). Regardless of device model, the disposable humidifier delivers humidified gases to the patient. Both models of the non-prefilled disposable humidity in water vapor form to respiratory gases delivered to patients to make the gases more comfortable to breathe. The disposable humidifier incorporates a pressure relief valve with an audible alarm at 4 psi or 6 psi. depending on the model selected.

In both models, air is channeled through the water-containing bottle where it becomes humidified before exiting the device and being administered to the patient.

The patient can influence the use of these devices by occluding or loosening secure connections. In cases where the patient is also the user, over or under filling the device and selection of incorrect oxygen percent concentration and gas input pressures may influence the use of the device.

This is a 510(k) premarket notification for the "Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve" and "Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve". The document asserts substantial equivalence to the predicate device "Salter Labs Bubble Humidifier (K161719)".

However, the provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. Instead, it summarizes non-clinical testing performed to demonstrate safety based on industry standards and establish substantial equivalence to a predicate device.

The document lists various tests performed and standards utilized, but it does not provide:

• A table of acceptance criteria with reported device performance values against those criteria.
• Sample sizes used for test sets.
• Information about ground truth establishment, experts, or adjudication methods.
• Details about MRMC studies or effect sizes for AI assistance.
• Information on standalone algorithm performance or training set details.

The document provides a "Summary of Non-Clinical Testing" and then lists specific types of tests, such as "Humidification Output," "Flow Rate," "Alarm," and "Pull Test." While it states that the results of these tests indicate substantial equivalence, it does not detail the acceptance criteria for each test or the specific reported performance values that met those criteria.

Therefore, I cannot populate the requested table or provide the detailed information about study design, ground truth, and sample sizes that would typically be found in a study demonstrating device performance against acceptance criteria.

The information that is available regarding acceptance criteria and performance is very high-level and can be inferred from the "Comparison of Technological Characteristics" table and the "SUMMARY OF NON-CLINICAL TESTING" section:

Inferred Information from the Document:

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

The document does not provide information for the following points as they are typically associated with clinical studies or more detailed performance reports, which are not present here:

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests, not diagnostic accuracy requiring expert ground truth.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests. For these tests, the "ground truth" would be established by the defined test methods and measurement standards (e.g., a specific method to measure humidification output).
8. The sample size for the training set: Not applicable, as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not a machine learning device.

Conclusion from the document:
The document concludes that "Based on the testing performed, including humidification output and additional gas pathway biocompatibility testing according to ISO 18562, it can be concluded that the subject devices do not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Hudson RCI Bubble Humidifiers are assessed to be substantially equivalent to the predicate devices." This statement implies that all the non-clinical tests were successfully completed and the devices met the performance expectations for substantial equivalence.

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The BONHAWA Respiratory Humidifier is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing patients 20 kg and up, child to adults in hospitals. It adds heat and moisture to the flow of gases. The flow may be from 2 to 70 L/min depending on the patient interface.

The BONHAWA Respiratory Humidifier provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients without bypassed upper airways in hospitals.

The BONHAWA Respiratory Humidifier is a heated humidifier with integrated blower, heater plate and heated breathing circuit that delivers warm and humidified respiratory gas to a patient via nasal cannula. A blower inside the device blends the externally provided oxygen with entrained filtered air and controls the gas flow rate delivered to the patient per the professional user established setting. An internal oxygen sensor monitors and reports the delivered oxygen concentration. The patient interface, heated breathing circuit chamber and chamber adapter are single use.

The provided text is a 510(k) Premarket Notification for the BONHAWA Respiratory Humidifier. It focuses on demonstrating substantial equivalence to a predicate device (Airvo 2 Humidifier series) and a reference device (Airvo 3 High Flow Humidified Oxygen Delivery Device) based on technical characteristics and performance testing against recognized consensus standards.

However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device. The device described is a physical medical device (a respiratory humidifier), not an AI/ML-driven diagnostic or therapeutic software. Therefore, the specific questions related to AI/ML device performance metrics (e.g., sample size for test sets, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable and are not addressed in this filing.

The "Performance Testing" section (Page 11) states that substantial equivalence is based on:

• Product validation and risk mitigation verification testing.
• Meeting pertinent recognized consensus standards:
  • ISO 80601-2-74:2017 (Respiratory humidifying equipment)
  • IEC 60601-1:2005+AMD1:2012 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2:2014 +A1:2020 (Electromagnetic disturbances)
  • IEC 60601-1-8 (Alarm systems)
  • ISO 10993-1 (Biocompatibility)
  • ISO 18562-1 (Biocompatibility of breathing gas pathways).

