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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.

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LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.

TheLTV2 Series Ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following types of ventilatory support:

• . Positive Pressure Ventilation, delivered invasively or non-invasively (via mask).
• . Assist/Control, SIMV, CPAP, and NPPV modes of ventilation.
  The ventilator is suitable for use in professional healthcare facilities, including during intrahospital transport.

The LTV2 Series ventilator supports adult and pediatric patients weighing at least 10 kg (22 lb) in professional healthcare facilities response with invasive or noninvasive ventilation presets. These settings can be easily refined using the touch-turn-touch interface on the LED display. The ventilator also provides a wide range of ventilation therapies to meet demanding patient needs, including volume control, pressure control, pressure support and spontaneous breath types. Combined with the spontaneous breathing trial function, the ultra-sensitive flow trigger facilitates weaning patients weighing at least 10 kg (22lb).

The provided document is an FDA 510(k) premarket notification for the LTV2 Series Ventilators. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a study with a test set, expert ground truth, and statistical analysis as would be done for a novel AI/ML device.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for performance metrics (like sensitivity, specificity, F1 score), sample sizes for test and training sets, expert adjudication, MRMC studies, and ground truth establishment is not present in this document because it's not relevant to a 510(k) submission for a non-AI/ML medical device like a ventilator.

The document describes the device's technical specifications and compares them to predicate devices, along with listing applicable performance standards and verification testing (e.g., waveform, alarms, endurance). The conclusion explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject, predicate and reference devices, no clinical studies were deemed to needed to support this submission."

To address your request, I will explain why your specific questions are not applicable to this document and provide the information that is available.

Reasoning for Inapplicability of AI/ML-focused Questions:

The LTV2 Series Ventilator is a mechanical device, not an AI/ML diagnostic or prognostic tool. Therefore, the regulatory pathway (510(k)) and the evidence required to demonstrate safety and effectiveness for this type of device differ significantly from what would be expected for an AI/ML device.

• Acceptance Criteria & Reported Performance (Table A): For a mechanical device, performance is evaluated against engineering specifications, industry standards (e.g., IEC 60601 series, ISO 80601-2-12 for ventilators), and comparison with predicate devices. There isn't a "test set" in the sense of a dataset of medical images or patient records, or metrics like sensitivity/specificity for a diagnosis. Performance is about meeting physical parameters (e.g., tidal volume range, breath rate range, pressure control range, alarm specifications, electrical safety).
• Sample Sizes, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth (Questions 2-7): These questions are highly specific to the validation of AI/ML algorithms, particularly in medical imaging or diagnostic contexts. They relate to how a model's output is compared against a clinical "truth" established by human experts or other definitive sources. For a ventilator, "performance" is demonstrated through non-clinical testing (e.g., mechanical testing, software V&V, endurance testing) confirming it adheres to its design specifications and relevant safety/performance standards.
• Training Set & Ground Truth Establishment (Questions 8-9): These apply to the development and training of machine learning models. A mechanical ventilator does not have "training data" in this sense. Its design and functionality are based on engineering principles and verified through physical testing.

Information Available from the Document (Addressing Relevant Aspects):

The document demonstrates the device's safety and effectiveness by showing substantial equivalence to existing predicate devices and compliance with recognized performance standards.

1. Table of "Acceptance Criteria" (derived from technical specifications and standards) and "Reported Device Performance" (implied by meeting standards and equivalence to predicates):

For a mechanical ventilator, "acceptance criteria" are typically defined by engineering specifications and compliance with relevant international standards. "Reported device performance" is confirmed through design verification and validation testing, ensuring these specifications and standards are met. The document states:

"Successful test results (electrical safety testing, mechanical testing, software V&V, and waveform verification tests) ensured the proposed ventilator does not raise any different questions of safety and effectiveness."

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

• Not Applicable in the AI/ML sense. For this mechanical device, performance is evaluated through design verification and validation testing, and compliance with standards. There is no "test set" of patient data or images. Performance is based on physical property testing, software validation, and electrical safety testing.
• The data provenance for such tests are typically in-house lab reports and compliance certificates from testing bodies, not clinical data from specific countries or retrospective/prospective studies.

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

• Not Applicable. "Ground truth" established by experts is a concept for AI/ML diagnostic or prognostic devices. For a ventilator, the "truth" is whether the device meets its engineered specifications and performs reliably according to intended use and recognized standards. This is assessed by engineers, quality control personnel, and regulatory specialists.

