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The LNCS Sensors and Cables are indicated for the continuous nonitoring of functional oxygen saturation I he LNCS Sellsons and Cables are multided for and continued by an SpO2 sensor) for use with adult, pediatric, infant, and of arterial nemogroum (op(0)) and pare (motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The LNCS Oximetry Sensors are fully compatible disposable and reusable sensors for use with Masimo SET compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors.

The LNCS DC-I/DC-IP reusable sensors are essentially identical to Masimo LNOP-DC-I/DC-IP sensors except for the connector at the end of the cable which interfaces with the LNCS patient cable. The emitter and detector are mounted in opposing halves of the molded clothespin style sensor with contoured pads to maintain contact with the patient's fingers. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) and detector are used in both the LNCS DC-I/DC-IP and LNOP-DC-I/DC-IP sensors. The patient contacting materials in the LNCS DC-I/DC-IP and LNOP-DC-IP sensors are the same. The LNCS DC-I/DC-IP sensors are supplied non-sterile.

The LNCS TC-I and TF-I reusable sensors are essentially identical to Masimo LNOP-Ear and TF-I sensors except for the connector at the end of the cable which interfaces with the LNCS patient cable. The same emitter (with Red wavelength of 653/659 nm and Infrared wavelength of 880 nm respectively) and detector are used in both the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors. The patient contacting materials in the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors are the same. The LNCS TC-I and TF-I sensors are supplied non-sterile.

The LNCS disposable sensors are similar in construction to the predicate devices except that the LNCS sensors are cable based while the LNOP sensors are flex circuit based. The emitter and detector are connected to the cable assembly. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masimo's LNOP series of disposable sensors. Four sizes of disposable LNCS sensors are available for use with adult, pediatric, infant and neonatal patients. The four sensors are essentially identical except for the emitter and detector spacing and size and orientation of the bandage material. The patient contacting materials in the LNCS disposable sensors are the same that is used in Masimo's LNOP sensor line. The LNCS disposable sensors are supplied non-sterile for single patient use.

The LNCS patient cables are similar in construction to the predicate device enabling the LNCS Oximetry Sensors to be connected to Masimo and Masimo compatible pulse oximeter monitors.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary indicates that the accuracy of the LNCS oximetry sensors is equivalent to the predicate devices. The summary explicitly states:

Note: The document states that the "LNCS oximetry sensors are substantially equivalent...and performance to predicate sensors" and that "The accuracy of the LNCS oximetry sensors is equivalent to those of the predicate devices." The specific accuracy values presented in the "Clinical Testing" section are attributed to "SPO2.COM Disposable and Reusable sensors." While these are listed as predicate devices in the 510(k) (K033298), the document implies that the LNCS sensors achieve equivalent performance to these predicate devices, thus meeting these implied acceptance criteria.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "healthy adult volunteer subjects" and "adults, pediatrics and infants and neonates" were included. However, the exact number of subjects or data points is not provided.
• Data Provenance: The study was conducted on "healthy adult volunteer subjects" and involved "induced hypoxia." This indicates a prospective clinical study. 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 Qualifications of Those Experts

• Number of Experts: Not applicable in this context. The ground truth for SpO2 measurements is not established by human experts in the typical sense of image or diagnostic interpretation.
• Qualifications of Experts: Not applicable. The ground truth relied on a CO-Oximeter to measure arterial hemoglobin oxygen from arterial blood samples.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement from a CO-Oximeter, not through human interpretation requiring 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

• MRMC Study: No, an MRMC study was not done. This device is an oximeter sensor, not an AI-powered diagnostic tool that assists human readers.

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

• Standalone Performance: Yes, the clinical testing describes the standalone performance of the oximetry sensors against a reference standard (CO-Oximeter). The device itself is the 'algorithm' in this context, directly measuring and reporting SpO2.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. This is an objective, gold-standard measurement for blood oxygen saturation.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a medical device (sensor) and its performance, not a machine learning model that would typically have a distinct training set. The device's design and parameters are established through engineering and previous device iterations rather than a "training set" in the AI sense.

