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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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Disposable manual resuscitator with CO2 detection for use with patients requiring manual ventilatory support. The CO2 detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO2 detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO2 detector detects approximate ranges of CO2 by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings.

The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. It incorporates a feature CO2 detection.

The provided text describes a 510(k) submission for the EMS Disposable Manual Resuscitator with CO₂ Detection. The submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study to establish new performance criteria. Therefore, several of the requested categories are not applicable or cannot be extracted directly from this type of document.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics from a formal study. Instead, it relies on demonstrating equivalence to predicate devices. The "Performance Standards / Specifications" section explicitly states "None applicable under Section 514," indicating that no specific performance standards were applied or tested against as part of this submission for the modified device.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

Due to the nature of a 510(k) submission based on substantial equivalence, a traditional "study that proves the device meets acceptance criteria" as might be seen for a novel device or a de novo application is not detailed in this document. The focus is on comparison to predicates.

1. Sample size used for the test set and the data provenance: Not applicable / Not specified in this 510(k) summary. The document compares the modified device to predicate devices based on attributes and materials, not on a formal test set with clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable / Not specified. Ground truth establishment would typically be for a de novo study involving clinical data, which is not detailed here.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable / None specified.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a manual resuscitator with a CO₂ detector, not an AI-powered diagnostic device involving human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The ground truth concept is generally for diagnostic or prognostic devices, where a reference standard is needed for comparison. This submission relies on substantial equivalence and material/design comparisons to predicate devices.

7. The sample size for the training set: Not applicable / Not specified. This document does not describe a training set as it's not a machine learning or AI-based device.

8. How the ground truth for the training set was established: Not applicable / Not specified.

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Disposable manual resuscitator with CO2 detection for use with patients requiring manual ventilatory support. The CO2 detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO2 detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO2 detector detects approximate ranges of CO2 by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings.

The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. It incorporates a feature CO2 detection.

Here's a breakdown of the acceptance criteria and study information for the EMS Disposable Manual Resuscitator with CO2 Detection, based on the provided text:

Preamble:

It's important to note that this document is a 510(k) submission, not a full clinical study report. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, rather than proving novel efficacy or conducting extensive new performance studies. Therefore, the "study" referred to here is primarily a comparison to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the attributes of the predicate devices. The "reported device performance" is the statement of equivalence to these attributes.

Summary of Device Performance:

The document explicitly states: "There are no differences between the proposed modification, that of adding CO2 detection capabilities to the exhalation port of the manual resuscitator, and the predicates." This statement implies that the EMS Disposable Manual Resuscitator with CO₂ Detection meets all the acceptance criteria by being functionally and materially identical or equivalent to the predicate devices with CO₂ detection capabilities, and other attributes identical to other predicates.

Regarding "The Study That Proves the Device Meets the Acceptance Criteria":

The provided text doesn't describe a traditional "study" with a test set, experts, and ground truth in the way one might expect for a novel device's performance evaluation. Instead, the "proof" for a 510(k) submission primarily relies on:

• Comparison to legally marketed predicate devices: The core argument is that the device is substantially equivalent to existing devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
• Verification of attributes: The table explicitly compares attributes of the new device to predicates, indicating "Yes" for matching characteristics.
• Statement of no differences: The crucial statement "There are no differences between the proposed modification... and the predicates" serves as the primary evidence.

Given this context, the following points address your specific questions:

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

• Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission based on predicate device comparison. There isn't a "test set" of patient data or device performance data gathered for this specific submission beyond the functional demonstration inherent in comparing specifications.
• Data Provenance: Not applicable. The "data" here is the descriptive comparison of the device's design, materials, and intended use against legally marketed predicate devices (EMS DMR K912203B, K924610A, and Nellcor Puritan Bennett DMR2 Plus with CO2 Detection K973419, and Nellcor Puritan Bennett EasyCap CO₂ Detector K894053 and K944400). This is a retrospective comparison of device specifications/features to already approved devices.

