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VentStar Resus heated (N) (MP17030): VentStar Resus heated (N) with manual PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source (resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient.

The product allows short-term ventilation with humidified breathing gas and additional PEEP.

It can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port.

The product is suitable for patients with a maximum body weight of 10 kg (22 lb).

VentStar Autobreath heated (N) (MP17031): VentStar AutoBreath heated (N) with automatic PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient.

The product allows automatic short-term ventilation with humidified breathing gas and additional PEEP.

The valve is controlled via the AutoBreath function of the resuscitation module. The product can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port.

The product is suitable for patients with a maximum body weight of 10 kg (22 lb).

The subject devices, VentStar Autobreath heated (N) (MP17031) and VentStar Resus heated (N) (MP17030), are two heated disposable single limp breathing circuits with humidifier chamber for connection to the humidifier MR850 by Fisher and Paykel (K073706), for neonatal patients with a maximum body weight of 10 kg for use with the Dräger BabyRoo TN300 (K230278) and Dräger Resuscitaire (K120642).

The VentStar Resus heated (N) MP17030 is equipped with a manual PEEP valve which enables the setting of a PEEP by the operator directly. The operator can control the inhalation and exhalation.

The VentStar Autobreath heated (N) MP17031 is equipped with an automatic PEEP valve. With the Autobreath function a respiratory rate can be adjusted on the resuscitation module and a machine controlled consistent inspiration rate can be applied to the patient.

The heated breathing circuits are intended for conveying breathing gases (air and/or oxygen) from a breathing gas source (resuscitation module) to the humidifier chamber and finally to the patient.

Both breathing circuits are designed for a flow range from 5 to 15 L/min.

The heating of the hoses is done by using electrical heating wires inside the wall of the hoses. These wires have specific electrical resistances to generate a specific heating power. The heating plate of the humidifier chamber is positioned at the heater of the humidifier.

The provided FDA 510(k) Clearance Letter for the VentStar Resus and Autobreath Heated Devices (K242769) outlines the regulatory approval process for these medical devices. However, it does not contain information related to software, artificial intelligence (AI), diagnostic studies, or the acceptance criteria for such studies.

The document pertains to the physical characteristics, safety, and functionality of heated disposable breathing circuits for neonatal ventilation. The performance data section refers to non-clinical testing covering mechanical, thermal safety, environmental conditions, electrical safety, electromagnetic compatibility, functional verification, and performance capacity and accuracy, all conducted against established medical device standards.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance related to AI, ground truth, expert consensus, sample sizes for training/test sets, or MRMC studies, as none of this information is present in the provided text.

The information primarily focuses on:

• Device Description: Heated disposable breathing circuits for neonatal patients.
• Intended Use: Conveying humidified breathing gas from a resuscitation module to a patient.
• Comparison to Predicate Devices: Demonstrating substantial equivalence based on physical and functional characteristics.
• Performance Data: References to compliance with various ISO and IEC standards for electrical safety, EMC, functional performance, and biocompatibility.

**To directly answer your numbered points based solely on the provided document: **

1. A table of acceptance criteria and the reported device performance: Not provided in the document in the context of diagnostic performance or AI. The performance section mentions compliance with various standards (e.g., IEC 60601-1, ISO 5367), implying that the acceptance criteria are adherence to these established engineering and safety standards, rather than diagnostic accuracy metrics.
2. Sample sizes used for the test set and the data provenance: Not applicable or not provided. The testing discussed is non-clinical (mechanical, electrical, etc.), not a data-driven diagnostic study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI models (e.g., expert reads of medical images) is not relevant to the described device testing.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in diagnostic tasks. The device is a breathing circuit, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no mention of an algorithm or AI.
7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. Ground truth for this device would be defined by engineering specifications and physical measurements (e.g., resistance levels, heating efficiency, material composition).
8. The sample size for the training set: Not applicable, as there is no AI/machine learning component mentioned.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (breathing circuits) and its compliance with safety and performance standards for hardware, not a software/AI driven diagnostic tool. Therefore, the questions related to AI performance, ground truth establishment, and clinical study methodologies are not addressed by the provided text.