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

• Not Applicable. Adjudication methods are used in studies involving human interpretation or labeling of data, typically for AI/ML validation. This is a mechanical device.

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

• Not Applicable. MRMC studies are for evaluating the impact of AI assistance on human performance in diagnostic tasks. This is a mechanical ventilator.

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

• Not Applicable. This refers to the performance of an AI algorithm on its own. While the ventilator has internal algorithms for control, its "performance" is inherently tied to its mechanical function, and its safety/effectiveness is not evaluated as a standalone AI system.

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

• Not Applicable in the AI/ML sense. The "ground truth" for a mechanical ventilator's performance is its adherence to its design specifications, established engineering principles, and compliance with international performance and safety standards for ventilators. This is verified through objective measurements, calibrations, and stress tests.

8. The sample size for the training set:

• Not Applicable. A mechanical ventilator does not have a "training set" in the context of machine learning.

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

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

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The Multi-Link X2 ECG Cable and Leadwire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables) are reusable, nonsterile and can be reprocessed.

The Multi-Link™ X2 ECG Cable and Leadwire System is a product portfolio that is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes. The system consists of Reusable Trunk Cables (K980582, K101660, K162432), Reusable Leadwires (K980582) and Disposable Single Patient Use Leadwires (K101660, K162432). The existing portfolio is compatible with the following ECG monitoring platforms: Philips, Mindray, Nihon Kohden, GE, and Spacelabs. The subject device of this pre-market notification consists of a modified set of Reusable Trunk Cables that are designed to be compatible with the following cardiac defibrillation systems: Physio Control Lifepak, Zoll R, and Zoll X monitoring platforms. The subject device is used to transmit signals from patient electrodes and sensors to support continuous ECG monitoring only. The subject device does not interpret or deliver the shock applied when the defibrillators are in use.

The provided text describes a 510(k) premarket notification for the "Multi-Link X2 ECG Cable and Leadwire System." This submission is to introduce a modified set of reusable trunk cables to expand system compatibility with additional FDA-cleared ECG monitoring platforms. The document outlines the device's intended use, indications for use, and a comparison to a predicate device (K162432).

Crucially, this document is for a medical device that transmits ECG signals from electrodes to monitors, i.e., it's a cable system. It is not an AI/algorithm-based diagnostic device. Therefore, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/algorithm performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies) are not applicable to this submission.

Instead, the acceptance criteria for this device are related to its electrical and mechanical performance, and its ability to properly and safely transmit signals without interference or degradation. The "study" proving it meets these criteria is a series of non-clinical performance tests against established industry standards.

Here's how to interpret the information provided in the context of the requested questions, noting where the requested information is not applicable:

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

For a cable system, acceptance criteria are typically defined by performance standards. The reported performance is "Pass" for all tests, indicating it met the criteria defined by the applicable standards.

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: Not explicitly stated in terms of number of cables tested, but the tests were performed on representative samples to demonstrate compliance with standards. For physical devices, sample sizes are typically determined by statistical methods or engineering judgment to ensure sufficient confidence in product safety and performance.
• Data Provenance: The testing is non-clinical performance testing of the device itself (a cable system), not data from patient studies. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply. The tests were performed in a lab setting to relevant international and national standards.

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 is a hardware device (cable system) for signal transmission, not an AI/algorithm. "Ground truth" in the context of expert review of images or data is not relevant here. The ground truth for cable performance is defined by the technical specifications and standards (e.g., voltage, resistance, signal integrity, mechanical strength).

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

• Not Applicable. As explained above, this device does not involve human interpretation or subjective assessment of data for "ground truth" adjudication. The tests involve objective quantitative measurements against defined thresholds in relevant 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. MRMC studies are used to evaluate diagnostic accuracy and reader performance of AI systems.

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

• Not Applicable. This is a physical cable system, not an algorithm.

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

• The "ground truth" for this device's performance is established by international and national engineering and medical device standards (e.g., ANSI AAMI IEC 60601 series, ANSI AAMI EC53, IEC 60068 series, IEC 60529). These standards define the acceptable performance characteristics for ECG cables, including electrical properties, mechanical durability, and safety features like defibrillation protection. The device's performance is measured against the thresholds and methodologies specified in these standards.

8. The sample size for the training set

• Not Applicable. This device does not use a "training set" as it is not an AI/machine learning algorithm.