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

• Ground Truth for Training Set: Not applicable. As mentioned above, this is not an AI/ML device where a training set with established ground truth would be relevant in the same way. The device's operating principles are based on established physiological and photometric principles.

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The NC Adapter Cable with Nellcor sensors are indicated for the continuous noninvasive monitoring of functional I its readiner of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediation informator of Liveral In hospitals, hospitals, hospital-type facilities, mobile, and home environments.

The NC Adapter Cable is fully compatible oximetry cable that allows the use of Nellcor Sensors with Masimo SET Radical pulse oximeter monitors. The cable represents a design change to the Masimo patient cables and the MS board. The NC Adapter Cable is similar in construction to the predicate device enabling the Nellcor Sensors to be connected to Masimo SET Radical pulse oximeters. The NC Adapter Cable is designed, and manufactured for full compatibility with Masimo SET Radical pulse oximeters using Nellcor Sensors. The NC Adapter Cable is constructed of similar materials and components of equivalent specifications as used in the predicate devices.

Here's a summary of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated as a numerical value for the test set. The text mentions "healthy adult volunteer subjects" and separately "neonatal sensors were validated on adult volunteers." It doesn't specify the number of subjects used in either case.
• Data Provenance: The studies used human subjects, but the country of origin is not specified. The study is prospective, as it involved "progressive induced hypoxia" in volunteers.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable/not mentioned. The ground truth was established using a CO-Oximeter, not human expert consensus for interpreting medical images or signals.
• Qualifications of Experts: N/A.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. The ground truth was determined by a CO-Oximeter, which is an objective measurement tool, not subject to human interpretation requiring adjudication.

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

• No, a MRMC study was not performed. This device is an adapter cable for a pulse oximeter, and the performance testing focuses on the accuracy of its physiological measurement against a reference standard, not on human reader interpretation.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was performed in the sense that the device's measurement (SpO2) was compared directly against an objective ground truth (CO-Oximeter). There isn't an "algorithm" in the typical sense of AI/image analysis, but the device's output itself was evaluated.

7. Type of Ground Truth Used

• Ground Truth: Arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. This is an objective, laboratory-based measurement.

8. Sample Size for Training Set

• Not applicable/not mentioned. Pulse oximeters (and their cables) are generally based on physical principles of light absorption and are typically calibrated and validated through engineering tests and clinical studies (as described here) rather than trained on large datasets like machine learning models. The text describes performance testing, not a training phase.

9. How Ground Truth for Training Set Was Established

• Not applicable. As noted above, this device's performance is not based on a "training set" in the context of machine learning. The clinical validation described establishes its accuracy against a known truth.

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The Masimo SET® Intellivue Pulse Oximeter Module is intended for the continuous noninvasive monitoring of functional oxygen saturerial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals and hospital-type facilities.

The IntelliVue Pulse Oximeter Module is indicated for the continuous nonitoring of functional organization of financed for I ne ment vice culse oximicle moduced by an Spo-sensor). The Intellivie Pulse Oximeter Module is indicated for are with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The Masimo SET® IntelliVue Pulse Oximeter Module is a continuous noninvasive, arterial oxygen saturation and pulse rate montor. The Masimo SET Intellivue Module features Masimo SET algorithms in a Philips single-width Intellivae compatible module.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "0% - 69% unspecified": For saturation below 70%, the device's accuracy is not specified in the "Specifications and Operating Ranges" table for any patient group or condition. The text later reiterates this as "0% - 69% unspecified".

