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The Heated Breathing Tube is intended to be used for non-invasive respiratory therapy, such as CPAP/BiPAP therapy. It provides air connection between positive pressure ventilation, respiratory humidification therapy instrument, and ventilation mask, nasal cannula, trachea cannula etc. With the function of heating inside breathing tube, it can prevent condensation of the therapy air in the tube.

This device is single patient use only for adults.

The Compressor Nebulizer is mainly composed of the compressor and nebulizer kit(Optional). The compressor is mainly composed of shell, compressed motor, pump, fuse wire, air filter, power cord and plug (NB-1100,NB-1101,NB-1102,NB-1103 applicable), PCB (only model NB-1102,NB-1103applicable). The device is equipped with a nebulizer kit including Nebulizer Cup, Air Tube, Mouthpiece(Optional), Adult Mask(Optional), Child Mask(Optional) to easily delivery the medical aerosol. The Nebulizer kit is available in three models/configurations as below.

• NK-101: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask, Mouthpiece;
• NK-301: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask;
• NK-501: Nebulizer Cup, Air Tube, Mouthpiece
  This device operates on the Venturi principle. According to the principle of Venturi, the compressed air of the motor is used to form a high-speed air flow through the small pipe mouth. The negative pressure generated drives the liquid or other fluid to spray together on the barrier, and under the high-speed impact makes the droplets turn into mist particles to spray from the outlet trachea.

The provided FDA 510(k) clearance letter and summary pertain to a "Compressor Nebulizer" and a "Heated Breathing Tube," but the main body of the 510(k) summary and the comparative particle test tables focus on the "Compressor Nebulizer" (Model NB-1100, NB-1101, NB-1102, NB-1103) and its predicate "NE-C801 Nebulizer Compressor System." The "Heated Breathing Tube" mentioned in the clearance letter is inconsistent with the detailed submission summary. Therefore, the analysis will focus on the Compressor Nebulizer (JOYTECH NB-1103).

Based on the provided document, the acceptance criteria are implicitly derived from the comparative particle test results between the subject device (JOYTECH NB-1103) and the predicate device (OMRON NE-C801). The study aims to demonstrate substantial equivalence by showing that the differences in technological characteristics do not raise different questions of safety or effectiveness. The core of this demonstration lies in the comparative aerosol performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a "pass/fail" format. Instead, it presents a comparison table and concludes that the devices are "Equivalent" or "Similar" for various parameters. For the aerosol performance metrics, the implication is that the subject device's performance should be comparable to, or within an acceptable range of, the predicate device's performance across different drug types and patient interfaces.

Given the structure, the reported device performance is the reported data in the comparative particle test tables. The "acceptance criteria" are implicitly that the subject device's performance metrics (MMAD, GSD, Respirable Dose, Respirable fraction, Total delivered Dose, Total delivered Dose fraction, Coarse Particle Fraction, Fine Particle Fraction, Ultra-Fine Particle Fraction) are comparable to (i.e., not significantly worse than) the predicate device.

Key Performance Metrics for Aerosol Performance (Based on Comparative Particle Test)

4. Adjudication Method for the Test Set

Since the ground truth is established through objective laboratory measurements rather than human interpretation, an adjudication method (like 2+1 or 3+1 for expert review) is not applicable.

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

No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical laboratory comparison of aerosol performance between the subject device and a predicate device. It assesses the physical characteristics of the aerosol produced, not human reader performance with or without AI assistance. This question is not applicable to this type of device and study.

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

This question typically applies to AI/software as a medical device (SaMD). The device in question is a Compressor Nebulizer, a physical medical device. Therefore, a standalone algorithm-only performance assessment is not applicable. The performance tested is the physical device's ability to generate aerosols.

7. The Type of Ground Truth Used

The ground truth for the device's performance (specifically aerosol characteristics) is established by objective, quantitative laboratory measurements of particle size, distribution, and drug delivery efficiency, as obtained using standard analytical methods (e.g., based on FDA guidance and potentially pharmacopeial standards for aerosol drug delivery systems). This is presented as "Particle Size characterization testing" on Page 13.

8. The Sample Size for the Training Set

The document describes non-clinical testing for a physical device, comparing its performance to a predicate device. There is no mention of a training set as this is not a machine learning or AI-based device. This question is not applicable.

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

As there is no training set for this device, this question is not applicable.

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The THERMALITE® CPAP Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with noninvasive ventilation for adult patients.
It is compatible with the Philips Respironics DreamStation 2 heated humidifiers.

The Exceleron Medical, LLC (Exceleron) THERMALITE® CPAP Heated Tubing (THERMALITE) is a heated tube that connects between a continuous positive airway pressure (CPAP) machine and the patient's interface, typically a CPAP mask. The THERMALITE is compatible with the Philips Respironics DreamStation 1 and DreamStation 2 heated humidifiers.
The THERMALITE has a unique design that helps prevent condensate from forming within the heated air stream during CPAP therapy by controlling the airflow temperature, creating an environment to maintain water in its vapor form. This condition of condensation is commonly known as "rainout," and is usually the result of temperature and humidity differentials between the device versus the surrounding air.
The THERMALITE is available in a three (3) or two (2) wire configuration.

