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The ReDe Mask is indicated for use by healthcare facility procedural areas and recovery rooms as an adjunct to monitor breathing in adult patients who are sedated for a diagnostic or therapeutic procedure. The ReDe Mask measures the time period between the current and previous exhalation and illuminates a colored light during the exhalation that reflects the interval of time between breaths. If the interval is less than 7.5 seconds, the green light illuminates during exhalation; if the interval is greater than 7.5 seconds, the yellow light illuminates during exhalation; and if the interval between breaths is 20 seconds or longer, the red light flashes continuously. The ReDe Mask is only to be used when supplemental oxygen is provided by the facemask. The ReDe Mask is not a standalone device and is only to be used as an adjunct to pulse oximetry.

The ReDe Mask is a breathing frequency monitor that provides a visual signal at each breath event (i.e., an inhalation followed by an exhalation). The proposed device consists of a temperature-sensing circuit attached externally to a standard face mask. This circuit continuously analyzes the temperature inside the face mask and determines when a breath event has occurred.

The ReDe Mask is designed to detect breathing events (cycles of inhalation followed by exhalation) by measuring temperature changes in the immediate vicinity of a patient's nose and/or mouth. Exhalations produce a temperature warming as expired air exits the mouth and nose, while inhalations result in a temperature cooling as ambient air and supplied oxygen enter the mask. The overall pattern is thus one of repeating periods of a warming and a cooling phase with every breath. The rate of warming and cooling, that is, the slope of the temperature change (degrees C per unit time) depends on the vigor with which the patient is breathing, which can range from very shallow breathing (small slope values) to vigorous breaths (large slope values). The ReDe Mask's breath detection algorithms are based on continuously measuring the warming and cooling slopes coupled with real-time analysis to determine the changeover point from negative slope (inhalation phase) to positive slope (exhalation phase). It is the detection of inflection points in the slope (negative to positive) that yield the elapsed time period between successive breaths. With each new breath the elapsed time between inflection points is used to determine which LED to illuminate.

This document focuses on the ReDe Mask, a breathing frequency monitor. 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 tabular format with specific numerical targets. However, the various bench, biocompatibility, and clinical tests imply performance requirements. I will derive implied acceptance criteria and reported performance from the text.

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

• Human Factors and Usability Validation (Study 1): 30 anesthesia care providers. Provenance not explicitly stated (likely prospective, conducted for this submission).
• Human Factors and Usability Validation (Study 2): Complete spectrum of healthcare providers who may use the device. Provenance not explicitly stated (likely prospective, conducted for this submission), "conducted inside the intended environment of use."
• Comparison of Accuracy With Capnograph: 38 individuals (non-patient volunteers). Provenance not explicitly stated (likely prospective, conducted for this submission).
• Comparison of Accuracy With ExSpiron and Capnograph: 50 individuals (non-patient volunteers). Provenance not explicitly stated (likely prospective, conducted for this submission).

The document does not specify the country of origin for these studies, but they were conducted in support of an FDA 510(k) submission, suggesting they align with US regulatory standards.

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)

The ground truth for the clinical accuracy comparisons was established using objective measurement devices:

• Capnograph (end-tidal CO2 measurements): Described as the "gold standard in monitor the breathing rate of a patient."
• ExSpiron (bioimpedance measurements): Used in conjunction with the capnograph.

The human factors and usability studies involved "anesthesia care providers" and "the complete spectrum of health care providers who may use the device." Their "correct interpretation" and "overwhelming positive feedback" served as an evaluation of usability, rather than ground truth generation for medical conditions.

No specific number or qualifications of "experts" (e.g., radiologists) were mentioned for establishing ground truth in the context of identifying medical conditions, as the device is a breathing monitor rather than a diagnostic tool.

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

The document does not describe an adjudication method like "2+1" or "3+1" that would typically be used for expert consensus on diagnostic imaging. Instead, the accuracy studies compared the ReDe Mask's performance directly against established measurement devices (capnograph, ExSpiron). For human factors studies, a "study monitor observed and recorded any instances of subject difficulty, mishandling and/or misuse." This suggests direct observation and recording rather than a consensus-based adjudication process.