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

• Test Set Description:
  • Motion and No Motion Studies: "healthy adult volunteer subjects during no motion and motion conditions who were subjected to a progressive induced hypoxia"
  • Low Perfusion Studies: "healthy adult volunteer subjects to low perfusion conditions and to a progressive induced hypoxia"
  • Neonates (Accuracy Basis): "clinical studies on adult volunteers and 1% was added to account for the properties of fetal hemoglobin"
• Sample Size: The exact number of subjects for the clinical studies (test set) is not specified in the provided text.
• Data Provenance: The studies were conducted on "healthy adult volunteer subjects" and involved "human blood studies." The country of origin is not explicitly stated, but the context of an FDA submission (K040259, U.S. Department of Health & Human Services) strongly suggests the studies were conducted in the United States or overseen by US regulations. The studies were prospective, involving induced hypoxia and real-time monitoring.

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

• Number of Experts: Not applicable in the traditional sense for this type of medical device study.
• Qualifications of Experts: The ground truth was established by objective medical instruments, not by expert interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by direct measurement with reference devices.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a primary component of the diagnostic process.

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

• Yes, a standalone performance assessment was done. The studies explicitly compare the device's readings (algorithm only output) to established reference measurements (CO-Oximeter and ECG) without human intervention in interpreting the device's output. The device itself is an automated measurement tool.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • For Saturation (% SpO2): Arterial blood samples measured by a CO-Oximeter. This is an objective laboratory measurement.
  • For Pulse Rate (bpm): Measurements from an ECG monitor. This is an objective physiological measurement.
  • For Low Perfusion (Bench Testing): The "Biotek Index 2 simulator and Masimo's simulator" were used, which are controlled bench test environments designed to simulate physiological conditions with known outputs.

8. The Sample Size for the Training Set

• Training Set for Empirical Data: The text states, "The values in the look-up table are based upon human blood studies against a mu the Masmo 021 - miedir as betwarers in induced hypoxia states during motion and non-motion conditions."
• Sample Size: The exact sample size for the training set (the "human blood studies" used to derive the look-up table) is not specified in the provided text.

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

• Ground Truth for Training Set: The ground truth for the empirical look-up table was established through "human blood studies against a CO-Oximeter" in "induced hypoxia states during motion and non-motion conditions." This indicates that, similar to the test set, the reference measurements for oxygen saturation were obtained from a CO-Oximeter. The mechanism for grounding the pulse rate data in the training set is not explicitly detailed but would logically follow similar objective physiological measurements.

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The Masimo SET® Rad-5v Pulse Oximeter is intended for non-continuous noninvasive monitoring of finctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO3 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments.

The Rad-5v Handheld Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.

The Masimo SET® Rad5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for 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 SET® Rad-Sv Handheld Pulse Oxineter is noninvasive, arterial oxygen saturation and pulse rate monitor. The Rad-ITIC Mannin SEE - Not of Principely that continuously displays numeric values for SpO2 and pulse rate, as well as LED indicator bars for Pulse Amplitude Index (PAI) and Signal Quality (SQ).

Here's an analysis of the acceptance criteria and the studies that prove the Masimo SET® Rad-5v Pulse Oximeter meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" presented above are directly derived from the device's stated "Specifications and Operating Ranges" and the accompanying notes, which describe the validation methods and expected accuracy.

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

The document does not explicitly state a numerical "sample size" for the test set in terms of the number of subjects or data points. However, it mentions:

• Human Blood Studies on Healthy Adult Volunteers: Used for no motion and motion accuracy (induced hypoxia).
• Clinical Studies on Neonates: Used for no motion conditions and low perfusion.
• Bench Top Testing: Used for low perfusion accuracy against simulators.

The data provenance is prospective human studies conducted as "clinical studies" and "human blood studies" as well as bench testing. The country of origin is not explicitly stated, but the company address is in Irvine, CA, USA, and the submission is to the US FDA, implying testing was likely conducted in the USA or under US regulations.

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

The document does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study and therefore no effect size for human readers with and without AI assistance can be determined. Pulse oximetry is a direct measurement device, not typically requiring human interpretation of complex images or data in an MRMC study context.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was done. The entire testing described (bench testing and clinical studies against co-oximeters and ECG) establishes the algorithm's performance without specific human interpretation or intervention in the measurement process, other than device operation. The device continuously displays numeric values, implying an algorithmic output.

