Search Results

The IRMA mainstream gas analyzer is intended to be connected to other medical devices for monitoring of breath rate and the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane 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. IRMA CO2 may also be used in the emergency medical services environment and road ambulances.

Note: An IRMA mainstream gas analyzer shall only be connected to medical backboard devices approved by PHASEIN.

IRMA is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical backboard device for display of respiratory parameters. IRMA is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the M80 device as a host backboard display to IRMA. There are no changes to the previously cleared sensor technology.
The following IRMA models are available:
a) IRMA CO2 (model/catalogue number 200101), measurement of CO2.
b) IRMA AX+ (model/catalogue number 200601), measurement of CO2, N2O and anesthetic agents with automatic agent identification
The IRMA product family also includes the adult and pediatric/infant Airway Adapter. A modura holder and velcro holder are offered as optional accessories.

The provided 510(k) summary for the IRMA - Infrared Mainstream Gas Analyzer (K123043) describes the device, its intended use, and comparison to predicate devices, but it does not explicitly list quantitative acceptance criteria or a detailed study proving the device meets specific performance metrics.

However, based on the information provided, we can infer the acceptance criteria and the nature of the study:

Inferred Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion is substantial equivalence to the predicate devices (ISA - Infrared Sidestream Gas Analyzer, K103604, and VEO Multigas Monitor for Pocket PC, K081601) in terms of performance, safety, and effectiveness. The reported device performance is that it met or exceeded these criteria.

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

(See table above)

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

• Sample Size: Not explicitly stated. The document mentions "calibrated gas samples" and "legally marketed anesthesia and ventilation devices," but no specific number of samples or devices is provided.
• Data Provenance: Not explicitly stated. The testing was described as "in direct comparison to predicates," suggesting laboratory or simulated use environments rather than clinical patient data. There is no mention of 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:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It's likely that the "ground truth" for gas concentrations was established by the calibrated gas samples themselves rather than human experts, and the performance with anesthesia/ventilation devices was assessed against their known specifications.

4. Adjudication method for the test set:

• Adjudication method: Not described. Given the nature of objective gas measurement, it's unlikely that human adjudication (e.g., 2+1, 3+1) was used for establishing ground truth regarding gas concentrations. The comparison would be against known reference values from calibrated samples.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a gas analyzer, not an AI-assisted diagnostic tool that requires human interpretation of images or other data.

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

• Standalone Performance: Yes, implicitly. The device itself performs the gas analysis. The "testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices." This implies evaluating the device's ability to accurately measure gases against a known standard (calibrated gases) and its functional compatibility with other medical equipment, without direct human intervention in the measurement process itself. The IRMA is a sensor that interfaces with a "medical backboard device for display of respiratory parameters," indicating its standalone measurement capability.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for gas concentration measurements was established using calibrated gas samples. For compatibility and functional testing, the "legally marketed anesthesia and ventilation devices" would serve as a benchmark for expected performance and integration.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable or not specified. This device is an infrared gas analyzer, a sensor technology, not a machine learning or AI-based system that typically uses a "training set" in the conventional sense. Its "training" would be inherent in its design, calibration, and manufacturing process based on physics and spectroscopy principles, rather than a data-driven model.

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

• Ground Truth for Training Set: Not applicable in the context of an AI/ML training set. For a physical device like this, the "ground truth" for its development would be based on established scientific principles of infrared spectroscopy and gas analysis, validated through rigorous engineering design, component selection, and manufacturing quality control.

Ask a specific question about this device

The ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for display of real time and derived monitoring data of the following breathing gases:

ISA CO2: CO2

ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.

ISA is a sidestream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to a Host/Backboard Device for display of respiratory parameters. ISA is connected to the patient breathing circuit via the Nomoline sampling line that includes a water separation section and a bacteria filter.

The following ISA models are available:

a) ISA CO2 (model/catalogue number 800101), measurement of CO2.
b) ISA AX+ (model/catalogue number 800601), measurement of CO2, N2O and 5 Anesthetic agents with automatic agent identification
c) ISA OR+ (model/catalogue number 800401), measurement of CO2, O2, N2O and 5 Anesthetic agents with automatic agent identification (includes paramagnetic oxygen sensor).

The ISA product family also includes the disposable Nomoline sampling line. A clamp adapter and modura holder are offered as optional accessories.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on a comparative evaluation against a predicate device. The performance is reported as being "equivalent or superior" to the predicate.