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, an MRMC comparative effectiveness study was not done. The ReDe Mask is a breathing frequency monitor, not an AI-assisted diagnostic tool that would typically involve "human readers" or "AI assistance" in the context of interpreting medical images or data. The studies focused on its standalone performance and usability compared to established medical monitoring devices and user interfaces.

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

Yes, standalone performance was assessed in the "Comparison of Accuracy With Capnograph" and "Comparison of Accuracy With ExSpiron and Capnograph" studies. In these studies, the ReDe Mask's detection of exhalation and low respiratory rates was compared directly with the capnograph and ExSpiron, without human intervention in the ReDe Mask's core function of detecting breaths and illuminating lights. The human involvement was in observing these lights and verifying their accuracy against the reference devices.

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

The ground truth used for the accuracy studies was based on objective measurements from:

• Capnograph: Considered the "gold standard in monitor the breathing rate of a patient," measuring end-tidal CO2.
• ExSpiron: A bioimpedance measurement device.

8. The sample size for the training set

The document does not provide information on a "training set" or "validation set" in the context of machine learning, as the ReDe Mask's breath detection relies on a temperature-sensing circuit and algorithms, rather than being explicitly described as an AI/ML device requiring significant training data. The "bench testing" and "clinical testing" described are for verification and validation of the device's performance against its specifications and predicate devices.

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

As no specific "training set" is mentioned for an AI/ML model, the establishment of ground truth for such a set is not applicable based on the provided text. The device's breath detection algorithms are based on "continuously measuring the warming and cooling slopes coupled with real-time analysis to determine the changeover point from negative slope (inhalation phase) to positive slope (exhalation phase)." This suggests a rule-based or signal processing approach rather than data-driven machine learning that would require a distinct training set with ground truth labels.

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Use of the Fukuda Denshi model DS-7141 Portable Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, STlevel and yentricular arrhythmias), respiration, non-invasive and or invasive blood pressure, temperature, pulse oximetry and/or CO2. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-7141 is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7141s also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

The DS-7141 Portable Patient Monitor is a pre-configured monitor meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR or recovery areas of the hospital or clinic. An optional Battery Pack Operation allows the DS-7141 to be used to rouito, patients during intra-hospital transport. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the systems recorder.

The DS-7141 is an addition to the DS-7100 Series Patient Monitor Line up. (K032290). It is the same as the predicate devices in that it uses identical hardware and software which allows for the monitoring of EEC, RESP, SpO2m BP, NIBP and Temp. It additionally includes identical telemetry capabilities as the predicate. The DS-7141 adds EtCo2 monitoring capability to the DS-7100 series of Portable Patient Monitors by the integration of a MediCO2 MicroStream TM module which was designed and manufactured by Oridion and previously cleared under 510(k) (K964239).

The DS-7141is a self contained monitors which include an 8.4 inch TFT color LCD display which can display up to 6 waveforms. All input operation is performed on the monitors touch screen controls. Additional standard features include an Ethernet LAN for connection to Fukuda Denshi Central Stations, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously and an alarm pole feature on the top of device that alerts to alarm conditions through 9 corresponding flashing patterns.

The provided text describes a 510(k) submission for the Fukuda Denshi DS-7141 Portable Patient Monitor, focusing primarily on its equivalence to previously cleared devices rather than extensive new clinical studies with detailed acceptance criteria and performance metrics.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table for the DS-7141 itself, beyond general "performance specifications" being met. The core of this submission relies on demonstrating substantial equivalence to predicate devices and adherence to recognized standards.

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

The document does not specify a distinct "test set" with a defined sample size in the context of clinical data for algorithmic performance. The testing described is more aligned with product verification and validation (safety, environmental, performance specifications, and adherence to standards) rather than a clinical trial evaluating algorithmic accuracy against a ground truth dataset in the typical sense of AI/ML device testing.

The provenance of data is not mentioned in terms of country of origin or whether it was retrospective or prospective, as it does not appear to be a study of patient data.

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

Not applicable. This submission is about a patient monitor with integrated components, not an AI/ML diagnostic or prognostic device that relies on expert interpretation of output to establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

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

No. The document makes no mention of an MRMC study or any studies involving human readers, with or without AI assistance. The device is a patient monitor, not an interpretive AI system for imaging or other complex data.

