Search Results

The intended use of the Philips NM3 Respiratory Profile Monitor, Model 7900, is to provide:

• cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
• spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
• continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).
  The intended use of the VentAssist software option is to provide:
• non-invasive monitoring of work of breathing per minute in adult patients receiving pressure support mechanical ventilation.
• on-demand advice in mechanically ventilated adult patients as prescribed by the caregiver regarding (a) modifications to the current pressure support settings in order to assess the work of breathing and breathing pattern and (b) modifications to ventilation in order to maintain end-tidal CO2 in a range determined by the physician. The patients should be hemodynamically stable and must be breathing spontaneously.

The NM3 monitor with VentAssist is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography and pulse oximetry in all of these clinical settings. It is intended to serve all of the same purposes as the flow, carbon dioxide, pulse oximetry, and cardiac output monitoring components of the predicate NM3 monitor with the addition of the optional VentAssist software.
Combination CO2 adapter/flow sensors (neonatal, pediatric, adult), combination adult CO2 adapter/flow sensors with a partial rebreathing valve and flow sensors (infant/neonatal, pediatric/adult) are connected with a male pneumatic connector to the NM3 monitor. Sidestream airway adapters and nasal cannulas are available which are connected with a sample cell connector to a receptacle on the LoFlo Module which can be interfaced to the NM3 monitor. All of these sensors are already legally marketed as accessories of 510(k) cleared Respironics-Novametrix NM3 monitor. The pulse oximetry sensors are connected to the NM3 monitor via a connector on the front panel of the monitor. All of the pulse oximetry sensors are already legally marketed as accessories of the 510(k) cleared NM3 monitor and Masimo predicate devices.
The principal function of the flow portion of combination sensors and flow sensors is to provide a differential pressure signal related to flow and airway pressure relative to atmospheric pressure. These sensors are often placed in the breathing circuit between the endotracheal tube and the ventilator circuit Y piece and may also be used in conjunction with a face mask or mouthpiece. The flow measurement portion of the NM3 monitor consists of a microprocessor-based data acquisition system that measures flow, and pressure and interfaces with a Capnostat 5 CO2 sensor. The CO2 airway adapter portion of the combination sensors, allow the Respironics-Novametrix CO2 mainstream gas sensor, the Capnostal® 5, to attach to it and measure the concentration of CO2 in the airway using infrared technology. When CO2 measurements are combined with airway flow and volume measurements, other parameters such as CO2 production and dead space can be calculated in all patient populations. The Capnostat 5 sensor as a mainstream gas analyzer includes a sample cell positioned in the breathing circuit through which a patient's inspiratory and expiratory gases flow. The LoFlo module, a sidestream type of gas analyzer, samples gases at 50 ml/min from a sampling port in an adapter placed in a breathing circuit or from a nasal or oral cannula. The gas then passes through a sampling tube to the sample cell, where the gas components are measured. The combination adult CO2 adapter/flow sensors with a partial rebreathing valve with periodic activation of the rebreathing valve allow pulmonary capillary blood flow and cardiac output to be calculated using the differential Fick method.
The VentAssist software option comprises a new screen with a soft key that provides ondemand ventilator-independent open-loop advice with respect to the level of pressure support and ventilation. As an advisory system, the clinician can choose to accept or reject the advice, alleviating any issues of safety and effectiveness. Additionally, an improved method for the calculation of plateau pressure has been included, as well as a new calculated parameter for work of breathing (WOB). The WOB parameter facilitates the goal of reducing excessive work of breathing per minute, or power of breathing (WOB/min), for mechanical ventilatory support in patients with respiratory failure. The WOB/min parameter is implemented using an Artificial Neural Net (ANN) and is used by the PSV Advisor software. The VentAssist PS/V Advisor is a rule based system which provides on-demand advice for the setting of the PSV level and ventilator support levels, based upon WOB/min, breathing frequency, tidal volume, ideal body weight, and end-tidal CO2. The advice is based upon a set of logic rules developed and refined in conjunction with experienced critical care clinicians at teaching University hospitals. Decision support advice offered by the VentAssist software is available during monitoring of adult patients. The monitor uses the sensor-type (adult, pediatric, or neonate), as well as patient data entered into the monitor, to enable appropriate features.

