Search Results

The Masimo MightySat-OTC is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Masimo MightySat-OTC is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions.

The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease and treatment decisions using the device should only be under the advice of a healthcare provider.

The subject device, MightySat-OTC, is a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in individuals 18 years and older. The predicate MightySat that was previously cleared under K181956, has the same intended use as the subject device except it is cleared for prescription use only.

The subject device is identical to the predicate with the RRp and PVi parameters have been disabled in the subject device and the labeling has been modified to provide additional information on the role of pulse oximeters for OTC users. There were no hardware changes made to the MightySat Rx (predicate device, K181956) that resulted in the MightySat-OTC. Like the predicate device, the subject device, has the combined function of a pulse oximeter monitor and a reusable sensor. It includes a color display, enclosed by plastic housing, and powered by two alkaline "AAA" batteries. It also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile device application.

Here’s an analysis of the acceptance criteria and study details for the Masimo MightySat-OTC, based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size: 39 healthy volunteer subjects.
• Data Provenance: The study was a prospective clinical performance testing conducted in accordance with ISO 80601-2-61. The location of the study is not explicitly stated, but it is a clinical study involving human volunteers. Data includes varying skin pigmentation, measured using the color-based Massey-Martin scale.

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

The document does not specify the number or qualifications of experts used to establish ground truth. For pulse oximetry, the ground truth for SpO2 is typically established through arterial blood gas analysis (reference oximeter), usually performed by trained medical professionals, but this detail is not provided.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). For pulse oximetry clinical studies, ground truth is generally obtained directly from standardized reference methods (e.g., CO-oximetry of arterial blood samples), not through expert adjudication of interpretations.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the device against a reference method for SpO2 and PR accuracy. The document mentions human factors and usability testing to validate user understanding of labeling and device outputs for OTC use, but this is a different type of study than an MRMC comparing human reader performance with and without AI assistance.

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

Yes, the primary clinical performance testing for SpO2 and Pulse Rate accuracy appears to be a standalone (algorithm only) evaluation. The device measures and displays physiological signals directly, and the clinical study evaluates the accuracy of these measurements against a reference standard. The "human factors and usability testing" is a separate evaluation of the user interface and labeling for OTC use, not directly related to the algorithm's diagnostic performance with human input.

7. The Type of Ground Truth Used

The ground truth for SpO2 accuracy is based on a reference standard, specifically arterial blood oxygen saturation (SaO2), as implied by the "SaO2 range" in the performance tables. For pulse oximeters, this typically involves drawing arterial blood samples and analyzing them with a laboratory CO-oximeter.

8. The Sample Size for the Training Set

The document does not provide a specific sample size for the training set. It mentions that "the calibration curve has been adjusted to allow for improved accuracy performance, including across different skin pigments and genders." This implies that data was used to train or refine the device's algorithms, but the size and characteristics of that dataset are not detailed in this submission.

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

The document states that the calibration curve was "adjusted to allow for improved accuracy performance, including across different skin pigments and genders." While it doesn't describe the exact process for establishing ground truth for this internal adjustment/training, it would typically involve similar methods to the clinical validation: comparing the device's readings to arterial blood gas measurements from a diverse population.

Ask a specific question about this device

Alio is a wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings. The data includes measured hemoglobin (Hgb) and hematocrit (Hct), skin temperature, auscultation sound data, and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the HCP's review.

The data also include a qualitative indicator of abnormal levels of potassium derived from relative variability of photoplethysmography waveforms and medically accepted threshold values.

Alio is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to provide measurement of heart rate, skin temperature, Hgb, Hct and a qualitative risk assessment of the patient having an abnormal potassium level. The SmartPatch sensor is indicated to record and transmit auscultation sound data. For qualitative assessment of abnormal potassium levels, and quantitative measurement of heart rate, skin temperature, Hgb and Hct, the SmartPatch should be placed on an arm based arteriovenous access on patients with end stage kidney disease (ESKD).

Alio is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices. Therapeutic management decisions, including management of dyskalemia, should be made based on a complete assessment of the patient's condition and should not be based solely on Alio.

Alio is a wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings. Alio is intended to be used on general care patients and patients with end stage kidney disease (ESKD), who are 18 years of age or older in clinical and non-clinical settings. Alio includes the following components:

Alio SmartPatch: The Alio SmartPatch is a flexible, silicone-encased patch designed to be worn between the cannulation sites of the arteriovenous (AV) fistula or graft for up to seven days. It houses numerous sensor technologies which collect data for the derivation of physiologic parameters including hemoglobin, hematocrit, an assessment of normal or abnormal (hyper or hypokalemic) levels of serum potassium (K+), skin temperature, auscultation sound data, and heart rate. The data from the sensors is transmitted from the SmartPatch to the Alio Hub via a bluetooth connection. The data is then transmitted to the Alio Cloud, via the Alio Hub, where it is analyzed and made available to a clinical care team via the Alio Portal.