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

Not explicitly a "standalone" algorithmic study in the modern sense. The "host testing" of the integrated MediCO2 MicroStream™ module at the OEM facility would evaluate its performance specifications in isolation before integration, which could be considered a form of standalone testing for that specific component. However, this is for a physiological measurement device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be derived from:

• Engineering Specifications and Benchmarks: For parameters like accuracy of measurements (ECG, SpO2, NIBP, Temp, EtCO2), stability, and response times.
• Standardized Test Conditions: Environmental testing (temperature, humidity, vibration), electrical safety tests.
• Reference Devices: Performance of integrated modules (e.g., EtCO2) would be compared to known accurate reference devices or established functional standards.

8. The Sample Size for the Training Set

Not applicable. The document does not describe an AI/ML algorithm that would have a "training set" in the context of machine learning model development.

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

Not applicable, as there is no described training set for an AI/ML algorithm.

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The Polaris 2004 Capnograph is intended for the continuous, non-invasive measurement and monitoring or respiration rate and carbon dioxide concentration of the expired and inspired breath of neonatal, pediatric and adult patients wherever these measurements are required by attending medical personnel.

The Oridion Polaris Capnograph (the device being modified-K950388) is a device that measures end tidal CO2 (EtCO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR). The capnograph module of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status.

This 510(k) summary does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as it primarily focuses on demonstrating substantial equivalence to a predicate device. However, it does reference compliance with a standard.

Here's an attempt to extract and infer information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The document primarily discusses device modifications and equivalence to a predicate, not performance testing on a specific "test set" of patient data.

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

This information is not provided in the document. As no specific "test set" or clinical study with patient data results are detailed, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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 mention of an MRMC study. This device is a capnograph, a medical instrument that measures physiological parameters. It does not appear to involve image interpretation or AI for diagnostic assistance to human readers.

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

This information is not explicitly stated as a "standalone" study in the context of an algorithm. However, the device itself, the Polaris 2004 Capnograph, operates independently to measure and display CO2 and respiration rate. The document implies that its performance (e.g., accuracy of CO2 measurement) was validated against the EN864 standard. This standard would dictate the methods for testing the device's inherent measurement capabilities.

7. The Type of Ground Truth Used

The primary "ground truth" referenced for performance is the EN864 standard for capnographs. This standard likely specifies objective criteria and methods for evaluating the accuracy and performance of carbon dioxide analyzers, which would involve calibrated gas mixtures or other validated reference methods.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a hardware medical instrument for physiological measurement, not an AI/machine learning algorithm that requires a "training set" of data in the conventional sense.

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

This information is not applicable/not provided for the same reasons as point 8.

Summary of what the document implies about validation:

The primary "study" proving the device meets acceptance criteria is the demonstration that the modified Polaris 2004 Capnograph conforms to the EN864 standard for capnographs. The 510(k) process for this device relies heavily on the concept of substantial equivalence to a previously cleared predicate device (Polaris Capnograph K950388). The document emphasizes that the modifications introduced (e.g., MiniMediCO2 module, aluminum manifold, removal of water trap with Filterline K980324) do not alter the fundamental safety, efficacy, or intended use, and leverage components or concepts already cleared by the FDA in other devices (e.g., MiniMediCO2 module in Microcap K981114, Filterline in K980324). Therefore, the "proof" is largely based on demonstrating that these changes maintain the performance characteristics of the predicate device and meet an internationally recognized standard.

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The MicroCap Plus /NPB-75 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and of arterial oxygen saturation (SpO2) and pulse rate.

The Oridion MicroCap Plus/NPB-75 (the device being modified) (K964239) is an integrated instrument that measures end tidal CO2 (EtCO2) and saturated arterial oxygen (SpO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR) and as a derivative of the saturated arterial oxygen measurement the devices measure and display the pulse rate (PR). The capnograph section of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status. The pulse oximeter module in both devices measures the oxygenated hemoglobin (HbO>) and displays the results as a percent of oxygen and as a plethysmographic waveform.

The provided text describes the MicroCap Plus/NPB-75 device, a combination oximeter/carbon dioxide gas analyzer. The document is primarily a 510(k) summary for a modification to an existing device, specifically changing the pulse oximeter module. However, it does not contain specific acceptance criteria, study details, or performance data for demonstrating the device meets any acceptance criteria. It mainly focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as these details are not present in the provided document.

