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The Edwards Algorithm for Measurement of Blood Hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥ 40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight Oximeter Cable and non-invasive ForeSight sensors (large) in cerebral locations.

The Edwards Algorithm for Measurement of Blood Hemoglobin is intended for use as an adjunct monitor of relative and total hemoglobin concentration of blood in individuals at risk for reduced-flow or no-flow ischemic states in surgical and ICU settings.

The Edwards Algorithm for Measurement of Blood Hemoglobin is intended for continuously and non-invasively monitoring the relative and total hemoglobin values in the blood of patients requiring advanced hemodynamic monitoring in a critical care environment. The outputs of the algorithm include the relative changes in total hemoglobin in blood ( $\Delta$ tHb) and total hemoglobin in blood (tHb) parameters and are derived from the relative change in concentration of total tissue hemoglobin ( $\Delta$ ctHb parameter) measured by the ForeSight Oximeter Cable on the HemoSphere Advanced Monitoring Platform (K213682, cleared June 22, 2022).

The subject algorithm provides relative blood hemoglobin ( $\Delta$ tHb; measured in g/dL of blood) values continuously as a change over time from 0 g/dL. It can also be calibrated using an optional input of reference blood hemoglobin measurements such as ones obtained in vitro from a blood gas analyzer. When calibrated, it provides the value of total blood hemoglobin (tHb).

Additionally, the algorithm also provides three secondary output flags:
o DoNotCalibrate Flag: This flag is intended to indicate when a calibration should not be performed.
o Recalibrate Flag: This flag is intended to indicate when a new calibration is recommended.
o Unstable Flag: This flag is intended to indicate when the input signal ( $\Delta$ ctHb) is unstable.

The provided text describes the Edwards Algorithm for Measurement of Blood Hemoglobin, an algorithm intended for continuously monitoring changes to hemoglobin concentration. Here's a breakdown of the acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The results demonstrated that the subject device subject device met the acceptance criteria of 1g/dL with a bias close to 0 and precision less than 1g/dL". While it mentions meeting the criteria, the exact numerical values for bias and precision are not explicitly provided in the text beyond "close to 0" and "less than 1g/dL". The 1g/dL criteria appears to be for RMSE/ARMS.

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

• Sample Size: 83 patients
• Data Provenance:
  • Country of Origin: Data was collected from 5 sites across the US and EU.
    • Amsterdam, The Netherlands (European Union) - 27 patients (32.53%)
    • Santander, Spain (European Union) - 8 patients (9.64%)
    • Greenville, North Carolina, USA - 18 patients (21.69%)
    • Sacramento, California, USA - 11 patients (13.25%)
    • Chicago, Illinois, USA - 19 patients (22.89%)
  • Retrospective or Prospective: Retrospective analyses were performed on data already collected, independent of the device development.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth. However, it indicates that the device's performance was compared against a "laboratory co-oximeter," which implies a gold standard measurement method rather than expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory co-oximeter measurements, not through expert adjudication of human interpretations.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the algorithm's direct performance against a laboratory co-oximeter. The text states, "No clinical trial was performed in support of the subject 510(k) submission."

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

Yes, a standalone performance study was done. The performance data was assessed by comparing the device's output to laboratory co-oximeter measurements, without human interaction with the algorithm's output during the measurement process. The algorithm's outputs are numerical values for hemoglobin concentration.

7. The Type of Ground Truth Used

The ground truth used was laboratory co-oximeter measurements of total hemoglobin values in blood. This is considered a highly accurate and objective reference method for hemoglobin quantification.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set. The descriptions provided are solely for the retrospective analysis performed for validation (the test set).

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

The document does not provide information regarding how the ground truth for the training set was established, as details about the training phase are not included in the provided text.

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Radius VSM:

The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.

The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.

The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.

The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.

The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.

The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVI as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PV i measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

Devices with Masimo technology are only indicated for use with Masimo accessories.

Radius VSM Accessories:

Radius VSM ECG Electrodes are disposable, single-patient ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.

Radius VSM Blood Pressure Cuffs are accessories intended to be use with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.

The Radius VSM and Accessories is a wearable, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of monitoring technologies based upon the hospital's and clinician's assessment of what technologies are appropriate. The purpose of this submission is the premarket notification for the introduction of Masimo Radius VSM and Accessories, including its use with the previously cleared Root (K191882) and Masimo Patient SafetyNet (K071047).

The Radius VSM and Accessories system comprises of the Radius VSM Wearable Monitor, Radius VSM ECG Module and Electrodes, and the Radius VSM NiBP Module and Cuff.