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

• Not Applicable. As above, no training set is used.

In summary, the document details the non-clinical performance testing of an ECG cable and leadwire system to demonstrate its substantial equivalence to a predicate device. The "acceptance criteria" are embodied by the various ANSI, AAMI, and IEC standards listed, and the "study" proving compliance is a series of laboratory tests where the device passed all criteria. The questions related to AI/algorithm development, such as "expert ground truth," "MRMC studies," and "training/test sets," are not relevant to this specific medical device submission.

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The Multi-Link™ X2 ECG Adapters and Leadwires are used to transmit ECG signals from the electrodes to ECG monitors for monitoring purposes. The Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link Direct-Connect Leadwires are single-patient-use, nonsterile and cannot be reprocessed. The Multi-Link X2 ECG Adapters and Direct Connect Leadwire System are used with any patient population requiring ECG monitoring.

The Multi-Link™ X2 ECG Cable, Adapter and Direct Connect Leadwires is an FDA cleared accessory portfolio. The cleared device portfolio consists of adapters & leadwires (reusable adapters and direct connect disposable single patient use leadwires, K163316), and (leadwires reusable, and disposable single patient use, K162432). The cleared portfolio is compatible multiple FDA cleared ECG monitoring platforms, such as Philips, Mindray, Nihon Kohden, GE and Spacelabs. This pre-market notification is to expand the portfolio to be used with additional FDA cleared ECG monitoring platforms.

The Subject device, Multi-Link ™ X2 ECG ADAPTER AND LEADWIRES consists of reusable adapters and direct connect single patient use leadwires that connect to FDA cleared Dräger Infinity (R) monitoring platforms. Design modifications are made to allow for connections with specific additional platforms to allow patients to move throughout the facility without the hassle of disconnecting and reconnecting leadwires.

The system is used to transmit signals from patient ECG electrodes to monitoring equipment, providing patients with continuous ECG (electrocardiogram) monitorina.

This device is common to both industry and medical establishments. The Multi-Link™ X2 ECG ADAPTER AND LEADWIRES is not a stand-alone device but is used with the host monitoring device and functions as conductors on the system to carry the electrical signals.

The provided document is a 510(k) summary for Vyaire Medical's Multi-Link X2 ECG Adapter and Leadwires. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets a set of acceptance criteria through a clinical study.

Therefore, this document does not contain the information requested about acceptance criteria and a study proving the device meets them. It details non-clinical performance testing against established standards for medical electrical equipment and ECG cables, but it does not describe a study to establish performance metrics against acceptance criteria as typically defined for an AI/ML-driven device or a diagnostic accuracy study.

Specifically, the document states:

• "No clinical studies were deemed needed to support this submission." This explicitly indicates that a study demonstrating device performance against clinical acceptance criteria was not conducted or required for this 510(k) clearance.
• The performance data section (Section 7.0, 7.1, 7.3) lists compliance with various safety and electrical standards (e.g., AAMI ANSI ES 60601-1, AAMI ANSI IEC 60601-2-27, AAMI ANSI EC53). These are general safety and performance requirements for the device type, not specific diagnostic performance metrics (like accuracy, sensitivity, specificity) for a particular medical condition.
• The device's function is to transmit ECG signals, not to interpret them or provide a diagnosis. This means the performance metrics would revolve around signal integrity and electrical safety, which are covered by the listed standards, rather than diagnostic accuracy.

Given this, I cannot extract the requested information as it is not present in the provided text.

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The Multi-Link™ X2 ECG Adapter and Lead Wire System are used in telemetry to transmit ECG and/or SpO2-signals from the electrodes and sensors to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Adapters are reusable, nonsterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Lead Wire System are used with any patient population requiring ambulatory monitoring, and are compatible with the Philips MX40 electrocardiograph monitor.

The Multi-Link™ X2 ECG AND SpO2 ADAPTERS is a reusable telemetry Adapter that connects the Philips IntelliVue MX40 (cleared under telemetry transmitter K172226), on one end to Vyaire-owned lead wires (cleared under K980582 and K101660) and market available SpO2 sensors (cleared under K172226 and K111888) on the other end. The Adapter functions to transmit signals from patient ECG electrodes and SpO2 sensors to ambulatory monitoring equipment, providing ambulatory patients with continuous ECG (electrocardiogram) and SpO2 (blood oxygen saturation) monitoring.