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Oxymag is a controlled volume, pressure and time cycled emergency and transport ventilator. It is intended for use with infant, child, and adult patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require the ventilatory support.

It is intended for pre-hospital and hospital use including intra-hospital, inter-hospital and transport settings.

Oxymag provides a mixture of ambient air and oxygen at concentrations adjusted by the operator using the accurate oxygen concentration system using the venturi principle. O2 concentration is obtained through a galvanic cell by passing gas through the sensor. In addition, it performs the control of flows and pressures in the respiratory circuit to provide the ventilation modalities appropriate to the patient's condition.

The associated accessories include:

• Power outlet 12V/3,34A
• AC cable
• Disposable respiratory circuit
• 02 extension
• Environment filters

The provided document is a 510(k) summary for the Oxymag - Transport and Emergency Ventilator. It focuses on demonstrating substantial equivalence to a predicate device (O-two e700, K141595) rather than establishing novel performance acceptance criteria or conducting a comprehensive study to prove these criteria.

Therefore, the document does not contain the specific information requested in most of your numbered points, as it's not a study designed to establish and prove acceptance criteria for a new device's performance in a clinical setting with human subjects. Instead, it describes bench testing, software verification, electrical safety, and biocompatibility to confirm the device operates as intended and is comparable to an already cleared device.

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

Acceptance Criteria and Device Performance (Based on Comparison to Predicate):

The submission demonstrates substantial equivalence by comparing the Oxymag's parameters and features to those of the predicate device, e700. The "acceptance criteria" are implicitly that the Oxymag's performance is equivalent or does not raise new safety or effectiveness concerns compared to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary, formal "acceptance criteria" for a study are not explicitly stated in the way one might find in a clinical trial protocol. Instead, the performance is demonstrated by comparison with a predicate device and through various forms of engineering and non-clinical testing.

The provided "Table 1. Comparison table between the subject and predicate devices" serves as the primary evidence for this. Instead of a 'reported device performance' against a strict new acceptance criterion, it shows 'equivalence' or 'similarity' to the predicate.

Regarding the Study (Performance Data provided for Substantial Equivalence):

The document explicitly states: "There were no animal or clinical studies done for the subject device." This means that most of the specific questions about sample sizes, human experts, adjudication, and MRMC studies are not applicable to the data presented for this 510(k) submission.

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

• Sample Size: Not applicable. No human test subjects were used. Performance data was derived from bench testing.
• Data Provenance: Not applicable for human data. Bench testing was performed on the device itself.

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

• Not applicable. No human test set requiring expert ground truth was used.

4. Adjudication method for the test set:

• Not applicable. No human test set was used for adjudication.

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

• Not applicable. No MRMC study was done, as this is a ventilator and not an AI-assisted diagnostic device, and no human studies were conducted.

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

• Not applicable in the context of an algorithm's diagnostic performance. However, "Performance testing was conducted on the Oxymag to determine its specifications regarding ventilatory parameters" and "verification of technical data, comparison between Oxymag and the predicate e700, human factors evaluation, validation of ventilatory modes, alarm system, monitored parameters, auto test, hardware and mechanical specifications" serve as standalone device performance evaluations in a non-clinical setting.

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

• For Biocompatibility: International standard ISO 10993-1 and FDA Guidance as recognized by FDA.
• For Electrical Safety and EMC: IEC 60601-1, IEC 60601-1-8, IEC 60601-1-12, IEC 80601-2-12, IEC 80601-2-55 for safety; IEC 60601-1-2 for EMC; AIM 7351732 for RFID.
• For Software: FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
• For Mechanical Testing: Device specifications based on engineering design and comparison to the predicate device's established performance. The "ground truth" here is the established and expected performance curves and parameter ranges for ventilators, often derived from industry standards and the predicate device's known capabilities.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set as this is not an AI/machine learning device requiring such.

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

• Not applicable. No training set was used.

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The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, shortterm, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.

The device consists of a modulator (an exhalation valve that opens at PIP and closes at PEEP), a mechanical manometer, a resistor (which is referred to as the PEEP Valve) attached within the exhalation path for elevating the PEEP further than can be set with the modulator, a patient connector tee to supply gas flow, entrain additional air, and connect to a face mask or a tube inserted into a patient's airway, and two associated accessories. It is intended to be used by properly trained personnel in any environment in which emergency ventilation is required.

