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The butterflyBVM™ when used in transport and non-clinical emergency settings (e.g., EMS, non-hospital) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, infants, and neonates.

The butterflyBVM™ when used in professional healthcare facilities (e.g., hospitals) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, and infants.

The butterflyBVM™ is a three-in-one bag-valve-mask capable of resuscitating adults, adolescents, children, infants, and neonates. The maximum tidal volumes (Vt) delivered by the butterflyBVM™ can be set via the tidal volume dial, as needed, to ranges that are generally appropriate for the size of patient receiving care. The butterflyBVM™ also has an adjustable peak inspiratory pressure (PIP) dial to help prevent barotrauma. The tidal volume and PIP are selected by aligning the dials to the Vt/PIP indicator. Patient-facing accessories such as masks, laryngeal mask airways, endotracheal tubes, end-tidal CO2 samplers, and the like can be connected to the patient connection port. Exhalation accessories such as bio filters and PEEP valves can be connected to the exhalation port. Supplemental oxygen can be added via the oxygen inlet port. The device is operated by manually squeezing the side arms together with either one or two hands. A cover is provided over the PIP dial to provide instruction to the user via images and words to first set the tidal volume for the procedure based on the assessment of the patient.

The provided FDA 510(k) clearance letter and summary for the butterflyBVM device offers details about its acceptance criteria and the study conducted to demonstrate performance. Here's a breakdown of the requested information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Details of the Study Proving Acceptance Criteria

The primary study mentioned directly addressing quantitative performance criteria is a "Comparative Testing" study titled "In a study of the butterflyBVM versus the Ambu Spur II [Merrell et al. 2023]".

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state a sample size for the comparative testing portion of the PIP Dial study. It mentions failures (e.g., "1 failure", "23 failures", "32 failures"), which implies multiple tests were conducted, but the total number of tests or devices tested is not provided.
• Data Provenance: The study is referenced as [Merrell et al. 2023]. Given this is a 510(k) submission, it is assumed to be an internal, pre-market engineering or bench-top study conducted by Compact Medical, Inc., or a contracted firm. The country of origin and whether it was retrospective or prospective is not explicitly stated, but such a study would typically be prospective bench testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. The study described is a bench testing/engineering study, not a clinical or human perception study requiring expert ground truth setting. The ground truth (target pressures, delivered volumes, oxygen concentrations) is established by measurement devices and consensus standards (ISO 10651-4).

4. Adjudication Method for the Test Set

• Not applicable. This was a bench testing study comparing device measurements to target values and predicate device performance. No human adjudication was involved.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a bench testing comparison of device performance parameters. It does not involve human readers (clinicians) interacting with cases or assessing improvements with AI assistance.

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

• This is not an AI/Software as a Medical Device (SaMD). The butterflyBVM is a manual emergency ventilator. Therefore, the concept of standalone algorithm performance (without human-in-the-loop) is not applicable. The device's performance is inherently tied to a human operator, but the presented data focuses on the device's mechanical and functional capabilities.

7. The Type of Ground Truth Used

• The ground truth for the performance parameters (PIP, delivered volume, oxygen concentration) was established through measurement against recognized consensus standards (primarily ISO 10651-4) using calibrated laboratory equipment. For comparative testing, the performance of the predicate device (Ambu Spur II) also served as a comparative benchmark to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is a mechanical medical device, not an AI/machine learning product. Therefore, there is no "training set" in the context of AI model development.

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

• Not applicable, as explained in point 8.

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EOlife is intended for use with emergency manual resuscitation devices to measure ventilatory flows and display visual guide on the insufflated volume, and ventilation frequency to ensure adequate ventilation of adult cardiopulmonary arrest patient during cardiopulmonary resuscitation (CPR) performed by healthcare professionals.