The document only states:

• Device Description: The MicroCap Plus/NPB-75 measures end tidal CO2 (EtCO2), saturated arterial oxygen (SpO2), breath rate (BR), and pulse rate (PR).
• Substantial Equivalence: The modified device (using the NPB MP507 SpO2 module) is substantially equivalent to the predicate device (using the MP204 module) in terms of indications for use and technological characteristics. The MP507 is described as an "improved version" of the MP204.
• Intended Use: For continuous, non-invasive measurement and monitoring of CO2 concentration, respiration rate, arterial oxygen saturation (SpO2), and pulse rate by trained healthcare providers in various critical care settings.

Without a performance study section or specific testing results, it's impossible to derive the requested information.

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The indications for use for the Passport 2™ include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3 or 5 lead measurements
• Heart Rate derived from selected sources (SpO2, ECG, IBP, NIBP)
• Blood Oxygenation (SpO2 )* measurement/waveform
• ST Segment Analysis
• . . Lethal Arrhythmia Detection
• Non Invasive Blood Pressure (NIBP) measurement
• . Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites
• Respiration Rate/ waveform derived from ECG or CO2
• CO2 . Inspired and end tidal mainstream/waveform
• Temperature measurement via YSI 400/700 series probes
  The target populations are adult, pediatric and neonate with the exception of the Lethal Arrhythmia Detection and ST Segment Analysis for which the target populations are adult and pediatric only. The monitor is intended for use in the health care facility setting.
  The Passport 2 has the capability of interfacing with Datascope's Gas Module II, displaying the measurements of Anesthetic Gases, O3, N2O, and CO2.

• The Passport 2 monitors the SpO2 parameter via the Masimo SET® 2000 Pulse Oximeter Technology and Accessories (K990966). The Masimo SET® 2000 Pulse Oximeter Technology and Accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO,) and pulse rate (measured by an SpO2, sensor) and are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities. mobile, and home environments.

Passport 2 is a transportable, multi-parameter physiological monitor designed to monitor ECG, Heart Rate derived from selected source (SpO2, ECG, IBP and NIBP), SpO2 level, ST Segment (adult and pediatric only), Arrhythmia (adult and pediatric only), Blood Pressure (both Invasive and Non-Invasive), Respiration Rate (derived from ECG or CO2), CO2 and Temperature, and for adult, pediatric, and neonatal patients who are under the care of a physician, within the confines of a health care facility.
The Passport 2 can display measurements of five Anesthetic Gases (Halothane, Enflurane, Isoflurane, Sevoflurane, and Desflurane), O2, No O, and CO2 via connection to the stand alone Gas Module II ( K974903). The optional MediCO2 Microstream™ CO2 module (K964239), which uses the Oridion Microstream™ CO2 provides EtCO2, FiCO2 and Respiration Rate monitoring.
The optional built-in recorder provides hard copies of all digital data and waveforms as well as Tabular & Graphic Trend Information. Through its Comm Port the Passport 2 can communicate with the Visa Central Station (K913576), Gas Module II (K974903), Defibrillator (K930548), a Hospital's Nurse Call System or a Remote Color Display.

The provided 510(k) summary for the Datascope Passport 2™ Vital Signs Monitor describes its intended use and general performance testing, but it does not contain specific acceptance criteria tables nor detailed studies proving the device meets those criteria.

Instead, the document primarily:

• Identifies legally marketed predicate devices to establish substantial equivalence.
• States that the device has undergone "extensive safety and performance testing" to ensure it "meets all functional requirements and performance specifications" and complies with various industry standards (e.g., ANSI/AAMI EC13, IEC 60601-1 series).
• Mentions that certain components (NIBP system, SpO2 system, CO2 module, Gas Module II) are identical to or incorporate technology from previously cleared devices, making their performance substantially equivalent by reference.

Therefore, many of the requested details about specific acceptance criteria and the studies proving their achievement are not explicitly present in the provided text.

However, I can extract and infer information where possible based on the text provided.

Acceptance Criteria and Device Performance

The document does not provide a table of specific numerical acceptance criteria for each physiological parameter (e.g., accuracy range for NIBP, arrhythmia detection sensitivity/specificity) and the reported performance. It only states that the device was tested to "meet all functional requirements and performance specifications."

