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The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous nomitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatic, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion and motions, for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) 10 multiparameter devices for display on those devices.

The Masimo LNOP® Series of Sensors are indicated for the following:

• A single use oximetry sensor intended for adults and pediatrics greater than 30 kg
• A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg
• A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg
• A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg
• A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg
• A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg

The Masino PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShareTM.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liquid crystal display) display that shows the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.

The submitter, Masimo Corporation, provided information on the performance validation of their Masimo SET® Radical Pulse Oximeter with SatShare™.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The accuracy specifications (e.g., ± 2 digits) generally represent one standard deviation, encompassing 68% of the population, as stated in the document.

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

The document does not explicitly state the exact sample sizes (number of subjects) for each clinical study (test set). However, it does specify:

• Adults, Pediatrics: "human blood studies on healthy adult volunteers"
• Neonates: "human blood studies on neonates"
• Data Provenance: The studies were conducted on "healthy adult volunteers" and "neonates" in induced hypoxia states and under various motion and low perfusion conditions. The studies appear to be prospective as they involved inducing specific conditions (hypoxia, motion) to assess device performance. The country of origin is not explicitly stated but is implicitly within the scope of FDA regulations, suggesting the US.

3. Number of Experts Used to Establish 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. It relies on objective measurement devices for ground truth:

• For SpO2: A laboratory co-oximeter was used for arterial blood samples.
• For Pulse Rate: An ECG monitor was used.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by objective laboratory co-oximeters and ECG monitors, not through expert adjudication.

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 MRMC comparative effectiveness study was done. This device is a pulse oximeter, which provides direct physiological measurements, not interpretations that would typically involve human "readers" or AI assistance in that context. The "AI" (Masimo SET technology) is integral to the device's function, not an add-on for human interpretation.

6. 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 Masimo SET® Radical Pulse Oximeter with SatShare™. The device directly measures and displays SpO2 and pulse rate; the performance metrics are accuracy against established gold standards (co-oximeter and ECG), not human interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was:

• Laboratory Co-Oximeter: For functional oxygen saturation of arterial hemoglobin (SpO2), determined from arterial blood samples. This is an objective, laboratory-based gold standard.
• ECG Monitor: For pulse rate. This is an objective, clinical gold standard.

8. The Sample Size for the Training Set

The document does not explicitly state a separate "training set" sample size. The "values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and nonmotion conditions." This implies that data from human studies was used to develop and refine the device's algorithms and look-up tables (effectively the training data for the device's inherent "algorithm"). The size of these studies is not quantified.

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

The ground truth for what would be considered the "training set" (the data used to establish the device's empirically derived equations and look-up tables) was established by:

• Human blood studies on healthy adult volunteers in induced hypoxia states during motion and non-motion conditions.
• Measurements taken against a laboratory co-oximeter. This indicates that the device's internal algorithms were developed and calibrated by comparing its readings to highly accurate co-oximetry measurements from real human blood samples under various challenging conditions.

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The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO- sensor) for adult, pediativ, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motions, for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multiparameter devices for display on those devices.

The Masimo LNOP® Series of Sensors are indicated for the following:

• A single use oximetry sensor intended for adults and pediatrics greater than 30 kg
• A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg
• A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg
• A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg
• A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg
  A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg

The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShare™.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liquid crystal display) display that shows the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.

Here's a breakdown of the acceptance criteria and study information for the Masimo SET® Radical Pulse Oximeter with SatShare™, based on the provided document:

Acceptance Criteria and Device Performance

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Clinical Studies): The document does not specify the exact number of subjects/cases used for each clinical study (adult, pediatric, neonatal, motion, no-motion, low perfusion). It only refers to "human blood studies on healthy adult volunteers" and "human blood studies on neonates."
   • Data Provenance: The provenance is not explicitly stated in terms of country of origin of the data. However, the studies were conducted by Masimo Corporation, located in Irvine, CA, USA, and followed US regulatory standards (21CFR, Part 812, Part 50, Part 56). The studies were prospective, involving induced hypoxia in healthy volunteers and directly measuring performance in neonates.

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

   • The document does not mention the use of experts to establish ground truth for the test set in the conventional sense of human readers interpreting images. Instead, the ground truth for oxygen saturation (SpO2) was established using a laboratory co-oximeter on arterial blood samples. For pulse rate, an ECG monitor served as the ground truth. These are objective gold-standard measurements rather than subjective expert consensus.

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

   • Not applicable. The ground truth was established by objective laboratory instruments (co-oximeter, ECG), not through human adjudication of differing interpretations.