The provided text is a 510(k) Premarket Notification for a medical device called "THERMALITE CPAP Heated Tubing." It details the device's characteristics, indications for use, comparison to a predicate device, and a summary of performance testing. However, it does not contain specific acceptance criteria values or detailed study results in the format typically requested for AI/ML device performance.

Therefore, many of the requested items cannot be fully answered with the provided text. I will answer what is available and indicate where information is missing.

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

The document lists various tests performed based on international standards and guidance documents. It states that "Test results indicated that the Exceleron THERMALITE complies with the applicable Standards and guidance documents" and "Test results indicated that the Exceleron THERMALITE complies with internal requirements, applicable Standards, and the guidance documents." However, it does not provide specific numerical acceptance criteria (e.g., "temperature must be within X +/- Y °C") or the exact reported performance values (e.g., "observed temperature was Z °C").

Acceptance Criteria and Reported Device Performance (as far as available in the text):

The purpose of the device is to provide "warmed and/or humidified breathing gases" and "prevent condensate from forming within the heated air stream during CPAP therapy by controlling the airflow temperature, creating an environment to maintain water in its vapor form." The predicate device description mentions "air passing through the tubing is warmed to or above the dew point (of the air existing the humidifier) reducing or eliminating water condensation and/or pooling of water in the breathing circuit 41 °C. The raising of the gas temperature does not exceed." This implies a performance target but no specific results for the subject device are given beyond general compliance. |

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

This information is not provided in the document. The document refers to "test results" and "verification and validation activities" but does not detail the sample sizes for these tests or the data provenance. These are bench tests on the device itself, not clinical studies with patient data.

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 question is not applicable as the device is a heated tubing for CPAP machines, not an AI/ML diagnostic or therapeutic device requiring expert interpretation of results or establishment of ground truth from clinical data. The "ground truth" for this type of device is established through engineering and performance specifications and testing against those specifications and relevant international standards.

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

This question is not applicable for the same reasons as #3. There is no clinical imaging or diagnostic data 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 a physical medical device (heated tubing), not a software/AI device that would involve human readers or AI assistance.

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

This question is not applicable. This is a physical medical device.

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

The "ground truth" for this device is based on engineering specifications, compliance with international standards (e.g., ISO, IEC), and internal requirements for safety and performance (e.g., biocompatibility limits, electrical safety thresholds, EMC limits, and performance parameters for heating and humidification as defined in the standards). It is not derived from clinical expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device's ground truth would be.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

This question is not applicable. See #8.

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The Hudson RCI Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit of breathing gas between a patient and a ventilator and to maintain the temperature of humidified inspired gas.

The Hudson RCI® Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit for respiratory gas between a patient and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier (K131912). The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.

The Dri-Tech Breathing Circuits are designed to be used with various patient interfaces such as oral tracheal tubes, nasal tracheal tubes, endo-bronchial tubes, and masks (for noninvasive ventilation therapies such as CPAP, BiPAP, and Mask usage). As such, Dri-Tech Breathing Circuits are designed and will be manufactured to conform to the test requirements of ISO 5367:2014 "Anaesthetic and respiratory equipment -- Breathing sets and connectors".

The adult dual limb configuration consists of 19mm ID inspiratory limbs with 22mm connectors that are compliant to ISO 5356-1.2015 Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. The adult circuits have a length of 1.7m on the inspiratory limb, and are kitted with the accessories described below:

• Tubing Adaptor: 22mm male to male adaptor for various connections as required.
• . Elbow Adaptor: Adaptor for connecting to the circuit wye to the patient interface to allow the circuit to exit the patient perpendicularly for optimal placement.
• . Tubing Hanger: Optional accessory for hanging the circuit to reduce pull on the patient interfaces and ventilator/humidifier connections.
• . Humidifier Limb: Required tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.

Optional Ventilator Accessory available for the Dri-Tech Dual Limb Breathing Circuit:

• . Dri-Tech Ventilator Accessory: Optional tee accessory capable of providing the 10 LPM flow required for the expiratory star lumen tubing. This ventilator accessory is comprised of male and female medical grade air DISS connectors to connect between the air hose and ventilator, a standard Christmas tree adaptor for connecting the tubing to, and an on/off valve to start and stop the flow.
  The adult single limb configuration is identical to the inspiratory limb of the dual limb configuration, however, is packaged with a different set of adaptors to facilitate connections and use with non-invasive therapies as described below:

• Humidifier Line: Optional tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.

• Exhalation Port Adaptor: Optional adaptor including an exhalation port and connector for the pressure monitoring line.

• Pressure Monitoring Line: Optional accessory tubing for use with units without an Airway Pressure Monitor.

• Pressure Monitoring Assembly: Optional accessory containing a tee and tubing for pressure monitoring on units with an Airway Pressure Monitor.

• 15mm Adaptor: Optional accessory required for connecting to certain patient interfaces.

• Male Luer: Optional accessory for required for certain setups to connect the pressure monitoring line.

• Tubing Hanger: Tubing hanger designed for single limb tubes and pressure monitoring lines to reduce pull on the patient interfaces and ventilator/humidifier connections.

