Search Results

The Capnostream™35 monitor is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.

The Capnostream™35 monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up . The OxiMax SPD™ alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Nellcor™ respiration rate parameter is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Other than the OxiMax SPD™ alert and Nellcor™ respiration rate features, the device is intended for use in hospitals, hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.

The microMediCO2 module provides the following inputs to the host monitor: EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).

The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2, Pulse Rate, Respiratory Rate, and saturation pattern detection (SPD) parameters to the host for display. The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.

The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

The device is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.

This document is a 510(k) summary for the Capnostream™ 35 Portable Respiratory Monitor. It details the device's indications for use, technological characteristics, and performance data from non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics like accuracy, precision, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices through validation of software functions, usability testing, and wireless connectivity.

• Software Validation: "to ensure that all modified software functions as intended."
  • Reported Performance: Passed. Implicitly, the software performed as expected and intended.
• Cybersecurity Documentation: "identified cybersecurity risks and summarized how they were mitigated."
  • Reported Performance: Cybersecurity risks were identified and mitigated.
• Usability Testing (per IEC 60601-1-6): "assessed the ability of 15 intended users with varying levels of experience to perform key tasks as well as understand Capnostream™35′s display."
  • Reported Performance: Passed.
• Wireless Connectivity Testing: "The wireless communication testing passed for all wireless key types compatible with the device."
  • Reported Performance: Passed.

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

• Usability Testing:

  • Sample Size: 15 intended users.
  • Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. It's implied to be prospective testing specific to this device.

• Other tests (Software, Cybersecurity, Wireless Connectivity): Sample sizes for data points are not specified, as these are typically functional or engineering tests rather than studies on a "test set" of patients or data records.

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

This information is not provided in the document. The listed tests (software validation, usability, wireless connectivity) do not typically involve establishing a clinical "ground truth" derived from expert consensus in the same way a diagnostic algorithm might. Usability testing relies on user feedback, and software/connectivity validation relies on engineering specifications.

4. Adjudication method for the test set

This information is not provided as it's not applicable to the types of tests described. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving expert interpretation, which is not what was performed for these non-clinical tests.

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

There is no indication that an MRMC comparative effectiveness study was done. The device description and performance data focus on device functionality and its equivalence to predicates, not on AI assistance to human readers or effect sizes of such assistance. The device is a monitor, not an AI diagnostic tool.

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

The performance data listed (software validation, usability, wireless connectivity) are for the device as a standalone product in terms of its functions. There is no mention of an "algorithm only" performance study separate from the device's integrated operation. The device itself performs continuous non-invasive monitoring and provides specific parameters and alerts.

7. The type of ground truth used

• Software Validation: The "ground truth" is adherence to predefined software requirements and specifications.
• Usability Testing: The "ground truth" is the successful and easy completion of key tasks by users and their understanding of the display, measured against usability objectives.
• Wireless Connectivity Testing: The "ground truth" is successful connection and data transmission/reception according to wireless communication standards and protocols.

These are functional and engineering "ground truths," not clinical ones like pathology or expert consensus on patient conditions.

8. The sample size for the training set

This information is not provided. The document describes non-clinical performance tests of a medical monitor, not the development or training of a machine learning algorithm.

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

This information is not provided, as there is no mention of a training set or ground truth establishment for algorithm training in the context of this device's K200594 submission.

Ask a specific question about this device

The Capnostream™35 is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.

The Capnostream™35 also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.

The device is intended for use in hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.

The microMediCO2 module provides the following inputs to the host monitor:

EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).

The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2 and Pulse Rate parameters to the host for display.

The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.

The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

The device is intended for use in hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for AI/Machine Learning devices. Instead, it describes a medical device (Capnostream™35 Portable Respiratory Monitor) undergoing a 510(k) submission for substantial equivalence to predicate devices, focusing on regulatory compliance, safety, and general performance testing.

Therefore, many of the requested fields regarding AI/ML study details (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) cannot be extracted from this document.

However, I can extract information related to the device's general performance testing and intended use, which are analogous to acceptance criteria and their verification in a non-AI/ML context.

Here's an interpretation based on the provided text, focusing on the closest available information to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with numerical targets as they would be for an AI model's precision or recall. Instead, the device's "performance" is considered in relation to meeting standards and demonstrating substantial equivalence to predicate devices.

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

• Not applicable for AI/ML device. The document describes non-clinical performance and safety testing against engineering standards and comparison to predicate devices, not AI model evaluation with specific test sets of patient data.

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

• Not applicable. This pertains to clinical data labeling for AI/ML, which is not described here.

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

• Not applicable. This pertains to expert consensus for AI/ML ground truth, which is not described here.

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 such study was mentioned. This is not an AI-assisted device.

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

• No standalone algorithm performance study was described in the context of AI/ML. The device itself is a standalone monitor, and its "performance" was evaluated through engineering tests and comparison to predicates.

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

• Ground truth in this context typically refers to established engineering specifications, performance standards (e.g., ISO, IEC), and the known performance of the predicate devices. For instance, the accuracy of CO2 measurement would be validated against calibrated gas mixtures, and SpO2 against controlled hypoxia studies, which are the "ground truth" for those physiological parameters under specific test conditions. The document states "Appropriate safety, environmental and performance tests were conducted to ensure that the specifications of the Capnostream™35 were met."

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Summary of the Study (as described in the document):

The "study" described is a non-clinical performance testing and substantial equivalence assessment for product clearance. It involves:

• Performance Testing: Conducted according to specific ISO standards (ISO 80601-2-55, ISO 80601-2-61) for the respective measurement parameters (capnography and pulse oximetry).
• Electrical Safety Testing: Performed per IEC standards (IEC 60601-1, IEC 60601-1-8, IEC 60601-2-49, IEC 60601-1-12, IEC 60601-1-6).
• Electromagnetic Compatibility (EMC) Testing: Performed per IEC 60601-1-2.
• Environmental Testing: Verification of features like IP54 rating, shockproof status, sunlight readability, hot swap battery, and altitude capacity.
• Software Testing: To validate performance and substantial equivalence.
• Wireless Communication Testing: According to FDA guidance for wireless medical devices.
• Hazard Analysis: Conducted in compliance with ISO 14971:2012 to assess and mitigate risks.

The overarching goal was to demonstrate that the Capnostream™35 Portable Respiratory Monitor has the "same intended use, technological characteristics and performance as its predicate devices" and that its functionality in new intended environments (out-of-hospital EMS) was verified through testing against relevant standards. The document concludes that "Testing did not raise any concerns when compared to its predicate devices therefore the subject device is substantially equivalent to its predicate devices."

Ask a specific question about this device