Search Results

Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant:
Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by premature and infant (birth to 2 years) patients in professional healthcare environments.

Hudson RCI® Comfort Flo® Plus Cannulas and Comfort Flo® Soft Plus Cannulas Extra Small:
Hudson RCI® Comfort Flo® Plus Cannulas and Comfort Flo® Soft Plus Cannulas Extra Small are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.

Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant
Hudson RCI® Comfort Flo Plus Cannulas Extra Small
Hudson RCI® Comfort Flo Soft Plus Cannulas Extra Small

This is a 510(k) clearance letter for a medical device (nasal cannula), not an AI/ML-driven device. Therefore, the information typically requested for AI/ML device validation (such as expert consensus, MRMC studies, or training/test set details) is not applicable.

The document describes the device, its intended use, and a summary of non-clinical testing performed to demonstrate substantial equivalence to predicate devices. It clearly states that no clinical testing was performed.

Here's a breakdown of the requested information based on the provided document, highlighting why many points are not applicable for this type of device clearance:

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

   • The document lists various non-clinical performance tests but does not provide a table of specific acceptance criteria with corresponding reported device performance values. Instead, it generally states that testing was conducted "to demonstrate substantial equivalence." For example, it lists "Relevant Humidity Output testing" but doesn't state the specific humidity output range considered acceptable or the measured output. This is typical for a 510(k) submission where broad equivalence is the goal rather than meeting precise performance thresholds for novel functionality.

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

   • Not applicable. This is a physical medical device. Testing involved bench tests on manufactured units, not data sets in the AI/ML sense. Data provenance, retrospective/prospective, and sample sizes for test sets (in the context of patient data) are not relevant as no human or clinical data was used for validation.

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. No "ground truth" was established by experts in the context of diagnostic performance, image interpretation, or similar AI/ML applications, as this is a physical medical device.

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

   • Not applicable. There was no test set requiring expert adjudication for performance evaluation.

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 device, and no MRMC study was conducted. The document explicitly states "No clinical testing was performed."

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

   • Not applicable. This is not an algorithm-based device.

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

   • Not applicable. The concept of "ground truth" as it applies to AI/ML model validation is not relevant here. The device's performance was evaluated against engineering specifications and industry standards for physical device functionality (e.g., flow rates, material compatibility, strength).

8. The sample size for the training set

   • Not applicable. There is no AI/ML model, and thus no training set.

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

   • Not applicable. There is no AI/ML model, and thus no training set or ground truth establishment for it.

In summary, the provided document is a 510(k) clearance for a physical medical device, not an AI/ML-driven product. Therefore, most of the requested information related to AI/ML validation (ground truth, expert studies, training/test sets) is irrelevant to this submission.

The acceptance criteria for this device focus on:

• Biocompatibility: Meeting ISO standards (e.g., ISO 10993 series, ISO 18562 series) to ensure the materials are safe for patient contact and breathing gas pathways. The document lists the specific ISO standards used.
• Performance Bench Testing: Covering aspects like visual inspection, humidity output, thermal overshoot, connection strength, leak testing, headgear testing, shelf life, and useful life. While the specific numerical acceptance criteria for each test (e.g., "humidity output must be within X amount") are not explicitly listed in this summary, the document indicates these tests were performed and implicitly met the company's internal acceptance criteria for demonstrating substantial equivalence.
• Substantial Equivalence: The overarching acceptance criterion for a 510(k) is demonstrating that the device is "as safe and as effective" as a legally marketed predicate device, based on the non-clinical testing performed.

The "Study that proves the device meets the acceptance criteria" for this product consists of the various Non-Clinical Testing described on pages 16-17, primarily Biocompatibility Testing and Performance Testing (Bench), which were conducted to support the claim of substantial equivalence to the predicate devices.

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OPT94X Model:
The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.

This device is designed to be used in a hospital, sub-acute facility or long-term care facility by appropriately qualified healthcare professionals.

MYOPT9X Model:
The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and and humidified respiratory gases to the upper airway.

This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

The F&P Optiflow+ Nasal Cannula range is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy.

The F&P Optiflow+ Nasal Cannula range is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.

The provided FDA 510(k) clearance letter and summary for the F&P Optiflow+ Nasal Cannula Range does not contain specific acceptance criteria or an analytical study proving the device meets those criteria.