• Bacterial/Viral Electrostatic Filter: Optional accessory in specific kit codes for user convenience.
  The Hudson RCI® Dri-Tech Breathing Circuits are sold non-sterile.

The provided document describes the FDA 510(k) premarket notification for the Hudson RCI Dri-Tech Breathing Circuits. This document outlines the device's characteristics, intended use, and a comparison with a predicate device, along with a summary of non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria in the form of numerical performance targets, nor does it detail a study that proves the device meets such criteria using a test set, expert adjudication, or MRMC/standalone performance metrics. The information provided heavily focuses on bench testing to established industry standards (e.g., ISO 5367:2014, ISO 80601-2-74:2017) and biocompatibility testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance as requested, because specific numerical acceptance criteria (e.g., a specific percentage for sensitivity or specificity) are not stated for AI/algorithm performance. The document describes a comparison to a predicate device and adherence to recognized standards, which are the basis for the FDA's substantial equivalence determination for this breathing circuit, not an AI-powered diagnostic device.

Similarly, other requested information such as sample size for the test set, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone performance, and ground truth establishment are not applicable to the type of device and testing described in this FDA submission. The device is a medical accessory, not an AI/ML-driven diagnostic or assistive tool.

Key takeaways from the document regarding "acceptance criteria" and "study":

• Acceptance Criteria (as implied by the regulatory submission): The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to a predicate device and meeting the requirements of recognized international standards for breathing circuits. These standards define performance characteristics such as resistance to flow, compliance, and leakage.

  • Resistance to Flow: Less than 1.8 cmH2O @ 30 LPM (per ISO 5367:2014)
  • Compliance: Less than 5 mL/cmH2O @ 60 cmH2O (per ISO 5367:2014)
  • Leakage: Less than 30 ml/min @ 60 cmH2O (per ISO 5367:2014)
  • Biocompatibility: Meeting the requirements of ISO 10993-1:2018 and ISO 18562-1:2017 for gas pathway evaluation (particulate matter, VOCs, leachables in condensate).
  • Safety: Meeting ISO 80601-2-74:2017 (Safety Testing), IEC 60601-1:2005 (Electrical Safety), and IEC 60601-1-2:2014 (EMC).
  • Useful Life: Meeting requirements for an intended 12-day useful life.

• Study That Proves the Device Meets the Criteria: The "study" described is a compilation of non-clinical bench testing.

  • Performance Testing (Bench): This included verification of features like length, leakage rate, compliance, resistance to flow (with and without bend), adaptor retention, circuit weight, ventilator accessory flow rate, expiratory star lumen tubing kink and crush resistance, moisture removal, and pressures.
  • Biocompatibility Testing: Evaluated cytotoxicity, irritation/intracutaneous reactivity, sensitization, genotoxicity, material mediated pyrogenicity, and extractables/leachables. Gas pathway evaluation included particulate matter and VOCs.
  • Electrical Safety and EMC Testing: Per IEC 60601-1 and IEC 60601-1-2.
  • Human Factors and Usability Testing: Summative testing was performed.

Therefore, I cannot populate the table or provide detailed responses to the AI/ML-specific questions as they are not relevant to the provided text.

In summary, based on the provided document:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria (derived from standards):
     • Resistance to Flow:

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VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.

VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.

The subject devices (VentStar Helix Dual Heated N Exten. Kit and VentStar Helix Heated (N) Plus), two inspiratory (and expiratory) heated disposable breathing circuits with humidifier chamber are designed for neonatal patients with a tidal volume of up to 100 mL, for conduction of humidified breathing gas from the humidifier to the patient. VentStar Helix Dual Heated N Exten. Kit is a dual heated breathing circuit and VentStar Helix Heated (N) Plus is a single heated breathing circuit to be connected to a humidifier MR850 by Fisher and Paykel, both tested for system compatibility and released for use with Dräger Babylog VN-Series ventilators.

Additionally, this submission comprises a neonatal humidifier chamber and a double connector for connection to the ventilators as accessories to the above mentioned medical devices.

This is a 510(k) premarket notification for breathing system heaters, not an AI/ML device. Therefore, the requested information about acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance is not applicable.

The document discusses the substantial equivalence of the VentStar Helix Dual Heated N Exten. Kit (MP02280) and VentStar Helix Heated (N) Plus (MP02608) to previously cleared predicate devices. Substantial equivalence is determined by demonstrating that the new devices are as safe and effective as the predicate devices, despite some technological differences.

Here's the relevant information about the device's technical specifications and the non-clinical studies performed to demonstrate its safety and effectiveness:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides extensive comparison tables (Table 1 and Table 2) between the new devices and their predicate devices. These tables list various technical characteristics and performance parameters, indicating whether they are "Same," "Similar," or "Different" compared to the predicate. For characteristics marked "Different," numerical values are provided for both the subject device and the predicate device. These differences were evaluated through non-clinical testing to ensure they do not raise new questions of safety or effectiveness.

Due to the extensive nature of the comparison, which lists numerous parameters like hose diameter, length, resistance, compliance, leakage, volume, warm-up time, humidification output, and electrical data, a comprehensive reproduction of all "acceptance criteria" (which are implicitly the performance of the predicate device or established standards) and "reported device performance" in a single table format is beyond the scope of a short answer. However, the tables clearly highlight these comparisons.

