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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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The Mercury Medical STATCO2TM End Tidal CO2 Detector is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

The Mercury Medical STATCO2™ uses the same technology as the Nellcor Easy Cap II, (K894053, FENEM submitter). The STATCO2™ End Tidal CO2 Detector is a "Single Patient Use" only device. The device assists in verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end tidal CO2 when clinically significant. The device consists of a housing unit made with material of polycarbonate, filter media consisting of 3M Filtrete GSB30 and Bregas C-it Indicator, 510(k) K000520 mounted to the housing.

The Mercury Medical STATCO2™ End Tidal CO2 Detector is a device designed to assist in verifying tube placement during endotracheal or nasotracheal intubation and to detect approximate ranges of end-tidal CO2. The device's acceptance criteria and the study proving its performance are primarily based on demonstrating substantial equivalence to a predicate device and adherence to relevant technical standards, rather than a traditional clinical study with detailed performance metrics and expert-established ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not detail a specific "test set" in the context of a clinical performance study with a defined sample size. The device's performance is established through a demonstration of substantial equivalence to an existing predicate device (Nellcor Easy Cap II, K894053) and adherence to international and industry standards (ISO 5356-1:1987 and ASTM F1054). This approach is typical for 510(k) submissions where a new device is shown to be as safe and effective as a legally marketed predicate device.

Therefore, there is no explicit sample size reported for a clinical test set to assess device performance in this submission. The data provenance is based on the technical specifications and performance of the predicate device and the adherence of the new device to established engineering standards. The submission itself is a premarket notification (510(k)) from the United States.

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

No explicit "ground truth" establishment by experts for a specific test set is described in the provided documents. The basis for safety and effectiveness relies on:

• The established performance and safety record of the predicate device.
• Compliance with technical standards.
• The regulatory body (FDA)'s review of the submission, where their experts (e.g., in the Division of Anesthesiology, General Hospital, Infection Control and Dental Devices) assessed the data provided by the manufacturer.

4. Adjudication Method for the Test Set

Not applicable. There was no specific clinical "test set" requiring an adjudication method by external experts in the context of this 510(k) summary. The FDA's review process serves as the primary "adjudication" of the submitted information.

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

No. The provided documentation does not mention an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a semi-quantitative detector, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical, semi-quantitative CO2 detector, not an algorithm, and its use inherently involves a human (physician or medical professional) interpreting its visual output.

7. Type of Ground Truth Used

The "ground truth" in this submission is implicitly established by:

• The performance of the predicate device, which was previously cleared by the FDA and serves as the benchmark for substantial equivalence.
• The requirements set forth by international and industry standards (ISO 5356-1:1987 and ASTM F1054) for physical and functional characteristics.

There is no mention of "expert consensus, pathology, or outcomes data" being specifically used to establish ground truth for this device's performance in a de novo study.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device's design and manufacturing are based on established engineering principles and the specifications of the predicate device.

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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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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