Search Results

Ask a specific question about this device

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

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

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

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

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

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

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

The AirLife DuoTherm™ Humidification System consists of:

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

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

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

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

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

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

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

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

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

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

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

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

Ask a specific question about this device

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.

Ask a specific question about this device

The Misty Finity is a nebulizer designed for administration of aerosolized drug to the respiratory system. Misty Finity may be used with pediatric (ages 2 years and above) and adult patients. The product is single patient use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician.

The Misty Finity nebulizer is a small volume nebulizer designed to deliver continuous aerosolized drugs to the respiratory system over extended periods of time. The Misty Finity is a single patient use device, and may be used for multiple treatments. The nebulizer is filled with a liquid, typically respiratory medication and connected to the air source via flexible tubing operating between 2 LPM and 4 LPM. The nebulizer is disassembled and reassembled after adding the medication in the bottom (reservoir), and then the device is reassemble in a snap fit. The Misty Finity consists of three components: nebulizer top, one-piece jet, and nebulizer bottom. The Nebulizer is marketed with oxygen tubing and an adult aerosol mask. Both tubing and mask are single-use accessories. The pediatric aerosol mask can be ordered online/from the company website.

The provide text describes a 510(k) premarket notification for the AirLife™ Misty Finity™ Nebulizer. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's diagnostic performance against specific acceptance criteria in the way an AI/ML medical device might.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this document.

However, I can extract the acceptance criteria and performance data related to the device's functional characteristics, as presented in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by compliance with the USP 38 <601> standard for "Products for Nebulization – Characterization Test" and a series of ISO 10993 standards for biocompatibility. The performance data presented are the results of these characterization tests.

2. Sample size used for the test set and the data provenance:
Not applicable. This is a premarket notification for a medical device (nebulizer), not an AI/ML diagnostic device with a "test set" in the traditional sense. The performance data relates to the physical and functional characteristics of the nebulizer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of an AI/ML device, refers to expert labeling or definitive diagnoses. For this nebulizer, "ground truth" would be objective measurements from laboratory testing, not expert consensus on interpretations.

4. Adjudication method for the test set:
Not applicable.

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

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used:
For the Performance Testing (Aerosol Characterization), the ground truth is established by the standardized methods of the USP 38 <601> using specialized laboratory equipment (7-stage Cascade Impaction - NGI) to objectively measure particle size distribution and drug delivery.
For the Biocompatibility Testing, the ground truth is established by standardized laboratory tests adhering to various AAMI/ANSI/ISO 10993 standards, employing validated biological and chemical assays.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device requiring a training set. The performance data is derived from physical and chemical testing of the device itself.

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

Ask a specific question about this device

The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to any patient using a heated humidifier. The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician. The Artofill Humidification Chamber is compatible with the Fisher and Paykel MR850 system.

The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients.

The provided text describes a 510(k) premarket notification for the AirLife Autofill Humidification Chamber, comparing it to a predicate device (MR290 Humidification Chamber). The document focuses on demonstrating substantial equivalence rather than a study with acceptance criteria and a detailed performance evaluation of an AI-powered device.

Therefore, the requested information components related to AI/algorithm performance, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.

The document primarily evaluates the physical and functional characteristics of a medical device (humidification chamber) against recognized standards and a predicate device.

Here's the closest representation of the requested table and related information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly compliance with relevant medical device standards and demonstrating performance comparable to the predicate device. The "acceptance criteria" for each performance characteristic are often defined by the standard itself or by the performance of the predicate device.

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

Not applicable, as this is a physical device and the tests are for its physical and functional characteristics, not an AI algorithm. There is no "test set" in the sense of a dataset for an algorithm. The "tests" refer to laboratory evaluations of the device's physical properties.

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. The "ground truth" for a physical medical device typically refers to engineering specifications, performance standards, and the capabilities of a predicate device, not expert consensus on interpretations of data.

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

Not applicable. This is not a study involving human adjudication of results from an AI algorithm.

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-powered device or a study involving human readers.

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

Not applicable. This is a physical device, not an algorithm.