For example, for VentStar Helix Dual Heated N Exten. Kit (MP02280) compared to predicate RT265 (K103767):

The document states that "Performance data related to each proposed modification has been tested and evaluated" and "High level summary reports included in this 510(k) demonstrate that the subject devices are substantially equivalent to the predicate device." This implies that the acceptance criteria are met if these differences do not negatively impact safety and effectiveness, as determined by the non-clinical testing against relevant standards.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device that uses test sets of data in the common understanding for AI performance evaluation. The "test set" here refers to the physical devices and materials subjected to non-clinical laboratory testing. The provenance of these physical samples is from the manufacturer, Drägerwerk AG & Co. KGaA (Germany). The studies are prospective in the sense that they are conducted specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., expert annotations on medical images) is not relevant for this type of device submission, which relies on engineering and biocompatibility testing against established standards.

4. Adjudication method for the test set: Not applicable. This concept is not relevant for the type of non-clinical testing performed for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For this device, "ground truth" refers to the established requirements and performance limits defined by international consensus standards and the performance characteristics of the predicate devices. For example, specific thresholds for electrical safety, biocompatibility, resistance, and humidification output are defined by standards like IEC 60601-1, ISO 5367, and ISO 18562. The device's performance is measured against these objective, quantifiable benchmarks.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Studies and Standards:

The study that proves the device meets the acceptance criteria is a series of non-clinical tests covering various aspects:

• Mechanical Performance: Demonstrated conformance to ISO 5367 (Breathing sets and connectors) and ISO 80601-2-12 (Critical care ventilators).
• Thermal Safety: Implied by testing against the aforementioned standards and the device's function as a heated breathing circuit.
• Environmental Conditions: Not explicitly detailed beyond compliance with relevant standards.
• Electrical Safety and Electromagnetic Compatibility (EMC): Tested according to IEC 60601-1 (basic safety and performance) and IEC 60601-1-2 (EMC).
• Functional Verification and Performance Capacity and Accuracy: Demonstrated through compliance with ISO 5367, ISO 80601-2-12, ISO 5356-1 (Conical connectors), and ISO 80601-2-74 (Respiratory humidifying equipment).
• Biocompatibility Testing: Materials and completed products were evaluated through biological qualification safety tests as outlined in ISO 10993-1 ("Biological Evaluation of Medical Devices") and ISO 18562 series ("Biocompatibility evaluation of breathing gas pathways in healthcare"). Specific tests included:
  • Emissions of particulate matter (ISO 18562-2)
  • Emission of VOC with additional humidity (ISO 18562-3)
  • Leachables in condensate (ISO 18562-4)
  • Extraction (ISO 10993-18)
  • Material characterization (ISO 10993-18)
  • Cytotoxicity (ISO 10993-5)
  • Sensitization (ISO 10993-10)
  • Irritation (ISO 10993-10)

The "acceptance criteria" are implicitly defined by the requirements of these recognized consensus standards and the performance characteristics of the predicate devices, which the subject devices "meet all applicable requirements of" and are found to be "substantially equivalent" to. The testing demonstrates that despite some technological differences, no new safety or effectiveness concerns are raised compared to the predicate devices.

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The Sunset Heated CPAP Tube is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for adult patients. It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics Dreamstation Heated Humidifier.

The Sunset Heated CPAP Tube warms air, or breathable gas, as it travels to and from the respiratory patient along the breathing circuit of a respiratory system. It reduces condensation that can form in breathing circuit. The Sunset Heated CPAP Tube has a proprietary connector with two locking tabs that makes it compatible with the Respironics System One and with the Respironics Dreamstation series.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Sunset Heated CPAP Tube":

The provided document is a 510(k) Premarket Notification from the FDA, which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria and study outcomes in the way a clinical trial or a more comprehensive performance study would. Therefore, much of the requested information (like specific numerical performance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truths) is not explicitly available in this type of regulatory submission.

However, I can extract the general categories of testing performed and the standards met, which imply the acceptance criteria.

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

The document does not provide a table with specific numerical acceptance criteria alongside reported device performance values. Instead, it indicates that the device was tested against and meets the requirements of various international and national performance and safety standards. This implies that the acceptance criteria are embedded within these standards.

General Categories of Bench Testing Performed:

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

The document does not specify numerical sample sizes for any test sets. The testing described (bench testing, usability testing, biocompatibility) is indicative of engineering and lab-based evaluations rather than patient studies. Therefore, data provenance in terms of country of origin or retrospective/prospective nature isn't applicable in the context typically understood for clinical data. The testing is non-clinical, likely conducted in a lab environment.

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

This information is not provided in the document. The type of testing described (bench, safety, biocompatibility, usability) typically relies on expert engineers, testers, and potentially human factors specialists, but the document does not detail their numbers or qualifications, nor does it explicitly mention "ground truth" establishment in the context of expert consensus as one would for image interpretation or diagnosis.

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

This information is not provided in the document and is generally not applicable to the types of bench and safety testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints or image interpretation where expert disagreement might arise.