EOlife is a medical device dedicated to healthcare professionals to help them providing manual ventilation during cardiopulmonary resuscitation (CPR). EOlife is intended to be connected to any standard manual resuscitator for adults including a bag and a mask or endotracheal tube (ET tube) and supraglottic airway (SGA) device and to be used during manual ventilation of an adult cardiopulmonary arrest patient. EOlife is a portable device composed of an electronic control unit including an embedded software, a removable and rechargeable battery pack and of a single use flow sensor: FlowSense. EOlife does not present direct contact with the patient. Only the ventilation air flow is in contact with the internal part of FlowSense (indirect contact with the patient). During manual ventilation, EOlife measures the ventilation parameters (insufflated volumes, tidal volumes, ventilation frequencies, ) and gives real-time feedback to the user about the quality of the ventilation provided to the patient compared to the 2020 AHA (American Heart Association) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 3: Adult Basic and Advanced Life Support. The aim is to help the user ventilate according to the recommended frequencies (10 cycles per minute) and volumes (6-8 ml/kg of ideal body weight).

The provided text describes the EOlife device, a medical device intended to assist healthcare professionals in manual ventilation during cardiopulmonary resuscitation (CPR) by measuring ventilatory flows and displaying visual guides on insufflated volume and ventilation frequency. The document is a 510(k) premarket notification by Archeon Medical to the FDA, asserting substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a "Comparison of Technological Characteristics with Predicate Device" (Table 1) and a "Summary of Performance Testing" (Table 2). The most relevant section for acceptance criteria related to product performance is the "Measuring range and accuracy of ventilation values" and "Measuring range and accuracy of ventilation frequencies" within Table 1.

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

The document explicitly states: "The subject EOlife did not require clinical studies to support substantial equivalence." Instead, it relies on non-clinical (bench) testing, usability testing, and comparison to a predicate device.

• Test Set Description: The "test set" in this context refers primarily to the testing conducted on the physical device and its software, rather than a dataset of patient cases.
• Sample Size:
  • For the performance metrics (Vi, Vt, Freq), the specific number of tests or samples used to derive the RMSE values is not provided.
  • For biocompatibility, electrical safety, EMC, battery, power supply, mechanical, and software testing, the sample size is also not explicitly stated. These types of tests typically involve a limited number of devices to demonstrate compliance with standards.
  • For usability testing, "rounds of formative and summative testing" were performed, but the number of participants or test scenarios is not specified.
• Data Provenance: The testing was related to the device itself (hardware, software). No patient data is mentioned as being used for testing. The manufacturer, Archeon Medical, is based in Besançon, France. Therefore, the testing would presumably have been conducted there or by affiliated labs.

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

This information is not provided as the submission focuses on non-clinical testing and comparison to a predicate device, not on diagnostic performance against human expert-established ground truth on a patient dataset. The "ground truth" for the device's measurements (volume, frequency) would be established by calibrated measurement equipment used in the bench testing.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no human expert-based ground truth or adjudication process described for clinical effectiveness. The assessment is against technical specifications and established standards through bench testing.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The subject EOlife did not require clinical studies to support substantial equivalence." The device is positioned as an "adjunct tool" providing real-time feedback, not as an AI diagnostic tool that human readers would interpret. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

The performance testing (bench testing) described in Table 2, specifically the "Accuracy assessment of the values measured and displayed by EOlife," can be considered a form of standalone performance assessment of the device's measurement capabilities. The software within the device operates autonomously to measure and display parameters ("algorithm only"). However, this is for measurement accuracy, not for a diagnostic or interpretive task that would typically be associated with "standalone AI performance" in imaging or other clinical decision support contexts. The device's primary function is to provide real-time guidance to a human user, making it inherently "human-in-the-loop" in its intended use.

