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The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.

It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.

Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.

The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).

The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.

The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.

The mainstream gas analyzers are characterized by the following features:

• Low system integration complexity
• Low power consumption
• Fast startup time
• Low weight < 30g
• Visual status indicator

The provided document is a 510(k) clearance letter and summary for the Medical Gas Analyzer (AG200). It does not contain information about a study proving the device meets its acceptance criteria.
The document states: "the subject device does not require clinical test data to support substantial equivalence." This means that the device was cleared based on its similarity to existing devices and bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in a real-world setting.

Therefore, I cannot provide the requested information about the study proving the device meets acceptance criteria, the sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, or training set details as they are not present in the provided text.

However, I can extract the acceptance criteria as reported in the document through comparison with the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "device performance" parameters.

1. Table of Acceptance Criteria and Reported Device Performance (as implied by comparison to predicate/reference devices):

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

• Sample Size: Not specified. The document refers to "bench tests" and "software validation testing" but does not provide details on the number of samples or test cases used.
• Data Provenance: Not applicable, as no human clinical or retrospective/prospective data is mentioned. The testing described is "bench testing" and "software validation testing," which are laboratory-based and device-centric.

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

• Not applicable. The document does not describe the establishment of a ground truth by experts for a test set. Testing was primarily technical compliance ("bench tests") and software validation. For the manual anesthetic agent selection, it mentions "qualified clinicians" but no specific number or qualifications are provided, nor is their role in establishing "ground truth" for the device's performance defined.

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

• Not applicable. There is no mention of an adjudication method, as the tests were not clinical studies requiring expert review of medical data.

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. No MRMC comparative effectiveness study was conducted. The device is a Medical Gas Analyzer, not an AI-assisted diagnostic or interpretive tool for human readers.

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

• The testing described, primarily "bench tests" and "software validation testing," assesses the device's performance in a standalone capacity (algorithm only). However, the results are presented as "Pass" for compliance with standards rather than specific performance metrics (e.g., accuracy, precision) in a standalone context beyond what is listed in the performance table. The distinction of "standalone performance" as it typically applies to AI algorithms is not explicitly made, but the listed performance characteristics are inherent to the device itself.

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

• For the bench tests, the ground truth would be established by reference measurement devices or calibrated gas mixtures with known concentrations, as well as adherence to the requirements outlined in standards like ISO 80601-2-55. This is typically a known, controlled input.

8. The sample size for the training set:

• Not applicable. The device is a hardware-based gas analyzer with software; it is not an AI/machine learning device that requires a training set in the conventional sense.

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

• Not applicable. As noted above, the device does not use a "training set" in the context of machine learning.

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The Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status.

Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration. The device is intended for use by qualified medical personnel within a hospital, ambulatory care, transport, or any other clinical environment.

The TG-980P and TG-980P1, collectively referred to as TG-980P/TG-980P1, are CO2 Sensor Kits used to measure the concentration of carbon dioxide (CO2 or CO2) during patient expiration. The TG-980P/TG-980P1 is intended for use by qualified medical personnel as an aid for determining patient ventilatory status within a hospital, ambulatory care, transport, or any other clinical environment.

The TG-980P/TG-980P1 CO2 Sensor Kit comprises three main components: a CO2 sensor, an interface connector, and a sensor cable. It utilizes the mainstream measurement method to sample gas directly from the patient's airway and non-dispersive infrared (NDIR) absorption technology to measure CO2 concentration during patient expiration. CO2 gas absorbs infrared light at specific wavelengths, and the amount absorbed is directly related to CO2 concentration. The CO2 sensor is equipped with a light source that generates infrared light. The light passes through an attached Nihon Kohden accessory (except the Thermal Airflow Sensor) through which the expired air flows and is converted by photodetectors to voltage, which is used to calculate CO2 concentration. The calculated digital data is then transmitted and displayed on a connected patient monitor or other device.

The TG-980P/TG-980P1 CO2 Sensor Kit can be connected via the interface connector and used with Nihon Kohden devices for which the operator's manual specifies compatibility with the TG-980P/TG-980P1.