Alio Hub: The Alio Hub is designed for use in clinical and non-clinical use settings. It automatically communicates with the activated Alio SmartPatch via Bluetooth and uploads physiological data to the Alio Cloud via cellular connection.

Alio Cloud: The Alio Cloud allows clinicians to access patient data collected via the Alio SmartPatch and wirelessly transferred from the Alio Hub to the secure server (the Alio Cloud).

Alio Portal: The Alio Portal stores data received from the Alio Cloud database that supports storage, analytics, system monitoring and visualization capabilities. This data is encrypted and HIPAA compliant. The Alio Portal also serves as the interface with the HCP who can then visualize and interact with data being generated by the system.

The provided text describes the Alio device, its intended use, and summaries of non-clinical and clinical testing performed for its 510(k) submission (K223073).

Unfortunately, the provided text does not contain the specific acceptance criteria or detailed study results (like sensitivity, specificity, accuracy metrics with confidence intervals for Hgb, Hct, or potassium levels) in a format suitable for a table of acceptance criteria vs. device performance. It broadly states that the device "meets its design requirements and intended use" and "can accurately assess abnormal potassium levels and measure hemoglobin (Hgb) and hematocrit (Hct)."

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance as requested. I can, however, extract and summarize the other requested information based on the provided text.

Here's a summary of the available information regarding the Alio device's clinical study:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The document indicates that the device "meets its design requirements and intended use" and "can accurately assess abnormal potassium levels and measure hemoglobin (Hgb) and hematocrit (Hct)." However, specific numerical thresholds for accuracy, sensitivity, or specificity as acceptance criteria are not detailed.
• Reported Device Performance:
  • The study "establish[ed] the accuracy of Alio in the assessment of abnormal potassium levels, and measurement of Hgb and Hct, compared to the standard of care blood results and heart rate."
  • "The results of the study demonstrate that Alio can accurately assess abnormal potassium levels and measure hemoglobin (Hgb) and hematocrit (Hct) when placed on an arteriovenous access site in patients with ESKD."
  • "The results further confirm that Alio can still accurately measure heart rate and record auscultation sound data at the new location."
  • No specific performance metrics (e.g., mean absolute error, correlation coefficients, sensitivity, specificity, AUC) or their numerical values are provided in this summary document.

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

• Sample Size for Test Set: 125 subjects.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was described as a "multicenter, prospective study." Given the FDA submission, it's highly likely to be U.S.-based, but this is an inference, not a direct statement.
  • Retrospective or Prospective: Prospective. The text states: "An IRB-approved clinical study has been conducted to validate the ability of Alio to quantify the new measurements and support the proposed expanded indications. Alio was studied in a multicenter, prospective study with 125 subjects."

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

• This information is not provided in the text. The ground truth was established by "standard of care blood results" for Hgb and Hct, and for abnormal potassium levels, but the expertise involved in interpreting these and deriving final ground truth labels is not specified.

4. Adjudication method for the test set

• This information is not provided in the text.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not described. The study focused on the accuracy of the device in assessing physiological parameters compared to standard of care, not on human reader performance with or without AI assistance. The device is described as a "secondary, adjunct patient monitor," suggesting it aids, but does not necessarily directly compare, human diagnostic performance.

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

• Yes, the described study appears to be a standalone performance evaluation of the Alio device's algorithm. The "AI/ML algorithm used in the calculation of the new physiologic parameters" is specifically mentioned. The study assessed the device's ability to "accurately assess abnormal potassium levels, and measure hemoglobin (Hgb) and hematocrit (Hct)" against "standard of care blood results." This implies the algorithm's output was directly compared to ground truth, which is characteristic of a standalone study.

7. The type of ground truth used

• For Hemoglobin (Hgb) and Hematocrit (Hct): "standard of care blood results."
• For Abnormal Potassium Levels: "standard of care blood results." The study objective was to establish accuracy compared to "standard of care blood results."
• For Heart Rate: "standard of care blood results" (implied as part of the comparison, though usually heart rate ground truth comes from ECG or other direct measurements). The text states "compared to the standard of care blood results and heart rate," which might imply different methods for heart rate ground truth.
• The study stated it evaluated patients within "defined Hgb and Hct reference ranges (7-15 g/dL Hgb, 21-45% Hct)." This suggests quantitative comparison with clinical lab values.