This device is common to both industry and medical establishments. The Multi-Link X2 ECG and SpO2 Adapter is not a stand-alone device but is used with the host monitoring device and functions as conductors on the system to carry the electrical signals.

This looks like a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria for aspects like diagnostic accuracy.

Based on the provided document, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance characteristics and standards to which the device was tested, with all tests reported as "Pass." This indicates that the device met the requirements of these standards, which serve as the acceptance criteria for the safety and essential performance of such medical electrical equipment.

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

The document does not specify the sample size (number of units or test cycles) used for each test. The tests are general performance and safety tests for a medical device adapter, not clinical studies involving patient data. Therefore, concepts like data provenance (country of origin, retrospective/prospective) are not applicable in this context.

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

This information is not applicable. The device is a cable/adapter for transmitting ECG and SpO2 signals. The "ground truth" for the test set is established by recognized engineering and medical standards (e.g., AAMI, IEC, ISO) for electrical safety, performance durability, and compatibility. It does not involve expert interpretation of medical images or data that would require a panel of clinical experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are technical compliance tests against engineering standards, not diagnostic assessments requiring human adjudication.

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

No. This type of study assesses the impact of AI on diagnostic accuracy or reader performance in clinical scenarios, often involving interpretation of medical images. The Multi-Link X2 ECG and SpO2 Adapter is a signal transmission device, not an AI-powered diagnostic tool, so an MRMC study is not relevant or included in this submission.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The device is a hardware component (adapter/cable), not an algorithm or AI system. Its function is to transmit signals, which is assessed through technical performance tests.

7. Type of Ground Truth Used

The "ground truth" for the performance tests in this submission is the established technical specifications and performance requirements outlined in the referenced international and national standards (AAMI, ANSI, IEC, ISO). Compliance with these standards indicates the device meets the accepted safety and performance criteria for its intended function.

8. Sample Size for the Training Set

Not applicable. This device is a hardware accessory and does not involve AI or machine learning, therefore, there is no "training set."

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

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

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The Vyntus BODY is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for future reference or report generation purposes.

The products can be utilized with patients aged 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists.

Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).

A qualified physician has to reassess all Vyntus BODY measurements. An interpretation by SentrySuite is only significant if it is considered in connection with other clinical findings.

The Vyntus BODY is a whole-bodyplethysmograph and consists of the Vyntus BODY cabin, an ultrasonic flow sensor (USS), and a shutter. The Vyntus BODY system allows the determination of a subjects' pulmonary function status. It includes the determination of the subjects' ventilatory flows and volume by means of the USS. The measurement of the lung diffusion by the DLCO technique is accomplished with the supply of test gas and the gas analyzers for methane (CH4) and carbone monoxide (CO).

All variants are stationary and not battery operated. The sensor data is sent to a host computer system via cable connection for processing, storage, and reporting. The host computer can be networked via LAN, WLAN, or Internet.

All measurements are performed with the use of the Windows based operating software SentrySuite (SeS). The SeS software also stores the measurement results and provides output capabilities.

The host computer, monitor, and printer are mounted on the Vyntus Cart. Use of the cart is optional; computing equipment may be placed on other furniture.

The provided text is a 510(k) summary for the Vyntus BODY, a pulmonary-function data calculator. It outlines the device's characteristics, its comparison to predicate devices, and the performance data submitted to support its substantial equivalence. However, it does not contain a detailed study report that proves the device meets specific acceptance criteria with reported device performance metrics and specific sample sizes for test sets.

The document focuses on demonstrating substantial equivalence to predicate devices, rather than an independent performance study against predefined criteria.

Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not explicitly provided in this document.

Here's what can be extracted and what is missing:

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

The document mentions "Accuracy testing" as one of the performance data provided. In the "Patient User Interface Specifications" table (Page 7-8), it lists performance specifications for flow and volume accuracy which can be considered acceptance criteria. However, it does not explicitly provide the reported device performance against these criteria in a clear table format. The table below presents the acceptance criteria as listed:

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

• Sample size for the test set: Not mentioned.
• Data provenance: Not mentioned. The document primarily refers to "Accuracy testing" as a type of performance data provided, but without details on the studies or datasets used for this testing.

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

This information is not provided. The device is a "Pulmonary-function data calculator," suggesting that its accuracy would likely be evaluated against established physiological measurement standards, not necessarily against expert human interpretation in the same way an AI diagnostic imaging tool would be.

