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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) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of pulse rate (PR) of adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused.

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.

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.

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.

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 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 be connected 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, pediatic 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:

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

Devices with Masimo technology are only indicated for use with Masimo sensors and cables.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) for adults and pediatics during no motion conditions in hospitals and hospital-type facilities.

PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the connected 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 the same as the predicate (Rad-97 product family) cleared under K183697. 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), 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 addition of indications for PVi, an index previously cleared as an informational index.

Here's a breakdown of the acceptance criteria and study information for the Masimo Rad-97 Pulse CO-Oximeter and Accessories, specifically for the PVi indication, based on the provided text:

Acceptance Criteria and Reported Device Performance for PVi

Note: The provided text does not explicitly define acceptance criteria as a specific numerical benchmark for AUC. Instead, it states that the "test results supported the ability of PVi to provide an indication of fluid responsiveness."

Study Details for PVi Indication

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

• Sample Size: A combined total of 182 subjects were included across 6 highlighted studies that involved mechanically ventilated adult patients.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they involved "undergoing surgeries, where PVi was monitored for fluid responsiveness using volume expansion changes (fluid bolus infusions)."

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 specified. The ground truth was established by monitoring "cardiac output response" to "fluid bolus infusion," which suggests physiological measurements rather than expert consensus on a subjective interpretation. The text does not mention expert review for establishing ground truth for PVi functionality.

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

• Not applicable/Not specified. The determination of fluid responsiveness based on cardiac output response to fluid bolus infusion is a direct physiological measurement, not an interpretation requiring adjudication by multiple experts.

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 PVi feature is a non-invasive monitoring parameter, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

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

• Yes, this was a standalone performance evaluation. The PVi feature provides a continuous non-invasive measurement (algorithm only) and is intended as an "indicator of fluid responsiveness." The assessment focused on the device's ability to correlate PVi changes with fluid responsiveness, without a human interpretation step being part of the primary evaluation of the PVi's accuracy itself.

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

• The ground truth was established by monitoring the cardiac output response to fluid bolus infusion. This represents physiological outcomes data (changes in a patient's hemodynamic status).

8. The sample size for the training set

• Not specified. The provided information focuses on the validation of the PVi feature for its updated indications, using published studies. It does not detail the initial development or training phases of the PVi algorithm itself.

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

• Not specified. As mentioned above, the document focuses on the validation studies for the expanded PVi indication, not the initial development or training.

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Masimo Rad-97 Pulse CO-Oximeter and Accessories:

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 multi-parameter 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, 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. 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

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

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

Masimo Radical-7 Pulse CO-Oximeter and Accessories

The Radical-7 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 Radical-7 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 Radical-7 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 Radical-7 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 hospitals and hospital-type facilities.

The Radical-7 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 Radical-7 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 hospital-type facilities, home environments, and transport within healthcare facilities.

The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

Masimo Radius-7 Pulse CO-Oximeter and Accessories:

The Radius-7 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 Radius-7 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 Radius 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 Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoplobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.

The Radius-7 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 hospitals and hospital-type facilities.

The Radius-7 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 hospitaltype facilities, home environments, and transport within healthcare facilities.

The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

The subject of the submission is to add Respiration Rate from photoplethysmogram (designated as RRp) feature to the previously cleared Masimo Pulse Oximetry devices. The RRp feature that was previously cleared as part of MightySat fingertip pulse oximeter under K181956. RRp feature determines the patient's respiration rate by analyzing cyclic variations in photoplethysmogram (pleth) to establish respiration measurement. The devices in which the RRp feature is being added as part of this submission are the previously cleared Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, and Masimo Radius-7 Pulse CO-Oximeter.

Rad-97 Pulse CO-Oximeter: Masimo Rad-97 System and Accessories (Rad-97), is a portable monitor that features a touchscreen that provides a display and control user interface for monitored parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery. The Rad-97 comprises of technologies that enable the device to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or capnography parameters or noninvasive blood pressure (NIBP) parameters which were all previously cleared under K183697.