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

The "ground truth" in this context is based on established medical device standards (e.g., ISO, IEC) and the performance characteristics of a legally marketed predicate device (MR290 Humidification Chamber).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm.

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

Not applicable. This is a physical device, not an AI algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device

The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel MR850 humidifier. The AirLife Infant Heated Wire Circuit is used with pediatic population. specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 vears of age) pediatric subgroups. 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 Infant Heated Wire Circuit is used for flow rates greater than 4 LPM.

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 humidifiers.

This document describes the regulatory submission for the AirLife Infant Heated Wire Circuit, a medical device. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing an AI/ML study. Therefore, some of the requested information regarding AI-specific criteria (like MRMC studies, training set details, expert qualifications for ground truth in AI, etc.) is not applicable to this document.

Here's an analysis based on the provided text:

Device: AirLife Infant Heated Wire Circuit
Intended Use: To deliver and warm breathing gases before they enter the patient's airway, used with a Fisher and Paykel MR850 humidifier for neonatal and infant pediatric populations.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a single table directly comparing acceptance criteria and a single "reported device performance" value for each. Instead, it lists numerous performance tests against established standards. The general acceptance criterion for all these tests is compliance with the specified standard.

Here's a table summarizing the performance characteristics and their corresponding standards, implying that the device met these standards to be considered substantially equivalent. The "Reported Device Performance" column indicates the successful completion of the test in compliance with the standard mentioned.

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

The document does not specify exact sample sizes (e.g., number of circuits tested) for each performance test. It only states that "The following tests were performed for the proposed device to support the substantial equivalence decision." The data provenance is internal testing conducted by the manufacturer to demonstrate compliance with international standards. This is prospective testing against product specifications. There is no mention of country of origin for any data or retrospective analysis as would be relevant for an AI/ML study.

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

This information is not applicable. The "ground truth" for this device is established by objective performance criteria defined in international standards (e.g., ISO, IEC). Performance is measured against these engineering and safety specifications, not against expert human interpretations or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., medical imaging reads). For device performance testing against objective standards, the results are typically determined by measurement and adherence to predefined pass/fail criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic accuracy or clinical utility where human readers are involved, often in the context of AI/ML software. This document describes the safety and performance testing of a physical medical device (heated breathing circuit).

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

This information is not applicable as the device is a physical heated breathing circuit and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is objective, measurable criteria and limits set forth in recognized international standards (e.g., ISO 5367, ISO 8185, IEC 60601-1, ISO 10993 series). This is akin to engineering specifications and regulatory standards. It is not based on expert consensus, pathology, or outcomes data in the manner relevant to an AI/ML diagnostic system.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The device likely underwent design verification and validation testing, which is similar in concept to testing for traditional devices.

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

This information is not applicable as this is not an AI/ML device and therefore has no "training set" or corresponding ground truth establishment in that context. The "ground truth" for its design and manufacturing is based on established engineering principles, material science, and compliance with the aforementioned international performance and safety standards.

Ask a specific question about this device

The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatic population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediative subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a supervision and by skilled clinicians.

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 MR850.

The provided text describes a 510(k) premarket notification for a medical device called the "AirLife Infant Single Limb Heated Wire Circuit." It focuses on demonstrating substantial equivalence to a predicate device. The information required for outlining acceptance criteria and a study proving a device meets them is not fully contained within this document because it is a submission for substantial equivalence, not a detailed clinical study report for a novel device.

However, based on the provided text, I can infer and extract some relevant details pertaining to performance testing and general acceptance principles for this type of device.

Here's an attempt to answer your request using the available information, with clear indications of where information is directly stated versus inferred as typical for a 510(k) submission:

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

The document lists performance characteristics and the relevant standards they were tested against. For a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" are implied to be meeting the requirements set forth in these standards. The "reported device performance" is a general statement of compliance, rather than specific numerical results.

