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Intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a gas measurement device for measuring the percentage of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.

Similar to their predicates the devices are non-sterile, disposable, single patient use, intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a device for measuring the percentage of CO2 in the patient's exhalation when connected to a capnograph.

The device's main components are PVC tubing, airway adapter and a luer connector.

Microstream™ Advance Adult-Pediatric Intubated Filter Line can be used only with Microstream™ capnography technology.

Microstream™ Luer Adult-Pediatric Intubated Sampling Line can be used with any capnograph with a luer connection.

An Accessory (extension line) to the proposed devices: Microstream™ Advance Filter Line, MRI is composed of PVC tubing and a luer connector. It is Intended to be used when longer tubing is required to allow CO2 sampling for environments such as an MRI suite. The straight tubing is then connected to the FilterLine/ Sampling Line end from one side and from the other side to the monitor, which is placed outside of MRI suite.

The main reason for this submission is the modification of the CO2 tubing to material not made with phthalates.

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Microstream Luer Adult-Pediatric Intubated Sampling Line and Microstream Advance Adult-Pediatric Intubated Filter Line.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text outlines performance tests conducted, but it merges the acceptance criteria with the performance results. For clarity, I will present the acceptance criteria based on the "Same as predicate" statements and the performance reported when new criteria were established for the modified devices.

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

The document states that "Bench testing was conducted to ensure the devices' performance." This implies physical testing of the devices. However, the specific sample size (number of units tested) for the bench tests is not explicitly mentioned in the provided text.

The data provenance is laboratory-based bench testing of the physical devices. There is no indication of country of origin for the data or whether it was retrospective or prospective in the context of patient data, as this was a bench study.

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

This information is not applicable as the study described is a bench performance study and not a clinical study with a test set requiring expert ground truth establishment. The "ground truth" for these tests would be the established engineering and ISO standards for device performance (e.g., specific tensile strength, pressure drop limits).

4. Adjudication Method for the Test Set:

This information is not applicable as the study is a bench performance study and does not involve adjudication by experts for clinical outcomes or image interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable as the device is a physical medical device (sampling line) and not an AI-powered diagnostic or assistive tool.

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

This information is not applicable as the device is a physical medical device and does not have an algorithm for standalone performance.

7. The Type of Ground Truth Used:

For this bench study, the "ground truth" refers to established engineering standards, regulatory requirements (e.g., ISO 10993 for biocompatibility), and performance specifications derived from the predicate devices. For example, for tensile strength, the ground truth is "at least 2kg," and for leak tightness, "2 mBar/sec leak rate @ 100 mBar."

8. The Sample Size for the Training Set:

This information is not applicable as the study is a bench performance study of a physical device and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as in point 8.

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The Masimo Root Monitoring System and Accessories are indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances.

The Masimo Root Monitoring System and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).

The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories 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 hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multiparameter devices for the display of those devices.

The optional Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+) and accessories including Nomoline, intended to be connected to other medical backboard devices for monitoring of breath rate and 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, infant, and neonatal patients.

The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

The optional temperature module is indicated to measure temperature (oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

The Masimo Root Monitoring System and Accessories (Root) is a multifunctional device that monitors vital signs for neonatal to adult patients. Parameters monitored by Root are from cleared measurement modules and their corresponding accessories, consisting of:

• . Masimo Radical-7 and Radius-7 Pulse CO-Oximeter measurement modules and accessories (i.e. RD SET disposable sensors, RD Rainbow sensors, RAS-45 or RRa sensors) with technologies for the monitoring of non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and respiratory rate (RRa);
• Masimo Sweden ISA-Infrared Sidestream Gas Analyzer measurement modules (ISA) and accessories (Nomoline product family) with technologies for breathing gases and respiratory rate monitoring, including inspired/expired gases during anesthesia, recovery and respiratory care;
• Masimo Sedline Sedation Monitor measurement module and accessories (i.e. RD . Sedline EEG sensor) with technologies for state of the brain by real-time data acquisition and processing of EEG signals and Patient State Index (PSI) which is an EEG variable that is related to the effect of anesthetic agents;
• Temperature measurement module and accessories (i.e. temperature probe) with technologies for oral/axillary body temperature measurements; and
• . Non-invasive blood pressure measurement module and accessories (i.e. reuse and disposable pressure cuffs) with technologies for systolic, diastolic and mean arterial pressure (MAP) measurements.