This submission is for a labeling change only. The document explicitly states:

• "The modification in scope of this 510(k) submission is to change the labeling of the subject device only, specifically to the Indications for Use statement."
• "The subject device's technological characteristics, material composition, and intended use remain identical to those of the predicate device."
• "No new performance or biocompatibility testing was conducted on the subject device since the device design is identical to the predicate device."

Therefore, the information requested regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets cannot be extracted from this document because such studies were not conducted for this specific 510(k) submission.

The clearance is based on the device being substantially equivalent to a previously cleared device (F&P Optiflow+ Nasal Cannula range, K162553), with the only change being an updated Indications for Use statement to be more defined and aligned with current labeling requirements. The original predicate device (K162553) would have had performance data supporting its clearance, but that data is not detailed in this particular document.

Summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance: Not provided in the document as no new performance testing was conducted. The document states the device's characteristics and performance are identical to the predicate device.
2. Sample Size for Test Set and Data Provenance: Not applicable, as no new performance testing was conducted.
3. Number of Experts and Qualifications: Not applicable, as no new clinical study requiring expert review was conducted.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no new clinical study was conducted.
6. Standalone Performance (Algorithm only): Not applicable, as this is a medical device (nasal cannula), not an AI/algorithm-based device.
7. Type of Ground Truth Used: Not applicable, as no new performance testing was conducted.
8. Sample Size for Training Set: Not applicable.
9. How Ground Truth for Training Set Established: Not applicable.

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Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings.

Sterile Water for Inhalation, USP is a sterile, single-dose medical device provided in durable Polypropylene (PP) bottles, which are resistant to breakage and designed for safe and easy handling. The bottles are available with two types of closures:

• A 36 mm PP screw cap with a PP/PET aluminium induction seal .
• A 28mm bromobutyl stopper with an aluminium seal .
  The bottles are available in the following volume configurations:
• . 1000mL PP bottles with either a bromobutyl stopper and aluminium seal, or a PP/PET aluminium induction seal, PP screw cap, and tamper-evident plastic shrink wrap.
• 500mL PP bottles with a PP/PET aluminium induction seal, PP screw cap, and tamper-. evident plastic shrink wrap.
  Sterile Water for Inhalation, USP is not for parenteral administration or irrigation. The product is For Inhalation Therapy Only. It is supplied sterile and intended for single use only. Discard any unused portion.

The provided text describes a 510(k) summary for a medical device called "Laboratorios Biogalenic Sterile Water for Inhalation, USP." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

It's important to note that this document does not describe a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device performance evaluation. Instead, it's a regulatory submission demonstrating the substantial equivalence of a general medical device (sterile water for inhalation) to an existing one. The "acceptance criteria" here refer to regulatory requirements for substantial equivalence, not performance metrics like sensitivity, specificity, or AUC as seen in AI/ML device evaluations.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to the information provided in this document as it relates to an AI/ML device.

However, I can extract information related to the "performance testing" conducted for this non-AI/ML device to demonstrate its substantial equivalence to the predicate device.

Summary of Acceptance Criteria and Device Performance (Non-AI/ML Device)

The "Laboratorios Biogalenic Sterile Water for Inhalation, USP" is a non-AI/ML medical device. Its acceptance criteria and performance are assessed through physicochemical, biological, packaging, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify a distinct "test set" in the context of an AI/ML algorithm. The tests described are laboratory-based validation tests performed on samples of the manufactured device.
• The provenance of the data (e.g., country of origin, retrospective/prospective) is not detailed for these specific tests. These are standard validation tests for manufacturing processes and product integrity.

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

• This concept is not applicable as there is no "ground truth" derived from expert consensus for a diagnostic medical device in this context. The validity of the tests (e.g., sterility, leak resistance) is determined by established scientific methods and standards (USP, ASTM, ISO).

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

• Not applicable. The tests are laboratory-based with objective outcomes against defined 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, as 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, as this is not an AI/ML device.

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

• The "ground truth" for this device's performance is established by scientific standards and analytical methods defined in regulations and industry standards (e.g., USP for sterility, ASTM for packaging, ISO for biocompatibility and sterilization). It's not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic AI/ML device.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device. There is no training set for an algorithm.

