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The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatal patients during no motion conditions in hospitals and hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatic patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediativ and infant patients.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.

The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K180046, and has the same indications for use. The Rad-97 comprises of the same measurement technologies as cleared in the predicate, which includes the Masimo rainbow SET technology, capnography technology, and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.

The subject of this submission is the update to the SpO2 performance specification for the RD SET Disposable sensors for the neonate population to match that of the cleared 1.5% Arms for adults (K180046).

The document describes a 510(k) premarket notification for the "Masimo Rad-97 and Accessories" with a focus on an update to the SpO2 performance specification for the neonate population. The primary goal of the submission is to demonstrate that the device, specifically the RD SET Disposable sensors, maintains its performance for neonates consistent with previously cleared specifications for adults.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state "acceptance criteria" in a table format with a pass/fail. Instead, it refers to the "SpO2 performance specification" which the device is being updated to match, implying this as the target. The key performance metric cited is ARMS (Accuracy Root Mean Square).

The acceptance criteria for SpO2 accuracy are implicitly set by the previously cleared performance for adults, which is 1.5% ARMS. The submission aims to align the neonate performance with this.

Reported Device Performance:

While the aggregated data shows an ARMS of 3.185%, the document states, "The analysis of the clinical data further supported the safe form, fit, and function of the RD SET Disposable Sensor on neonates. The Arms performance was calculated for reference purposes." And "The results of the clinical testing supported the subject device did not raise any different questions of safety and effectiveness as compared to the predicate device." This suggests that the clinical data, despite not strictly meeting the 1.5% ARMS in all ranges for neonates in the initial and aggregated studies, was deemed sufficient to support substantial equivalence due to the nature of the submission (labeling update, not a new device or significant modification) and the "reference purposes" of the ARMS calculation in this context. The core assertion is that the same device is being used, and the form, fit, and function for neonates are supported.

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

• Initial Study: 19 neonatal subjects.
• Aggregated Study: 42 neonatal subjects (including 22 pre-term neonates). This aggregation combines data from the initial study with data from "prior studies."
• Data Provenance: The studies collected "convenience blood samples from an arterial line" in a "clinical environment." The document specifies that the aggregated data was from "3 different sites." The country of origin is not explicitly stated, but given the FDA submission, it's typically assumed to be conducted in the US or under comparable ethical/clinical standards acceptable to the FDA. The data is prospective clinical data collected for the purpose of verifying the device's performance on neonates.

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

The ground truth for SpO2 measurements was established using a reference co-oximeter from arterial blood samples. This is a direct, objective measurement, not one established by human expert consensus or interpretation. Therefore, the concept of "number of experts" or their "qualifications" for establishing ground truth as typically applied to image-based AI studies (e.g., radiologists interpreting images) is not applicable here. The accuracy of the co-oximeter itself would be the relevant qualification.

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

Since the ground truth is established by a reference co-oximeter on arterial blood samples, there is no adjudication method involving human experts for the test set.

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. This device is a physiological monitor (pulse oximeter), not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting AI outputs. The "AI" aspect is not explicitly mentioned or studied in the context of human reader improvement.

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

The device itself provides the SpO2 measurements. The study assesses the accuracy of these measurements against a reference standard. While the device (Masimo Rad-97 with RD SET Disposable sensors) operates without human intervention in generating the SpO2 reading, the study framework is not typically referred to as a "standalone" or "algorithm only" study in the context of AI regulatory submissions. It's a performance validation study for a medical device. The "algorithm" here is the signal processing within the oximeter. The ARMS metric specifically reflects this standalone device accuracy.

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

The ground truth used was objective reference measurements of SaO2 (arterial oxygen saturation) from arterial blood samples analyzed by a reference co-oximeter.

8. The sample size for the training set

The document does not mention a training set in the context of model development or machine learning. This submission is for a medical device (pulse oximeter) that relies on established physiological principles and signal processing, not a de novo AI/ML algorithm that requires distinct training and test sets in the typical sense. The device's underlying algorithms were presumably developed and validated in prior clearances (K180046). This submission is an update to the labeling for a specific patient population (neonates) using an existing sensor, justifying it with clinical performance data on that population.