7. The Type of Ground Truth Used:

• For the measurement accuracy of volume and frequency values during bench testing, the ground truth would be established by precision laboratory instruments and simulated ventilation profiles (e.g., using a test lung and a ventilator simulator with known, calibrated outputs).
• For biocompatibility, electrical safety, EMC, mechanical, and software validation, the ground truth is compliance with international consensus standards (e.g., ISO, IEC, UN).
• For usability, the ground truth is the successful and safe completion of critical tasks by users as assessed in human factors testing.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The EOlife device is described as having "an embedded software that contains algorithms," but the document does not indicate that these algorithms (for measuring ventilatory flows and providing guidance) were developed using machine learning or required a "training set" of data in the typical sense. It appears to be based on programmed logic and physics models rather than statistical learning from a large dataset.

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

This information is not applicable/not provided for the same reasons as point 8.

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The Sotair™ device is intended for use with a manual resuscitator with air-tight connections, in non-breathing patients that require flow controlled ventilation using ambient air or a supplemental oxygen source. The Sotair device is a single use, disposable device added to a manual resuscitator and can be used for in-hospital, emergency, and transport care. The adult Sotair device comprises a flow-limiting valve that limits the inspiratory flow enabling providers to ventilate approximately 55 liters-per-minute (LPM). The flow-limiting valve is intended to minimize gastric inflation during manual ventilation. The Sotair device can be disabled by removing the manual resuscitator to its conventional operation. The Sotair device is intended for adult use only.

The Sotair™ device is a universal safety accessory device that is compatible with all manual resuscitators and airway interfaces that have standard ISO 5356-1:2015 15/22 mm connections. The Sotair device's flow-limiting function has been tested with the following bag resuscitators: [List of compatible resuscitators provided in the document]. The Sotair device is not compatible with manual resuscitators that have a built-in flow limiting device. The Sotair device uses a flapper valve with a blade design to limit the flow rate.

The provided text describes the Sotair™ Device, a flow-limiting valve for manual resuscitators, and its equivalence to a predicate device. However, the text does not include a table of acceptance criteria and reported device performance in the specific format requested. It also does not contain information on sample sizes, data provenance, ground truth establishment methods, or the involvement of experts in establishing ground truth for a test set. There's no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, as this is a medical device, not an AI/software product in the traditional sense described by those elements of the prompt.

Based on the available information, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various performance tests conducted. While it states that the testing "met the requirements" or "demonstrated that the Sotair device met the product specifications and also performed equivalent to the predicate device," it does not provide specific acceptance values or the quantitative results from these tests in a table format.

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

• Test Set Sample Size: Not explicitly stated for any of the tests.
• Data Provenance: The studies were conducted by SafeBVM Corporation (submitter) and its contracted consultants/labs. The country of origin for the data is not specified beyond the submitter's address in Chesterfield, MO, USA. The studies are described as "performance testing" and "simulated-use Human Factors Engineering / Usability Engineering (HFE/UE) Summative / Validation Study," implying prospective testing rather than retrospective data analysis.

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. The "ground truth" for the device's performance appears to be established through adherence to engineering standards (ISO) and functional testing against design specifications and a predicate device, rather than expert consensus on a diagnostic output.

4. Adjudication method for the test set:

Not applicable or not described in the document, as it pertains to a physical medical device's performance against predefined criteria and 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. The Sotair™ Device is a mechanical medical device (flow-limiting valve), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

Not applicable. The device is a mechanical component of a manual resuscitator, not an algorithm. Its performance is inherent to its physical design and function.

7. The type of ground truth used:

The ground truth used for evaluating the Sotair™ device's performance is based on:

• Biocompatibility Standards: Adherence to ISO 10993 and ISO 18562.
• Mechanical and Functional Specifications: Meeting predetermined product specifications for various mechanical properties and functionality (e.g., flow rate, leakage, resistance, valve function).
• Equivalence to Predicate Device: Direct comparison testing to demonstrate equivalent performance to the legally marketed predicate device (Smart Bag MO) in Valve Functionality Testing.
• Human Factors/Usability Criteria: Meeting usability criteria for intended users, uses, and use environments as per FDA guidance.