The VORTRAN GO₂VENT with PEEP Valve provides short-term, constant flow, pressure-cycled ventilatory support in either pressure control or pressure support mode. In pressure support mode, the rate dial of the VORTRAN GO₂VENT with PEEP Valve is set so that the baseline pressure is set above the set PEEP. This allows the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. In pressure control mode, the device will automatically cycle between PIP and PEEP when connected to a patient's airway.

The working mechanism of the VORTRAN GO₂VENT with PEEP Valve consists of a moving diaphragm that opens the exhalation path when the pressure reaches PIP and closes when the pressure reaches PEEP. Without the PEEP Valve, PEEP will be approximately 20% of the set PIP. With the PEEP Valve attached, the PEEP will be increased from this value up to 24 cm-H₂O depending on the patient's compliance and the VORTRAN GO₂VENT with PEEP Valve's settings. The PEEP Valve is attached within the exhalation path by connecting it between the modulator and the patient connector tee. The pressure at which the diaphragm opens and closes against the valve is controlled by the amount of spring force acting against the diaphragm's movement. The spring force is adjusted by manually turning a threaded knob that varies the amount of spring compression.

The device is constructed of a variety of plastics such as K-Resin, HDPE, polycarbonate, and silicone, as well as copper beryllium springs. The VORTRAN GO₂VENT with PEEP Valve is an external communicating device with limited and prolonged tissue contact duration (up to 30 days) via the breathing gas pathway.

The associated accessories were included with the cleared predicate device (K162968) and include:

• . Elbow flex hose for connecting the patient connector tee to a face mask or a tube inserted into a patient's airway
• Oxygen tubing for connecting the patient connector tee to a gas supply

The provided text describes the 510(k) premarket notification for the VORTRAN GO2VENT with PEEP Valve. It includes information on performance testing which addresses acceptance criteria.

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

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the sample size used for the mechanical performance testing. It also does not provide details on the data provenance, such as country of origin or whether the studies were retrospective or prospective.

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 and not provided in the document. The device is a medical device, and its performance is evaluated against engineering and biological standards, not through expert-labeled data like in AI/imaging studies.

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

This information is not applicable and not provided in the document for the reasons stated above.

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 information is not applicable. The device is a powered emergency ventilator, not an AI or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.

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

This information is not applicable for the reasons stated above.

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

For biocompatibility, the "ground truth" was regulatory guidance and recognized ISO standards. For mechanical testing, the "ground truth" was compliance with internationally recognized ISO standards for lung ventilators and connectors.

8. The sample size for the training set

This information is not applicable as this is a medical device approval, not an AI/machine learning model.

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

This information is not applicable as this is a medical device approval, not an AI/machine learning model. The relevant "ground truth" for compliance was established through recognized international standards.

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MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilation used for ventilation and oxygen inhalation with either a mask or tube.

Patient groups
Adults and children with a body weight of over 22 lbs (10 kg) where spontaneous respiration has failed or is inadequate.

Users Qualified medical personnel only

Intended environments of use
· Mobile use for emergency medicine and primary care during emergency deployments
· During land or air transport or transfer between hospital rooms and departments

MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilator. Highly compressed medical oxygen is used as the ventilation gas; this is reduced to the necessary operating pressure via an external pressure reducer. The oxygen is supplied at the compressed gas connection. The ventilation parameters – frequency and tidal volume - are linked together and can be set using the adjusting knob on the device. The ventilation gas is transported to the patient through the ventilation hose via the patient valve and ventilation mask or via the tube. The lip membrane in the patient valve allows the patient exhalation of expiration gas. In order to monitor the patient, the device features continuous measurement of the airway pressure as well as a visual and audible alarm system.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the MEDUMAT Easy CPR device.

Here's a breakdown of the requested information:

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

The document doesn't explicitly list "acceptance criteria" for each performance metric in a table format with specific numerical targets. Instead, it states that various tests were conducted to "verify the safety and effectiveness" and that "the performance of MEDUMAT Easy CPR is at least as good as the performance of the predicate device." The "Test results" section for performance testing only indicates "Passed."