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

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

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The Hudson RCI Comfort Flo® CubCannula™ is a single use nasal cannula intended to administer respiratory gas to a spontaneously breathing patient through both nostrils delivering flow rates ranging from 1 to 25 LPM.

CubCannula™ is a patient interface used to deliver heated and humidified gas to the following populations:

• · Neonates, birth to 1 month of age
• · Infants, 1 month to 2 years of age
• · Children, 2 to 12 years of age

CubCannula™ is designed for use in professional healthcare environments and must be prescribed by a physician.
CubCannula is used in conjunction with the Humidification System intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

The Comfort Flo® CubCannula™ is a single patient use nasal cannula containing two-prongs intended to administer gas to a spontaneously breathing patient through both nostrils. CubCannula™ is a patient interface used as a conduit to deliver heated and humidified gas to the following pediations: neonates, infants, children. The nasal cannula incorporates soft prongs, a soft, silicone, kink and crush resistant lariat, in addition to a color-coded bolo for easy size identification. The CubCannulas will be available in five sizes: Extra Small (XS), Small (XS), Small (XS), Small (XS), Medium (M), Large (L), and Extra Large (XL). The nasal cannula will be secured to the patient's face via use of Hydrocolloid pads (CubPads™) to assist with easy positioning and change out of the cannula during use.

The CubCannula™ will be individually packaged with a pair (2) of CubPad™ replacements will be available in a separate package.

Based on the provided text, the device in question is the Hudson RCI Comfort Flo® CubCannula™, a nasal cannula. The document is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study as might be done for a novel device or pre-market approval (PMA) pathway.

Therefore, the information regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with pre-defined primary and secondary endpoints is not explicitly present for this 510(k) submission. Instead, the focus is on demonstrating equivalence through non-clinical testing (biocompatibility and bench testing).

Here's an analysis of the provided information relative to your questions, with specific callouts where information is not available due to the nature of a 510(k) substantial equivalence submission:

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

The document does not present a formal table of acceptance criteria with corresponding performance results in the way a clinical study report would. Instead, it lists the non-clinical tests performed and states that they revealed "passing results" or that "emissions are well below the health-based thresholds." The "acceptance criteria" are implied by the standards cited and the statement of compliance.

Implied Acceptance (Compliance) and Reported Performance (Statement of Passing):

2. Sample sized 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 as it pertains to a 510(k) submission based on non-clinical (bench) testing, not a clinical study. The "test set" would refer to the physical units of the device tested in the lab, but the number of units is not specified. There is no patient data or country of origin for the data as no clinical testing was performed ("No clinical testing was performed").

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

This is not applicable as there was no clinical study, no patient data, and therefore no "ground truth" established by experts in the context of clinical interpretation or outcomes. The ground truth for the non-clinical tests would be the established performance standards set by the cited ISO and ASTM documents.

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

This is not applicable as there was no clinical study or expert review for 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 is not applicable. The device is a physical medical device (nasal cannula), not an AI-powered diagnostic or assistive tool.

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

This is not applicable, as it is not an algorithm-based device.

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

Since no clinical study comparing the new device's performance against a "ground truth" in patients was conducted per the document ("No clinical testing was performed"), the concept of "ground truth" in a clinical sense is not applicable. For the non-clinical testing, the "ground truth" is adherence to the specified performance characteristics and safety profiles as measured against the requirements of the cited ISO and ASTM standards. These standards define the acceptable range for each test parameter (e.g., cytotoxicity, leachable substances thresholds, connection strength, leak rates).

8. The sample size for the training set

This is not applicable. This is a physical device, not an AI/machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

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Hudson RCI® Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by adult and pediatic (2 years and above) patients in professional healthcare environments.

Hudson RCI® Comfort Flo® Plus cannulas are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by adult and pediative (12 years and above) patients in professional healthcare environments.

Hudson RCI® Comfort Flo Nasal Cannulas:
Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated humidified air to spontaneously breathing patients. Sizes available include adult and pediatric.