Regarding the study proving the device meets acceptance criteria:

The document broadly states: "The following tests were performed for the proposed device to support the substantial equivalence decision," and "The test results demonstrate that the device is as safe and effective as the predicate and therefore substantially equivalent to the predicate device." This indicates that a series of performance bench tests were conducted to verify compliance with the listed international standards (ISO, IEC, AAMI). These are typically laboratory-based engineering and material tests, not clinical studies involving human subjects in an "AI" context.

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

• Sample Size: Not specified in the provided document. For engineering/bench tests, sample sizes would typically be determined by the specific standard's requirements (e.g., n=3, n=5, n=10 per test), but these details are not present.
• Data Provenance: The tests were performed by the manufacturer, CareFusion Inc., in support of their 510(k) submission to the FDA. The country of origin of the data would be the location where CareFusion conducted these tests, which is not explicitly stated but can be inferred as the US based on the company's US address. The data is retrospective in the sense that the tests were completed before the submission.

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

This is not applicable to this type of device and study. The testing described involves physical and electrical performance verification against defined standards, not evaluation by human experts or clinical ground truth.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed for image interpretation or diagnosis. Bench testing against standards does not typically involve such 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. This device is a heated breathing circuit, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.

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

This is not applicable. This device does not involve any algorithms or AI for standalone performance evaluation.

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

The "ground truth" for this device's performance testing is adherence to the technical specifications and safety requirements outlined in the referenced international standards (e.g., ISO, IEC, AAMI). For biocompatibility, it's the results of specific biological assays. For mechanical and electrical properties, it's measurement against defined limits.

8. The sample size for the training set

This is not applicable. The device is a physical medical device (breathing circuit), not a machine learning model. Therefore, there is no "training set" in the context of an AI/ML algorithm.

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

This is not applicable. As stated above, there is no training set for this device.

Ask a specific question about this device

This device is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing. The patient population includes adults, pediatrics, and infants that are spontaneously breathing. The product is a prescriptive device intended to be used in hospital setting.

Pneumatic jet nebulizer that aerosolizes medication by driving a high pressure gas through the jet stem across the one piece jet immersed in the solution.

The provided text describes the safety and effectiveness summary for the CareFusion AirLife Small Volume Nebulizer (K123527). This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail values. Instead, it presents performance data for "Aerosol Characterization" across various parameters for three common aerosolized medications (Albuterol Sulfate, Budesonide Suspension, and Cromolyn Sodium) at different flow rates. The implied acceptance is that these values demonstrate substantial equivalence to the predicate devices and are suitable for the intended use. The performance data is detailed in the table below:

Study Proving Device Meets Criteria:

The study demonstrating the device meets the criteria is a "Performance Test Summary" presented in the document, specifically focusing on Biocompatibility, Simulated Life-Time, and Aerosol Characterization.

• Biocompatibility: Performed according to ISO 10993-1. "Cytotoxicity, Sensitization and Irritation studies were concluded with satisfactory results."
• Simulated Life-Time: "No performance degradation was observed for at least 50 treatments."
• Aerosol Characterization: This was the primary performance test, using a Cascade Impactor (NGI) per USP 34 <1601> chilled to 5 °C with an extraction flow of 15 lpm for three common aerosolized medications. The results are detailed in the table above and described as showing the device "meets all performance requirements, and is substantially equivalent to the predicate devices."

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

• Sample Size: The document does not explicitly state the sample size (number of nebulizers tested) for the aerosol characterization or simulated lifetime tests. The values provided are "Mean and 95% confidence interval of the mean," which implies multiple measurements were taken, but the exact N is not given.
• Data Provenance: The document does not specify the country of origin of the data. The tests are non-clinical (laboratory-based) and are likely performed in-house or by a contracted lab. The study is prospective in the sense that the tests were conducted specifically for this submission to assess the device's performance.

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

This information is not applicable for this type of device and study. The "ground truth" for the performance tests (biocompatibility, simulated lifetime, aerosol characterization) is based on established scientific methods, standards (e.g., ISO 10993-1, USP 34 <1601>), and laboratory measurements, not on expert consensus from medical professionals.