The table "Comparison of Technological Characteristics" (Pages 6, 7, 8, 9) effectively serves as the "acceptance criteria" through a direct comparison to the predicate and reference devices, demonstrating that the subject device's specifications are either identical or offer non-inferior performance without raising new safety or effectiveness concerns.

Given the nature of the device, the following points address the relevant aspects of your request based on the provided text:

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

The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate and reference devices, and adherence to relevant consensus standards. The "reported device performance" is presented through direct specifications and the claim of meeting the standards.

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The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional.

F&P 950 Breathing Circuit Kits: 950A80J, 950A81J, 950A82J, 950A61J, 950A61J, 950A40J, AA451SU
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications.

F&P 950 Breathing Circuit Kits: 950P81J, 950P40J
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant, child and adolescent patients of its stated technical specifications.

F&P 950 Breathing Circuit Kits: 950N80J, 950N81J, 950N61J, 950N40J
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant and child patients, within the limits of its stated technical specifications.

The F&P 950 Respiratory Humidifier is designed to warm and humidify air after it leaves a commercially available flow source and to maintain the air in a warmed and humidified condition to the point of delivery into the patient via heated tubing.

The F&P 950 Respiratory Humidifier is made up of a heaterbase, sensor cartridge and expiratory heater wire adapter with breathing circuit kits to support the use with adult, pediatric and neonatal patients. Breathing circuit kits enable the use of the F&P 950 Respiratory Humidifier with clinical procedures such as invasive ventilation and nasal high flow.

The device is a programmable electrical medical device that uses sensors throughout the system to humidify the gas. Gas travels through the chamber where it is humidity is requlated through monitoring the gas temperature exiting the chamber to achieve the target humidity level. The gas is then transported to the patient through a heated delivery tube. The gas temperature exiting the heated delivery tube is monitored to minimize the formation of condensate.

The document is a 510(k) Summary for the F&P 950 Respiratory Humidifier and its accessory breathing circuit kits. It outlines the device's indications for use and compares its technological characteristics to a primary predicate device (F&P MR850 Respiratory Humidifier) and several secondary predicate devices for the various breathing circuit kits. The summary also details the non-clinical tests performed to demonstrate substantial equivalence.

Here's the requested information based on the provided text, focusing on acceptance criteria and supporting studies:

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

   Acceptance Criteria	Reported Device Performance
   Delivered humidity level (Bypassed airway)	>33mg/L for flow 12mg/L for flow

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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:

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The O2asis Personal Oxygen Humidifier is indicated to add moisture and may warm breathing gases for administration to infant, pediatric and adult patients in the home, hospital, and clinical settings. It is used with an external gas source of up to 6 Lpm via nasal cannula.

The O₂asis Personal Oxygen Humidifier is a self-contained, palm-sized, mobile device, making it possible for an individual to move the system to a new location without assistance. The O₂asis Personal OxygenHumidifier provides heat and humidified gas when used with a home oxygen concentrator or cylinder supply with flow rates up to 6 lpm. The subject device humidifies and heats the gas (oxygen) and delivers the warmed gas via a nasal cannula. When unplugged, the subject device provides passive humidification but no heat.

The Perma Pure LLC O2asis Personal Oxygen Humidifier, intended to add moisture and potentially warm breathing gases for patients, underwent various non-clinical testing to demonstrate its performance and substantial equivalence to predicate devices. The information provided heavily focuses on the comparison with predicate and reference devices and a summary of the types of tests conducted rather than a detailed study report with specific acceptance criteria and performance results in a table format.

Based on the provided information, the following can be extracted, acknowledging that detailed performance metrics and acceptance criteria values are largely absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria" and "Reported Device Performance": The document primarily lists the types of tests performed and broad statements of compliance ("The device meet the applicable performance for the applicable standards" or "The materials were found to meet the applicable endpoints"). Specific quantitative acceptance criteria and detailed performance results are generally not provided in this summary. The table uses predicate device performance as a proxy for implied acceptance criteria where available (e.g., humidification output).

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

This information is not provided in the document. The document describes non-clinical bench testing, biocompatibility testing, and a human factors study, but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature for any data collection). The tests appear to be conducted on the device itself (bench testing) or its components (biocompatibility).