Hudson RCI® Comfort Flo Plus Cannulas:
Cannula tube is assembled with other components to create a product named Comfort Flo® Plus Cannula with/ without Chin Strap. The Comfort Flo Plus cannulas are intended to be used in conjunction with the Humidification system intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It allows for the safe and effective delivery of heated, humidified oxygen therapy to the patients.

The Comfort Flo Plus Cannulas are available in small, medium and large configurations. The chin strap is also offered individually.

Hudson RCI® Comfort Flo Plus Cannulas:
Comfort Flo Soft Plus cannulas are the same as Comfort Flo Plus cannulas except for head strap. These have a soft/cushioned head strap for patient comfort.

It is used as an alternative to oxygen face mask and allows the patient to continue to talk, eat and drink while receiving the therapy.

Hudson RCI® Tracheostomy Adaptor:
The Hudson RCI® Tracheostomy Adapters are intended to be used in conjunction with tracheostomies in order to provide a secure connection to spontaneously breathing tracheostomy patients for oxygen therapy. It allows for the safe and effective delivery of oxygen therapy to the patient's trachea.

The Tracheostomy Adaptor consists of 15mm (female) connector with cap deflector which enables it to be attached to 15M conical connector of tracheostomy tube/ patient connector port and swivel connector (15F/22M) at another end in order to connect with breathing circuit/ humidification system.

It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.

The provided text is related to a 510(k) premarket notification for a medical device (nasal cannulas) and does NOT contain information about acceptance criteria or a study proving that the device meets specific performance criteria, especially not in the context of an AI/ML-driven medical device.

The document describes the device, its intended use, comparison to predicate devices, and a summary of non-clinical (bench) performance testing and biocompatibility testing. However, it explicitly states "This section does not apply. No animal testing was performed" and "This section does not apply. No clinical testing was performed" under "Performance Testing (Animal)" and "Performance Testing (Clinical)" respectively.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance from a test set, sample sizes for test/training sets, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device.

The document discusses tests like:

• Post aging Visual Inspection
• Relevant Humidity Output testing
• Thermal Overshoot testing
• Gas path and headgear joint and connection strength testing
• Flow Leak Test/ Gas path leak testing
• Head Gear Testing
• Shelf Life Testing
• Useful Life Testing
• Transportation simulation
• ISO gauging

These are all bench tests for a mechanical/physical device (nasal cannula), not studies that would involve AI/ML performance metrics like sensitivity, specificity, AUC, or the involvement of human readers/experts for ground truth.

In summary, the provided document does not contain the information required to answer your request about acceptance criteria and study details for an AI/ML medical device.

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This product is intended for delivery of respiratory gases to adult patients in a hospital.
This product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation. by individuals who perform anesthesia care or airway management.
This product is not intended for apneic ventilation
This product is not indicated for use during CPR.

Fisher & Paykel Healthcare has designed the F&P Optiflow™ System with Optiflow Switch interface that allows for mask ventilation without the need to remove the nasal interface from the patient during therapy.
To support this function, an Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility and Flow Diverter is required. The subject device in this 510(k) is the Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility that is also referred to in this submission as the Optiflow Switch interface.
The product is intended for delivery of respiratory gases to adult patients in a hospital. The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).
It is intended to be used in combination with a compatible respiratory humidifier. Optiflow Oxygen Kit and the Optiflow Flow Diverter (AA520J).

This document is a 510(k) Premarket Notification from Fisher & Paykel Healthcare Ltd for a medical device called the F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J). The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (Optiflow Nasal Oxygen Cannula with CO2 Sampling, K201723).

The document details the device's indications for use, its design and technological characteristics, and provides a summary of non-clinical tests performed to support its substantial equivalence. It does not contain information about acceptance criteria or a study that specifically "proves the device meets acceptance criteria" in terms of performance metrics like sensitivity, specificity, or reader improvement with AI assistance, as this is a medical device for respiratory gas delivery, not an AI/software device with diagnostic capabilities.

Therefore, many of the requested items (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth establishment) are not applicable to this type of device submission.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the format of performance metrics against a target value for a diagnostic device. Instead, substantial equivalence is claimed based on non-clinical testing against relevant international and national standards, and a comparison of technological characteristics with the predicate device. The performance data is summarized as conforming to these standards.