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

Not applicable or not mentioned. The device's primary function is to measure and calculate lung function parameters; its performance would likely be validated against metrological standards or established calibration methods, rather than through an adjudication process of expert interpretations.

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

Not applicable. The Vyntus BODY is a pulmonary function data calculator, not an AI-assisted diagnostic tool that aids human readers in interpreting complex medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function or validation.

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

The device itself is a standalone system for measurements, data collection, and analysis. It is designed to perform these functions "without human-in-the-loop performance" in terms of its direct measurement and calculation capabilities. The document states, "A qualified physician has to reassess all Vyntus BODY measurements. An interpretation by SentrySuite is only significant if it is considered in connection with other clinical findings." This indicates that while the device performs its analytical function standalone, ultimate clinical interpretation requires a physician.

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

The "Accuracy testing" mentioned would typically use calibrated instruments or known physical standards as ground truth for flow and volume measurements. The document references "ATS/ERS Task Force: Standardization of Lung Function Testing," implying that the device's performance is likely measured against these established international standards for pulmonary function testing.

8. The sample size for the training set:

Not applicable or not mentioned. The device appears to be a measurement and calculation system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on known physiological principles and instrumentation, likely calibrated against standard references.

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

Not applicable, as there's no indication of a "training set" for an AI/ML algorithm.

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The Vyntus ONE / SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test results can be saved for future reference or report generation purposes.

The products can be utilized with patients aged 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists.

Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).

A qualified physician has to reassess all Vyntus / SentrySuite measurements. An interpretation by Vyntus ONE / SentrySuite is only significant if it is considered in connection with other clinical findings. Additional for Vyntus ECG:

The Vyntus ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-lead ECGs are analyzed automatically and suggestions for the interpretation of the resting ECG can be made by the software.

ECG interpretation statements made by the Vyntus / SentrySuite represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.

The Vyntus ECG can be used for non-interpretive applications in patients age 4 years and older and a weight of 20 kg or higher. The Vyntus ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital). The Vyntus ECG is not intended for intracranial use. The Vyntus ECG is not intended for use in an EMS environment (Emergency Medical Services Environment). The Vyntus ECG is not intended for use in home healthcare environments. Automatic interpretation of the ECG is not possible for pediatric and adolescent patients below 16 years of age and for patients with pacemakers.

The Vyntus ONE is a full pulmonary function test (PFT) system, consisting of a main unit with the gas analyzers and electronics inside, a patient interface with a Flow Path Valve eDemand and an electronic demand valve inside and an ultrasound flow sensor (USS). The entire equipment is mounted on a cart which includes the isolation transformer and the support arm for the patient interface and the USS.

The Vyntus ONE is connected via USB interface to the desktop PC and enables the following standard measurements:

• Diffusion SB Realtime
• Diffusion SB Intra-breath
• FRC N2 washout
• Slow/forced spirometry and MVV

The Vyntus ONE also supports cardiopulmonary exercise testing (CPET). The specific hardware consists of the light-weight digital volume transducer (DVT) and an optional SpO2 pulse oximeter. It enables the following standard measurement features:

• Breath-by-breath (BxB) gas exchange
• Workload control for bicycle ergometer or treadmills
• Automatic workload protocols

Further optional hardware and software include:

• Vyntus ECG: 12-lead Electrocardiogram (ECG) recording (resting and stress ECG)
• ROcc, P0.1, MIP / MEP measurements

The Vyntus ONE device, a full pulmonary function test (PFT) system, was evaluated through non-clinical tests to determine its substantial equivalence to predicate devices. No clinical tests were performed.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the numerical sample size for the test set used in the non-clinical studies. However, the study involved various technical tests (risk management, usability, software life cycle, basic safety, EMC, biocompatibility, accuracy, climatic, and ATS/ERS standards).
The data provenance is not explicitly stated as retrospective or prospective, but given the nature of the testing (device performance, safety, and function tests against standards), it would typically be prospective testing conducted as part of the device development and validation process. The manufacturer is Vyaire Medical, Inc. based in Germany, implying the tests were conducted or overseen by German entities.

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

This information is not provided within the document. The ground truth for these non-clinical tests would typically be established by comparing the device's performance against recognized international standards (e.g., ISO, IEC, ATS/ERS). Therefore, the "experts" would be the technical committees and bodies responsible for defining these standards.