7. Type of Ground Truth Used

The ground truth used for the clinical and human blood studies was:

• Arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter: For SpO2 accuracy.
• ECG monitor: For pulse rate accuracy.

For bench testing, the ground truth was provided by:

• Brotek Index 2 simulator and Masimo's simulator: For low perfusion accuracy.

8. Sample Size for the Training Set

The document does not provide a sample size for the training set. It states that the "values in the look-up table are based upon human blood studies against a laboratory co-oximeters in induced hypoxia states during motion and non-motion conditions." This implies that data from human studies was used to develop or calibrate the device's algorithms (the look-up table), but the specifics of that dataset size are not detailed.

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

The ground truth for the look-up table (which serves as the basis for the algorithm's calculation) was established by:

• Human blood studies against a laboratory co-oximeter in induced hypoxia states during motion and non-motion conditions. The document indicates that the device's fundamental conversion algorithm from absorbance signals to SpO2 values is derived from these studies.

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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® RAD-5 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments.

The Rad-5 Handheld Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (Sp() ) and pulse rate (measured by an SpO2 sensor). The Rad-5 Handheld Pulse Oximeter is indicated for use with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.

The Masimo SET® Rad 5 Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and ition conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Masimo SET® Rad-5 Pulse Oximeter is a handheld pulse oximeter that measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It utilizes spectrophotometry and plethysmography principles. The device displays SpO2, pulse rate, alarm status, alarm silenced status, Perfusion Index Bar, Signal IQ Bar, Battery Status, APOD, and FastSat. It has adjustable alarm volume and averaging settings. It is powered by 4 AA batteries.

Here's an analysis of the acceptance criteria and study details for the Masimo SET® Rad-5 Pulse Oximeter, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number of subjects. The studies were conducted on:
     • Healthy adult volunteers (for no motion, motion, and low perfusion conditions).
     • Neonates (for no motion, motion, and low perfusion conditions).
   • Data Provenance: The studies were described as "human blood studies" and were clinical tests. The location is not specified, but given the company is based in Irvine, CA, and the FDA approval process, they were likely conducted in the US. The studies are prospective, involving "induced hypoxia states."

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

   • Number of Experts: Not applicable. The ground truth was established by a laboratory co-oximeter and an ECG monitor, not human experts for interpretation.
   • Qualifications of Experts: N/A.

3. Adjudication method for the test set:

   • Not applicable. The ground truth in this case is objective physiological measurements from a laboratory co-oximeter and an ECG monitor, not subjective interpretations requiring adjudication.

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, an MRMC study was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that relies on human readers' interpretation.

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

   • Yes, this was a standalone performance study. The device's accuracy was directly compared against a physiological ground truth (co-oximeter and ECG) under various conditions. The device's algorithm performs the measurements and calculations independently to determine SpO2 and pulse rate.

6. The type of ground truth used:

   • Clinical Ground Truth:
     • Co-Oximetry (Laboratory Co-Oximeter): Used to determine arterial hemoglobin oxygen saturation (SaO2) through arterial blood samples. This is considered the gold standard for oxygen saturation measurement.
     • Electrocardiogram (ECG Monitor): Used to determine true pulse rate.

7. The sample size for the training set:

   • The document implies that the "values in the look-up table are based upon human blood studies against a laboratory co-oximeters in induced hypoxia states during motion and non-motion conditions." This suggests that a dataset of human blood studies was used to develop and refine the algorithm's look-up table. However, the specific sample size of this training set is not explicitly stated.

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

   • As indicated in the "Principles of Operation" section, the "values in the look-up table" (which essentially represent the training data for the internal algorithm's calibration) were based on:
     • Human blood studies: Healthy adult volunteers were subjected to induced hypoxia states.
     • Comparison against a laboratory co-oximeter: Arterial blood samples were analyzed by a co-oximeter to provide the true oxygen saturation (SaO2) values.
     • This process was performed under both motion and non-motion conditions to build a robust look-up table for the device's internal calculations.