Root is intended to be used as a user interface to facilitate access control and monitoring device functions. Root displays patient monitoring information from the connected modules. Visual alarms are shown on the Root display and audible alarms are generated through the Root internal speaker. The user accesses the wired or wirelessly connected modules' monitoring functions, using the Root display. When the module is disconnected from Root, the monitoring information from the module is no longer displayed on Root. Data from connected modules, including patient monitoring data, can be communicated to network systems such as the Patient SafetyNet (K071047) and hospital EMR. Root also functions as a pass-through means for communicating information between connected devices and network systems.

The Root under K151644 consists of various measurement modules, including the ISA product family (ISA) and corresponding accessories, Nomoline product family (Nomoline).

The provided text describes a 510(k) premarket notification for the Masimo Root Monitoring System and Accessories. It outlines the device's indications for use, technological characteristics, and a comparison to predicate devices, focusing on the ISA and Nomoline components.

No clinical studies are mentioned for the subject device to support acceptance criteria within this document. The document explicitly states: "Clinical testing was not performed with the subject device, Root with ISA and Nomoline, to support substantial equivalence."

Therefore, I can only provide information based on the non-clinical testing and general specifications mentioned.

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

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

The document provides "Specifications" for the Root system and the ISA module, which can be interpreted as acceptance criteria for the non-clinical tests conducted. The "reported device performance" is implicitly that the device met these specifications, as the conclusion states the non-clinical testing "demonstrates that the subject device...is substantially equivalent to its predicate."

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The Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases.

The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor.

Environment of use - hospital, sub-acute, and pre-hospital settings

Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.

Dispo-Med has designed a series of exhaled gas sampling devices. They include:

• Nasal cannula styles that can provide supplemental O2 and sample exhaled gases
• Gas sampling only devices which sample the patient's exhaled gas at the nares or in the circuit

All of the devices have the same indications for use and therefore can be combined into a single submission.

We will present several different configurations which have been tested and compared to several predicates.

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

The provided text describes a 510(k) summary for DISPO-MED (MALAYSIA) SDN BHD regarding their Oxygen Delivery / CO2 Sampling Cannula Style and Gas Sampling Only Style devices. The document aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" with numerical targets in the same way one might find for a diagnostic test's sensitivity or specificity. Instead, it frames "acceptance" as demonstrating substantial equivalence to predicate devices through comparative performance testing and shared characteristics. The performance criteria are implicit within the comparative testing performed.

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of devices tested, number of simulated breaths, or duration of tests) for the comparative performance and mechanical testing. It mentions "several different configurations which have been tested".
• Data Provenance: The testing appears to be prospective (conducted specifically for this 510(k) submission) and simulated/laboratory-based. There is no mention of human subject data or data from a specific country of origin for the performance testing results themselves. The company, DISPO-MED (MALAYSIA) SDN BHD, is based in Malaysia.

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

• This information is not provided in the document. The "ground truth" for comparative performance data in this context would likely be derived from a validated capnometer or gas analyzer, rather than expert interpretation of data. The document focuses on the objective measurement and waveform equivalency.

4. Adjudication Method for the Test Set:

• This information is not applicable/provided. Since the testing is focused on objective measurements of gas sampling and mechanical properties, there wouldn't typically be a need for an adjudication method in the way one would for clinical image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This information is not applicable. This submission is for a physical medical device (nasal cannula/gas sampling line), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation. No MRMC study was performed.

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

• This information is not applicable. This is not an AI algorithm. The device performance (standalone) was evaluated in laboratory settings.

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

• The "ground truth" for the CO2 sampling performance was the measured CO2 concentration and waveform generated by the simulated breathing conditions. This would be established by a reference gas analyzer or capnometer, which serves as the "gold standard" for measuring CO2.
• For mechanical and material testing, the ground truth refers to established standards and specifications (e.g., ISO 594-2 for Luer fittings, standard material properties, and mechanical limits).

8. The sample size for the training set:

• This information is not applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.

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

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

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The Carinal VitaLine™ Set sampling line is intended to provide for CO2 measurement of intubated neonates and infants with a Microstream monitor. It enables either standard sampling via the airway adapter and main lumen of an endotracheal tube or sampling from the carina via the monitoring lumen of the same tube.

The set is intended for single patient use only.

The Carinal VitaLine Set comprises Microstream FilterLine ICU that is modified to enable the clinician to select between central monitoring from the trachea above the carina via the monitoring lumen of the ETT and traditional monitoring with a CO2 sampling airway adapter. The following components are included in the Carinal VitaLine Set:

• sampling line .
• airway adapter with tube and luer connected. .

The Carinal VitaLine Set is designed for use with an infant neonatal size uncuffed endotracheal tube equipped with a monitoring lumen. The endotracheal tube must be supplied by the end user and is not provided by Oridion as part of the Carinal VitaLine.