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

This information is not provided. The testing described is primarily non-clinical (bench, biocompatibility, software V&V, human factors). There is no mention of an expert panel establishing ground truth for a test set in the context of clinical imagery review or similar applications. The "Human Factors / Usability" study mentions a "user population," implying participation from intended users, but details on their qualifications or how "ground truth" was established are absent for this type of test.

4. Adjudication Method for the Test Set

This information is not provided. As the tests are non-clinical and do not involve diagnostic interpretation or multi-reader review, an adjudication method as typically understood in those contexts is not applicable or detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The device is a physical humidifier; its evaluation does not involve diagnostic image interpretation or AI assistance to human readers in a way that an MRMC study would be relevant.

6. If a Standalone (Algorithm Only) Performance Study Was Done

This is not applicable as the O2asis Personal Oxygen Humidifier is a physical medical device, not an algorithm or AI software. Therefore, no standalone algorithm-only performance study was conducted.

7. The Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" is based on adherence to:

• Engineering and Performance Standards: The device's physical performance (e.g., humidification output, temperature, flow rates) is measured against the specifications of relevant ISO and IEC standards.
• Biocompatibility Standards: The materials are tested against endpoints defined in ISO 10993 and ISO 18562 series.
• FDA Guidance Documents: For human factors/usability, the study adheres to FDA guidance, implying that successful completion against the guidance's recommendations constitutes the ground truth for usability.
• Design Specifications: Implicitly, the device's design and functionality are tested against its own pre-defined specifications.

There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth in the context of this device's evaluation, as these are typically relevant for diagnostic or treatment efficacy studies.

8. The Sample Size for the Training Set

This is not applicable. The O2asis Personal Oxygen Humidifier is a hardware device; it does not involve machine learning algorithms that require a "training set."

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

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

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The bubble humidifier is intended to add moisture to breathing gases for administration to patients >1 month in homecare, hospital, extended care and hospice.

The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.

The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410 mbars) safety valve is an empty, disposable, non-sterile, not made with natural rubber latex, device intended to humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve is provided with a 6 pounds per square inch (PSI) safety valve and can operate within flow rates of 6 to 15 liters per minute (LPM). The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks or cannulas, and use of optional oxygen tubing and water traps (face masks, 21 CFR 868.5580: nasal cannulas, 21 CFR 868.5340; oxygen tubing, 21 CFR 868.5860 and water traps, 21 CFR 868.5995 are 510(k) exempt).

This device is a passive device and is not a cascade humidifier, is not heated and is not prefilled.

The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located at the end of a PVC diffuser tube inside the humidifier bottle. The diffusor is designed to uniformly disperse the gas throughout the water. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The bottle is permanently marked with "minimum/maximum" water levels. The lid is marked with minimum source pressure, flow ranges and pressure value of the safety valve.

The provided document describes a 510(k) premarket notification for a medical device, specifically a "Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the device acceptance criteria and study information provided are tailored to this regulatory pathway, primarily involving performance testing and biocompatibility assessments related to a material change.

The document does not describe the development or evaluation of an Artificial Intelligence (AI) device. Consequently, several of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size, and ground truth for training set) are not applicable to this submission.

Here's an analysis of the provided information, addressing the relevant points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance specifications of the predicate device and relevant international standards. The "Performance Data" section indicates that the focus was on verifying that the material change did not adversely affect performance.

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

The document does not explicitly state the sample size for the performance tests conducted on the modified device (e.g., bond strength, cleaning, useful life studies). However, such tests would typically involve a statistically relevant number of units.

• Data Provenance: The tests were conducted internally by Salter Labs, the manufacturer. No country of origin for test data is specified beyond the manufacturer's location in Carlsbad, California, USA. The studies are prospective in the sense that they were designed and executed to evaluate the modified device.

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

This question is not applicable. The studies involved physical and chemical testing of the device, not the establishment of ground truth by human experts, as would be the case for diagnostic AI.

4. Adjudication Method for the Test Set

This question is not applicable. The tests involved objective physical and chemical measurements against predetermined specifications, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is not applicable. This is not an AI device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This question is not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• Established Performance Specifications: For parameters like flow rate, pop-off pressure, and mechanical integrity (bond strength), the "ground truth" refers to the pre-defined engineering and performance specifications that the device must meet, often derived from the predicate device's performance or relevant industry standards.
• International Standards (Biocompatibility): For biocompatibility, compliance with ISO 10993 standards (e.g., negative cytotoxicity, no irritation/sensitization) serves as the "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI device; therefore, there is no AI model requiring a training set.

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

This question is not applicable. There is no training set for an AI model.