8. The sample size for the training set:

Not applicable. The device is a mechanical product, not an AI model requiring a training set. The descriptions relate to performance testing and usability studies.

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

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

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Single patient use manual resuscitator for use in hospital, transport, emergency, and post-hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10 kg Child: less than or equal to 23 kg Adult: greater than 23 kg

Disposable manual resuscitator is disposable, medical device, which temporarily augment ventilation in patients during ventilatory insufficiency or ventilator failure. Disposable manual resuscitator uses a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the resuscitation bag and includes an oxygen enrichment (reservoir) system. Disposable manual resuscitator may be used in hospital, transport, emergency, and post hospital care to temporary ventilate a patient. Disposable manual resuscitator is for single patient used. It comprises of mask, oxygen tube, reservoir bag and resuscitator bag. It is used to temporary ventilate a patient for the given body mass ranges of: Infant - Less than or equal to 10 kg Child - less than or equal to 23 kg Adult - Greater than 23 kg.

The provided text is a 510(k) premarket notification for a medical device (Disposable Manual Resuscitator). This document outlines the manufacturer's claim of "substantial equivalence" of their device to a legally marketed predicate device.

Crucially, this document is NOT a study report for an AI/ML powered medical device, nor does it contain information about establishing ground truth, multi-reader multi-case studies, or training sets in the context of AI/ML.

The "Performance Data" and "Summary of Device Testing" sections refer to the physical and functional performance of the manual resuscitator as per established medical device standards (e.g., ISO 10651-4, ISO 5356-1, ISO 10993). These are tests for mechanical and material properties, not an AI algorithm.

Therefore, I cannot extract the information required for bullet points 1 through 9 from the provided text, as those points are specific to the validation of AI/ML systems.

Here's a breakdown of why the requested information cannot be found in this document:

• Acceptance Criteria for AI/ML and Reported Device Performance (Table 1): The document's "Performance Data" section in Table 1 refers to physical characteristics of a manual resuscitator (e.g., "Ventilation Bag Volume," "Max Delivered Volume," "Expiratory resistance," "Supplemental Oxygen%"). These are not acceptance criteria or performance metrics for an AI/ML algorithm.
• Sample Size for Test Set and Data Provenance: This pertains to data used to evaluate AI. The document describes testing of physical products, not data sets.
• Number of Experts and Qualifications for Ground Truth: No AI is involved, so no ground truth established by experts is mentioned.
• Adjudication Method: Not applicable for a non-AI physical device.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: This is for evaluating changes in human performance with AI assistance. Not relevant here.
• Standalone (Algorithm Only) Performance: Not applicable as it's not an algorithm.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: These concepts are central to AI/ML model development. The document describes product manufacturing and testing processes, not AI training.

In summary, the provided document details the regulatory submission for a physical medical device (a manual resuscitator) and demonstrates its substantial equivalence to a predicate device based on physical and functional testing. It does not involve any artificial intelligence or machine learning components, and thus the requested details regarding AI/ML acceptance criteria and validation studies are not present.

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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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Flexicare's Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.

Flexicare's Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of infants and children with a body weight of 22lbs to 66lbs (10-30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.

Flexicare's Infant Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight of up to 22lbs (10kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.

Flexicare's Single Use Resuscitator Bags are Single Use devices For manual ventilation of a patient by trained operators in emergency/critical situations where short term ventilation is demanded by the patient's medical condition (e.g. inadequate or no breathing). Manual squeezing of the resuscitator bag forces air or air /O2 mixture into the patient's lungs via a face mask or pre-positioned airway tube with a 15mm male connection. A reservoir bag is present at the distal end of the device which fills with supplementary O2 (if using). This can be squeezed into the resuscitator for administration if required.