4. 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. This type of study (MRMC comparative effectiveness with/without AI assistance) is not relevant for a pulse oximeter, which is a standalone measurement device, not an AI-assisted diagnostic imaging tool that requires human interpretation.

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

   • Yes, the entire clinical validation effectively demonstrates the standalone performance of the Masimo SET® Radical Pulse Oximeter. The device directly provides SpO2 and pulse rate readings, which were then compared against the established ground truth from co-oximeters and ECG monitors. There is no human-in-the-loop component in the primary function or performance evaluation described.

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

   • Objective Physiological Measurement:
     • For SpO2: Laboratory co-oximeter measurements from arterial blood samples.
     • For Pulse Rate: ECG monitor.
     • For Low Perfusion: Bench top testing against simulators (Biotek Index 2 simulator and Masimo's simulator).

7. The sample size for the training set:

   • The document states that the values in the device's look-up table are "based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and nonmotion conditions." However, it does not specify the sample size for this training data.

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

   • The ground truth for the training set (used to develop the empirically derived equation and look-up table) was established using human blood studies on healthy adult volunteers in induced hypoxia states, with comparisons made against a laboratory co-oximeter. This process involved collecting data under both motion and non-motion conditions.

Ask a specific question about this device

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and neonatal. patients during both no motion conditions, for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multiparameter devices for display on those devices.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liquid crystal display) display that shows the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.

The Masimo SET® Radical Pulse Oximeter with SatShare™ is a pulse oximeter intended for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult, pediatric, and neonatal patients across various healthcare settings.

1. Table of Acceptance Criteria and Reported Device Performance:

• Adults and Pediatrics: within ± 2 digits
• Neonates: within ± 3 digits |
  | Saturation (% SpO2) - Motion Conditions (70%-100%) | Adults, Pediatrics: ± 3 digits
  Neonates: ± 3 digits | The clinical studies show:
• Adults and Pediatrics: within ± 3 digits
• Neonates: within ± 3 digits |
  | Pulse Rate (bpm) - No Motion Conditions (25-240) | Adults, Pediatric, Neonates: ± 3 digits | The clinical studies show:
• Adults, Pediatric, Neonates: within ± 3 digits |
  | Pulse Rate (bpm) - Motion Conditions (25-240) | Adults, Pediatric, Neonates: ± 5 digits | The clinical studies show:
• Adults, Pediatric, Neonates: within ± 5 digits |
  | Low Perfusion Performance (SpO2) | ± 2 digits (> 0.02% Pulse Amplitude, % Transmission > 5%) | The clinical studies on healthy adult volunteers show performance within ± 2 digits. (Note: Neonate low perfusion clinical studies were also performed, and the results claim the device meets performance). |
  | Low Perfusion Performance (Pulse Rate) | ± 3 digits (> 0.02% Pulse Amplitude, % Transmission > 5%) | The clinical studies on healthy adult volunteers show performance within ± 3 digits. (Note: Neonate low perfusion clinical studies were also performed, and the results claim the device meets performance). |

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

The document mentions "human blood studies on healthy adult volunteers" and "clinical studies...on neonates." However, specific sample sizes (number of subjects/cases) for the test sets are not explicitly stated in the provided text for any of the clinical or bench tests.

Data Provenance:

• Clinical Studies: Healthy adult volunteers and neonates.
• Country of Origin: Not explicitly stated, but the studies followed US FDA regulations (21 CFR Part 812, Part 50, Part 56), implying they were conducted in the US or under US regulatory oversight.
• Retrospective or Prospective: The wording "clinical studies were performed" and "subjects during no motion and motions who were subjected to a progressive induced hypoxia" indicates these were prospective studies.

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 document. The ground truth for SpO2 was established by a laboratory co-oximeter and for pulse rate by an ECG monitor, not by expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The ground truth was established by objective medical devices (co-oximeter and ECG monitor), not through expert adjudication.

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

No, a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

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

Yes, the overall study, particularly the clinical trials, can be considered a standalone performance evaluation. The device (algorithm + hardware) directly measures SpO2 and pulse rate, and its performance is compared directly against reference devices (co-oximeter and ECG), not with human interpretation as an intermediate step. The document explicitly states the "Masimo SET® Radical Pulse Oximeter with SatShare™...returned the same saturation accuracy values...and pulse rate values" when compared to simulators in bench testing and against co-oximeters/ECG in clinical studies.

7. The Type of Ground Truth Used:

The ground truth for the clinical studies was established using objective medical reference devices:

• For oxygen saturation (SpO2): Laboratory CO-Oximeter analysis of arterial blood samples.
• For pulse rate: ECG Monitor.