Radical-7 Pulse CO-Oximeter: Masimo Radical-7 and Accessories, is a pulse co-oximeter that features a touchscreen that provides a display and control user interface for monitored parameters. It can be used either as a handheld or standalone monitor. Radical-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor. The Radical-7 comprises of technologies that enable the Radical-7 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), and acoustic respiration rate (RRa) parameters which were all previously cleared under K171121.

Radius-7 Pulse CO-Oximeter: Masimo Radius-7 and Accessories, is a wearable Pulse CO-Oximeter. Radius-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor via Bluetooth or WiFi. The Radius-7 comprises of technologies that enable the Radius-7 to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), and acoustic respiration rate (RRa) parameters which were all previously cleared under K171121.

The document provided explains the regulatory clearance of Masimo Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters with the addition of a Respiration Rate from photoplethysmogram (RRp) feature. The acceptance criteria and the studies proving the device meets these criteria are detailed below, focusing on the newly added RRp feature.

Acceptance Criteria and Device Performance

The core acceptance criterion for the RRp feature is its accuracy (ARMS) and mean error when compared to a gold-reference capnography.

Table of Acceptance Criteria and Reported Device Performance (RRp Feature):

Note: The document states the performance specification of RRp is "ARMS of ≤ 3.0RPM and mean error of 1", which is explicitly met by the reported performance.

Study Details Proving Device Meets Acceptance Criteria

1. Sample Sizes Used for the Test Set and Data Provenance:

• Prospective Clinical Study (Healthy Adults):
  • Number of Data Points: 7,751
  • Data Provenance: Not explicitly stated but implied to be from a controlled clinical setting, likely in the US (given FDA submission). It's a prospective study.
• Retrospective Clinical Validation Study (Hospitalized Adults):
  • Number of Data Points: 119,174
  • Data Provenance: Collected from hospitalized adults. Retrospective study. Country of origin not explicitly stated, but common for such studies to be multi-site or from a single clinical institution, likely in the US.
• Retrospective Clinical Validation Study (Hospitalized Pediatrics):
  • Number of Data Points: 35,390
  • Data Provenance: Collected from hospitalized pediatrics. Retrospective study. Country of origin not explicitly stated.

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

• The document does not specify the number or qualifications of experts involved in establishing the ground truth. The ground truth method relies on an FDA-cleared capnography device (Oridion Capnostream20, K060065) as the "gold-reference method." This suggests that the ground truth is derived from instrumental measurements rather than human expert interpretation of raw data.

3. Adjudication Method for the Test Set:

• Not applicable as the ground truth is established by a medical device (capnography) and not human consensus or adjudication. The comparison is between the device's RRp measurement and the capnography's measurement.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. The study focuses on the accuracy of the device's RRp measurement against a reference standard, not on how human readers' performance improves with or without AI assistance. The device is a monitor, not an AI-assisted diagnostic tool that requires human interpretation.

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

• Yes, the studies conducted demonstrate the standalone performance of the RRp algorithm. The device produces a directly measurable respiration rate (RRp) which is then compared to a reference standard (capnography). Human interpretation is not part of the RRp measurement process itself.

6. The Type of Ground Truth Used:

• The ground truth used is an instrumental reference standard: an FDA-cleared capnography device (Oridion Capnostream20, K060065), which is considered a "gold-reference method" for respiration rate measurement. This is a direct physiological measurement, not expert consensus or pathology.

7. The Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set. It mentions that the "technological characteristics of the RRp feature is the same as that of previously cleared reference predicate MightySat (K181956)." This implies that the RRp algorithm was likely developed and potentially trained using data before this specific submission, possibly on data sets contributing to the MightySat clearance. The presented studies are validation studies for the implementation of this existing feature on new devices.

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

• The document does not provide details on how the ground truth for the training set was established. Given that the RRp feature's technology is stated to be the same as a previously cleared predicate device (MightySat K181956), it can be inferred that the validation and potentially the training of the original algorithm would have followed similar rigorous methods, likely involving comparison to golden standards such as capnography. However, specific details for the training set's ground truth establishment are not present in this submission.

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