4. Adjudication method for the test set:

This information is not explicitly mentioned. For non-clinical validation studies against international performance standards, adjudication often involves documented verification and validation processes by the manufacturer and third-party testing labs, where results are compared against predefined criteria set by the standards.

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

No MRMC comparative effectiveness study was conducted or mentioned in this document. The device is a "Pulmonary-Function Data Calculator" and "Electrocardiograph," which perform measurements and analysis of lung function and ECGs, but there is no indication of AI assistance to human readers or interpretation within the scope of this submission. The device's ECG interpretation statements are explicitly mentioned as "partial qualitative information" and "no therapy or drugs can be administered based solely on the interpretation statements," implying human oversight is always required.

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

Yes, a standalone performance evaluation was done for the device. The non-clinical tests assess the device's functional performance, safety, and accuracy (e.g., flow, volume, and ECG measurements) independently against established technical standards, without human interpretation in the loop influencing the measurement accuracy itself. The device is intended for use by trained healthcare professionals under the direction of a physician, who then reassesses the measurements.

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

The ground truth for the non-clinical tests used for the Vyntus ONE device is based on established international and national standards and specifications. This includes:

• ISO 14971 (Risk Management)
• EN 62366 / IEC 60601-1-6 (Usability)
• ISO 62304 (Software Life Cycle)
• IEC 60601-1 (Basic Safety)
• IEC 60601-2 (EMC Compatibility)
• ISO 10993 (Biocompatibility)
• ATS/ERS Standardisation of Lung Function Testing

The performance characteristics (e.g., flow and volume accuracy/range/resolution) are also compared against the specifications defined by these standards, particularly the ATS/ERS standard.

8. The sample size for the training set:

This information is not applicable and not provided. The Vyntus ONE device is a medical device for measuring and analyzing physiological parameters, not an AI or machine learning model that requires a "training set" in the traditional sense for learning. Its functionality is based on established engineering principles and algorithms, validated against physical measurements and known standards.

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

This information is not applicable. As explained above, the device does not use a "training set" in the context of machine learning. Its internal algorithms and logic are developed and verified against known physical laws and validated measurement techniques, with performance assessed against established medical and engineering standards.

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The Vital Signs Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor. These gas sampling lines are used with GE Healthcare Compact Airway modules and CARESCAPE Respiratory modules for monitoring CO2, O2, N2O and anesthetic agents and with E-miniC for monitoring CO2.

Vital Signs Gas Sampling Lines consists of a disposable single patient use coextruded gas sampling line that is compatible with GE Healthcare Compact Airway, E-MiniC and CARESCAPE Respiratory Modules and are provided in four different lengths: 2 meters, 2.5 meters, 3 meters and 6 meters. The disposable single patient use gas sampling lines are smooth narrow diameter tubes that have standardized male luer connectors at both ends. The gas sampling line connects from a port in the breathing circuit to an expired gas monitor. The gas sampling line provides a conduit for drawing gas samples from the breathing circuit port to the gas monitor to analyze respiratory gases. These disposable single patient use gas sampling lines are used to transmit one directional flow of gas sample from the patient breathing circuit port to the gas module host device. A vacuum source and gas measurement sensors are located in the host device, which pull the gas from the breathing circuit port to the host device for gas monitoring. The gas sampling lines are accessories to the gas monitoring devices.

The provided text is a 510(k) summary for Vyaire Medical's Vital Signs™ Gas Sampling Lines. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It does not describe a study involving a medical device that uses artificial intelligence (AI) or machine learning (ML) or a multi-reader multi-case (MRMC) study. The document focuses on the physical and performance characteristics of a gas sampling line, which is a passive medical device.

Therefore, I cannot extract the information required by your prompt, such as:

1. A table of acceptance criteria and reported device performance related to AI/ML.
2. Sample size used for the test set and data provenance for an AI/ML model.
3. Number of experts used to establish ground truth for an AI/ML model.
4. Adjudication method for an AI/ML model.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance of an AI/ML algorithm.
7. Type of ground truth for an AI/ML model.
8. Sample size for the training set of an AI/ML model.
9. How ground truth for the training set of an AI/ML model was established.

The document details engineering performance tests (e.g., gauge test, separation force, leakage test, flow resistance test, biocompatibility) to show that the gas sampling lines meet specific technical standards (e.g., ISO 594-2, ISO 80601-2-55, ISO 10993 series). The "Acceptance Criteria" in the document refer to these engineering specifications, not to the performance of an AI/ML algorithm.

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