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The additional Masimo series of sensors are 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.

Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospital-type facilities, mobile, and home environments.

The following additional Masimo Sensor is indicated for the continuous noninvasive functional of arterial hemoglobin (SpO2) and pulse rate:

Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospitals, hospital-type facilities, mobile, and home environments.

The Masino series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently than unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin in arterial blood. This filing includes the addition of 2 reusable sensors and a disposable sensor.

1. Acceptance Criteria and Reported Device Performance:

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

   • Sample Size: Not explicitly stated, but the performance testing was conducted on "adult volunteers."
   • Data Provenance: The data was collected prospectively from "adult volunteers." The country of origin is not specified but implicitly the US, given the submission to the FDA.

3. Number of Experts and Qualifications for Ground Truth:

   • No information provided regarding experts. The ground truth was established by comparing the device's measurements to arterial blood samples analyzed on a laboratory CO-Oximeter, which is a recognized gold standard for oxygen saturation in medical contexts.

4. Adjudication Method for the Test Set:

   • Not applicable as the ground truth was derived from a laboratory instrument (CO-Oximeter) rather than human adjudication.

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

   • No. This study is about a medical device's accuracy in measuring physiological parameters, not about human readers' performance with or without AI assistance.

6. Standalone Performance (Algorithm only):

   • Yes. The study assessed the standalone performance of the LNOP-TF-I sensor by directly comparing its readings to a laboratory CO-Oximeter.

7. Type of Ground Truth Used:

   • The ground truth was established using arterial blood samples analyzed on a laboratory CO-Oximeter. This is considered a highly accurate, objective gold standard for measuring oxygen saturation.

8. Sample Size for the Training Set:

   • Not applicable. This device is a sensor for a pulse oximeter, and the performance testing described is for its accuracy in measurement, not for a trainable algorithm.

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

   • Not applicable, as there is no mention of a training set for an algorithm in this context. The device's function is purely measurement-based, not based on machine learning.

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The AC-1 Adapter Cable with Masimo sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor) for use with adult, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The AC-1 Adapter Cable is fully conpatible oximetry cable that allows the use of Masimo LNOP Sensors with Nellow and Nellcor compatible pulse oximeter monitors. The cable represents a design change to the Masino patient cables. The AC-1 Adapter Cable is similar in construction to the predicate device enabling the Masimo LNOP Sensors to be comected to Nelleor and Nellcor compatible pulse oximeter monitors.

This Masimo AC-1 Adapter Cable is a cable that connects Masimo LNOP sensors to Nellcor and Nellcor-compatible pulse oximeter monitors. The 510(k) summary doesn't outline acceptance criteria directly for the adapter cable itself but rather refers to the accuracy of the Masimo LNOP sensors when used with the AC-1 adapter cable. The study mentioned supports the substantial equivalence of this combination.

Here's a breakdown of the information requested based on the provided text:

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

Note: The acceptance criteria are "implied" because the document states the accuracy is "equivalent to those of the predicate devices" and then provides the accuracy values achieved. It doesn't explicitly state "Our acceptance criterion is an accuracy of X%."

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: Not explicitly stated. The document mentions "adult oximetry sensors on human volunteers under induced hypoxic conditions." It does not specify the number of volunteers.
• Data Provenance: Prospective. The study involved "human volunteers under progressive induced hypoxia." Country of origin is not specified, but Masimo Corporation is based in Irvine, CA, USA.

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 applicable. The ground truth was established by a CO-Oximeter, not human experts.

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

Not applicable. Ground truth was established by a CO-Oximeter.

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

Not applicable. This device is a cable for a pulse oximeter, not an AI-assisted diagnostic tool.

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

Yes, the performance listed directly reflects the accuracy of the Masimo LNOP sensors when used with the AC-1 Adapter Cable, measured against a CO-Oximeter. This is a standalone performance assessment of the device (or the device in combination with its intended sensor).