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

An MRMC study was not done. This type of study is irrelevant for a heated CPAP tube, as it is a physical medical device, not an AI-based diagnostic or assistive technology for human interpretation.

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

This concept is not applicable to the "Sunset Heated CPAP Tube" as it is a hardware device (a heated breathing tube), not an algorithm or software. It does not have an "algorithm only" performance.

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

For the bench, safety, and biocompatibility testing, the "ground truth" implicitly refers to compliance with the specified international and national standards. For usability testing, the "ground truth" would be adherence to human factors principles and satisfactory user performance/feedback, but the specific validation method is not detailed beyond stating it was "conducted as per the Guidance."

8. The sample size for the training set

The concept of a "training set" is not applicable here, as the device is a hardware product, not a machine learning model.

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

As there is no training set mentioned or implied, this question is not applicable.

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The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator or Infant Flow Generator (for single limb configuration) and include heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.

The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator or Infant Flow Generator (for single limb configuration) and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.

These devices are made of corrugated tubing (10mm in diameter), which houses the heated wires and are kitted with various adaptors and connectors to aid the respiratory care clinician in system configuration. In general these heated wire circuits are connected to both a ventilator and a Hudson RCI Neptune Heated Humidifier. The single limb configuration is compatible with the CareFusion Infant Flow system.

All Neonatal ConchaSmart Breathing Circuits have a useful life of 21 days. Neonatal ConchaSmart Breathing Circuits are sold non-sterile.

The provided text describes a 510(k) premarket notification for a medical device, the "Neonatal ConchaSmart Breathing Circuits." The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The document details the device's indications for use, technological characteristics, and performance data from non-clinical testing.

However, the information provided focuses on the physical and functional performance of the breathing circuits themselves, rather than an AI/ML-driven device's performance measured against acceptance criteria in a clinical or image-based diagnostic setting. Specifically, it does not contain the following information typically found in an AI/ML device submission for establishing acceptance criteria and proving performance:

• A table of acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC) and reported device performance against these.
• Sample sizes for test sets in an AI/ML context (e.g., number of images, patient cases).
• Data provenance (country of origin, retrospective/prospective) for an AI/ML test set.
• Number of experts and their qualifications for establishing ground truth for an AI/ML test set.
• Adjudication methods for AI/ML ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness study details (effect size of human reader improvement with AI assistance).
• Standalone performance (algorithm only without human-in-the-loop) for an AI/ML device.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data) for an AI/ML device.
• Sample size for AI/ML training set.
• How ground truth for the AI/ML training set was established.

The document discusses engineering acceptance criteria related to standards for breathing circuits (e.g., resistance to flow, compliance, leakage, useful life, electrical safety, biocompatibility) and confirms that the device passed these tests. It indicates the device functions as intended with a specific humidifier.

Therefore, I cannot extract the requested information as the document describes a traditional medical device (breathing circuits) and not an AI/ML medical device where such acceptance criteria and study designs (related to AI model performance, human-in-the-loop studies, ground truth establishment for AI) would be relevant.

The acceptance criteria and study described in the document are limited to the physical and functional aspects of a non-AI/ML medical device.

The closest information provided related to "acceptance criteria" and "study proving it meets criteria" is:

Acceptance Criteria (Extrapolated from "Test Objective" and ISO Standards):

Study Proving Device Meets Acceptance Criteria:

The study involved a series of non-clinical, laboratory-based tests.

1. Sample Size Used for Test Set and Data Provenance: The document does not specify a "sample size" in terms of number of patient cases or images, as it is not an AI/ML study. It refers to testing "the proposed devices," implying physical units of the Neonatal ConchaSmart Breathing Circuits. The tests were performed in a lab setting, not using human data/patients, so "provenance" in the sense of country of origin or retrospective/prospective is not applicable.
2. Number of Experts and Qualifications for Ground Truth: Not applicable for this type of device where laboratory measurements against international standards establish "truth."
3. Adjudication Method: Not applicable. Lab testing against defined physical and electrical parameters.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is for AI/ML devices involving human readers.
5. Standalone Performance: Not applicable in the context of an AI/ML algorithm. The device performance itself is evaluated (e.g., its resistance to flow, electrical safety, etc.).
6. Type of Ground Truth Used: The "ground truth" here is adherence to specified parameters and performance limits defined by international standards (e.g., ISO 5367, IEC 60601-1, ISO 8185, ISO 5356-1, ISO 10993) and the manufacturer's design verification testing for compatibility and durability.
7. Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable, as this is not an AI/ML device relying on a "training set" of data.

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AirLife Adult Heated Wire BiPAP/NIV Circuit is intended for use with adult population that requires mechanical ventilation. The AirLife Adult Heated Wire BiPAP/NIV Circuit is used with spontaneously breathing individuals that benefit from high flow therapy.

The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinicians. The AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to work with noninvasive ventilators and compatible to the Fisher & Paykel MR850 humidifier.

The AirLife Adult Heated Wire BiPAP/NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated wire circuit is intended for use for adult population that requires non-invasive (NIV) mechanical ventilation. It is intended for spontaneously breathing individuals who require mechanical ventilation. The duration of use is up to 7 days in a hospital environment. The aim is to maintain adequate ventilation and minimize the effort of breathing.