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

• Sample Size: Not specified. The document refers to "performance testing" and "non-clinical tests" but does not detail the number of units tested.
• Data Provenance: Not specified. Given the nature of the tests (biological evaluation, safety, performance, usability), the data would likely be from manufacturer-conducted in-house or contracted laboratory testing rather than patient data from a specific country. This would be prospective testing of device samples.

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

This is not applicable as the device is not an AI/diagnostic software. Ground truth in this context would be defined by the technical specifications and standards it must meet, not by expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set:

Not applicable. There's no diagnostic component requiring adjudication of human-interpreted results. Test results are against engineering specifications and standard requirements.

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

Not applicable. This device is a respiratory gas delivery interface, not an AI-powered diagnostic tool.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used:

The "ground truth" for this device would be defined by the technical specifications of the device itself and the requirements of the international and national standards (e.g., ISO 10993, ISO 80601-2-74, IEC 60601-1, ISO 5356-1, IEC 62366-1). For example, a flow range test would compare the device's actual flow output against its stated specification of 5-70 L/min.

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.

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HFT150 is for spontaneously breathing adult and pediatric patients (10 kg and up) who would benefit from receiving high flow warmed and humidified respiratory gases. The flow may be from 2 - 60 L/min depending on the patient interface. HFT150 is used in hospital and professional healthcare environments.

The HFT150 is a heated humidifier with integrated flow source and a heated breathing tube to deliver warmed and humidified gas flow to a patient. The HFT150 includes an integrated oxygen module, delivering an oxygen range of 21% to 100% to the patients. The HFT150 humidifier is comprised of two connected functional units. One is a motorized blower assembly that provides air flow and the delivery of supplemental oxygen to patients via an integrated oxygen module. The blower speed is directly related to total delivered flow and is controlled by software with a flow sensor. The blower assembly output connects directly to an integrated humidification tub. The second functional unit of the HFT150 is a heated humidifier. The tub is integral to the HFT150. Software monitors ambient temperature, humidity, and flow to optimize the humidity delivery to the patient and minimize condensation in the patient circuit. The HFT150 is protected from contaminants and pathogens by an integral anti-bacterial filter. The nasal cannulas, heated tubes, and water tubs are disposable and are for single use only. The HFT150 may be operated by nurses, respiratory therapists, or doctors and water tubs are disposable and are for single use only. The HFT150 may be operated by nurses, respiratory therapists, or doctors.

This document is a 510(k) summary for the HFT150, a respiratory gas humidifier. It focuses on demonstrating substantial equivalence to a predicate device, the AIRVO 2 Series Humidifier, rather than detailing the acceptance criteria for a specific AI algorithm or its performance in a clinical study. Therefore, most of the requested information regarding AI device performance, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not present in this document.

However, I can extract the general testing summary which outlines the types of evaluations performed on the HFT150 device to ensure its safety and performance, which are analogous to acceptance criteria in a broader sense.

Here's a breakdown of what information is available based on your request:

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

The document does not provide a table of specific numerical acceptance criteria for performance parameters (e.g., specific humidity levels or temperature accuracy) alongside reported device performance for the HFT150. Instead, it lists the standards to which the device was tested, implying that the acceptance criteria for these tests were meeting the requirements of those standards.

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

Not applicable. This document refers to device verification and validation testing against engineering standards rather than 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)

Not applicable. Ground truth establishment by experts is typically associated with AI/ML algorithm validation using clinical data, which is not the subject of this 510(k) summary.

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

Not applicable. Adjudication methods are used in clinical studies for establishing ground truth, which is not described here.

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

Not applicable. This document does not describe an AI-assisted device or MRMC study.

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

Not applicable. This document does not describe an AI/ML algorithm.

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

Not applicable. The "ground truth" for the device, in this context, is its adherence to the performance and safety specifications outlined in the referenced standards (e.g., "electrical safety compliance," "biocompatibility material standards," "flow rate accuracy"). These are verified through engineering and laboratory testing.

8. The sample size for the training set

Not applicable. There is no mention of an AI algorithm or a training set.

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

Not applicable. There is no mention of an AI algorithm or a training set.

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This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.

It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.

This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup.

This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.

The Fisher & Paykel Healthcare (F&P) Optiflow™ Oxygen Kit is a multiple-patient use breathing tube kit. This F&P Optiflow™ Oxygen Kit is presented as the AA451J.