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

The ground truth was established by a CO-Oximeter measuring arterial hemoglobin oxygen from arterial blood samples. This is considered a gold standard for blood oxygen saturation measurement.

8. The sample size for the training set

Not applicable. This device is a passive cable and does not involve machine learning or training sets in the conventional sense.

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

Not applicable, as there is no training set for this device.

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The SPO2.COM oximetry sensors and cables are intended for the continuous nominvasive monitoring of functional oxygen saturation of arterial hermoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The SPO2.COM Oximetry Sensors are fully compatible disposable replacement sensors for use with Nellon and Nelloor compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors.

The SPO2.COM RSI reusable sensor is essentially identical to Masimo LNOP-DCI sensor except for the end of the cable which interfaces with the Neller. The emitter and detector are mounted in opposing halves of the molded clothespin style sensor with contoured pads to maintain contact with the patient's fingers. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) and detector are used in both the SPO2.COM RSI and LNOP-DCI sensors. The patient contacting materials in the SPO2.COM RSI and LNOP-DCI sensors are the same. The SPO2.COM RSI sensors are supplied non-sterile.

The SPO2.COM disposable sensors are similar in construction to the predicate devices. The emitter and detector are connected to the cable assembly. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masimo's LNOP series of stime that that tour sizes of disposable SPO2.COM sensors are available for use with adult, pediatric, infant and neonatal cuspount our sensors are cssentially identical except for the emitter and detector spacing and size and orientation of the bandage material. The patient contacting materials in the SPO2.COM disposable schsors are the same that is used in Masimo's LNOP sensor line. The SPO2.COM disposable sensors are supplied non-sterile for single patient use.

The SPO2.COM patient cables are similar in construction to the predicate device enabling the SPO2.COM Oximetry Sensors to be connected to Nellcor and Nellcor The or oz. Out oximeters. The SPO2. COM oximetry sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

Acceptance Criteria and Study for SPO2.COM Oximetry Sensors

This response describes the acceptance criteria and the study conducted to demonstrate that the SPO2.COM Oximetry Sensors meet those criteria, based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary explicitly states that "The accuracy of the SPO2.COM oximetry sensors is equivalent to those of the predicate devices." While specific numerical acceptance criteria for accuracy of the predicate devices are not provided in the summary, the reported performance of SPO2.COM sensors aligns with typical accuracy requirements for pulse oximeters.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated. The study involved "healthy adult volunteer[s]" but the exact number of subjects or data points is not provided.
• Data Provenance: Prospective. The clinical studies were "performed using the SPO2.COM Adult and Reusable oximetry sensors on healthy adult volunteer[s]... who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter." This describes a prospective study design. The country of origin is not specified but implicitly implies the US, given the FDA submission.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not applicable for establishing ground truth as the ground truth was based on arterial blood samples analyzed by a CO-Oximeter.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. Ground truth was established by direct measurement from a CO-Oximeter from arterial blood samples. There was no expert consensus adjudication process described for the test set.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the accuracy of the device itself against a direct physiological measurement, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

• Standalone Study: Yes, a standalone (algorithm only) performance study was conducted. The clinical studies directly measured the performance of the SPO2.COM oximetry sensors (the device itself) against a CO-Oximeter, without human interpretation in the loop impacting the accuracy measurement.

7. Type of Ground Truth Used

• Type of Ground Truth: Direct physiological measurement (reference standard). The ground truth for the clinical accuracy study was "arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter." This is considered a gold standard for oxygen saturation measurement.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. Pulse oximeters operate on established physical principles (spectrophotometry) and typically do not involve AI/machine learning models that require a distinct "training set" in the conventional sense. The device's calibration and performance are based on the design of the emitter, detector, and the algorithms implemented to process the optical signals, which are validated in clinical trials.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there isn't a traditional "training set" for AI/ML in this device. The device's underlying principles and algorithms are based on established physiological and optical physics. The extensive validation through clinical trials (as described above) serves to confirm the device's accuracy against recognized reference standards.

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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.

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