The tubing leading to the CO2 monitor includes two dryer sections to support use in high humidity environments and prevent rapid occlusion of the tubing.

This document describes the Carinal VitaLine™ Set, an accessory for capnographs designed to measure CO2 in intubated neonates and infants. The submission focuses on demonstrating substantial equivalence to a predicate device, the Microstream FilterLine ICU (K980327).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as pass/fail thresholds in this document for each performance characteristic. Instead, the document presents a comparison of the Carinal VitaLine™ Set's performance characteristics against the predicate device's characteristics to demonstrate similarity and thus substantial equivalence.

2. Sample Sizes and Data Provenance

The document states that bench tests were performed. It does not provide specific sample sizes (e.g., number of units tested) for each bench test. The data provenance is implied to be from internal testing conducted by Oridion Medical 1987 Ltd., based in Jerusalem, Israel. The study type is retrospective, as it involves testing a developed product to compare its performance against a predicate.

3. Number of Experts and Qualifications

This submission does not involve human readers or experts for establishing ground truth, as it is a technical performance comparison of a medical device accessory through bench testing.

4. Adjudication Method

Not applicable, as this is a technical performance comparison of a medical device accessory through bench testing, not a study involving human interpretation or adjudication.

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

No MRMC comparative effectiveness study was conducted. This device is a capnograph accessory, and the study focuses on its technical performance characteristics rather than diagnostic accuracy or human reader performance.

6. Standalone Performance Study

Yes, a standalone performance study was done in the form of bench tests. These tests evaluated the device's inherent performance characteristics (Tensile Strength, Leak Tightness, Pressure Drop, Rise Time, and Delay Time) independent of human operators, comparing them directly to the predicate device.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" or reference for comparison was the performance specifications and characteristics of the predicate device (Microstream FilterLine ICU, K980327). The goal was to demonstrate that the Carinal VitaLine™ Set performed similarly enough to be considered substantially equivalent.

8. Sample Size for the Training Set

Not applicable. This submission describes testing for a medical device accessory, not a machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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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 Medley™ EtCO2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired. The Medley™ EtCO2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.

The EtCO2 Module is the newest module to the currently marketed Medley™ Medication Safety System (Medley™ System). ALARIS Medical will incorporate currently marketed Oridion capnograph technology and accessories into the Medley™ EtCO2 Module. The Medley™ EtCO2 Module will be used to measure inspired and expired carbon dioxide (FiCO2 and EtCO2 respectively) and Respiration Rate (RR) on patients in the operating room, ICU, NICU, transport and emergency treatment. This capnograph technology originates from the MediCap/NPB-75 (K964239).

The provided text describes the Alaris Medical Systems Medley EtCO2 Module, a capnograph designed to continuously monitor end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The document is a 510(k) premarket notification summary.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, does not explicitly state specific numerical acceptance criteria or performance metrics (like accuracy, precision, or bias) for EtCO2, FiCO2, or RR measurements. Instead, it makes a general statement:

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

The document does not provide details about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The evaluation appears to be based on demonstrating "substantial equivalence" to a predicate device and relies on the predicate's established performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not available in the provided text. No ground truth establishment by experts for a test set is described.

4. Adjudication Method for the Test Set

This is not applicable/not provided as no test set requiring expert adjudication for ground truth is described.

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

A MRMC comparative effectiveness study is not mentioned in the document. The device is a monitor, not an AI diagnostic tool requiring human reader interpretation or assistance.

6. Standalone Performance Study (Algorithm Only)

The document does not describe a standalone performance study in the context of an algorithm's performance. The Medley EtCO2 Module is a hardware device that incorporates "currently marketed Oridion capnograph technology." Its performance is evaluated against (or shown to be equivalent to) an existing predicate device rather than undergoing a separate standalone algorithm performance study. The statement "The performance data included in this submission indicate that the Medley" EtCO2 Module meets specified requirements" suggests internal testing was done, but no details of such a study are provided.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any performance evaluation. Given it's a capnograph, ground truth would typically come from a gold-standard CO2 measurement method, but this is not detailed. The primary basis for approval appears to be substantial equivalence to a predicate device.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. As a hardware medical device based on existing technology, the concept of a training set for an algorithm is not directly applicable in the information provided.

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

This is not applicable as no training set is described.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Oridion MicroCap/NPB-75, K964239) rather than detailing specific standalone performance studies with quantitative acceptance criteria, test sets, or ground truth establishment relevant to AI/algorithm performance. The approval hinges on the assertion that the "technological characteristics" and "performance data" show the device is "substantially equivalent" to the predicate.

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