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

As there is no mention of a training set for an AI/ML model, this question is not applicable based on the provided document. The device's core technology and its existing cleared performance for adults underpin the rationale for extending the performance specifications to neonates.

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The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal pation conditions in hospitals and hospitals and hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older

The optional Masimo Centroid O2 is intended for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The optional Masimo Centroid O2 is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) 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 and home environments.

Devices with Masimo technology are only to be used with Masimo sensors and cables.

The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.

The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K180046, and has the same indications for use. The Rad-97 comprises of the same measurement technologies as cleared in the predicate, which includes the Masimo rainbow SET technology, capnography technology, and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.

The subject of this submission, is the inclusion of Masimo Centroid 02 sensor to be used with the Rad-97 and similar devices that utilize Masimo SET technology.

The Centroid O2 is a family of wearable, battery operated, sensors that support Masimo SET technology. The Centroid O2 uses wireless communication to a host device (e.g., Rad-97, Radical-7) in order to support the continuous monitoring of Masimo SET parameters (SpO2 and PR). Centroid O2, similar to the previously cleared RD SET sensors (K180046), are intended for the noninvasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Centroid O2 consists of both disposable and reusable components. The disposable components include the sensor and wrist strap: the reusable component contains the hardware to transfer the measured data wirelessly. Centroid 02 uses a battery as a power source for the sensor and to enable measurement data to be transferred wirelessly to a host device (e.g. Rad-97, Radical-7).

The provided text describes the Masimo Rad-97 and Accessories device and the study conducted to ensure its accuracy. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "Accuracy (ARMS)*" for SpO2, with the reported performance values reflecting the device's accuracy within those ranges.

*ARMs accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- ARMs of the reference measurements in a controlled study.

The clinical study explicitly reports on "SpO2 No Motion Accuracy" with an Adjusted RMS of 1.3, which corresponds to an ARMs value of 2% during no-motion conditions. For "SpO2 Motion Accuracy," the Adjusted RMS is 2.2, corresponding to an ARMs value of 3% during motion conditions. These reported values directly align with the acceptance criteria for SpO2 for adults/pediatrics/infants during no motion and for all patient populations during motion.

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

The document states, "a clinical study was performed... on healthy adult volunteers." However, the exact sample size (number of healthy adult volunteers) used for the test set is not explicitly mentioned in the provided text.

The data provenance is prospective, as it was a "clinical study" performed specifically "to establish the accuracy (ARMs) of the Centroid O2 sensors." The country of origin of the data is not specified.

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

The document states that the comparison was made "in comparison to blood measurements from a laboratory CO-Oximeter." This implies that the ground truth for SpO2 measurements was established using a laboratory CO-Oximeter, which is a highly accurate reference method. It does not involve human experts in establishing the ground truth directly for SpO2 measurements in this context. The reliance is on the accuracy of the laboratory instrument.

4. Adjudication Method for the Test Set

Since the ground truth for SpO2 measurements was based on a laboratory CO-Oximeter, there was no human adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth for the test set. The CO-Oximeter serves as the objective reference standard.

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 a Multi Reader Multi Case (MRMC) comparative effectiveness study in the provided text. The device is a patient monitor, and the study focuses on the accuracy of the device's measurements (SpO2, PR, etc.) compared to a reference standard, not on human interpretation or the impact of AI on human reader performance.

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

Yes, a standalone study was done. The clinical study described "evaluate[d] the sensor's performance for no motion and motion conditions, in the range of 70% to 100% SaO2, in comparison to blood measurements from a laboratory CO-Oximeter." This is a direct assessment of the device's (and its underlying algorithm's) performance without human intervention in the measurement process itself.

7. The Type of Ground Truth Used

The type of ground truth used for the clinical study was laboratory-measured SaO2 (functional oxygen saturation of arterial hemoglobin) from a CO-Oximeter. This is an objective physiological measurement from a reference device.

8. The Sample Size for the Training Set

The provided text does not mention the sample size for the training set. The clinical study described is for validation/testing, not for training. The document states that the Masimo Rad-97 and Accessories (Centroid O2) uses "Masimo SET technology," which is an established technology, implying that the underlying algorithms would have been developed and potentially trained on prior datasets, but details of such training sets are not included here.