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

This information is not applicable as the study did not involve human interpretation or adjudication of results in the traditional sense of clinical studies. Performance metrics were derived from physical measurements.

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:

No. This was a non-clinical performance study of a medical device (nebulizer), not an AI diagnostic or assistive device. Therefore, no MRMC study, human reader improvement, or AI assistance was involved.

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

Yes, in essence. The performance tests conducted (biocompatibility, simulated lifetime, aerosol characterization) are standalone evaluations of the device's physical and functional properties, independent of human interaction or interpretation beyond performing the tests according to established protocols. There is no "algorithm" in the sense of AI here, but the device's performance was assessed directly.

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

The "ground truth" for this device's performance testing is based on objective physical measurements and adherence to recognized standards and protocols. For example:

• Biocompatibility: Conformance to ISO 10993-1.
• Aerosol Characterization: Data obtained using a Cascade Impactor (NGI) per USP 34 <1601>, which is a direct measurement method for particle size distribution and drug delivery.

8. The sample size for the training set:

Not applicable. This study does not involve a "training set" as it is not a machine learning or AI model development. It's a physical device being evaluated for performance against established standards.

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

Not applicable for the same reason as point 8.

Ask a specific question about this device

The Nebulizer cap is for use with Sterile Water or Saline for Inhalation, USP in 500 ml, 1000 ml, and 1500 ml bottles for inhalation therapy only.

A nebulizer cap deliver an aerosol of oxygen, air, and either water or saline. It consists of a dry device attached to a bottle of sterile solution. In use, the device attaches to a 50 psi source of oxygen. which is regulated by a flow meter. An air entrainment dial regulates airflow to adjust for desired oxygen concentration. The outlet port attaches to 22 mm corrugated tubing, which acts as a conduit for the aerosol to the patient.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Cardinal Health Airlife Nebulizer Cap:

Based on the provided document, the "acceptance criteria" and "study" are not presented in a typical format of a clinical trial or algorithm performance study. Instead, the document details a 510(k) premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device.

The "acceptance criteria" for a 510(k) submission are fundamentally based on demonstrating substantial equivalence, meaning the new device is as safe and effective as a predicate device. The "study" described is a non-clinical testing summary designed to prove this substantial equivalence.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "materials" and "the proposed device" being tested, implying that samples of the device and its components were subjected to various tests. It's not a human-subject study, so there's no "test set" in the sense of patient data.
• Data Provenance: The testing was carried out by the manufacturer, Cardinal Health, likely at their facilities or certified labs. No country of origin for specific "data" is mentioned, as it's not a study with diverse patient populations. This is retrospective in the sense that the testing was performed on the device components/product to satisfy regulatory requirements before marketing.

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

• This is not applicable as there is no "ground truth" in the context of expert consensus on medical images or diagnoses. The "ground truth" for this type of device (a nebulizer cap) is its adherence to material safety standards, functional specifications, and established engineering principles, which are verified through objective non-clinical tests rather than expert interpretation of a clinical outcome.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of expert opinions or clinical outcomes. The "adjudication" is essentially the regulatory body (FDA) reviewing the test results presented by the manufacturer to determine substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

• Not applicable. This is a physical medical device (nebulizer cap), not an AI algorithm or diagnostic tool that would involve human readers or AI assistance.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" here is based on accepted industry standards and regulatory requirements for medical device materials (e.g., ISO 10993 Part-1 for biocompatibility) and functional performance metrics. The predicate device's established safety and effectiveness also serve as a 'ground truth' benchmark for the substantial equivalence claim.

8. The Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for a physical medical device undergoing non-clinical testing for 510(k) submission.

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

• Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device. The "study" described is a series of non-clinical tests (biocompatibility, performance testing) to demonstrate substantial equivalence to a predicate device. The "acceptance criteria" are derived from the requirements for substantial equivalence, focusing on identical intended use, performance attributes, and similar technological characteristics, backed by evidence of material safety and functional equivalency. It does not involve AI, human readers, or clinical trials with ground truth established by experts or pathology in the way a diagnostic algorithm would.

Ask a specific question about this device