Here's a breakdown of the acceptance criteria and study information for the Philips NM3 Respiratory Profile Monitor with VentAssist, Model 7900, based on the provided text:

Important Note: The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices and describes the validation of the Work of Breathing (WOB/min) parameter and the PS/V Advisor. It does not provide a detailed table of specific acceptance criteria with numerical thresholds for performance, nor does it present the study results in a quantitative manner against those thresholds. Most of the information below is extracted from the "Validation" section and related descriptions.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit numerical acceptance criteria are not provided in the document. The validation focuses on the accuracy of WOB/min and the agreement with PS Advisor recommendations.

• Agreement with esophageal pressure measurement (cleared device: Bicore CP-100)
• Bias and precision of invasive vs. noninvasive WOB/min |
• "Validating the front end for esophageal pressure measurement with a cleared device, Bicore CP-100 Cardiopulmonary Monitor"
• "Comparing invasive measurements of WOB/min using the esophageal balloon to noninvasive measures of WOB/min derived from proximal flow and airway pressure data... (bias and precision of 0.84 ±2.2 J/min)" |
  | VentAssist PS/V Advisor (Clinician Agreement) |
• Clinician agreement with recommendations (implicit: high degree of agreement expected) |
• Two clinical studies conducted. One study: "clinicians agreed with the PS Advisor recommendations." (Published in Banner et al, Chest, 133(3):697-703, 2008)
• Second study: "similar but done blinded so the clinician was unable to see the recommendations of the PS Advisor." (No specific results provided in this document for the second study) |
  | VentAssist PS/V Advisor (Safety & Effectiveness) |
• As an advisory system, safety and effectiveness are supported by the clinician's ability to reject advice |
• "clinician can choose to accept or reject the advice, alleviating any issues of safety and effectiveness." |
  | WOB/min Algorithm Implementation |
• Proper implementation in the embedded system |
• "Validating that the WOB/min algorithm was properly implemented in the embedded system, the Philips NM3 Monitor." |

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

• WOB/min Validation: "ventilated adults in the ICU (MICU, CICU, SICU, burn unit, step-down unit) who were breathing spontaneously on pressure support ventilation."

  • Sample Size: Not explicitly stated.
  • Data Provenance: Prospective, collected from various ICU settings (MICU, CICU, SICU, burn unit, step-down unit). Country of origin is not specified but the context of "teaching University hospitals" for rule development suggests US-based.

• PS/V Advisor Clinical Studies:

  • Sample Size: Not explicitly stated for either study.
  • Data Provenance: Prospective, clinical studies. Country of origin not specified, but the context of "teaching University hospitals" for rule development suggests US-based. One study's results were published in "Banner et al, Chest, 133(3):697-703, 2008."

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

• WOB/min Validation:

  • Number of Experts: Not applicable in the context of ground truth for this parameter. Ground truth was established by invasive esophageal balloon measurements.
  • Qualifications: "experienced critical care clinicians at teaching University hospitals" were involved in the development and refinement of the logic rules, not in establishing ground truth for the WOB/min measurement itself.

• PS/V Advisor Clinical Studies:

  • Number of Experts: Not explicitly stated for the test set evaluation. The text indicates that the advice was based on "logic rules developed and refined in conjunction with experienced critical care clinicians at teaching University hospitals." These clinicians likely acted as the "experts" whose judgment was compared against the device's advice.
  • Qualifications: "experienced critical care clinicians at teaching University hospitals." No specific years of experience are listed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for either the WOB/min validation or the PS/V Advisor studies.

• For WOB/min, the comparison was directly between the device's measurement and invasive (esophageal balloon) measurements.
• For the PS/V Advisor, the first study involved clinicians agreeing or disagreeing with the recommendations. The second study was blinded. This implies a direct comparison of the device's advice to clinical judgment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a formal MRMC comparative effectiveness study, as typically understood in medical imaging or diagnostic contexts, was not described.
• The clinical studies for the PS/V Advisor involved clinicians evaluating the device's recommendations, which could be seen as a form of human-in-the-loop assessment. However, the document does not quantify an "effect size of how much human readers improve with AI vs without AI assistance" in terms of specific performance metrics. It rather indicates that clinicians "agreed with the PS Advisor recommendations."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, for WOB/min calculation: The "noninvasive work of breathing per minute parameter" was validated by comparing its autonomously calculated values to invasive measurements (bias and precision of 0.84 ±2.2 J/min). This represents the standalone performance of the WOB/min module.
• No, for PS/V Advisor: The VentAssist PS/V Advisor is explicitly an "advisory system" where the "clinician can choose to accept or reject the advice." Its validation inherently involves human interaction (clinician agreement).