Flexicare's Single Use Resuscitator Bags feature a one-way duck bill valve at the patient end to deliver fresh gas to the patient whilst preventing ingress of exhaled air and potential rebreathing. A one-way valve is also present at the distal end of the device, ensuring that upon squeezing the Resuscitator bag air only travels toward the patient, and upon release of a squeezed bag fresh ambient air with/without supplementary O2 is drawn in. Flexicare's Single Use Resuscitator Bags incorporate a pressure relief valve. This valve limits the pressure within the resuscitator and patient lungs to 60cmHzO (Adult) or 40cmHzO (Adult, Pediatric, Infant). One variant of Flexicare's Adult Single Use Resuscitator Bags does not feature a pressure relief valve.

Flexicare's Single Use Resuscitator Bags are comprised of disposable components including a compression bag, valves, tubing and connectors. The Single Use Resuscitator Bags are intended for Adult. Pediatric and Infant patients, are supplied non sterile and are for use by CPR-trained personnel only within a hospital and/ pre-hospital environments.

The provided text describes the acceptance criteria and a study demonstrating the Flexicare Single Use Resuscitator Bags meet these criteria by showing substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting recognized standards and performance characteristics comparable to the predicate devices. The "Outcome" column in the table below indicates that the Flexicare device "Passed" each test, implying that it met the respective criteria.

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

The document does not explicitly state the sample size (number of devices) used for each specific test in the "test set". However, it mentions "Verification tests were performed to establish the safety and efficacy of Flexicare's Adult Single Use Resuscitator Bag." and similarly for Pediatric and Infant versions. The tests would likely involve a statistically relevant number of devices to ensure reliability.

The data provenance is from Flexicare Medical Limited, United Kingdom. The study is retrospective in the sense that it compares the newly developed Flexicare device against existing, legally marketed predicate devices (Ambu SPUR II Adult, Pediatric, and Infant Single Patient Use Resuscitators) that have already been cleared by the FDA. The performance testing itself would be prospective for the Flexicare device.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance testing. Instead, the ground truth is established by objective measurements against recognized international standards and direct comparison of performance characteristics with legally marketed predicate devices.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method involving human reviewers for the test set. The validation relies on objective laboratory testing against predefined criteria and standards, and direct comparison of measured characteristics with those of predicate devices.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/CAD systems for image interpretation, which is not applicable to a manual resuscitator bag. The study is a non-clinical performance and biocompatibility evaluation.

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

No, a standalone (algorithm-only) study was not done. This device is a manual medical device and does not involve any algorithms or AI for its operation.

7. The Type of Ground Truth Used

The ground truth used for this device's validation is based on:

• Recognized International Standards: Compliance with standards such as BS EN ISO 10651-4:2009, ISO 10993 series, ISO 5356-1:2004, BS EN 13544-2:2002+A1:2009, BS ISO 18562-2 2017, and ASTM F1980.
• Performance Specifications of Legally Marketed Predicate Devices: The performance characteristics (e.g., volume, resistance, force, dead space, stroke volume, pressure relief) of the Flexicare devices are compared directly to those of the Ambu SPUR II predicate devices. The goal is to demonstrate "substantial equivalence," meaning the new device performs as safely and effectively as the predicate.
• Objective Laboratory Measurements: The "Non-clinical Test Results" section explicitly states that "Verification tests were performed to establish the safety and efficacy" including visual inspection, dimensional inspection, internal volume, valve function, drop testing, immersion in water, oxygen concentration, resistances, valve malfunction, tidal volume calculation, O2 tube testing, conical connector compliance, biocompatibility, and particulate emission testing.

8. The Sample Size for the Training Set

There is no training set as this is a physical medical device, not an AI or machine learning algorithm.

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

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

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Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg

This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer.

The PEEP Valve is a single patient use positive end expiratory pressure (PEEP) valve for use hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Intended for patients that the clinician has determined need PEEP.

The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems.

