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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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