The AirLife Adult Heated Wire BiPAP/NIV Circuit is a corrugated plastic tube with a spiral resistance wires within the tubing that generate heat to maintain temperatures and humidity. It is intended to warm gases before they enter a patient's airway. The device delivers humidity to patients requiring active non-invasive humidification, acting as a conduit transporting gases between ventilators, humidifiers and the patient. The AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to operate at a minimum flow rate of 3 LPM and a maximum flow rate of 60 LPM.

The AirLife Adult Heated Wire BiPAP/NIV Circuit is a medical device designed to warm and deliver breathing gases to adult patients requiring non-invasive mechanical ventilation. The device was tested against several industry standards to ensure its safety and effectiveness.

Here's a breakdown 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 defined by compliance with various international standards related to breathing system heaters, anesthetic and respiratory equipment, and biocompatibility. The reported device performance uniformly indicated "Pass" for all tested characteristics, demonstrating that the device meets these established standards.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size for individual tests conducted to prove compliance. However, the tests are a series of non-clinical performance and biocompatibility assessments performed on the device itself (e.g., inspiratory limb, extension line, dry line, system leak, resistance to flow). These typically involve a sufficient number of units to ensure statistical confidence and representativeness of the manufacturing process, as per the requirements of the standards cited.

The data provenance is from laboratory testing (non-clinical) of the device. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these are not relevant for non-clinical device performance studies.

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

For non-clinical performance and biocompatibility testing as described, the "ground truth" is established by the specified parameters and methodologies outlined in the referenced international standards (e.g., ISO, AAMI/ANSI/IEC standards). The experts would be the engineers, scientists, and technicians who are trained and qualified to conduct these tests according to the standard operating procedures derived from these international standards. Their qualifications would typically include degrees in relevant engineering or scientific fields, experience in medical device testing, and specific training on the standards being applied. The document does not specify the number of individual experts, as it is a standard part of a manufacturer's quality system to have qualified personnel perform such testing.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple human readers (e.g., radiologists reading images). This is a non-clinical performance and biocompatibility study. The "adjudication method" in this context is the comparison of the test results against the acceptance criteria defined by the relevant standards. A simple "Pass" or "Fail" determination is made based on whether the device's performance meets or exceeds the specified thresholds in the standards.

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

No. An MRMC comparative effectiveness study was not conducted, nor is it applicable to this type of device. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, usually in diagnostic imaging. This device is a heated breathing circuit, and its performance is assessed through objective physical and biological tests, not by human interpretation or AI assistance in a clinical setting related to diagnosis.

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

Yes, in a sense. The document describes the standalone (algorithm equivalent) performance of the device. The entire set of tests detailed under "Performance Testing" and "Biocompatibility" (e.g., System Leak Test, Resistance to Flow, Humidity Output, Cytotoxicity) measures the intrinsic performance characteristics of the device itself without direct human intervention in its operation during the test, beyond setting up and initiating the test. There is no "algorithm" in the conventional sense of AI, but rather the physical and chemical properties and functionality of the device are evaluated.

7. Type of Ground Truth Used

The ground truth used is based on established objective technical standards and regulatory requirements. This includes:

• Engineering/Performance Specifications: Derived from standards like ISO 5367, ISO 8185, ISO 5356-1, IEC 60601-1, and IEC 60601-1-2. These standards define acceptable ranges and limits for physical performance characteristics.
• Biocompatibility Standards: Derived from ISO 10993 series, which define acceptable levels of biological response for medical devices in contact with the body.

8. Sample Size for the Training Set

This is a non-clinical study for a medical device's physical and biological properties, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The device itself is the product being tested, not an algorithm being developed. The manufacturing process of the heated breathing circuits would have undergone internal validation and development which may involve iterative testing, but this is distinct from an AI training set.

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

As there is no "training set" in the AI sense, this question is not applicable. For the manufacturing process, the "ground truth" (i.e., desired specifications and performance) would be established through a combination of design requirements, risk analysis, and engineering specifications based on relevant standards and intended use.

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The AirLife Adult Heated Wire Circuit is intended to warm breathing gases before they enter a patient's airway. The AirLife Adult Heated Wire Circuit is used with the adult patient population that requires mechanical ventilation, positive pressure breathing or general medical gases. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor's supervision and by skilled clinicians. The AirLife Adult Heated Wire Circuit is compatible to the Fisher & Paykel MR850 humidifier.

The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifier.

The provided document is a 510(k) premarket notification for a medical device called the "AirLife Adult Heated Wire Circuit." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's performance against clinical acceptance criteria in the same way a novel device might.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and performance tests against recognized standards for breathing circuits and humidifiers, not clinical performance measures like sensitivity, specificity, or reader agreement for an AI diagnostic device.

Here's the breakdown of the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance statistics in a pass/fail format typical for a clinical study of an AI device. Instead, it lists the performance characteristics tested and the standards they comply with, implying that meeting these standards constitutes the acceptance criteria. The "reported device performance" is implicitly that the device did meet these standards, as stated in the conclusion.