8. The sample size for the training set

• The sample size for the training set is not provided. The text only mentions the clinical study for validation (test set) with 125 subjects. The AI/ML algorithm's training data is not described.

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

• This information is not provided, as the training set details are absent from this summary.

Ask a specific question about this device

The Polso™ Watch is a wrist-worn device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2), pulse rate, and respiration rate. The Polso™ Watch is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions.

The device is not intended to be used for diagnostic applications nor is it intended to independently guide treatment decisions. The device is not an apnea monitor. Physiological parameters will later be provided for remote review by a clinician.

The Polso™ Watch is a wearable device intended for non-invasive measurements and display of pulse rate (PR), blood oxygen saturation (SpO2), and respiration rate (RR). It is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor it is intended to independently guide treatment decisions.

The Polso™ Watch is worn on the wrist and features sensors that are located facing the radial artery and at the dorsal wrist, for measurement of physiological information. The Polso™ Watch screen displays measurements, battery status, Bluetooth connection status, and time of day. The Control Button allows navigation between different display screens. The Polso™ Watch is available in sizes S, M and L to cover wrist sizes from 5.5″ to 8.4″ circumference. The Polso™ Watch is powered by a rechargeable lithium-polymer battery.

The Polso™ Watch is paired with a companion mobile application (Polso™ App) on an Android device. The App is used to set up the Polso™ Watch and to review up to 3 months of measurement data.

The information provided primarily describes the Polso™ Watch, a pulse oximeter device, and its regulatory clearance. While it details what was tested (SpO2, Pulse Rate, Respiration Rate accuracy) and how (against gold standards, following ISO standards), it does not explicitly present specific numerical acceptance criteria for these accuracy metrics, nor does it provide the exact reported device performance values in a table as requested. Instead, it states the Polso™ Watch's accuracy for SpO2, Pulse Rate, and Respiration Rate in the comparison table with predicate devices.

Here's an attempt to address your request based on the available information, with clear indications where specific numerical data for acceptance criteria and reported performance is not explicitly detailed in the provided text.

Acceptance Criteria and Device Performance Study for Polso™ Watch

The Polso™ Watch underwent non-clinical and clinical testing to demonstrate its safety and performance and to establish substantial equivalence to predicate devices. The key performance metrics studied were SpO2 accuracy, Pulse Rate accuracy, and Respiration Rate accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for the accuracy tests (e.g., "Must achieve SpO2 accuracy of X% ARMS"). Instead, it compares the Polso™ Watch's stated accuracy to that of its predicate devices. We can infer the "acceptance" is based on demonstrating performance comparable to or better than the predicate, within recognized industry standards (ISO 80601-2-61).

Note on RR Accuracy and Display Range Units: The document consistently uses "BPM" (beats per minute) for Respiration Rate (RR) accuracy and display range of the Polso™ Watch, while using "RPM" (respirations per minute) for predicate devices. Assuming this is a clerical error and BPM is intended to mean respirations per minute in this context, the values are directly comparable.

2. Sample Size and Data Provenance

• SpO2 and Pulse Rate Validation Study:
  • Sample Size: 10 healthy adult subjects initially, with data on two additional subjects provided later, making a total of 12 subjects (for Fitzpatrick scores IV and VI).
  • Data Provenance: Not explicitly stated (e.g., specific country), but typical for a medical device regulatory submission, it would likely be from a controlled clinical trial setting. The studies were prospective as they were conducted to validate the device's performance.
• Respiration Rate Validation Study:
  • Sample Size: 31 adult subjects.
  • Data Provenance: Not explicitly stated. The study was prospective.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "manual, clinician-scored End Tidal Carbon Dioxide monitoring" and "arterial blood samples assessed by SaO2 CO-Oximetry" as gold standards. It does not specify the number or specific qualifications of the clinicians/experts involved in establishing these "manual" or "clinician-scored" ground truths.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the ground truth establishment in either of the clinical studies. The "gold standard" methods (arterial blood samples, manual clinician-scored ETCO2) inherently serve as the adjudicated truth.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how human readers/clinicians improve with AI vs. without AI assistance. The device is a measurement device (oximeter), not an AI-powered diagnostic imaging tool that typically involves MRMC studies for human reader performance.

6. Standalone (Algorithm Only) Performance

The "Reported Device Performance" listed in the table effectively represents the standalone performance of the Polso™ Watch (i.e., the algorithm/device output accuracy) without human-in-the-loop assistance for the core measurement functions.