Foremount Disposable PVC Resuscitators are portable medical devices used to temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. They consist of Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask, and optional Diverter Ring, PEEP Valve and Manometer. Foremount Disposable PVC Resuscitators come in three sizes along with a ventilation bag:

• . Infant - Less than or equal to 10 kg
• Child less than or equal to 23 kg ●
• Adult Greater than 23 kg. ●

The ventilation bags are available in three sizes based upon the intended patient population. They are provided with masks in three sizes (#1 - Infant, #3 - Child, and #5 - Adult). The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 40 cmH2O pop off valve for Child and Infant models. The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 60 cmH2O pop off valve for Adult models.

This is a 510(k) premarket notification for the Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and Accessories, including a PEEP valve and a disposable manometer. The submission aims to demonstrate substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define "acceptance criteria" in a dedicated table for each device component with specific numerical targets. Instead, it demonstrates performance by comparing the Foremount devices to their respective predicates or by stating that the device meets relevant ISO standards.

We can infer the acceptance criteria are met if the Foremount device's specifications and performance fall within acceptable limits defined by the predicate devices and applicable ISO standards.

Inferred Acceptance Criteria and Reported Device Performance (Resuscitator)

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The Ambu SPUR II resuscitator is a single patient use resuscitator intended for pulmonary resuscitation.

The range of application for each version is:

-Adult: Adults and children with a body weight more than 30 kg (66lbs).

-Paediatric: infants and Children with a body weights up to 30 kg (66lbs).

-Infant: Neonates and infant with a body weight up to 10kg (22lbs).

Ambu SPUR II Resuscitator is intended for manual pulmonary resuscitation. It is a disposable device intended for Single Patient Use only.

Ambu SPUR II Resuscitator is available in three sizes: Adult, Pediatric and Infant.

The main components of the product are a patient valve, a bag, an inlet valve, a reservoir bag/tube and an oxygen tube.

The patient valve directs the ventilation air through a patient connector into the patient airway and directs the patient expiration air through an expiration connector. The patient connector is constructed to turn around its own axis enabling the resuscitator to turn in relation to connected masks or endotracheal tubes.

A pressure limiting valve (40 cmHzO) with an override mechanism is placed in the patient valve housing of all Pediatric and Infant resuscitators. For the Adult resuscitators a pressure limiting valve is optional.

M-Port is mounted in the patient valve housing and provides access to the inspiratory and expiratory gas flow allowing connection of a syringe for drug delivery or a qas sampling line for measuring side stream EtCO2. When the M-Port is not used it is sealed with a cap and the resuscitator operates as a resuscitator without the M-Port. The M-Port is an optional feature.

The bag of the resuscitator is made of a flexible and elastic material. which ensures the bag to have sufficient compression and recoiling properties. When the bag is compressed, air is delivered via the patient valve to the patient.

The inlet valve allows ambient air to flow into the bag and prevents air flowing backwards from the bag through the inlet valve during ventilation.

The reservoir consists of either a reservoir bag (closed reservoir) or a reservoir tube (open reservoir) attached to the inlet valve.

Supplementary oxygen can be supplied through the oxygen tube attached to the oxygen connector (reservoir bag) or mounted inside the inlet valve assembly (reservoir tube). Supplementary oxygen flows into the reservoir attached to the inlet valve assembly.

A Face mask, Endotracheal Tube or Larynqeal Mask/Combitube can be connected to the patient connector of the resuscitator to ensure contact to the patient's airway.

The Ambu SPUR II Resuscitator complies with ISO 10651-4: Particular requirements for operator powered resuscitators.

The provided text is a 510(k) Premarket Notification from the FDA for the Ambu SPUR II Resuscitator. This document is a regulatory submission for a medical device and describes the device's technical specifications and how it demonstrates substantial equivalence to existing devices. It does not describe an AI/ML-driven medical device, nor does it detail a study that proves an AI/ML device meets specific acceptance criteria in the context of clinical performance or human reader improvement.

Therefore, the requested information, specifically regarding acceptance criteria and studies related to AI/ML device performance (like sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, training set details, etc.), cannot be extracted from this document, as it pertains to a manual medical device (resuscitator) and not an AI-powered diagnostic or assistive tool.