However, we can infer some criteria and reported performance from the comparison table and performance testing section.

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

The document does not specify the sample size for the test set in terms of number of devices or data points used for each performance test.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). The tests were conducted internally by the manufacturer (Weinmann Emergency Medical Technology GmbH + Co. KG, Germany) or by testing labs on their behalf.

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

This information is not provided in the document. The performance tests appear to be engineering verification and validation against technical specifications and predicate device performance, rather than clinical studies requiring expert ground truth establishment.

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

This information is not applicable/provided. The performance testing described is objective, technical verification against standards and predicate device characteristics, not subjective assessment requiring adjudication by multiple experts.

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

This is not applicable. The MEDUMAT Easy CPR is a hardware device (ventilator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this device.

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

This is not applicable. The device is a ventilator, not an algorithm. Performance testing was done on the device itself.

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

The "ground truth" for the performance testing can be considered:

• International Standards: For biocompatibility (ISO 10993, ISO 18562) and electrical safety/EMC (IEC 60601 series, AIM 7351731).
• Predicate Device Performance: For ventilation characteristics, pressure limits, demand flow mode, and respiratory resistances, the predicate device (Pneupac VR1 Standard) served as a benchmark for comparison.
• Internal Specifications/Design Requirements: For various technical data and functional tests.

8. The sample size for the training set:

This is not applicable. The MEDUMAT Easy CPR is a hardware medical device and does not involve machine learning or AI algorithms that require a "training set."

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

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

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ClearMate™ is intended to be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMate" enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing.

This device is intended to induce isocapnic hyperventilation in patients to speed up elimination of carbon monoxide (CO). Isocapnic hyperventilation can be defined as large increases in patient minute volume with minimal changes in arterial partial pressure of carbon dioxide (CO2). This device replaces CO2 levels in the airway, thereby maintaining CO2 levels in the blood that ultimately causes hyperventilation. This pneumatic device initially provides 100% supplemental oxygen (O2) at minute volumes selected based on patient weight. If the patient minute volume demand is more than the preset supplement O2 volume, this device supplies a mixture of 94%/6% (O2/CO2), which maintains CO2 levels in the airway to enable isocapnic breathing by partial simulated rebreathing (of CO2). This device consists of:

1. The subject of this De Novo, the Control unit ("briefcase"), connects to sources of O2 and CO2 (neither gas is supplied with this device). The unit includes pressure gauges to read the source gas pressures. Internal components control supplemental gas flowrates, gas concentrations, and CO2 diversion away from the gas delivery pathway should O2 pressures be insufficient. This unit weighs about 2 kg and is pneumatically driven (i.e., no electronics).
2. Two breathing circuits, which are not the subject of this De Novo, can attach to the gas outlet ports of the control unit. These circuits are constructed of reservoir bags (21 CFR 868.5320, Class I), oxygen cannulas (21 CFR 868.5340, Class I), masks (21 CFR 868.5550, cleared under K953107), valves (21 CFR 868.5870, cleared under K142402), resuscitation bags (21 CFR 868.5915, cleared under K912203), and/or tubing (21 CFR 868.5925, cleared under K161420).
3. Hoses for source gas connections and a device stand for steadying the device, which are a subject of this De Novo.

Here's a breakdown of the acceptance criteria and the study information for the ClearMate device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

The document primarily discusses preclinical (animal and bench) and clinical literature review, rather than a single prospective "test set" for the device itself in the traditional sense of an AI/algorithm.

• Bench Testing:

  • Breathing Circuit Performance: 10 samples of spontaneously breathing circuits and 10 samples of non-spontaneously breathing circuits (20 samples total).
  • Control Unit Performance: 10 control units.
  • Use Life Performance: 5 device samples.
  • Data Provenance: Retrospective, conducted by the applicant (Thornhill Research, Inc.) presumably in Canada (given the contact address is in Scottsdale, AZ, but the company is Thornhill Research, Inc., which is Canadian). This is inferred as internal testing presented to the FDA.