For example, for Non-Invasive Blood Pressure (NIBP), it notes:

• Acceptance Criteria (Implied): The NIBP measurement system used in the Passport 2 is the same as that used in Datascope's Accutorr Plus NIBP monitor (K983575). Therefore, the implied acceptance criteria would be those met by the Accutorr Plus, likely conforming to standards like ANSI/AAMI SP-10.
• Reported Device Performance: Not explicitly stated for Passport 2, but stated to be "identical" to the Accutorr Plus NIBP monitor.

Similarly, for SpO2:

• Acceptance Criteria (Implied): The SpO2 measurement system is the same as that used in the Masimo SET 2000 Pulse Oximeter (K974903 and K990966). The implied acceptance criteria would be those met by the Masimo SET 2000, likely conforming to standards like ISO 80601-2-61.
• Reported Device Performance: Not explicitly stated for Passport 2, but stated to be "identical" to the Masimo SET 2000 Pulse Oximeter.

For other parameters (ECG, Arrhythmia, Respiration Rate, CO2, Temperature), the document states that the Passport 2 was tested to comply with relevant standards (e.g., ANSI/AAMI EC13 and EC 11, AAMI ECAR-1987, EN 864-1997, EN 865-1997, IEC 60601-2-27, IEC 60601-2-30). However, the specific performance values (e.g., error margins, sensitivity/specificity rates) are not quantified in this summary.

Detailed Study Information (Based on Available Text)

Since no specific studies are detailed within this 510(k) summary, the following points are based on what can be inferred or stated as not provided:

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

   • Not provided in this summary. The document broadly states that the device "meets all functional requirements and performance specifications" and complies with various standards. For NIBP and SpO2, it refers to the performance of previously cleared devices whose technology is incorporated.

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

   • Not provided in this summary. Details on specific test subjects (number, age, health status) or the nature of data (retrospective/prospective, origin) for any performance testing are absent. The primary testing mentioned is "safety and performance testing" which generally implies in-house verification and validation, possibly against simulators or human subjects for certain parameters, but details are missing.

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 provided in this summary. Ground truth establishment, if applicable to the device's functions (e.g., for arrhythmia detection comparison), is not discussed. For vital sign monitors, ground truth is typically established by reference devices or calibrated instruments.

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

   • Not provided in this summary. Adjudication methods are typically relevant for subjective assessments or expert consensus in interpretation tasks, which are not detailed here for a vital signs monitor.

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/Not provided. This device is a vital signs monitor, not an AI-assisted diagnostic tool that involves "human readers" interpreting "cases" or "effect sizes of human improvement with AI." Its function is direct physiological measurement and display.

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

   • Yes, implied. The device itself is a standalone monitor that performs measurements (e.g., ECG, NIBP, SpO2) and algorithms (e.g., arrhythmia detection, ST segment analysis) without requiring human interpretation for its core function. Testing would focus on the accuracy and reliability of these algorithms against reference standards. The summary states "Final testing for the monitor included various performance tests designed to ensure that the device meets all functional requirements and performance specifications." This directly points to standalone performance testing.

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

   • Implied by device type. For vital signs monitors, ground truth is typically established using:
     • Reference standard instruments: For parameters like SpO2 (e.g., co-oximetry), NIBP (e.g., invasive arterial line measurement or a highly accurate reference NIBP device), Temperature (calibrated thermometer).
     • Standardized waveforms/inputs: For ECG feature detection (e.g., arrhythmia detection, ST segment analysis), validated databases of ECG signals or simulated signals with known characteristics may be used.
   • Explicit details are not in the summary.

8. The sample size for the training set:

   • Not applicable/Not provided. This document describes a traditional medical device, not a machine learning or AI-based system that uses a "training set" in the context of data-driven model development. The algorithms for vital sign processing in this device would have been developed through engineering principles, signal processing, and physiological modeling, not through training on large datasets in the modern AI sense.

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

   • Not applicable/Not provided. As stated above, there is no "training set" in the AI/ML sense described for this device.

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NIBP

The LIFEPAK®12 NIBP monitor non-invasively measures blood pressure of the adult and pediatric patients by professionally trained health care providers. It is not designed for continuous, unsupervised monitoring.