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

The document mentions "Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices."

• Sample Size: Not explicitly stated. The phrase "throughout the operating range" suggests a comprehensive set of conditions were tested, but the specific number of samples or data points is not provided.
• Data Provenance: The testing was conducted by Phasein AB (Sweden).
  • Country of Origin: Sweden.
  • Retrospective or Prospective: The testing appears to be prospective, specifically designed to evaluate the performance of the new device against the predicate.

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

The study relies primarily on a comparison against a "legally marketed anesthesia and ventilation devices" and "calibrated gas samples." This implies that the "ground truth" was established by the known concentrations of the calibrated gas samples and the established performance of the predicate device.

• Number of Experts: Not applicable in the traditional sense of human experts interpreting data. The ground truth seems to be objectively defined by the calibrated gas samples and the predicate's known performance.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth was established by calibrated gas samples and the predicate device's performance, not by expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is a gas analyzer, not an imaging or diagnostic device that typically involves human readers. The comparison was device-to-device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Yes, this was a standalone performance study. The ISA device's performance in analyzing gases was directly compared to a predicate device and calibrated gas samples. There is no mention of a human-in-the-loop component for the measurement of the gases, although the output data is intended for display to medical professionals who would then interpret it.

7. Type of Ground Truth Used:

The ground truth used was a combination of:

• Calibrated Gas Samples: Standardized gas mixtures with known concentrations, providing an objective ground truth for gas measurement accuracy.
• Performance of a Predicate Device: The Datex-Ohmeda S/5 (K051092) was used as a benchmark, implying its established and legally marketed performance served as a form of ground truth for comparison.

8. Sample Size for the Training Set:

The document does not describe a "training set." The testing performed was for efficacy and safety against a predicate, not for training an algorithm. This device is an infrared gas analyzer, which operates on physical principles of gas absorption rather than machine learning algorithms that typically require training data.

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

Not applicable, as there was no mention of a training set or machine learning algorithm.

Ask a specific question about this device

The VEO Multigas Monitor for Pocket PC, model 400601 is intended to provide monitoring of CO2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room and emergency medicine settings for adult, pediatric and infant patients.

The VEO Multigas Monitor for Pocket PC, model 400601 is a miniature mainstream infrared gas analysis bench. The complete multigas analyzer is contained within a transducer that is attached to the breathing circuit via an airway adapter.

The provided text is a 510(k) summary for the VEO Multigas Monitor for Pocket PC, model 400601. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information required to answer all your questions about acceptance criteria and the specific study proving the device meets those criteria.

Here's what can be extracted and what information is missing:

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

Missing Information: Specific numerical acceptance criteria (e.g., accuracy, precision ranges for gas measurements, response time) and the detailed results demonstrating how the device met these criteria.

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

Missing Information: The document states "Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices," but it does not specify the sample size of these tests or the data provenance. It implies prospective testing in a controlled lab environment with calibrated gases and existing devices.

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)

Missing Information: This document does not describe the use of human experts to establish ground truth for the device's performance. The ground truth for gas measurement devices typically comes from reference standards (calibrated gas samples) and other validated measurement instruments, not human expert interpretation in the way it would for imaging diagnostics.

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

Missing Information: Not applicable as the testing involves comparison to calibrated references and predicate devices, not subjective expert assessment requiring 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

Missing Information: This is not an AI-assisted diagnostic device, but a multigas monitor. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant or described.

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

The device is a "Multigas Monitor," implying standalone measurement. The testing described ("Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices") indicates a standalone performance evaluation against quantifiable standards. The device itself is not an "algorithm" in the typical sense of AI, but rather hardware and software that measures gas concentrations.

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

The ground truth for this type of device would likely be:

• Calibrated gas samples: Known concentrations of CO2, N2O, and anesthetic agents used as a reference.
• Measurements from legally marketed anesthesia and ventilation devices (predicates): These would serve as established, validated reference values for comparison.

Missing Information: While implied, the document doesn't explicitly state the exact "type" of ground truth used beyond "calibrated gas samples."

8. The sample size for the training set

Missing Information: As this document does not describe a machine learning or AI algorithm in the context of a "training set," this information is not provided and likely not applicable in the way you're conceptualizing it for an AI device. The device's underlying technology relies on established infrared gas analysis principles and sensor calibration, not a data-driven training process in the AI sense.