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

This document does not specify a "test set" in the context of clinical data for AI benchmarking. The tests performed are engineering and performance evaluations of the device itself (e.g., length, resistance, leakage). The document does not provide details on the sample size (number of devices tested), the provenance of the data (country of origin), or whether the testing was retrospective or prospective. These are typically internal validation tests by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" here is defined by the technical specifications outlined in the referenced ISO and IEC standards.

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

Not applicable. There is no human adjudication process involved as this is a technical device performance evaluation against standards.

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

Not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

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

Not applicable. This is a physical medical device (heated wire circuit), not an algorithm.

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

The "ground truth" for this device's performance is established by the technical specifications and test methodologies outlined in the referenced international standards (e.g., ISO 5367, ISO 8185, IEC 60601-1, ISO 10993 series). The device's performance is measured against these quantitative and qualitative criteria defined by the standards.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this type of device.

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Flexicare Neonatal Heated Wire Breathing Systems are intented for use to connect a patient's arway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Neonatal patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Neonatal (038-33-201U) size. For flow rates >4L/min.

Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.

Flexicare Neonatal Heated Wire Breathing Systems are sterile single patient use devices which form part of a respiratory humidification system. In this system the inspiratory limb delivers heated humidified gas to the patient and expiratory limb carries the expired gas away from the patient.

Flexicare Neonatal Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidification Chamber holds a volume of water and is placed onto a heater unit and fills automatically from a suspended water source. The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient.

The inclusion of a heated wire within the lumen of both the System tubes the amount that the humidified air cools when travelling to/from the patient. This in turn reduces the amount of condensation and water build-up within the System.

Flexicare's Neonatal Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Neonatal patients.

The provided text describes the Flexicare Neonatal Heated Wire Breathing Systems and Autofill Humidification Chamber seeking clearance via a 510(k) pathway, asserting substantial equivalence to predicate devices (Fisher & Paykel RT235 Heated Breathing Circuit and MR290 Autofill Humidification Chamber).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaways:

• Substantial Equivalence Study: The entire document is a 510(k) summary, which is a submission to the FDA to demonstrate that a new medical device is at least as safe and effective as a legally marketed predicate device. The "study" here is thus a comprehensive comparison and verification testing program, often referred to as non-clinical performance testing.
• No AI Component: The devices described (heated wire breathing systems and humidification chambers) are hardware-based medical devices. There is no mention of algorithms, artificial intelligence (AI), machine learning (ML), or software with diagnostic or therapeutic capabilities. Therefore, questions related to expert ground truth, adjudication, MRMC studies, or standalone algorithm performance are not applicable.
• Ground Truth for Testing: The "ground truth" for the non-clinical tests is based on established engineering principles, recognized international standards (ISO, ASTM, IEC, BS EN), and pre-determined acceptance criteria derived from the predicate device's performance or general medical device safety and efficacy requirements.

1. Table of Acceptance Criteria and the Reported Device Performance

The document provides two comparison tables (one for the breathing system and one for the humidification chamber) listing characteristics between the Flexicare device and its predicate. Additionally, a "Summary of performance Testing" table (page 10) outlines specific tests, their standards/acceptance criteria, and the outcome.

Flexicare Neonatal Heated Wire Breathing Systems

Flexicare Autofill Humidification Chamber

Performance Testing Summary (Page 10)

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

• Sample Size for Test Set: The document does not specify the exact number of units/samples used for each non-clinical test (e.g., how many systems were visually inspected, or how many were subjected to drop testing). It generally states "Verification tests were performed" or "Testing demonstrated."
• Data Provenance: The tests are explicitly referred to as "Non-clinical Test Results" and "Verification tests." These are laboratory-based engineering and performance tests conducted on the physical devices. The country of origin for the data is implicitly the UK, where Flexicare Medical Limited is located. The nature of testing is prospective in the sense that the new Flexicare devices were manufactured and then specifically tested against established standards and in comparison to a predicate device.

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

• Not Applicable. This is a non-clinical device clearance, not an AI/clinical diagnostic study. The "ground truth" for the test set is determined by the specifications in recognized international standards (ISO, ASTM, IEC, BS EN) and the pre-determined acceptance criteria established by the manufacturer, which are based on engineering requirements and predicate device performance. There are no "experts" establishing a clinical "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical device testing, there is no need for adjudication as typically understood in clinical or AI performance studies involving human readers. Test results are objectively measured against predefined criteria.

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. The device is not an AI-powered diagnostic tool, and no human-reader study was conducted or is relevant for this type of device clearance.

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

• Not Applicable. The device is a physical medical device (breathing systems and humidification chambers), not an algorithm or software. No standalone algorithm performance was evaluated.

7. The Type of Ground Truth Used

• The "ground truth" for these tests is based on:
  • Recognized International Standards: Such as ISO 5367, ISO 5356, ISO 8185, IEC 60601-1, ISO 10993, BS EN 556, ASTM F1886-09, ASTM F88-09, ASTM F1929-12. These standards define the expected performance metrics, safety requirements, and test methodologies for medical devices of this type.
  • Predicate Device Performance: Direct comparison to the Fisher & Paykel RT235 and MR290 devices forms a key basis for establishing substantial equivalence.
  • Pre-Determined Acceptance Criteria: For tests not covered by specific standards, Flexicare established internal "Pre-Determined Acceptance Criteria" based on engineering specifications and ensuring safety and effectiveness comparable to the predicate.