EtCO2

The use of the LIFEPAK®12 EtCo2 monitor is indicated whenever professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.

The LIFEPAK®12 defibrillator / monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system.
The users will be Advanced Life Support and Basic Life Support providers in a variety of hospital and pre-hospital settings. Emergency Medical Services users will include Paramedics and Emergency Medical Technicians trained and authorized to respond to medical emergencies. This device will be used in the pre-hospital setting and in the hospital, in critical areas (emergency departments, critical care, operating rooms, etc.) and on general duty floors (e.g. medical/surgical). It will also be used for patient transport (air and ground ambulance, in hospital transport, etc.)

Here's an analysis of the provided text regarding the acceptance criteria and study data for the NIBP and CO2 Options for the Physio-Control LIFEPAK®12 Defibrillator / Monitor System:

Based on the provided 510(k) summary, specific, quantitative acceptance criteria and the detailed study that proves the device meets those criteria are not explicitly described in the provided text. The document focuses primarily on establishing substantial equivalence to predicate devices and adherence to industry standards, rather than presenting a standalone performance study with detailed acceptance criteria and results.

However, we can infer some information from the text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit quantitative acceptance criteria are not provided. The document states that the device is subject to "extensive safety and performance testing" and that "Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."

The closest we get to "acceptance criteria" are the standards to which the device complies, implying that meeting the requirements of these standards constitutes acceptable performance.

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

• Sample Size for Test Set: Not specified. The document mentions "performance tests" and "safety testing" but does not provide any details about the number of subjects or cases used in these tests.
• Data Provenance: Not specified. There is no information provided about the country of origin of any testing data, nor if the data was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. There is no mention of any expert consensus or adjudication process for establishing ground truth during testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No. The provided text does not mention any multi-reader multi-case comparative effectiveness study or any evaluation of human reader improvement with or without AI assistance. This document describes a modification to a medical device (defibrillator/monitor) with NIBP and CO2 options, which are sensors/measurement tools, not AI-driven diagnostic interpretation tools.

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

• Standalone Performance Study: The document focuses on the device's performance in meeting standards and functional specifications. While "performance tests" are mentioned for the system, it's not described as an "algorithm only" study in the context of typical AI/software device standalone performance. The NIBP and CO2 functions are direct measurements, not an algorithm providing a diagnosis or interpretation that would typically have a "standalone" or "human-in-the-loop" comparison.

7. The Type of Ground Truth Used

• Type of Ground Truth: This is not explicitly stated as pathology, outcomes data, or expert consensus in the traditional sense. For NIBP and CO2 measurement, the "ground truth" would typically refer to accepted, gold-standard reference measurement methods. The document states compliance with standards like ANSI/AAMI SP-10-1992 and EN 864, which themselves define reference methods and accuracy requirements for such measurements. Therefore, the ground truth would be implicitly derived from these established reference measurement techniques as per the specified standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. This document describes a hardware device with integrated measurement capabilities (NIBP and CO2). There is no mention of an AI algorithm that would require a "training set" in the context of machine learning.

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

• Ground Truth for Training Set: Not applicable/Not specified. As there's no mention of a machine learning component requiring a training set, this information is not relevant to the provided text.

In summary: The 510(k) summary provided focuses on establishing substantial equivalence to predicate devices and adherence to recognized performance and safety standards. It does not contain the detailed, quantitative efficacy study results, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in submissions for novel diagnostic algorithms or AI-driven systems. The "studies" referred to are generally compliance tests against established engineering and medical device standards.

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THE MICROSTREAM FILTERLINE OR/EMS DEVICE IS USED WHENEVER THE PHYSICIAN NEEDS TO MEASURE THE CO2 IN AN INTUBATED PATIENT'S BREATHING.

The common product name for our accessory is a gas sampling tube. The gas sampling tube is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a male Luer lock at one end of the device for connecting to the airway adapter in the ventilator or anesthesia machine airway and a female Luer lock on the other end for connecting to the capnograph. The two connectors are joined by a plastic tube and an in line hydrophobic filter. One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar which draws a sample of the patient's breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation. The most common way (for intubated patients) to connect the sampling tube to a point where it can get a sample of the patients breathing is to connect one end of the sample tube to a point on the ventilator or anesthesia machine airway circuit. The anesthesiologist sometimes places a hydrophobic filter between the sample line and the capnograph to keep moisture from entering the capnograph. The Microstream Filterline OR/EM has integrated an in line hydrophobic filter between the patient and the Capnograph to reduce the amount of patient generated moisture that can enter the capnograph.