7. The Type of Ground Truth Used

• Work of Breathing Per Minute (WOB/min): The ground truth was invasive measurements of WOB/min using the esophageal balloon.
• VentAssist PS/V Advisor: The ground truth for evaluating the advice was the judgment/agreement of experienced critical care clinicians. The logic rules themselves were developed in conjunction with these experts.

8. The Sample Size for the Training Set

• WOB/min Artificial Neural Net (ANN): The sample size for training the ANN is not mentioned.
• VentAssist PS/V Advisor (Fuzzy Logic Rules): The document states the rules were "developed and refined in conjunction with experienced critical care clinicians." It does not specify a distinct "training set" of patients or cases used solely for this development, but rather implies an iterative process with clinical expert input.

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

• WOB/min Artificial Neural Net (ANN): How the ground truth for training the ANN was established is not provided. It's common for such ANNs to be trained on data where the output (WOB/min) is derived from invasive measurements using standard physiological models.
• VentAssist PS/V Advisor (Fuzzy Logic Rules): The ground truth for developing and refining the fuzzy logic rules was established through collaboration and consensus with experienced critical care clinicians at teaching University hospitals. This involved their expertise in defining appropriate PSV levels and ventilation adjustments based on various patient parameters (WOB/min, breathing frequency, tidal volume, ideal body weight, and end-tidal CO2).

Ask a specific question about this device

The intended use of the Philips NM3 monitor, Model 7900 is to provide:

• cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
• spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
• continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).

The NM3 monitor Model 7900 and its sensors are intended to be used by trained operators when spirometric, capnographic, pulse oximetry, or cardiac output monitoring is indicated in the judgement of a physician.

The use of the NM3 monitor Model 7900 for cardiac output monitoring is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO2 level cannot be tolerated.

The Philips NM3 monitor is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography and pulse oximetry in all of these clinical settings. It is intended to serve the same purposes as the flow, carbon dioxide and pulse oximetry monitoring components of the predicate NICO with MARS monitor.

In the NM3 monitor as in the NCO system, combination CO2 adapter/flow sensors (neonatal, pediatric, adult), combination adult CO2 adapter/flow sensors with a partial rebreathing valve and flow sensors (infant/neonatal, pediatricladult) are connected with a male pneumatic connector to the NICO monitor. Sidestream airway adapters and nasal cannulas are available which are connected with a sample cell connector to a receptacle on the LoFlo Module which can be interfaced to the NM3 monitor. All of these sensors are already legally marketed as accessories of 510(k) cleared Respironics-Novametrix predicate devices. The pulse oximetry sensors are connected to the NM3 monitor via a connector on the front panel of the monitor. All of the pulse oximetry sensors are already legally marketed as accessories of 510(k) cleared Masimo predicate devices.

The principal function of the flow portion of combination sensors and flow sensors is to provide a differential pressure signal related to flow and airway pressure relative to atmospheric pressure. These sensors are often placed in the breathing circuit between the endotracheal tube and the ventilator circuit Y piece and may also be used in conjunction with a face mask or mouthpiece. The flow measurement portion of the NM3 monitor is contained in the Mercury module which consists of a microprocessor-based data acquisition system that measures flow, and pressure and interfaces with a Capnostat 5 CO2 sensor. The CO2 airway adapter portion of the combination sensors, allow the Respironics-Novametrix CO2 mainstream gas sensor, the Capnostat® 5, to attach to it and measure the concentration of CO2 in the airway using infrared technology. When CO2 measurements are combined with airway flow and volume measurements, other parameters such as CO2 production and dead space can be calculated. The Capnostat 5 sensor as a mainstream gas analyzer includes a sample cell positioned in the breathing circuit through which a patient's inspiratory and expiratory gases flow. The LoFlo module, a sidestream type of gas analyzer, samples gases at 50 ml/min from a sampling port in an adapter placed in a breathing circuit or from a nasal or oral cannula. The gas then passes through a sampling tube to the sample cell, where the gas components are measured. The combination adult CO2 adapter/flow sensors with a partial rebreathing valve with periodic activation of the rebreathing valve allow pulmonary capillary blood flow and cardiac output to be calculated using the differential Fick method.