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The Flexicare FL-9000U Respiratory Humidifier Base is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used only with the Flexicare Heated Wire Breathing System and Flexicare Autofill Humidification Chamber.

The Flexicare FL-9000U Respiratory Humidifier Base is for use as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated adult patients and those receiving respiratory support, as part of a complete system including a Humidification Chamber and either a heated wire breathing circuit or limb, or a non-heated breathing circuit or limb.

The Flexicare FL-9000U Respiratory Humidifier Base is a non-sterile medical electrical device which when in use forms part of an actively humidified respiratory humidification system. The Flexicare FL-9000U features a heater plate that allows a humidification chamber containing a volume of water to secure in place above it. The Flexicare FL-9000U heats the water within a humidification chamber and provides current to heated wires within Heated Wire Breathing System (if using a heated system) to warm and humidify gases to be administered to the patient. The Flexicare FL-9000U Respiratory Humidifier Base is provided with temperature probe leads that connect to the patient end and humidification chamber end of a breathing system. These probes feedback to the FL-9000U which automatically adjusts heat and current accordingly to maintain the set gas temperature.

When in use the Flexicare FL-9000U Respiratory Humidifier Base has no contact with the patient. The probe tip of the temperature probe lead accessory contacts breathing gases that are to be delivered to the patient and is the only component of the device/its accessories with contact of this nature.

The Flexicare FL-9000U Respiratory Humidifier Base is mains powered (115V), intended for use within a hospital environment and intended for any patient population where active humidification is required.

The Flexicare FL-9000U Respiratory Humidifier Base is a respiratory gas humidifier designed to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance. The device's performance was evaluated against a predicate device, the Fisher & Paykel MR850 Respiratory Humidifier, to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were primarily established through a "comparison test" against the predicate device, the Fisher & Paykel MR850 Respiratory Humidifier (K073706), and adherence to various recognized standards. The reported device performance is presented as "Substantially equivalent" or "Pass" based on these comparisons and tests.

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

The document does not specify a "test set" in the context of a dataset for AI/ML performance evaluation. Instead, performance was evaluated through non-clinical testing on the physical device and its accessories. This involved:

• Comparison testing: Directly comparing the Flexicare FL-9000U with the predicate device (Fisher & Paykel MR850).
• Adherence to recognized standards: Testing the device against specific criteria outlined in various international standards (e.g., ISO, IEC, EN).

The provenance of this testing data would be from Flexicare's own testing facilities or accredited third-party laboratories performing these tests on the physical device. The information does not state the country of origin of the data explicitly, but Flexicare Medical Limited is based in the United Kingdom.

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

This information is not applicable in the context of this 510(k) summary. The device is a physical medical device, not an AI/ML diagnostic tool that requires expert-established ground truth from images or clinical data for performance evaluation in the same way. The "ground truth" for this device's performance is derived from physical measurements, electrical tests, and compliance with established engineering and medical device standards, as well as direct comparison to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. The evaluation of this physical medical device does not involve human readers or a consensus-based adjudication method for a test set of data.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI) where human reader performance is being evaluated, often with and without AI assistance. This device is a respiratory humidifier, a therapeutic device, and its performance evaluation does not involve such studies.

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

No, a standalone (algorithm only) performance evaluation was not done. This concept is specific to AI/ML software devices. The Flexicare FL-9000U is a hardware device with embedded software, and its evaluation focuses on its physical and electrical performance in delivering warmed and humidified gases, not standalone algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Flexicare FL-9000U Respiratory Humidifier Base is primarily established through:

• Engineering specifications and measurements: Direct measurement of physical characteristics (dimensions, weight), electrical parameters (voltage, current, power), temperature control, and sound levels.
• Compliance with international standards: Verification that the device meets the requirements outlined in standards like ISO 8185 for respiratory humidifiers, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC, and IEC 60529 for IP rating.
• Comparative performance to a legally marketed predicate device: Demonstrating that its performance in function is substantially equivalent to the Fisher & Paykel MR850 Respiratory Humidifier, which has an established safety and effectiveness profile. For humidity performance, a specific "Humidity Test Report (NO. HSO-VH-2600A-2015-01,1)" is referenced, implying data derived from specific testing protocols.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the sense typically used for diagnostic or predictive AI/ML devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device and is not an AI/ML algorithm that requires a "training set" for model development.

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

This information is not applicable for the same reason as point 8.

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The Hudson RCI® AquaPak® Prefilled Humidifier adds humidity to a patient's breathing gases.