This FDA 510(k) clearance letter pertains to a hardware device (CO2 Sensor Kit) and not an AI/ML software. Therefore, many of the requested criteria regarding AI-specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC study) are not applicable.

However, I can extract the relevant acceptance criteria and details of the non-clinical performance studies conducted for the device.

Acceptance Criteria and Device Performance (Non-AI Device)

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

The document provides the performance specifications for the CO2 Sensor Kit, rather than explicit "acceptance criteria" in the typical sense of a target for a specific study. The reported device performance is compared to the predicate device's performance.

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

The document states that Nihon Kohden conducted "non-clinical bench testing" as part of design verification and validation. It does not specify a "sample size" in relation to patient data or a test set of clinical cases. The testing appears to be primarily laboratory-based engineering verification and validation, rather than clinical studies with human subjects. Thus, there is no mention of data provenance in terms of country of origin or retrospective/prospective studies.

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)

Not applicable, as this is a hardware device primarily undergoing bench testing against engineering specifications and recognized standards, not a diagnostic AI/ML device requiring expert-established ground truth from clinical cases.

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

Not applicable. Adjudication methods are typically relevant for clinical studies involving multiple human readers interpreting results, especially for AI/ML devices. This device underwent non-clinical 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

Not applicable. This is a hardware CO2 sensor, not an AI-assisted diagnostic tool.

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

This is fundamentally a standalone hardware device performing a direct physiological measurement. Its performance is evaluated intrinsically through engineering tests and comparison to established standards, rather than as an "algorithm only without human-in-the-loop performance" in the context of AI. The measurements are presented on a host device, but the sensor itself performs the CO2 measurement.

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

The "ground truth" for evaluating this device's performance relies on physical and engineering measurement standards and reference gases. For example, CO2 partial pressure accuracy is measured against known concentrations of CO2 gases under controlled conditions. Similarly, response times, respiration rate accuracy, and environmental tolerances are measured against calibrated physical standards and established test methods outlined in the cited consensus standards (e.g., ISO 80601-2-55).

8. The sample size for the training set

Not applicable. This is a hardware CO2 sensor, not an AI/ML device that requires a training set.

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

Not applicable. (See answer to #8).

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The CO2 Sampling lines are the single patient, disposable device intended for monitoring expired gases from the patient.
Environment of use – hospital, sub-acute, and pre-hospital settings.
Patient population – Patients requiring expired gas monitoring.

Barbaras Development Inc. CO2 Sampling lines are the accessories in breathing system and intended for sampling of exhaled gases for monitoring, typically end-tidal CO2.

The Barbaras Development Inc. CO2 sampling lines are used to connect between the patient's end of the breathing system and the distant analyzer, such as the capnograph monitor, along this tube, the patient's breath is continuously sampled. the gas sampling is exhaust only and there is no gas flow back to patient.

The Barbaras Development Inc. CO2 Sampling Lines are a disposable, single patient use that allow to sample of patients exhaled gases. It consists of flexible extruded plastic tubes with and standard connectors on each end. We will present several different configurations like have the filter or without filter in the middle which have been tested and compared to predicates.

The Barbaras Development Inc. CO2 Sampling Lines are offered in the following models: 0184 CO2 Sampling line, 0184T CO2 Sampling line, 0139 CO2 Sampling line, 0182 CO2 Sampling line.

Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling line are connected to the monitor via a standard luer fitting, whether it is a female or male fitting.

The provided FDA 510(k) clearance letter details the clearance of CO2 Sampling lines manufactured by Barbaras Development Inc. The clearance is based on substantial equivalence to a predicate device, Tylenol Medical Instruments Co., Ltd - K181981 - CO2 sampling line, and a reference device, ProMedic – Gas Sampling Lines – K023579.

It's important to note that this document is a 510(k) summary for a medical device that is an accessory (CO2 sampling lines) and not an AI/ML powered diagnostic or prognostic tool. Therefore, many of the requested elements, such as MRMC studies, effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, adjudication methods, and training set details, are not applicable to this type of device and are not present in the provided text. The evaluation focuses on physical characteristics, material compatibility, and basic performance parameters against established standards.