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

• Not applicable. Ground truth, in the sense of expert consensus on patient data or clinical outcomes, is not established for this type of submission. The "ground truth" is effectively the established safety and effectiveness of the predicate devices as determined by their prior FDA clearances.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication method" in the context of this 510(k) submission. The comparison is a direct assessment of device characteristics against pre-defined market standards (the predicate devices).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This device is a manual medical device (resuscitator with CO₂ detection), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this submission.

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

• Not applicable. This device is a manual medical device, not an algorithm. Its function inherently involves human operation.

7. The Type of Ground Truth Used

• Implicit "Ground Truth": The "ground truth" is the established safety and effectiveness of the predicate devices (EMS Disposable Manual Resuscitator K912203B, K924610A, and Nellcor Puritan Bennett DMR2 Plus Manual Resuscitator with CO2 Detection K973419, and Nellcor Puritan Bennett EasyCap CO₂ Detector K894053 and K944400). The current device is deemed safe and effective because its characteristics are substantially equivalent to these already approved devices.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

• Not applicable. See point 8.

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The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.

The DMR2 Plus™ is available in three sizes and is for use on the following patient populations:

• Adult is indicated for use on adults >40 kg. .
• Child is indicated for use on children 10 40 kg. .
• · Infant is indicated for use on infants 5 10 kg

The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as hospital, transport, mobile and home.

The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support.

The DMR2 Plus™ is available in three sizes: adult, child and infant. It may be used by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated; such as, hospital, transport, mobile and home.

The DMR2 Plus™ consists of a compressible resuscitator bag that is available in either processed natural rubber or PVC. The swivel, patient connection and CO2 detector cartridge are connected to the nonrebreathing Valve (NRV) housing - all housings are K-resin. The oxygen accumulator assembly enables the use of three different styles of oxygen accumulators: large bore, small bore or flat bag.

During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.

The provided text does not contain specific acceptance criteria with numerical targets or detailed results of a study designed to prove the device meets those criteria. Instead, it states that "The safety and effectiveness of the DMR2 Plus™ has been demonstrated by design and testing." It then lists the standards and guidance followed for this testing.

Therefore, the requested information cannot be fully extracted as there is no table of acceptance criteria with reported device performance, information on sample sizes for test or training sets, ground truth establishment, expert involvement, or comparative effectiveness studies.

Based on the provided text, here is what can be inferred and stated:

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

The document does not provide a table with specific acceptance criteria (e.g., minimum flow rates, CO2 detection thresholds, etc.) or quantitative reported device performance data. It broadly states that the device was tested to relevant standards, implying it met the general requirements of those standards.

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

This information is not provided in the document.

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

This information is not provided in the document. The CO2 detection relies on "color comparison," which typically implies a visual assessment by a healthcare professional rather than a complex ground truth establishment process involving multiple experts.

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

This information is not provided in the document.

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 such study is mentioned or implied. The device is a manual resuscitator with an integrated CO2 detector, which is a physical device providing a direct visual indication (color change) rather than an AI-assisted diagnostic tool for human readers.

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

This is not applicable as the device is a manual resuscitator with a simple integrated CO2 detector (color comparison), not an algorithm or AI system. Its function is to provide a visual cue for human interpretation.

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

For the CO2 detection aspect, the "ground truth" would likely be based on actual CO2 levels as measured by a gold-standard CO2 analyzer, or verification of endotracheal tube placement by other clinical methods (e.g., direct visualization). However, the document only states that the detector "detects approximate ranges of CO2 by color comparison," indicating a visual, qualitative assessment. The safety and effectiveness demonstrations relied on adherence to international standards for resuscitators (ISO 8382, ISO 5356-1, ASTM F 920-93) and environmental testing. These standards define performance requirements and test methods for the physical and functional aspects of the device, rather than requiring a complex "ground truth" as might be seen for diagnostic imaging.

8. The sample size for the training set

This information is not provided in the document and is not applicable given the nature of the device (not an AI/learning algorithm).

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

This information is not provided in the document and is not applicable given the nature of the device.

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