Hudson RCI® AquaPak® Prefilled Humidifiers add water vapor (molecular H₂O) to a dry medical gas that is suspended in the gas to be inhaled by the patient.

The Hudson RCI® AquaPak® Prefilled Humidifiers are designed to add humidity to inspired gas, helping to control the drying and irritation of the respiratory mucosa. The humidifiers feature a micro-diffuser that produces smaller bubbles and greater surface agitation, allowing for a quiet operation and therapeutic humidity output.

Prefilled sterile reservoirs for AquaPak® Humidifiers come in four sizes; 190ml, 340ml, 540ml and 650ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides humidifier functionality.

Adaptor types provided with Hudson RC1® AquaPak® Prefilled Humidifiers feature an audible pressure relief valve, which indicates a restriction of gas flow to the user.

The provided text describes the 510(k) Summary for the Hudson RCI® AquaPak® Prefilled Humidifier. The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparative characteristics and non-clinical performance testing. However, it does not contain the detailed information required to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study proving the device meets those criteria, particularly for a medical AI/ML device.

Here's an analysis of what can be extracted and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Technology and Features" for the proposed device and predicate devices, which can be interpreted as performance specifications or criteria. It also mentions "Non-clinical Comparative Performance Testing" but doesn't explicitly state quantitative acceptance criteria for each test or detailed results.

Missing Information for Acceptance Criteria: The document describes the type of tests performed and the principle of the tests, but it lacks specific quantitative acceptance criteria (e.g., "Cannula Pop-Off strength must be > X Newtons") and the quantitative results (e.g., "Cannula Pop-Off strength was Y Newtons, which passed"). The "Reported Device Performance" column largely reflects the purpose of the test rather than the actual outcome against specific criteria.

2. Sample Sizes and Data Provenance

This document describes a physical medical device (humidifier), not an AI/ML device. Therefore, concepts like "test set," "training set," "data provenance," and "country of origin" as typically applied to AI/ML models are not directly applicable.

• Test Set/Training Set: Not applicable in the context of this traditional medical device. No data sets are mentioned for model training or testing.
• Data Provenance: Not applicable.

3. Number of Experts and Qualifications for Ground Truth

Not applicable for this type of device and study. The "ground truth" for a humidifier's performance would be derived from physical measurements and engineering specifications, not expert consensus on interpretations.

4. Adjudication Method

Not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used in evaluating subjective assessments, often in diagnostic imaging by multiple readers.

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

Not applicable. This is not an AI-assisted diagnostic device where human reader performance with and without AI would be compared.

6. Standalone Performance

The non-clinical performance testing summarized in Section K (Packaging Integrity, Ink Adherence, Cannula Pop-Off, Bottle Burst, Occlusion, Spitting, Humidification Output) represents the standalone performance evaluation of the device as an engineering product. However, the details of these studies, including specific protocols, sample sizes for each test, and quantitative results against pre-defined acceptance limits, are not provided in this summary document.

7. Type of Ground Truth Used

For the non-clinical comparative performance testing, the "ground truth" would be objective physical measurements and engineering standards (e.g., pressure readings, humidity measurements in mg H2O/L, observation of spitting/flooding). The document indicates that some tests referenced standards (ISTA 2A, ASTM F2252) while others did not ("N/A").

8. Sample Size for the Training Set

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

9. How Ground Truth for the Training Set Was Established

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

Summary of What the Document Provides regarding "Acceptance Criteria" and "Study":

The document provides a high-level summary of non-clinical bench testing conducted to demonstrate that the Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to predicate devices and will perform as intended.

• Acceptance Criteria (Implied): The implied acceptance criteria for the new device are that its performance (flow rate, occlusion notification, humidity output) is comparable to the predicate devices and meets its own stated specifications, and that it passes specific functional and integrity tests (e.g., no spitting/flooding, package integrity, ink adherence).
• Study: The "study" referenced is a series of "Bench Testing" activities focused on:
  • Packaging Integrity (referencing ISTA 2A)
  • Ink Adherence (referencing ASTM F2252)
  • Cannula Pop-Off, Bottle Burst, Occlusion Test
  • Spitting Test
  • Humidification Output Test

The document states that these tests were performed to "verify that the performance of the proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to the predicate device, and that the Hudson RCI® AquaPak® Prefilled Humidifier will perform as intended."

Missing Detailed Information:
The K141353 summary is intentionally concise and does not include the full study reports. To fully answer your question with explicit acceptance criteria, detailed results, and sample sizes for each bench test, one would need to refer to the complete study reports submitted to the FDA, which are not part of this summary document. The information provided is sufficient for a 510(k) summary (demonstrating substantial equivalence) but not for a detailed scientific publication of a study.