7. Type of Ground Truth Used

• For SpO2 and Pulse Rate: Arterial blood samples assessed by SaO2 CO-Oximetry (this is an objective, physiological measurement and considered a "gold standard").
• For Respiration Rate: Manual, clinician-scored End Tidal Carbon Dioxide (ETCO2) monitoring. This relies on expert observation/scoring of physiological data.

8. Sample Size for the Training Set

The document does not provide details on the training set sample size. It only discusses the clinical validation/test sets. As a measurement device (oximeter) based on photoplethysmography, its core algorithms are likely based on established physiological principles and signal processing, rather than deep learning that requires distinct, large training sets in the same way an imaging AI algorithm would. If machine learning was used in some aspect of signal processing, the training data would be internal and not specified here.

9. How Ground Truth for Training Set Was Established

Not applicable/not provided, as per item 8. The document focuses on the validation studies against established "gold standards," not the internal development/training process.

Ask a specific question about this device

The Rad-C Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp).

The Rad-G Pulse Oximeter and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments.

The Rad-G Pulse Oximeter and Accessories are indicated for the spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments.

The Rad-G is a handheld pulse oximeter that provides Masimo SET pulse oximetry and Respiration Rate from the Plethysmograph. The Rad-G is provided with an internal battery and a connection to an external power supply to support continuous monitoring. The technologies supported in the Rad-G are the same as what has been cleared with the Radical-7.

The Masimo Rad-G Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp). The device's performance specifications are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly detail the sample size for a specific clinical test set for the Masimo Rad-G. Instead, it states that "additional clinical testing was not deemed necessary to support the substantial equivalence" because the subject device "utilizes the same monitoring technologies as the predicate (K193242)," the Masimo Radical-7 Pulse Co-Oximeter and Accessories. The performance specifications listed are identical to those of the predicate device.

Therefore, the performance data for the Masimo Rad-G device is based on the data provenance of the predicate device, K193242, which is not detailed in this document.

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

Since "additional clinical testing was not deemed necessary" for the subject device due to its technological similarity to the predicate, this information is not provided for the Masimo Rad-G directly in this document. The ground truth would have been established during the development and clearance process of the predicate device (K193242), but details are not available here.

4. Adjudication Method for the Test Set

As "additional clinical testing was not deemed necessary" for the subject device, details on adjudication methods for a specific test set are not present in this document. This would have been part of the predicate device's (K193242) clinical validation.

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

No MRMC comparative effectiveness study is mentioned in the provided text for the Masimo Rad-G. The document focuses on demonstrating substantial equivalence to a predicate device rather than comparing against human readers or assessing improvement with AI assistance.

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

The performance specifications listed are for the device's direct measurements (SpO2, PR, RRp). These are standalone algorithms that continuously process physiological signals to output numerical values. The device itself is an automated measurement tool, thus its listed performance is inherently standalone (algorithm-only). The context implies that these are measurements derived directly from the device's sensor and internal processing, rather than requiring human interpretation for the primary output.

7. The Type of Ground Truth Used

Based on the nature of pulse oximetry and respiration rate measurements, the ground truth for establishing the accuracy of the predicate device (and by extension, the Masimo Rad-G) would typically involve:

• Fractional Arterial Oxygen Saturation (SaO2) from a co-oximeter and manual pulse rate counts for SpO2 and PR accuracy studies, often obtained from subjects undergoing induced hypoxia in controlled clinical settings.
• Reference respiration rate measurements (e.g., from capnography, impedance pneumography, or direct observation) for RRp accuracy studies.

The document states that the Masimo Rad-G utilizes the same principles of operation and has the same performance specifications as the predicate device (Masimo Radical-7, K193242). This indicates that the ground truth for the Masimo Rad-G's performance is derived from the ground truth established for the predicate device.

8. The Sample Size for the Training Set

The document does not describe the a "training set" in the context of machine learning, nor does it specify a sample size for such a set. The device utilizes established physiological measurement technologies (Masimo SET pulse oximetry and Respiration Rate from Plethysmograph) rather than a novel machine learning algorithm that would require a dedicated training set. The performance is validated against clinical trials previously conducted for the predicate technology.

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

Since there is no mention of a "training set" in the machine learning sense, this information is not applicable. The core technology and its accuracy were established during the development and clinical validation of the Masimo SET Pulse Oximetry and Respiration Rate from Plethysmograph system, which underlies both the predicate and subject devices. This would have involved comparing the device's measurements against accepted clinical reference standards (as described in point 7).

Ask a specific question about this device

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.

Ask a specific question about this device