• Animal Studies:

  • Fisher JA et al. (1999): Dog model (specific N not provided in the summary). Provenance: Published U.S. study.
  • Krech T et al. (2001): Mechanically ventilated sheep (specific N not provided in the summary). Provenance: Published U.S. study.

• Human Clinical Literature Review (considered as evidence of effectiveness):

  • Anand et al. (2017): 13 healthy volunteers (chronic smokers). Provenance: Published study (journal name "PLOS One" suggests an international publication, DOI:10.1371/journal.pone.0170621).
  • Rucker et al. (2002): 14 healthy volunteers. Provenance: Published U.S. study.
  • Takeuchi et al. (2000): Healthy human volunteers (specific N not provided in the summary). Provenance: Published U.S. study.
  • Katznelson et al. (2008): Specific N not provided in the summary (anesthetic agents study). Provenance: Published study.
  • Katznelson et al. (2011): 44 obese elective surgical patients (anesthetic agents study). Provenance: Published study.
  • Wu et al. (2015) - external study, not used for efficacy but for safety: 319 patients in treatment group, 320 in control group. Provenance: Chinese study, published in "Chinese Journal of Clinicians."

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

This device is not an AI/algorithm requiring expert-established ground truth for a test set in the diagnostic sense. The "ground truth" for its performance is derived from:

• Bench Testing: Engineering specifications and physical measurements. Experts involved would be engineering and quality control personnel. Their specific qualifications are not detailed, but they would be presumed to be qualified engineers/technicians.
• Animal Studies: Scientific observation and measurement by researchers/veterinarians.
• Human Clinical Studies: Clinical endpoints (e.g., COHb levels, elimination half-life, cerebral blood flow) measured by medical professionals and researchers. The peer-review process for these published studies implicitly involves expert clinicians and scientists.

4. Adjudication Method for the Test Set:

Not applicable, as this is not an AI/diagnostic algorithm using expert review for a "test set." For the literature review, the FDA's internal review team served as the adjudicators of the existing scientific evidence.

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

No, an MRMC comparative effectiveness study, in the context of human reader performance with/without AI assistance, was not performed. The device is a physical therapeutic device, not a diagnostic AI system intended to assist human readers.

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

Yes, the device itself is the "standalone" component. Its performance was evaluated independently through bench testing (as detailed in item #2) and animal studies. The human clinical studies also assess the device's effect on physiological markers when used therapeutically.

7. The Type of Ground Truth Used:

• Bench Testing: Device specifications, physical properties, engineering standards, and direct measurement of gas concentrations, flow rates, and pressures.
• Animal Studies: Physiological measurements (e.g., COHb levels, cardiac output, oxygen delivery) directly measured from the animal subjects.
• Human Clinical Studies (for effectiveness): Physiological measurements (e.g., COHb levels, elimination half-life, cerebral blood flow) obtained from human volunteers or patients using established medical measurement techniques.
• Human Clinical Study (Wu et al. for safety, but with limitations on efficacy): Clinical outcomes adjudicated by medical personnel based on consciousness, continence, disappearance of CO poisoning signs, EEG findings, and BI (Barthel Index) scores.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model requiring a training set in the machine learning sense. The device's design is based on scientific principles of isocapnic hyperventilation, not data training.

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

Not applicable (as above). The design and performance targets for the ClearMate device are based on established physiological principles and engineering requirements, not on a "ground truth" derived from a training dataset for an AI algorithm.

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The Puffin Lite Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.

The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The Puffin Lite Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, and manual ventilation as established by resuscitation guidelines to neonatal infants weighing less than 10 kg (22 lb). The resuscitation system includes two medical gas flowmeters, an integrated oxygen blender, airway pressure manometer, peak inspiratory pressure (PIP) control, positive end expiratory pressure (PEEP) control, a gas supply pressure alarm and T-piece resuscitator.

The Puffin Lite Infant Resuscitation System underwent bench testing to demonstrate conformance to performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual bench test. The testing was described as "bench testing," which typically involves laboratory-controlled environments and simulated conditions rather than real patient data. The data provenance is from this bench testing, not from human subjects or real-world clinical data. Therefore, there is no information on country of origin or whether the data was retrospective or prospective.