The kit consists of a dry line, water bag, humidification chamber, inspiratory limb, tubing clips and datechange stickers.

The flow source delivers gas through a dryline to a humidification chamber that sits on a humidifier. As the gas passes through the chamber, it is heated and humidified. The gas then flows through the inspiratory limb, through a hydrophobic filter and then through a patient interface into the patients' upper airway via the nose.

The AA451J kit delivers humidified respiratory gases at flows from 5 to 70 L/min. When used with an FDAcleared hydrophobic filter, the AA451J kit can be used on multiple patients. The kit is reprocessed between each patient. The kit can be exposed to a maximum of 30 reprocessing cycles and used for a maximum of 24 hours after setup.

The scope of this 510(k) submission is limited to the AA451J, F&P Optiflow™ Oxygen Kit. The flow source, humidifier, hydrophobic filter and interface are not in the scope of this submission.

The provided text does not contain information about the acceptance criteria or a study proving that a software device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a physical medical device, the "F&P Optiflow Oxygen Kit (AA451J)," which is a breathing set accessory for a respiratory humidifier.

The sections titled "PERFORMANCE DATA" (Section VII) and "CONCLUSION" (Section VIII) discuss performance testing, but this refers to non-clinical tests for the physical device's safety and effectiveness, such as biological evaluation, electrical safety, and respiratory humidifying equipment standards (e.g., ISO 10993-1, ISO 80601-2-74, IEC 60601-1). These tests are typically laboratory-based and relate to the device's physical properties, material compatibility, and functional performance (e.g., flow rates, humidification).

Therefore, I cannot provide the requested information regarding acceptance criteria for a software device based on the given input, as the document pertains to a hardware medical device.

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The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.

The F&P myAirvo 3 device is a heated humidifier flow source. The subject device is intended to treat spontaneously breathing patients, pediatrics and adults, who would benefit from receiving high flow, warmed and humidified entrained air and oxygen (if required).

The F&P myAirvo 3 is comprised of two main connected functional units: the blower and the humidifier.

The blower is a motorized fan assembly that provides air flow. The fan speed is directly related to the delivered flow and it is controlled by the software. The blower assembly output connects directly to a humidification chamber at the front of the device.

The second functional unit of the F&P myAirvo 3 device is a heated Passover humidifier. The water is contained in a humidification chamber positioned on a heater plate at the front of the unit. The gas is warmed and humidified in the chamber to the dew point set temperature, transported through the heated breathing tube and delivered to the patient through the selected interface.

This document is a 510(k) Summary for the F&P myAirvo 3, a respiratory humidifier. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not contain acceptance criteria or study data related to the performance of an AI/ML powered device. The provided text primarily focuses on comparative claims against a predicate device and adherence to various safety and performance standards relevant to a medical device's physical and functional specifications.

Therefore, I cannot extract information about acceptance criteria or a study proving an AI/ML device meets them from this document. The questions posed in the prompt (regarding AI/ML performance, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the content provided, as it describes a traditional medical device (a respiratory humidifier) and not an AI/ML algorithm.

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OPT96X Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

MYDUETXXX Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

The F&P Optiflow+ Duet Nasal Cannula is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy to spontaneously breathing patients. The F&P Optiflow+ Duet Nasal Cannula is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the F&P Optiflow+ Duet Nasal Cannula. It focuses on demonstrating the device's substantial equivalence to a legally marketed predicate device, rather than proving that an AI/ML powered device meets specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert consensus for ground truth, and MRMC studies for AI assistance cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

The document provides information on the non-clinical performance tests conducted for the F&P Optiflow+ Duet Nasal Cannula to demonstrate its substantial equivalence to its predicate device (F&P Optiflow+ Nasal Cannula OPT94X, K162553).

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria in a quantitative table format that shows a direct "acceptance criteria vs. reported performance" for the device's primary function in terms of a specific output (like an AI model's accuracy, sensitivity, or specificity). Instead, the "performance" is demonstrated through compliance with various international standards and general performance specifications like flow ranges.

However, we can infer some "performance" aspects from the comparison table on pages 6-7, although they are mostly qualitative or specify operating ranges.

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