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

Missing Information: Not applicable for the reasons stated in point 8.

Ask a specific question about this device

The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.

The provided text describes the EMMA Emergency Capnometer and states that testing was done in direct comparison to predicates throughout the operating range using calibrated gas samples and legally marketed anesthesia and ventilation devices. The conclusion was that the device demonstrated performance, safety, and effectiveness equivalent or superior to its predicates in all characteristics. However, the document does not explicitly detail specific acceptance criteria or provide a table of reported device performance against those criteria.

Given the information provided, I can only address some of your questions.

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

The provided text does not contain a specific table of acceptance criteria with corresponding reported device performance values. It only generally states that the device "demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics."

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

The text mentions "calibrated gas samples" but does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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 is not applicable as the study involved "calibrated gas samples and legally marketed anesthesia and ventilation devices" rather than human-interpreted data requiring expert consensus for ground truth.

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

This is not applicable, as there's no indication of human adjudication for the device performance 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a capnometer, not an AI-assisted diagnostic tool for human readers.

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

The testing described ("Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices") inherently represents a standalone performance evaluation of the EMMA Emergency Capnometer. There is no mention of a human-in-the-loop component for the performance assessment itself.

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

The ground truth was established by "calibrated gas samples" and the performance of "legally marketed anesthesia and ventilation devices" (presumably as a reference standard for comparison with the device's measurements).

8. The sample size for the training set

The device is a hardware capnometer, not based on a machine learning algorithm that requires a training set. Therefore, a training set is not applicable or mentioned.

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

As there is no training set for this type of device, this question is not applicable.

Ask a specific question about this device

The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.

The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.

The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.

The provided 510(k) summary for the EMMA Emergency Capnometer focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study with specific performance metrics. Therefore, many of the requested details are not explicitly present in the document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

The documentation does not provide specific quantitative acceptance criteria (e.g., a target accuracy range for CO2 concentration or respiratory rate) with corresponding reported device performance. Instead, it states a general conclusion about equivalence or superiority.

The key statement is from section 12: "The EMMA Emergency Capnometer demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics."

Study Information

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

   • Sample Size: Not specified.
   • Data Provenance: The study involved "calibrated gas samples and legally marketed anesthesia and ventilation devices." This suggests a laboratory or bench testing environment. There is no information regarding country of origin or whether the data was retrospective or prospective in a clinical setting.

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

   • Number of Experts: Not mentioned.
   • Qualifications of Experts: Not mentioned. The ground truth was likely established by the "calibrated gas samples" (known concentrations) and possibly measurements from the "legally marketed anesthesia and ventilation devices" (which would have their own validated measurement capabilities).

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. The study appears to be a direct comparison against a known standard (calibrated gas) and established medical devices, rather than a subjective assessment requiring expert adjudication.

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:

   • Was an MRMC study done? No. This device is an emergency capnometer, a medical measurement device, not an AI-powered diagnostic tool requiring human reader interpretation. The study described is a device-to-device performance comparison.

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

   • Yes, implicitly. The testing described ("Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices") is a standalone performance test of the device itself, without human interpretation of its outputs being part of the primary evaluation.

6. The type of ground truth used:

   • Ground Truth Type: A combination of "calibrated gas samples" (representing a known, accurate CO2 concentration) and measurements from "legally marketed anesthesia and ventilation devices" (which are themselves considered accurate and reliable benchmarks). This is akin to a reference standard or benchmarking against established, validated measurement systems.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device does not appear to be an AI/machine learning product requiring a training set in the conventional sense. Its development and validation are based on established engineering principles for gas analysis.

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

   • Not applicable/Not mentioned, as there is no mention of a training set for an AI/ML model.

Summary of Device Performance and Equivalence Claim:

The 510(k) submission for the EMMA Emergency Capnometer establishes substantial equivalence primarily through direct comparative testing against its predicate devices (Tidal Wave Model 610, Novametrix Medical Systems Inc. and VEO Multigas Monitor for Pocket PC, Phasein AB). The "testing vs. predicates" section (11) indicates that the device was compared using "calibrated gas samples and legally marketed anesthesia and ventilation devices" across its operating range. The conclusion (12) states that the EMMA Emergency Capnometer "demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics." This implies that the device's accuracy in measuring CO2 concentration and respiratory rate was found to be at least as good as, if not better than, the predicate devices when tested under controlled conditions.

Ask a specific question about this device