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

Since the document does not provide information on a training set, it does not describe how the ground truth for a training set was established. The clinical study focuses on evaluating the Centroid O2 sensor's performance against a reference (laboratory CO-Oximeter) during no-motion and motion conditions.

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The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatic patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediativ and infant patients.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internally rechargeable battery.

The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K170168. and has the same indications for use. The Rad-97 comprises the same measurement technologies as cleared in the predicate, which includes the Masimo Rainbow SET technology, capnography technology and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.

The Rad-9, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 was also cleared in K170168. The Rad-9 model includes the Masimo SET technology (a subset of Masimo Rainbow SET technology), which provides pulse oximetry parameters of SpO2, PR, Pi, and PVi. The Rad-9 model can be optionally available with NIBP technology.

Masimo's Rad-97 has improved SpO2 measurement accuracy for motion and no motion conditions with RD SET Disposable sensors previously cleared under K170168. Masimo improved its RD SET Disposable sensors through sensor characterization, facilitating a SpO2 measurement accuracy claim of 1.5% Ams during no-motions conditions for patient populations (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Masimo's SpO2 measurement accuracy claim with RD SET Disposable Sensors is 1.5% Arms during motion conditions for patient population (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Although they now include improved sensor characterization, the RD SET Disposable sensors are substantially equivalent to the currently marketed product.

Additionally, this submission includes the following sensors that have non-significant changes: the Multisite Reusable Sensors (K111888), the RD Specialty Sensors (K101896), and the RD reusable sensors (K051212).

Here is a summary of the acceptance criteria and study information for the Masimo Rad-97 and Accessories, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "Accuracy (ARMS)" specifications in the document.

Note: The clinical study specifically focused on SpO2 accuracy claims for no-motion and motion conditions for adult, pediatric, and infant populations. The document states that "Accordingly, the claimed Ams value is 1.5% during no-motion conditions for adults, pediatrics, and infants, and the claimed Arms value is 1.5% during motion conditions for adult, pediatrics, and infants." This implies that the reported study results support these specific claims, which are the acceptance criteria.

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

The document states: "The study was done on healthy adult volunteers".

• Sample Size: Not explicitly stated as a number, but refers to "healthy adult volunteers."
• Data Provenance: Clinical study, likely prospective, conducted on "healthy adult volunteers" at an unspecified location (typically assumed to be U.S. unless otherwise specified in FDA submissions).

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

Not applicable for this type of device and study. The ground truth for SpO2 accuracy is typically established by comparing the device's readings to arterial blood samples analyzed by a laboratory CO-Oximeter (as stated in the document: "in comparison to blood measurements from a laboratory CO-Oximeter"). No human expert "adjudication" of the ground truth is mentioned or implied for SpO2 measurements.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 is directly derived from laboratory CO-Oximeter analysis of blood samples, not from expert adjudication of images or signals that would require an adjudication method like 2+1 or 3+1.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study described is a clinical accuracy study comparing the device's measurements directly to a reference standard (laboratory CO-Oximeter). It does not involve human readers or assess their improvement with AI assistance.

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

Yes, the clinical study performed was a standalone performance evaluation of the device (algorithm only) comparing its SpO2 measurements against a reference standard. The "human-in-the-loop" aspect for a device like a pulse oximeter is generally the medical professional interpreting the device's output, but the accuracy study assesses the device's measured values directly.

7. The Type of Ground Truth Used

Laboratory Standards: The ground truth for SpO2 measurements was established by "blood measurements from a laboratory CO-Oximeter."

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It focuses on the validation study (test set).

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

The document does not provide information on how the ground truth for the training set was established. This information is typically not included in a 510(k) summary for device modifications unless the model itself is novel and the training process is a key part of the submission. The device (Masimo Rad-97) and its underlying Rainbow SET technology are described as substantially similar to a cleared predicate (K170168), even with improved sensor characterization.

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The Masimo Rad-97 and Accessories are indicated for hospital-type facilities, mobile, and home environments.

The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rad-97 and Accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused. In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.