8. The Sample Size for the Training Set

• Not Applicable. This refers to machine learning models, which are not part of this submission. There is no "training set" in the context of this traditional medical device clearance. The development of the device itself would involve engineering design and iterative prototyping, but not a dataset for training an algorithm.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The Hybernite RT heated breathing circuits are intended to carry warmed/moistened gas from the humidifier to the patient's airways. The Hybernite RT breathing tubes are indicated for patient populations from neonates to adults. They may be used in the home or hospital environments. They are for single patient use only.

The Hybernite RT is a breathing system heater according to 21 CFR§ 868.5270. A breathing system heater is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm breathing gases before they enter a patient's airway. The Device family "Hybernite RT" is the name for dual wire passive heated breathing circuits optimized for patient category and application. The Hybernite RT is optimized for 3 patient categories, adult, paediatric and neonatal. Within each patient category there is a dual limb and single limb version to accommodate the specific clinical application as tabulated below; the device is intended to act as a conduit for the breathing gasses delivered from the ventilator to the humidifier, from the humidifier to the patient and if applicable from the patient to the ventilator. The product family of Hybernite RT is defined as the combination of non- heated and heated breathing tubes intended to deliver the desire air temperature at the patient port when used in combination with a Humidifier. The Hybernite RT tubing has a range of tubing dimensions (Internal diameter from 10 mm to 22 mm and length from 0.3 meter to 2.4 meters) depending on the clinical application that can be connected to a humidifier. That means that the performance requirement in terms of desired patient port temperatures is controlled by the Humidifier. The Hybernite RT functions as a heating element. All members of this device family therefore share the same basic design and performance characteristics as related to the safety and efficacy of the device, the same intended use and function and device classification. The heated tubing comprises a single limb single lumen smooth bore tube containing 2 heater wires that are embedded in the tubing construction. The heating wires are physically separated from the lumen of the tubing. When a voltage is applied, a current flows through the heating wires. Due to the wire resistance, heat is dissipated through the wall of the tube construction into the air flow in the lumen of the tubing. As a result, the air passing through the tubing is warmed reducing or eliminating water condensation and/or pooling of water in the breathing circuit and the problems associated with such condensation. The nonheated tubing has the same construction as the heated tubing without the heating wires incorporated. The lead from the heated limb can be connected to the humidifier to supply the heating. The Hybernite RT does not have sensing functionality. However it is equipped with a flow probe port and a temperature probe port which connect with the sensors of the humidifier. Based on these readings the humidifier regulates the power supplied to the Hybernite RT. All the cuffs of the Hybernite RT breathing tubes are standard cuffs. As such, the Hybernite RT breathing tubes can be connected to ventilators and masks that have standard male/female outlet connectors. The Hybernite RT can be used in a hospital environment in combination with the Fisher & Paykel MR 850 Heated Humidifier.

The provided document is a 510(k) summary for the Hybernite RT, a heated breathing circuit. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical data and testing conducted.

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

The document does not explicitly state "acceptance criteria" with numerical targets for clinical performance that would typically be found in an AI/diagnostic device submission. Instead, it focuses on demonstrating substantial equivalence to predicate devices through compliance with established standards and comparable performance characteristics for a breathing system heater.

The performance characteristics evaluated are:

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

The document does not specify a "test set" in the context of an AI/diagnostic algorithm using patient data. The testing described is primarily for engineering and safety performance of the physical device.

• Performance Testing: "Comparative performance testing has been done for the Hybernite RT and Intersurgical Predicate utilizing the Fisher & Paykel MR 850 Heated Humidifier." No specific sample size (e.g., number of circuits, number of test runs) is provided, nor is the provenance of this testing (e.g., conducted internally, by a third-party lab, country of origin).
• Biocompatibility Testing: "All materials utilized in the Hybernite RT circuits have been evaluated according to tests outlined in ISO 10993-1." This involves material samples, not a patient test set.
• Usability Study: "The device has been subject to a usability study according to IEC 62366." The number of participants or details of the study are not provided.

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

This information is not applicable to this submission. The device is a heated breathing circuit, and its performance and safety are evaluated against engineering standards and physiological parameters (e.g., temperature, flow resistance), not by expert interpretation of medical images or diagnostic data. Therefore, there is no "ground truth" in the sense of expert consensus on diagnostic findings.

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

Not applicable. As described above, there is no test set requiring expert adjudication for ground truth establishment.

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

Not applicable. This is a submission for a physical medical device (heated breathing circuit), not an AI-powered diagnostic or assistive tool for human readers. There is no AI component, and thus no human-in-the-loop performance study or MRMC study was conducted.

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

Not applicable. There is no algorithm for this device.

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

Not applicable in the typical sense for an AI/diagnostic device. For this physical device, "ground truth" for performance is established by objective measurements against harmonized standards (e.g., ISO, IEC) and internal specifications. For instance, temperature measurements are compared against a maximum allowable temperature (40°C), and resistance to flow is measured and compared against ISO 5367 requirements. Biocompatibility is assessed through standardized tests on materials.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set or AI component.

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