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Use to assist verification of tube placement during endotracheal intubation. Use on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant.

The subject device, when connected between an endotracheal tube and a breathing device, detects approximate ranges of end-tidal CO2 by color comparison in patients. The detector may be used during patient transport or in any location where intubations are performed. It may be used for up to 2 hours. The subject device is non sterile and is intended for single use.

The provided text describes the 510(k) summary for the Nellcor™ EASYCAP II Adult Colorimetric CO2 Detector and Nellcor™ PEDCICAP Pediatric Colorimetric CO2 Detector. It focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a full-fledged study as would typically be done for a novel device or AI/ML-based diagnostic.

Therefore, many of the requested elements (like a test set sample size, expert consensus for ground truth, MRMC study, effects size of human readers, training set details) are not applicable (N/A) because the submission relies on bench testing and biocompatibility testing to establish substantial equivalence by comparing the device's characteristics to a legally marketed predicate, rather than a clinical performance study with human subjects interpreting results.

Here's how the available information maps to your request:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" for the device's performance are primarily that its technological characteristics are comparable to a predicate device and that any differences do not raise new questions of safety or effectiveness. The reported "performance" is demonstrated through bench testing and biocompatibility.

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The Neo-StatCO2

Mercury Medical, Inc. Neo-StatCO2

This document describes the Neo-StatCO2 device, a colorimetric breath indicator for CO2 that helps verify proper intubation. The submission aims to demonstrate substantial equivalence to predicate devices, particularly the Mercury Medical Mini-StatCO2 (K031411).

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria by comparing the new device (Neo-StatCO2) to predicate devices in terms of its physical, performance, and operating characteristics. The primary new "performance" aspect is the expanded patient population, which required specific testing.

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "The only difference between the Mercury Mini-Stat CO2 is the expansion of the patient population to include patients with a body weight of 250 g to 6 Kg which we have demonstrated as being effective via comparative bench testing."

This implies that the "comparative bench testing" was the study conducted to ensure the device's effectiveness for the expanded patient population (neonate and infant - 250g to 6 kg) under the specified tidal volumes and breath rates.

Additional Information (Based on the Provided Text):

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

• Sample size: Not specified. The document mentions "comparative bench testing" but does not give specific numbers for the test set used in this bench testing.
• Data provenance: The testing was described as "bench testing," suggesting a laboratory environment. There is no information about the country of origin or whether it was retrospective or prospective.

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

• Not applicable as the testing was "bench testing." Ground truth would likely be established by objective measurements of CO2, tidal volume, and breath rate, rather than expert interpretation of the device's color change.

4. Adjudication method for the test set:

• Not applicable for bench testing. The evaluation would be based on direct measurement outcomes rather than human 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:

• No. This device is a colorimetric indicator, not an AI-assisted diagnostic tool.

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

• Yes, implicitly. The "comparative bench testing" would be a standalone performance evaluation of the device's ability to change color under specific simulated conditions, independent of human interpretation for the physical manifestation of the color change itself. The human-in-the-loop aspect refers to a clinician interpreting the color output. The bench testing would confirm the device produces the correct color change.

7. The type of ground truth used:

• For the "comparative bench testing," the ground truth would be precise, known values of CO2 concentration, tidal volume, and respiratory rate, simulated in a controlled environment. The device's color change would then be observed and compared against these known conditions to verify its accuracy.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/machine learning algorithm that requires a training set in the conventional sense.

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

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

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Used to assist verification of tube location during oral or nasal placement of a gastric tube in adults.

The Kendall CO2nfirm NOW™ CO2Detector is a disposable device that is used during the oral or nasal placement of a gastric tube to preliminarily determine if the tube is properly placed by detection of CO2

Based on the provided 510(k) summary for the Kendall C02nfirm NOW™ C02 Detector, here's an analysis of the acceptance criteria and supporting study information:

The Kendall C02nfirm NOW™ C02 Detector is a disposable device used to assist in the verification of gastric tube placement by detecting CO2.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria or specific performance metrics for the Kendall C02nfirm NOW™ CO2 Detector. Instead, it relies on demonstrating equivalence to predicate devices and meeting industry standards.

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

The 510(k) summary does not provide details on a specific "test set" in terms of subject or patient data. The non-clinical testing described focuses on demonstrating design equivalence to predicate devices and adherence to industry standards for device construction and function. It does not mention a clinical study involving human subjects or patient data. Therefore, there's no information on sample size, country of origin, or whether it was retrospective or prospective for a clinical test set.

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

Since no clinical test set with human subjects or patient data is described, there is no mention of experts being used to establish ground truth in this context. The evaluation appears to be purely technical and comparative against existing devices and standards.

4. Adjudication Method for the Test Set

Given the absence of a clinical test set and expert review for ground truth, no adjudication method is described.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance. The device is a diagnostic tool, not an AI-powered image analysis system.

6. Standalone Performance Study

The summary describes "Nonclinical Testing" conducted to demonstrate design equivalence and adherence to industry standards. This can be considered a form of standalone testing in the sense that the device itself was tested for its physical and functional characteristics. However, it's not a standalone clinical performance study in the way it's typically understood for diagnostic algorithms (e.g., performance metrics like sensitivity, specificity on a clinical dataset). The testing described is more about the intrinsic properties of the device (colorimetric detection, materials, construction) rather than its diagnostic accuracy in a clinical setting.

7. Type of Ground Truth Used

For the nonclinical testing, the "ground truth" implicitly used would be:

• Predicate Device Performance: The established functionality and performance of the Easy Cap® CO2 detector and Pedi-Cap® CO2 detector.
• Industry Standards: The requirements and specifications outlined in EN1615:2000 and ISO 594, Parts 1&2.
  The summary does not mention pathology, outcomes data, or expert consensus in a clinical context as ground truth.

8. Sample Size for the Training Set

No training set is mentioned. This device is a passive, colorimetric CO2 detector, not a machine learning or AI-driven system that requires a "training set" in the computational sense.

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

As there is no training set for an AI/ML model, this question is not applicable. The device's function is based on a well-understood chemical principle, not on learned patterns from a dataset.

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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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