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

The subject device, Masimo Rad-97 System and Accessories (Rad-97) product family, features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internally rechargeable battery.

The Rad-97 product family comprises the same measurement technologies as cleared in the predicate, Root (with connected external Radical-7 and capnography (ISA) and internal NIBP modules), which includes the Masimo Rainbow SET technology, capnography technology and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (PI), Pleth Variability Index (PVI), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa) and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.

The Rad-97 product family is available with different measurement parameter configurations, ranging from a fully loaded configuration to a simplified configuration with pulse oximetry parameters only. In a fully loaded configuration, the Rad-97 model includes all parameters provided by the Masimo Rainbow SET technology including SpO2, PR, PI, PVI, SpCO, SpMet, SpHb, SpOC and RRa. Additionally, this fully loaded version can be optionally available with either NIBP or capnography technology.

The Rad-9 model, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 model includes the Masimo SET technology (a subset of Masimo Rainbow SET technology), which provides pulse oximetry parameters of SpO2, PR, PI and PVI. The Rad-9 model can be optionally available with NIBP technology.

Same as the predicate, the Rad-97 product family includes inout/output interfaces for connection to external devices. Furthermore, same as the predicate, the Rad-97 product family can communicate through wired/wireless connection with networked systems such as Patient SafetyNet (K071047) and/or hospital electronic medical/health record (EMR) systems.

The RD SET Disposable Sensors, listed with other cleared accessories in Section 11.7, are the same as the currently marketed product. The only change is the added labeling information regarding the sensors' performance in terms of limits of agreement (LOA) as defined by Bland-Altman.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported performance for "Upper 95% LOA" (3.15%) indicates that the device did not meet the specified acceptance criterion of "< 3%". The reported performance for "Lower 95% LOA" (-2.21%) indicates that the device met the specified acceptance criterion of ">= -3%".

The document also lists other accuracy specifications for various parameters, but it does not explicitly state an "acceptance criteria" alongside them in the same format as the LOA for SpO2. These are presented as general "Accuracy (ARMS)" specifications.

Accuracy (ARMS) Specifications (not explicitly presented as acceptance criteria vs. performance in the provided text, but rather device specifications):

• ARMS defined as a statistical calculation of the difference between device measurements fell within +/- ARMs of the reference measurements in a controlled study.

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

• Sample Size: Not explicitly stated as a number. The study was conducted on "healthy adult volunteers."
• Data Provenance: Retrospective or Prospective is not explicitly stated, but clinical studies are generally prospective. The data is from "healthy adult volunteers," implying a clinical study setting. Country of origin is not specified, but the Masimo Corporation is based in Irvine, CA, USA, suggesting the study likely took place in the USA or under its regulations.

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 text. The ground truth for SpO2 was established by "blood measurements from a laboratory CO-Oximeter," which is an instrument, not human experts.

4. Adjudication Method for the Test Set

• Not applicable. The ground truth was established by an instrument (laboratory CO-Oximeter) comparing directly to the device measurements; there was no human adjudication process involved for establishing the ground truth.

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

• No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting cases with and without AI assistance. This document describes the performance of a medical device (oximeter) and its various physiological monitoring capabilities, not an AI-powered diagnostic imaging tool that would typically undergo MRMC studies.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, a standalone performance study was done. The clinical study described "evaluate the sensor's performance for no motion condition, in the range of 70% to 100% in comparison to blood measurements from a laboratory CO-Oximeter." This evaluates the device directly against a reference standard, which is a standalone performance assessment.

7. Type of Ground Truth Used

• The ground truth used for SpO2 was instrumental measurement / reference standard. Specifically, it was "blood measurements from a laboratory CO-Oximeter."

8. Sample Size for the Training Set

• This information is not provided in the text. The document describes a clinical study for validating the device's accuracy, not for training a new algorithm. The device incorporates "Masimo Rainbow SET technology," which is a pre-existing technology, and the study is for the performance of the integrated product and its sensors.

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

• This information is not provided in the text, as no specific training set or new algorithm development is detailed. The technology itself (Masimo Rainbow SET) is described as utilizing principles of spectrophotometry and photoplethysmography, implying established scientific principles rather than a continuously trained machine learning model.

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