Here's the breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes "Non-Clinical Testing Summary" and "Performance testing" categories, indicating that these were the acceptance criteria for the device. The reported performance is generally stated as "performed equivalent to the predicate" and "All testing demonstrated that the subject devices are substantially equivalent to the predicate." No specific numerical results are provided in this summary.

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

The document does not specify the sample size used for the non-clinical testing (test set) or any specific data provenance beyond the general statement that testing was performed.

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

Not applicable. This device is a passive accessory (CO2 sampling line) and does not involve subjective interpretation or diagnosis by experts to establish a "ground truth" as would be the case for an AI-powered diagnostic device. Its performance is measured against engineering standards and functional equivalence.

4. Adjudication Method for the Test Set

Not applicable. There is no "ground truth" established by experts that would require an adjudication method for this type of device. Performance is determined by objective physical and functional tests against industry 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. This letter is for a CO2 sampling line, which is a physical accessory, not an AI-powered medical device.

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

Not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation is established through objective engineering standards and performance specifications (e.g., ISO 80369-7 for luer fittings, ISO 80601-2-55 for flow/leaks, and ISO 10993 for biocompatibility) and comparative functional equivalence to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML or algorithm-based device.

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

Not applicable. This device does not involve a training set.

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AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.

AIM is a single-use, non-sterile bite block with integrated oxygen (O2) delivery and expired gas sampling tubing for patients undergoing procedures where supplemental oxygen and expired gas sampling is required expired. When paired with an oxygen supply and a capnography monitor, AIM can be left in place after the procedure to deliver oxygen and monitor CO2 levels.

AIM consists of a bite block, an attached oxygen delivery line and an attached CO2 sampling line. It delivers oxygen and samples exhaled CO2 in the oropharynx.

The provided text describes a 510(k) summary for a medical device named AIM, which is a bite block with integrated oxygen delivery and expired gas sampling tubing. The summary compares AIM to a predicate device, DualGuard™ (K140473), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets these criteria, based on the provided document:

Acceptance Criteria and Device Performance Study for AIM

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes performance tests by comparing the AIM device to its predicate, DualGuard™. The acceptance criteria appear to be equivalent or better performance than the predicate device.

Note: The primary acceptance criterion for many of the performance and mechanical tests is "Comparison to predicate," implying that the AIM device must perform equivalently or better than the legally marketed predicate device.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices tested) for the performance, mechanical, or aging tests. It mentions "All AIM samples passed the non-clinical tests, and all samples passed the performance tests..." which suggests that all units tested within the sample passed, but the size of "all samples" is not quantified.
• Data Provenance: The study appears to be retrospective in the sense that it's a submission for regulatory clearance based on historical testing. The data originates from simulated conditions (e.g., "simulated oxygen delivery," "simulated EtCO2 values," "simulated respiratory conditions"). The geographic origin of the data/testing is not explicitly stated, but as it's an FDA submission, the testing would typically be conducted under recognized standards, often implicitly in the US or by labs adhering to US-acceptable standards.

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

Not applicable. This device is not an AI/ML device that generates diagnostic outputs requiring expert interpretation for ground truth. The acceptance criteria relate to physical performance (FiO2, EtCO2, mechanical properties) measured by instrumentation under simulated conditions, compared against a predicate device. There is no mention of human expert adjudication for ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. As noted above, the ground truth is based on physical measurements and comparisons to a predicate device, not human interpretation or consensus.

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

No, an MRMC study was not done. This type of study is typically performed for AI-assisted diagnostic devices where human readers interpret medical images or data. The AIM device is a physical medical device for oxygen delivery and CO2 monitoring, not an AI diagnostic tool.