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

This information is not applicable. The study involved bench testing of a medical device, where acceptance criteria were based on engineering and performance specifications (e.g., pressure, flow, FIO2 accuracy) rather than expert interpretation of medical images or data. Ground truth was established by measuring the physical performance parameters of the device against predefined technical requirements.

4. Adjudication method for the test set:

Not applicable. As the study was bench testing against predefined technical specifications, there was no need for an adjudication method by human experts for the "ground truth." The "passing" or "failing" of a test was determined by whether the device's measured performance fell within the specified limits.

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

Not applicable. This is a 510(k) submission for a physical medical device (infant resuscitator) and not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

Not applicable. This device is not an algorithm or an AI system. It is a physical medical device (infant resuscitator) that is intended for use by trained medical professionals.

7. The type of ground truth used:

The ground truth used for this study was the engineering and performance specifications outlined in the acceptance criteria. The device's performance was measured against these objective, predefined technical requirements. There was no reliance on expert consensus, pathology, or outcomes data in the context of this bench testing.

8. The sample size for the training set:

Not applicable. This device is not an AI or machine learning system that requires a "training set" of data.

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

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

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The SafeT T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10 kg (22 lb).

The SafeT T-Piece Resuscitator is a single-use, non-sterile, manually operated, gas-powered resuscitator for use with patients less than 10 kg (22 lb). It is a simple T-Piece resuscitator with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve to protect against excessive pressure. The T-Piece resuscitator can be connected to the patient via a face mask or tube. The subject device consists of several components: T-Piece patient valve with variable PEEP dial and integrated manometer, Adjustable inspiratory pressure controller, 40 cm H2O pressure relief valve, 7' Oxygen tubing with a red universal (Fits-all) connector, 20" x 10 mm circuit tubing, Face mask.

The provided text is a 510(k) summary for the Ventlab, LLC SafeT T-Piece Resuscitator, a medical device for emergency respiratory support. It details the device's characteristics and its comparison to predicate devices to establish substantial equivalence for FDA clearance.

Crucially, this document does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) study. It focuses on the substantial equivalence of a physical medical device (a resuscitator) based on its technological characteristics and performance testing against established standards, not on an algorithm's performance in interpreting medical images or data.

Therefore, many of the requested points, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI, are not applicable to the context of this document.

However, I can extract the closest analogous information regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of this physical medical device:

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

The document doesn't present a specific "acceptance criteria" table in the way one might for an AI device (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" are implied by the compliance with applicable performance standards and the comparative data to predicate devices. The "reported device performance" is demonstrated by stating that the subject device "met all quantitative and qualitative requirements" of these standards and by the head-to-head comparison data presented in the "Substantial Equivalence Comparison Table" and subsequent discussion.

The most direct representation of "acceptance criteria" and "reported device performance" is found within the "Substantial Equivalence Comparison Table" itself, where critical performance metrics of the SafeT T-Piece Resuscitator are compared against those of the predicate device (Mercury Medical Neo-Tee) and a reference device (Fisher & Paykel NeoPuff).

Here is a partial table, extracted and reformatted from the "Substantial Equivalence Comparison Table" that acts as the primary evidence of meeting "acceptance criteria" (i.e., being substantially equivalent to the predicate device):

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The MOVES® SLC™ is a portable computer controlled, electrically powered emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

a. Suction
The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.

b. Supplementary Oxygen
The MOVES® SLC™ is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.

c. Patient Monitoring
The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® SLC™ device (K140049), a portable multifunction patient support and monitoring system with the following capabilities:

• Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
• Delivery of oxygen-enriched air that may be supplied from an external oxygen source or generated internal to the system with the on-board oxygen concentrator.
• Patient monitoring functions including the following patient parameters: Pulse Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.
• Suction/aspirator pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous negative pressure.

The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.