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The Humidifier Heater Base PMH7000PLUS/PMH7000 is intended to add moisture and to warm the breathing gases for administration to the patient.

The Humidifier Heater Base, PMH7000PLUS/PMH7000 is intended for use on adult at hospital and home.

The Humidifier Heater Base, PMH7000PLUS/PMH7000 is a humidifier incorporating with ventilator and provides respiratory humidification through patient breathing circuit for adult at hospital and home.

This heater base features a dual temperature servo control system which regulates the temperature of the gas delivered to the patient and the gas at outlet of humidifying chamber. It continuously monitors temperatures by a dual temperature probe. The heater base warms and humidifies the gas through the humidifier chamber and in addition a heater wire in the patient breathing circuit further controls same gas temperature. The operator is allowed to set the temperature of two locations: temperature of the chamber outlet gas and the gas immediately before delivered to the patient.

The Humidifier Heater Base PMH7000PLUS/PMH7000 is equipped with alarms which activate audible and visual indicators to alert the operator of adverse conditions. Alarms are provided for high and low airway temperature, high and low chamber outlet temperature probe disconnect or fault condition, heater wire fault connection, and the light identifies the area of alarm.

The Humidifier Heater Base PMH7000PLUS/PMH7000 includes several safety features such as prevention of excessive heating which can be harmful to the patient or can cause damage to the heater base itself. To ensure patient safety, the heater base will shut down under any alarm conditions if it continues for 10 minutes.

The Humidifier Heater Base are available in two models, PMH7000PLUS and PMH7000. PMH7000PLUS/PMH7000 has both inspiratory and expiratory heater wires for use in the inspiratory and expiratory limbs of breathing circuit. The use of the expiratory heater wire with PMH7000PLUS/PMH7000 is to control humidity in the expiratory limb and to reduce moisture returned to the ventilator.

The provided text is a 510(k) summary for a medical device (Humidifier Heater Base PMH7000PLUS/PMH7000). It describes the device, its modifications, and its substantial equivalence to a predicate device. However, this document does not contain explicit acceptance criteria tables, detailed study designs with sample sizes, information on ground truth establishment with expert qualifications, adjudication methods, or MRMC comparative effectiveness studies typically found for AI/ML device submissions.

The documentation focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and design modifications. The modifications mainly concern changes to the front and side panel design and the heater wire connector interface to improve maneuverability and connectivity. The core technological characteristics, intended use, operating principle, and performance (temperature and humidity output) are stated to be equivalent to the predicate device.

Therefore, many of the requested data points (especially those related to AI/ML device evaluation) are not present in this type of submission.

Here's an attempt to extract the available information:

• Acceptance Criteria and Reported Device Performance: Explicit acceptance criteria in a table format with specific performance metrics are not detailed in this 510(k) summary. The document states that "Non-clinical testing of Humidifier Heater Base PMH7000PLUS/ PMH7000 has been carried out covering mechanical, electrical and thermal safety, environmental conditions and electromagnetic compatibility, functional verification, and performance capacity and accuracy." It also states, "PMH7000PLUS/ PMH7000 meets the requirements of the IEC 60601-1 and IEC 60601-1-2 electro medical and EMC standards" and "complies with performance and safety requirements of the ISO 8185 particular standard for Humidification Systems." This implies the acceptance criteria were compliance with these specific standards for safety and performance, but the numerical target values are not provided. The reported device performance is that it meets these requirements.

• Sample Size for Test Set and Data Provenance: Not applicable. This device is not an AI/ML device tested with a "test set" of patient data. The evaluation was based on non-clinical engineering and performance testing.
• Number of Experts and Qualifications for Ground Truth: Not applicable. No experts were used to establish ground truth in the context of diagnostic performance for patient data, as this is not an AI/ML diagnostic device.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not conducted as this is not an AI/ML device that assists human readers.
• Standalone Performance: A standalone performance evaluation was done in the sense of the device's electrical, mechanical, and thermal safety and its ability to meet performance standards (e.g., temperature and humidity output) independently. The testing was "non-clinical."
• Type of Ground Truth Used: The "ground truth" here refers to compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 8185, ANSI/AAMI ES60601-1) and the functional specifications of the device itself (e.g., set temperature, humidity output).
• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
• How Ground Truth for the Training Set was Established: Not applicable.

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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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