(135 days)
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.
| Feature | Acceptance Criteria | Reported Device Performance (Centroid O2) |
|---|---|---|
| SpO2, no motion | 70-100%, 2%, adults/pediatrics/infants | Bias: -0.5, Adjusted Precision: 1.2, Adjusted RMS: 1.3 (corresponds to 2% ARms) |
| 70-100%, 3%, neonates | (Not explicitly detailed for neonates in the clinical study results, but implied to meet this) | |
| SpO2, motion | 70-100%, 3% adults/pediatrics/infants/neonates | Bias: -0.9, Adjusted Precision: 2.0, Adjusted RMS: 2.2 (corresponds to 3% ARms) |
| SpO2, low perfusion | 70-100%, 2%, adults/pediatrics/infants | (Clinical study results provided focus on no motion and motion conditions; low perfusion not explicitly detailed in the results table) |
| 70-100%, 3%, neonates | (Clinical study results provided focus on no motion and motion conditions; low perfusion not explicitly detailed in the results table) | |
| Pulse rate, no motion | 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates | (Clinical study focused on SpO2 accuracy; PR accuracy not detailed in the provided clinical study results) |
| Pulse rate, motion | 25-240 bpm, 5 bpm, adults/pediatrics/infants/neonates | (Clinical study focused on SpO2 accuracy; PR accuracy not detailed in the provided clinical study results) |
| Pulse rate, low perfusion | 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates | (Clinical study focused on SpO2 accuracy; PR accuracy not detailed in the provided clinical study results) |
*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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).