The provided text is a 510(k) summary for the MOVES® SLC™ medical device, which is an emergency ventilator with additional functions. This document describes the device, its indications for use, and its comparison to predicate devices to demonstrate substantial equivalence. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

Specifically, the document:

• Does not provide a clear table of acceptance criteria and reported device performance. It offers a comparison table of features and characteristics between the MOVES® SLC™ and predicate devices, including some performance specifications like frequency range, tidal volume, and SPO2 accuracy, but these are comparative, not acceptance criteria.
• Does not mention anything about sample sizes used for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance. This is because the device is a piece of hardware (ventilator, monitoring, suction, oxygen concentrator) and not an AI/software device that would typically involve such studies for regulatory clearance.
• Does not discuss a training set or how ground truth for a training set was established. This is irrelevant for a hardware medical device of this type.
• States that "Testing was conducted in accordance with all referenced standards and regulations, and to validate all system requirements" and a "Summary of Performance Testing" section mentions that "The results of performance testing demonstrate that the characteristics the MOVES® SLC™ are substantially equivalent to the identified predicates in terms of ventilator characteristics, patient monitoring performance, ability to delivery supplemental oxygen, and provide airway suction." However, it does not explicitly detail the specific performance test results against a defined set of acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on demonstrating substantial equivalence to existing predicate devices based on features, characteristics, and compliance with general medical device standards, rather than proving performance against specific acceptance criteria through clinical studies involving human readers or AI algorithms.

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This Device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.

The VORTRAN® GO2VENT™ provides short term, constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. In the pressure support mode, the rate dial of the VORTRAN® GO2VENT™ is set so that the baseline pressure is above the set PEEP allowing the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for patient care. The working mechanism of the VORTRAN® GO2VENTTM consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The VORTRAN® GO2VENT™ will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient). The VORTRAN® GO2VENT™ is not an ICU stand alone ventilator with multiple monitoring features. Set up and use of the VORTRAN® GO2VENT™ is simple. Set desired flow and adjust pressure dial to obtain desired I-time and/or tidal volume (see tidal volume chart in instructions), and adjust rate dial to obtain desired rate and I to E ratio.

The VORTRAN® GO2VENT™ is a powered emergency ventilator. The device was found substantially equivalent to its predicate device (VORTRAN® Automatic Resuscitator (VAR-Plus), K041473) based on non-clinical performance data and material biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

The device's acceptance criteria are based on compliance with the following standards:

• ASTM Designation: F 920 - 93 (Reapproved 1999): "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans."
• ISO 10651-5: "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators."

The table below summarizes some key operational characteristics of the device and how they compare to the predicate, demonstrating that the new device meets the same specifications:

In addition, specific modifications were tested:

• MR Conditional: The new beryllium-copper springs were tested according to ASTM F2052 and verified as MR Conditional for a static magnetic field of 3-Tesla or less, and a spatial gradient magnetic field of 10,000-gauss/cm or less.
• New Entrainment Connectors: All testing data showed that the change in the knobs for FiO2 delivery did not degrade performance and the device delivers the required specifications.
• New Beryllium-Copper Springs: Tested for performance and fatigue.

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

The document concerns non-clinical performance testing only. There is no specific "test set" sample size in terms of clinical data or patient cases mentioned. The testing was conducted on the device itself and its components. The data provenance is from non-clinical laboratory testing performed by the manufacturer and a third-party (Shellock MR Testing for MR Conditional verification). The data is retrospective in the sense of comparing the new device against previously documented performance of the predicate device and established standards.

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

Not applicable, as this was a non-clinical device performance and material compatibility study, not an expert-driven ground truth establishment for a diagnostic or AI algorithm.

4. Adjudication method for the test set:

Not applicable, as this was non-clinical device performance testing against established standards and predicate device specifications, not a clinical trial requiring adjudication of patient outcomes or 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:

No. This is not an AI-enabled device; it is a powered emergency ventilator. Therefore, no MRMC study or AI assistance evaluation was performed.

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

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

7. The type of ground truth used:

The ground truth for the device's performance is compliance with established engineering and medical device standards (ASTM F 920-93 and ISO 10651-5) and the performance specifications of the predicate device. Material compatibility was assessed against materials used in previously cleared devices.

8. The sample size for the training set:

Not applicable, as this is hardware medical device. There is no "training set" in the context of machine learning.

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

Not applicable, no training set or ground truth in the context of machine learning.