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

Yes, in a sense, the performance tests for FiO2, EtCO2, and CO2 waveforms were evaluative of the device's standalone performance under simulated conditions, without direct human intervention as part of the measurement process itself. The "algorithm" here refers to the physical design and function of the device rather than a computational algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests (FiO2, EtCO2, CO2 Waveforms) was established by:

• Instrumental measurement under simulated conditions: The values of FiO2 and EtCO2, and the characteristics of CO2 waveforms, were presumably measured by calibrated instruments under controlled, simulated physiological conditions.
• Comparative equivalence to a legally marketed predicate device: The performance of the AIM device was directly compared to the performance of the DualGuard™ predicate device under the same simulated conditions. The predicate device's performance effectively served as a reference or "ground truth" for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. The AIM device is a physical medical device, not an AI/ML model that requires a training set of data.

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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The Oxy2Pro is a single patient, disposable procedural mask with access for the insertion of oral scopes, probes, delivery of supplemental oxygen and monitoring breathing by providing a means to sample exhaled CO2. It is for nonintubated, adult patients who are breathing spontaneously.

The Southmedic Oxy2Pro is designed to have a flexible, thin membrane that is intended to be breached when requiring oral access for scope entry. This slitted membrane is intended to allow the mask to return to a closed- mask functionality after having been used with a scope. This device is to be used in conjunction with FDA cleared capnographs.

Here's a breakdown of the acceptance criteria and study information for the Oxy2Pro device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria for the Oxy2Pro mask was that its performance for FiO2 (fraction of inspired oxygen) and EtCO2 (end-tidal carbon dioxide) should not be statistically significantly less than the predicate device (K172365) at the tested flow rates.

The study results demonstrate the following:

The document concludes that the "Oxy2Pro mask was not statistically significantly less than the predicate for FiO2 or EtCO2 at the tested flow rates, meeting the acceptance criteria."

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

• Sample Size for Test Set: Not explicitly stated in terms of a number of masks or subjects. The document mentions "testing was completed under simulated conditions at various flow rates." This implies a series of measurements were taken at different flow rates, but the number of devices tested or repetitions of each test is not specified.
• Data Provenance: The testing was "completed to evaluate the ability to deliver FiO2 and sample EtCO2 relative to the predicate device." It was performed by an "Accredited third-party testing" organization. The location of this organization and whether the data is retrospective or prospective is not specified. Given the context of a 510(k) submission, it is likely prospective testing specifically conducted for this submission.

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

N/A. This information is not relevant or applicable to the type of performance testing described. The "ground truth" (or reference standard) in this context is the measured FiO2 and EtCO2 values under controlled simulated conditions, using calibrated equipment. It does not involve expert interpretation or consensus.

4. Adjudication Method for the Test Set

N/A. As the testing involved objective measurements under simulated conditions, there was no need for an adjudication method by experts.

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

N/A. This type of study is typically performed for AI/image analysis devices where human readers provide interpretations. The Oxy2Pro is a medical device for oxygen delivery and CO2 sampling, and its performance is evaluated objectively through physical measurements, not human interpretation.

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

N/A. This concept is for software algorithms. The Oxy2Pro is a physical device; its performance is standalone in the sense that it functions physically to deliver oxygen and sample gas.

7. Type of Ground Truth Used

The ground truth used was simulated conditions with true baseline EtCO2 at 5%. This implies a controlled environment where the actual concentration of inspired oxygen and exhaled CO2 was known and measured with high precision using reference instruments.

8. Sample Size for the Training Set

N/A. The Oxy2Pro is a physical medical device, not an AI or machine learning algorithm, so there is no training set in this context.

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

N/A. As there is no training set, this question is not applicable.

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Endure ETCO2/O2 Nasal Cannula has two functions

• 1. It is intended to deliver supplemental Oxygen to patients and

2. to obtain CO2 sampling of exhaled air

Environment of use: The device is intended to be used in hospitals, surgery centers and other acute care centers.

Patient population: Patients requiring supplemental Oxygen and/or requiring CO2 monitoring. Intended for patients above 12 years of age.

Endure Industries has designed an ETCO2/O2 nasal cannula and an exhaled gas sampling device. The features include sampling of CO2 from exhaled air to a capnograph. It can provide supplemental O2 and sample exhaled air at the same time. The device is configured in such a way that it has a nasal cannula with a division to deliver oxygen through one nares and sample exhaled gases through the other.