The document primarily focuses on bench testing and compliance with recognized consensus standards to demonstrate the safety and effectiveness of the manual resuscitator in comparison to predicate devices, rather than AI-related performance metrics.

However, I can extract the acceptance criteria and performance data for the manual resuscitator itself, as presented in the document, though it won't be AI-related.

Here's an attempt to answer the request based only on the provided document, interpreting "acceptance criteria" as the performance parameters tested for this manual device:

Device: Ambu SPUR II Adult, Pediatric, and Infant Resuscitator (a manual medical device, not an AI/ML device)

The document describes the device's substantial equivalence to predicate devices based on its intended use, operation, technological characteristics, and performance testing. The "acceptance criteria" here refer to the successful passing of various performance tests as per recognized consensus standards for manual resuscitators.

Table of Acceptance Criteria and Reported Device Performance (for the Manual Resuscitator)

AI/ML Specific Questions (Cannot be answered from the provided document as it is for a manual medical device)

Since this document describes a manual medical device (resuscitator) and not an AI/ML diagnostic or assistive device, the following points regarding AI/ML studies are not applicable and thus, no information can be extracted:

2. Sample sizes used for the test set and the data provenance: Not applicable. The document refers to engineering bench tests, not clinical data sets for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, this was not done as it's not an AI device. The document explicitly states "No Clinical tests are performed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is objective measurements against engineering standards.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory submission for a traditional, manual medical device. It thoroughly outlines the bench testing and compliance with established standards to demonstrate safety and effectiveness. However, it does not contain any information related to AI/ML device performance, human-AI interaction studies, or the methodologies typically employed for AI/ML model validation.

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The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.

The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support. A manual resuscitator is a resuscitation device in which ventilation of the lungs is produced by the operator compressing the compressible unit of the device, the ventilation bag. The ventilation bag is self-inflating: the compressed bag will refill with ambient air via the bag inlet valve. The resuscitator provides positive pressure ventilation of the lungs (when used with a face mask). The resuscitator can be used to provide supplemental oxygen when used with the oxygen kit, the NeoNatalie Resuscitator Oxygen Kit. When a resuscitator fitted with an oxygen reservoir is used to provide supplemental oxygen, the ventilation bag will refill with oxygen from the oxygen reservoir. The NeoNatalie Resuscitator is made of polysulfone, silicone rubber and stainless steel. The NeoNatalie Resuscitator is reusable resuscitator which may be sterilized by autoclaving.

The provided text describes the regulatory clearance for the NeoNatalie Resuscitator and includes a comparison to a predicate device, as well as general information about testing performed. However, it does not contain the detailed clinical study information typically provided when discussing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device.

The NeoNatalie Resuscitator is a mechanical medical device (manual resuscitator), not an AI/ML device, and therefore the specific questions regarding test sets, training sets, ground truth, expert adjudication, and MRMC studies are not directly applicable in the way they would be for an AI/ML diagnostic or predictive tool.

Based on the provided text, here's an attempt to answer the questions, highlighting where the information is not directly available or applicable:

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

The document frames the "acceptance criteria" and "device performance" in terms of compliance with international standards and functional requirements for a manual resuscitator, rather than traditional clinical performance metrics like sensitivity or specificity for an AI algorithm.

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Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.

Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.

The document provided outlines the A Plus Medical Babi.Plus™ Neonatal Resuscitation Bag and its substantial equivalence to a predicate device. The primary study presented relates to comparative technological characteristics rather than a clinical study involving human patients or complex AI algorithms.

Here's a breakdown of the requested information based on the provided text, noting where information is not applicable or not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the ISO 10651-4:2002 standard ("Lung ventilators - Part 4: Particular requirements for opered resuscitators") and the predicate device's performance. The "Babi.Plus™" column shows the reported device performance.

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