8. The Sample Size for the Training Set:

The document mentions that the "look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and nonmotion conditions." This refers to the development/calibration of the device's a-priori look-up tables. However, like the test set, the specific sample size for this internal "training" or calibration set is not explicitly stated in the provided text.

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

The ground truth for the training/calibration set (which informed the device's look-up tables) was established by:

• Human blood studies on healthy adult volunteers.
• Induced hypoxia states (to achieve various saturation levels).
• Measurement of arterial hemoglobin oxygen using a laboratory co-oximeter.
• These studies were conducted during both motion and non-motion conditions.

Ask a specific question about this device

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatic, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motions, for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multiparameter devices for display on those devices.

The Masimo LNOP® Series of Sensors are indicated for the following:

A single use oximery sensor intended for adults and pediatrics greater than 30 kg

A single use oximetry sensor intended for nediatics and small adults greater than 10 kg and less than 50 kg

A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg

A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg

A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg

A reusable oximetry sensor intended for pediatives and small adults greater than 10 kg and less than 50 kg

The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SETº Radical Pulse Oximeter with SatShare™

The following are additional SatShare cables indicated for connection to the following multi-parameter monitors:

Ohmeda - RGM Respiratory Monitor and

Datex-Ohmeda - M-EST and M-ESTP Modlucs

Draeger - Vitalert 1000, 3200, Evita 2 dura, Julian Anesthetic Workstation, and Narcomed 4 Monitors Airshields - Multiparameter Monitor with Ohmeda SpO2

Datascope - Passport Monitor with Datascope SpO2 and Accutor Monitors with Nellcor SpO2 and Datascope SpO2 GE/Marquette - Tram 100A and Tram 500A modules with Ohmeda SpO2

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET I ho reasme of 2 - 1 the really and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial tecmoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liguid crystal display) display the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.

Here's a breakdown of the acceptance criteria and the study information for the Masimo SET® Radical Pulse Oximeter with SatShare™:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents accuracy as "± X digits" which typically refers to the root mean square (RMS) difference when compared to a reference method, encompassing 68% of the population.

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

• Sample Size for Test Set:

  • Adult/Pediatric No Motion & Motion: Not explicitly stated as a number, but studies were conducted on "healthy adult volunteers."
  • Neonatal Motion: Not explicitly stated as a number, but studies were conducted on "neonates."
  • Low Perfusion: Not explicitly stated, as this was primarily bench-top testing supplemented by clinical studies mentioned generically for "healthy adult volunteer subjects" and "neonates with low perfusion conditions."

• Data Provenance: Clinical studies were performed on "human blood studies on healthy adult volunteers" and "neonates." The location (country of origin) is not specified, but the studies were conducted under U.S. regulations (Title 21 of Federal Regulations (21CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects, and Part 56 - Institutional Review Boards). This suggests a U.S. origin for the clinical data. The studies were prospective as induced hypoxia and motion conditions were deliberately applied.

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

• Number of Experts: Not applicable in the traditional sense of experts interpreting images or conditions. The ground truth was established by laboratory co-oximetry and ECG monitors.
• Qualifications of Experts: Not applicable. The reference methods are objective devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established directly by comparison to objective reference devices (laboratory co-oximeter for SpO2, ECG monitor for pulse rate). There was no mention of human adjudication of the reference standards themselves.

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

• Was an MRMC study done? No. This device is a pulse oximeter, and its performance is assessed against physiological measurements, not against human reader interpretations of medical images or conditions.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed and the device is not an AI-assisted diagnostic tool that aids human readers.

6. Standalone Performance Study

• Was a standalone performance study done? Yes. The entire description of accuracy in the document refers to the performance of the Masimo SET® Radical Pulse Oximeter with SatShare™ alone (algorithm only) compared to the reference standard. The goal was to validate the device's measurements of SpO2 and pulse rate.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • SpO2: Laboratory co-oximeter measurements from arterial blood samples.
  • Pulse Rate: ECG monitor.
  • Low Perfusion SpO2/Pulse Rate: Bench-top testing against a Biotek Index 2 simulator and Masimo's simulator.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated within the 510(k) summary. The document mentions that the values in the look-up table (used by the device's software to find SpO2 saturation) are "based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and nonmotion conditions." However, the exact sample size for these initial studies used to develop the algorithm/look-up table is not provided. The accuracy results presented are for validation/testing, not training.

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

• How Ground Truth for Training Set Was Established: According to the "Principles of Operation" section, the device uses "an empirically derived equation in the Masimo SET® Radical II's software." The "values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and nonmotion conditions." This indicates that the training ground truth for the look-up table was established by laboratory co-oximetry measurements from arterial blood samples under defined induced hypoxia, motion, and non-motion conditions in healthy adult volunteers.

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