The provided text describes the 510(k) premarket notification for the Endure ETCO2/O2 Nasal Cannula (K213767). It indicates that the device is substantially equivalent to a legally marketed predicate device (K010024 Oridion Nasal CO2/O2 Cannula). The document focuses on demonstrating this equivalence, rather than setting and proving acceptance criteria in the traditional sense of a clinical trial for a new therapeutic or diagnostic device.

However, based on the information provided, we can infer the "acceptance criteria" through the comparative performance testing and the "study" that proves the device meets (or is equivalent to) those criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the Endure ETCO2/O2 Nasal Cannula performs similarly or identically to the predicate device (Oridion K010024) in key functional areas.

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

The document does not specify a distinct "test set" in terms of patient data or a specific number of devices. The performance testing appears to be primarily laboratory-based comparisons between the proposed device and the predicate.

• Test Set Sample Size: Not explicitly stated for performance tests. The comparison of physical measurements, CO2 sampling, and O2 flow rates implies a limited number of devices were tested against each other.
• Data Provenance: Not applicable in the context of patient data for the performance comparison. The tests were likely conducted in a controlled lab environment. The document states "Age testing done with cannulas manufactured in 2019" which suggests a retrospective analysis of previously manufactured devices for aging studies.

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

Not applicable. This is not a study requiring expert clinical assessment for ground truth. The performance testing involves objective measurements (e.g., CO2 levels, O2 flow, physical dimensions) and adherence to standards (e.g., ISO 10993, ISO 18562).

4. Adjudication Method for the Test Set

Not applicable. There is no clinical imaging or diagnostic interpretation involved that would require an adjudication method like 2+1 or 3+1.

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 medical accessory for delivering oxygen and sampling CO2, not an AI-powered diagnostic tool.

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

Not applicable. This is a hardware device, not an algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility: Compliance with international standard ISO 10993-1 and ISO 18562. This represents established biological safety standards.
• For Performance Testing (CO2, O2, Physical): Comparison against the performance of the legally marketed predicate device (K010024 Oridion Nasal CO2/O2 Cannula). The predicate device's performance established the "ground truth" or benchmark for equivalence.
• For Age Testing/Shelf Life: Laboratory-based aging studies where the performance of aged devices is compared to new devices (and found equivalent to "cannulas manufactured in 2022").

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

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

Not applicable.

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Intended use The Dräger CO2 Mainstream Sensor for measuring the CO2 concentration in breathing gas (CO2 mainstream sensor).

Indications The CO2 mainstream sensor enables the diagnosis and monitoring of patients by measuring CO2. The use of the medical device is limited to one patient at a time.

The CO2 Mainstream Sensor is designed for continuous, non-invasive mainstream measurement of Carbon Dioxide. The sensor is able to monitor CO2 using an infrared absorption technique and measures end tidal CO2 and inspired CO2 and calculates the respiratory rate. The data are processed by a microcontroller and provided to the parent device via a serial interface.

The sensor is adapted to the breathing system by airway adapters (CO2 measuring cuvettes).

Here's a summary of the acceptance criteria and study information for the CO2 Mainstream Sensor, based on the provided FDA 510(k) premarket notification:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics of the CO2 Mainstream Sensor with corresponding reported values in a consolidated format. However, it mentions extensive testing against various standards, which imply certain performance criteria. The key performance-related mention is the "Measuring range," which has been slightly extended compared to the predicate device.

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

The document does not explicitly state the sample size for specific performance tests or studies like clinical trials in terms of the number of patients or specific data points. The testing mentioned is primarily bench testing and in vitro evaluations against technical standards and requirements.

The data provenance is not specified beyond indicating "extensive testing" and "well-established methods." It's reasonable to infer these tests were conducted by the manufacturer (Drägerwerk AG & Co. KGaA) in Germany, given the submitter's location. The studies appear to be retrospective in nature, drawing from the predicate device's established performance and applying new testing to demonstrate equivalence or improvement.