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o two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and transport ventilator designed for use in the pre-hospital, inter-hospital and transport settings. It is intended for use with adult, child, infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require ventilatory support.

The proposed o_two e700, o_two e600 and o_two e500 are time-cycled, volume-constant and pressure controlled (o_two e700 only) emergency and transport ventilators. They are electronically controlled, pneumatically powered ventilators which can be run using AC/DC power adapter or an internal rechargeable Lithium Ion battery pack. The devices use a 4.3" TFT screen to display live ventilation parameters (Tidal and minute volumes, proximal airway pressure and breathing rate) as well as ventilation pressure & volume wave forms, ventilation modes, settings, alarm limits and battery status. The wide range of both visual and audible alarms provides the healthcare professional with warnings of any changes in patient or device parameters.

The provided text describes the O-Two Medical Technologies' e700, e600, and e500 Electronic Transport Ventilators and their substantial equivalence to predicate devices, but it does not contain the specific information requested in the prompt regarding acceptance criteria, performance tables, sample sizes, expert qualifications, or ground truth establishment.

The document is a 510(k) premarket notification for device clearance, which focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) rather than providing detailed acceptance criteria and performance study outcomes in the format you've requested.

Here's what can be extracted based on the document, and what is explicitly not available:

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

• Not explicitly provided in the requested format with specific numerical acceptance criteria and performance metrics for an AI/algorithm-based device.

• The document primarily presents a comparative table showing the characteristics and specifications of the proposed devices against the predicate devices (Oxylog 3000 and CAREvent PAR) to demonstrate "Substantial Equivalence." Instead of acceptance criteria, it lists features and parameters and asserts "Yes" for substantial equivalence or notes specific differences.

  • Example from the document (partial):

• The "Summary of Performance Testing" section lists qualitative findings from a comparative bench test:
  • "Both ventilators delivered equivalent volume-time, pressure-time and flow-time wave forms under the same ventilation mode;"
  • "Both ventilators were responsive to spontaneous breathing trigger;"
  • "Ventilation Vt, frequency and I:E ratio or Ti of both units were close to target or preset parameters;"
  • "Both units delivered similar pressure supports."

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

• Not available. The document mentions "comparative side-by-side bench testing" but does not specify sample sizes (e.g., number of test cases, simulated patient scenarios, or real patient data) or data provenance. It's bench testing, implying simulated rather than patient data.

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

• Not applicable / Not available. This is a ventilator device, and the testing described is bench testing against established performance metrics and comparison to predicate devices, not an AI/imaging diagnostic device requiring human expert ground truth for interpretation.

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

• Not applicable / Not available. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of this submission.

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 not done. This is not relevant for an electronic transport ventilator. The study focused on proving substantial equivalence through bench testing and comparison of specifications to predicate devices, not on human reader performance with or without AI assistance.

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

• Not applicable. The device is a ventilator, a physical system with embedded software, not a standalone algorithm for diagnostic or interpretative tasks. The "Summary of Performance Testing" refers to bench testing of the device's operational performance.

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

• For the bench testing, the "ground truth" would be the expected physical performance parameters and waveforms based on established engineering and medical device standards (e.g., IEC 60601 series, EN 794-3, ISO 10651-3, ISO 80601-2-12) and the known performance of the predicate devices. The device's output (volume-time, pressure-time, flow-time waveforms, Vt, frequency, I:E ratio, etc.) was compared against these established targets.

8. The sample size for the training set

• Not applicable / Not available. This is not an AI/machine learning device that uses a "training set" in the conventional sense. The device's software logic is developed based on engineering principles and validated through testing.

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

• Not applicable / Not available. As this is not an AI/machine learning device requiring a training set, the concept of establishing ground truth for a training set does not apply.

In summary: The provided FDA document is a 510(k) clearance letter and summary for a medical device (electronic transport ventilator). It demonstrates "substantial equivalence" to predicate devices through comparative bench testing and specifications. It does not contain the specific information about AI/algorithm performance, detailed acceptance criteria tables, sample sizes for AI model development/testing, or expert-based ground truth evaluations as typically found in submissions for AI-enabled diagnostic or interpretive devices.

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