The provided text is related to a 510(k) premarket notification for a medical device called "Microstream Filterline OR/EMS". This document describes the device, its intended use, and its substantial equivalence to a previously approved device. However, it does not include information about acceptance criteria or a study proving the device meets acceptance criteria as typically understood for performance metrics of a device or algorithm.

The document is a regulatory submission for premarket clearance, which is focused on demonstrating substantial equivalence to a predicate device, not necessarily on detailing performance studies with specific statistical outcomes against acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the provided text does not contain it. The concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as outlined in the prompt (e.g., in terms of sensitivity, specificity, or improvement with AI assistance) is not present in this regulatory document, which focuses on device description and regulatory clearance.

The document's purpose is to get the device approved for market based on its similarity to an already approved device, rather than to present detailed performance study results that would typically include acceptance criteria tables, sample sizes, ground truth establishment, or AI-related metrics.

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THE MICROSTREAM FILTERLINE NC DEVICE IS USED WHENEVER THE PHYSICIAN NEEDS TO MEASURE THE CO₂ IN A PATIENT'S BREATHING IN A NON INTUBATED PATIENT.

The common product name for this device is a gas sampling nasal cannula . The gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a nasal cannula at one end of the device for connecting to the patient's nose and a female Luer lock on the Other end for connecting to the capnograph. The design and construction of the nasal cannula is almost identical to the nasal oxygen cannula 21 CFR 868.5340. The main difference is that instead of flowing oxygen through the cannula to the patient we use a vacuum to draw a sample of the breathing from the patient.

The two connectors are joined by a plastic tube and an in line hydrophobic filter.

One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar which draws a sample of the patient's Breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation.

The anesthesiologist sometimes places a hydrophobic filter between the sample line and the capnograph to keep moisture from entering the capnograph. The microstream nasal cannula filterline has integrated an in line hydrophobic filter between the patient and the capnograph to reduce the amount of patient generated moisture that can enter the capnograph.

The provided text describes a 510(k) submission for a medical device called the "Microstream Nasal Cannula Filterline." This submission focuses on establishing substantial equivalence to a previously approved device rather than presenting a de novo study with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth cannot be extracted from this document, as it is not a clinical study report.

Here's an analysis of the provided information relative to your request:

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

• Not Applicable. The document does not provide a table of acceptance criteria or performance metrics. This submission is for a 510(k) and relies on demonstrating "substantial equivalence" to a predicate device (K964239), not on proving specific performance against predefined criteria in a new clinical study. The FDA's letter states, "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

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

• Not Applicable. There is no mention of a test set with a specific sample size. The submission is based on the claim that the device is "identical to the same device described as an accessory to the NPB-75/microcap capnograph/pulse oximeter in approved submittal K964239." This implies that the performance data for the predicate device is being leveraged, rather than new performance data for this specific accessory.

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. No ground truth establishment is described, as there is no new test set or clinical study presented in this document.

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

• Not Applicable. No test set or adjudication method is described.

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 gas sampling line accessory for a capnograph, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

• Not Applicable. This is a hardware accessory, not an algorithm. Standalone performance as described is not relevant.

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

• Not Applicable. No ground truth is described because no new clinical study is presented for this 510(k). The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set

• Not Applicable. This device is a physical accessory, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

• Not Applicable. As above, there is no training set for this type of device.

Summary of available information:

The document is a 510(k) premarket notification for a Class II medical device (Microstream Nasal Cannula Filterline). Its purpose is to demonstrate substantial equivalence to an already approved predicate device (mentioned in K964239). The device is a "gas sampling nasal cannula" designed to conduct a sample of the patient's breathing from the nose to a capnograph for CO2 measurement, featuring an integrated hydrophobic filter. The FDA found the device substantially equivalent.

No clinical study data, performance metrics, or specific acceptance criteria are provided in this submission, as the regulatory pathway chosen (510(k)) for this type of device relies on demonstrating equivalence rather than conducting new efficacy or performance trials.

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