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 ground truth for testing in the context you describe (e.g., radiologists for image interpretation). The testing conducted is primarily objective, technical verification and validation against pre-defined standards and specifications for a CO2 sensor. Therefore, the "ground truth" for the test set would be derived from:

• Reference gases with known concentrations for CO2 measurements.
• Calibrated instruments for temperature, humidity, pressure, and electrical measurements.
• Standardized test procedures and benchmarks for software, EMC, and safety.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned, as this type of human expert consensus is not typically applicable to the kind of technical and bench testing described for this device. Test results would be compared directly to the specified standards and requirements.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. The CO2 Mainstream Sensor is a measurement device where its output is directly read rather than interpreted by multiple human readers in a comparative setting.

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

Yes, the testing described appears to be primarily standalone performance testing, focusing on the algorithm (implicitly, the sensor's measurement principle and data processing) and hardware of the device itself. The "Discussion of Non-clinical Testing" section lists various technical evaluations, including software, electrical safety, EMC, and specific performance requirements from ISO 80601-2-55 for respiratory gas monitors. These are conducted on the device's inherent capabilities without human intervention for interpretation as part of the performance evaluation.

7. The Type of Ground Truth Used

The ground truth used for the technical testing would be:

• Reference Standards: Such as known concentrations of CO2 for accuracy testing, established environmental conditions (temperature, humidity, pressure), and defined electrical safety limits.
• Calibration Standards: High-precision instruments used to calibrate and verify the accuracy of the sensor's measurements.
• Compliance to Standards: The device's performance is measured against predefined thresholds and specifications outlined in the various IEC and ISO standards listed (e.g., ISO 80601-2-55 specific requirements for respiratory gas monitors).

8. The Sample Size for the Training Set

This device appears to be based on an established measurement principle (infrared absorption), and the submission focuses on demonstrating substantial equivalence through non-clinical testing rather than development of a novel algorithm that would require a "training set" in the machine learning sense. Therefore, there is no mention of a training set sample size as it's not applicable to the development verification of this type of device.

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

As there is no "training set" mentioned in the context of machine learning, this question is not applicable to the information provided. The principles the device operates on are well-understood physics, and the validation relies on meeting established technical specifications and standards rather than learning from a dataset.

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The Endoscopy Oxygen Mask is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.

The Endoscopy Oxygen Mask is a multi-port mask that serves several functions: A standard oxygen mask for when a patient requires supplemental oxygen; Sampling of exhaled gases for monitoring, typically end-tidal CO2; Additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and sampling exhaled gases.

The provided document describes the Endoscopy Oxygen Mask (K220533) and its substantial equivalence to a predicate device, the Panoramic Oxygen Mask (POM) (K172365). The acceptance criteria for the new device are primarily demonstrated through comparative non-clinical testing against the predicate device, showing similar performance in key aspects.

Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format for each performance metric. Instead, it relies on demonstrating similarity or equivalence to the legally marketed predicate device (K172365) through non-clinical comparative testing. The performance is reported in terms of this similarity.

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

The document does not specify a "sample size" in terms of number of patients or clinical samples because it describes non-clinical comparative performance testing using simulated patient settings. Therefore, there is no data provenance in terms of country of origin or retrospective/prospective study design as this was not a clinical study.

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

This information is not applicable. The study was non-clinical and did not involve human experts establishing ground truth for a test set. Performance metrics were based on simulated parameters and physical measurements.

4. Adjudication method for the test set

This information is not applicable as there was no test set requiring expert 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

This information is not applicable. This device is an Oxygen Mask with Gas Sampling, not an AI-assisted diagnostic tool involving human readers.

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

This information is not applicable. This is a medical device, not an algorithm. The performance testing was for the device itself in simulated environments.

7. The type of ground truth used

For %CO2 accuracy and Respiration rate, the "ground truth" was established by simulated patient settings at different breath rates, tidal volumes, and known CO2 concentrations.

For Biocompatibility, the "ground truth" was established by standards such as ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 18562-2.

8. The sample size for the training set

This information is not applicable. There was no "training set" as this is not a machine learning or AI-based device.

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

This information is not applicable as there was no training set.

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