I am unable to find the specific study and acceptance criteria within the provided text that would allow me to populate the table and fully answer all aspects of your request. The document is primarily a 510(k) summary for a medical device (Philips NM3 monitor), which outlines its intended use, technological characteristics, and substantial equivalence to a predicate device, but does not detail specific performance studies with acceptance criteria in the format requested.

The document states that the device includes components (flow sensors, CO2 sensors, pulse oximetry sensors) that are "already legally marketed as accessories of 510(k) cleared Respironics-Novametrix predicate devices" or "Masimo predicate devices." This suggests that the performance validation for these components might have been conducted and cleared under those previous 510(k) submissions, and this current submission is for the integrated "Philips NM3 monitor" system.

Therefore, many of the requested fields cannot be directly extracted from the provided text. To answer your complete request, information from detailed performance studies (which are typically part of a 510(k) submission but not fully contained in the summary provided) would be necessary.

Ask a specific question about this device

The intended use of the Mercury module with Capnostat 5 is to provide: spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.

The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intention norminds for monthsive non emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the flow and carbon dioxide monitoring component of the NICO monitor. The Mercury module with Capnostat 5 is the flow and carbon dioxide monitoring component of the presently 510(k) cleared NICO with MARS monitor. It has been designed to include all of the functionality of the flow and carbon dioxide monitoring components of NCO with CO massurament workilling for a with Capnostat 5 is intended to provide all of the existing flow and CO2 measurement capabilities of the NICO Model 7300 of continuous monitoring of respiratory flow and pressure, and CO2 during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostal 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.

The provided document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Mercury Module with Capnostat 5 CO2 Sensor, primarily focusing on its substantial equivalence to a predicate device and its intended use. It does not detail specific performance studies, acceptance criteria, or the methodology for proving these criteria.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided text.

Ask a specific question about this device

The intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

The LoFlo C5 CO2 sensor is designed for continuous, non-invasive sidestream monitoring of carbon dioxide. Carbon dioxide is measured on-airway using an infrared absorption (IR) technique. The airway adapters and associated nasal cannulas are already legally marketed as accessories to the predicate device. The LoFlo C5 CO2 sensor is an integrated microprocessor based data acquisition system consisting of CO2 measurement, control circuitry and a high speed serial interface. The LoFlo C5 CO2 sensor uses SRAM for data storage and an EEPROM to store system parameters. The firmware resides in a PROM. The operations performed by the LoFlo C5 CO2 sensor include data acquisition, parameter calculation, zeroing, heater control and corrections to the CO2 signal for N2O, O2 and barometric pressure.

The provided text is a 510(k) summary for a medical device (LoFlo C5 CO2 Sensor) and does not contain detailed information about acceptance criteria or specific study results that prove the device meets acceptance criteria. The document mainly focuses on describing the device, its intended use, technological characteristics, and its substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information about acceptance criteria and study details from this document.

The following information is NOT available in the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not specify any quantitative acceptance criteria or report performance metrics against such criteria.
2. Sample size used for the test set and the data provenance: No information on test set sample sizes or data provenance (country of origin, retrospective/prospective) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The concept of "ground truth" and expert involvement for a test set is not discussed.
4. Adjudication method for the test set: No information is given regarding adjudication methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: MRMC studies and effect sizes are not mentioned.
6. If a standalone study (algorithm only without human-in-the-loop performance) was done: Standalone performance testing is not detailed.
7. The type of ground truth used: The establishment of ground truth is not described.
8. The sample size for the training set: Training set information is not provided.
9. How the ground truth for the training set was established: Ground truth establishment for a training set is not discussed.

Ask a specific question about this device