The provided text describes the acceptance criteria and study results for the Masimo Radius VSM and Accessories device, focusing specifically on the Non-invasive Blood Pressure (NiBP) feature.

1. Acceptance Criteria and Reported Device Performance (NiBP Feature):

The clinical performance analysis for the NiBP feature supported by the Masimo Radius VSM device had the following acceptance criteria and reported values:

The device met all specified acceptance criteria for the NiBP feature.

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

• Sample Size:
  • NiBP Feature: 89 subjects.
  • ECG Waveform Comparison: 31 subjects.
  • Patient Posture, Position, and Activity: 20 subjects.
  • Aggregate Respiration Rate (First Study): 48 subjects.
  • Aggregate Respiration Rate (Second Study): The number of healthy volunteer subjects is not explicitly stated, but it's implied to be a separate group for validation of integration.
• Data Provenance: The document does not explicitly state the country of origin. The studies are described as "clinical studies," implying prospective data collection for the purpose of validating the device. The term "healthy volunteer subjects" used in the fifth study further suggests prospective, controlled data collection.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number or qualifications of experts used to establish ground truth for any of the studies mentioned.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method for the test set data.

5. MRMC Comparative Effectiveness Study:

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human readers improving with AI assistance is made in the provided text. The studies focus on device performance against reference measurements or previously cleared monitors/algorithms, not on human-AI collaboration.

6. Standalone Performance (Algorithm Only):

• For the NiBP feature, the study was conducted to validate the clinical performance of the Radius VSM's NiBP feature against reference blood pressure measurements, implying standalone performance of the algorithm integrated into the device.
• For the ECG waveform comparison, the device's ECG output was compared to an existing FDA-cleared ECG monitor, indicating standalone performance of the device's ECG functionality.
• For the patient posture, position, and activity feature, the testing supported the "correct integration of the algorithm that was previously cleared," suggesting a focus on the device's implementation of an existing standalone algorithm.
• For the Aggregate Respiration Rate, the algorithm's performance was evaluated against manually annotated capnography data, indicating standalone algorithm performance.

7. Type of Ground Truth Used:

• NiBP: Clinical performance was validated through comparison against "reference blood pressure measurements."
• ECG: Comparison against an "FDA cleared ECG monitor."
• Patient Posture, Position, and Activity: Based on the "correct integration of the algorithm that was previously cleared." The original ground truth for this algorithm (K191882) is not detailed here, but the study validates its implementation in the new device.
• Aggregate Respiration Rate: "Reference respiration rate derived from manual annotated capnography data."

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for training sets for any of the algorithms or features. The studies described are validation (test set) studies.

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

As no information regarding training sets is provided, there is no detail on how their ground truth was established. The document focuses on the validation of integrated features, some of which (like PVi, RRa, and position monitoring) leverage previously cleared Masimo technologies, implying that their development and training (if applicable) occurred prior to this submission.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

4. Adjudication method for the test set

• This information is not provided in the text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not described. The study focused on the accuracy of the device in assessing physiological parameters compared to standard of care, not on human reader performance with or without AI assistance. The device is described as a "secondary, adjunct patient monitor," suggesting it aids, but does not necessarily directly compare, human diagnostic performance.

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

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

7. The type of ground truth used

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

8. The sample size for the training set

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

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

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

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Radius T wearable thermometer is intended for single-use, continuous noninvasive measurement of body temperature on the upper chest via wireless communication to a smart device application or compatible patient monitor (i.e., Masimo Root, Masimo Rad-97).

The Radius T is indicated for single-use, continuous body temperature measurements of persons 5 years of age or older in hospitals, hospital-type facilities, and home environments.

Radius T is a wearable, battery powered thermometer that is applied to the body to continuously provide body temperature measurements. The Radius T continuously approximates based upon the surface temperature at the application site. The body temperature data from the Radius T is transferred wirelessly to a monitoring device (e.g., Root, Rad-97) or smart device application for continuous display and monitoring.

As part of this submission, the software of the Root (K191882) and Rad-97 (K193626) is being modified to support the communication and display compatibility for the Radius T.

The provided text is a 510(k) Premarket Notification from Masimo Corporation for their Radius T Wearable Thermometer. While it mentions clinical testing and provides performance specifications, it does not contain the detailed information required to fully answer all aspects of your request, particularly regarding the specifics of the clinical study, sample size for test datasets, expert qualifications, or adjudication methods.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (FeverScout Continuous Monitoring Thermometer, K181013) rather than a comprehensive, detailed report of a study proving the device meets specific acceptance criteria in the way an AI/ML device study might.

However, based on the information available, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifies performance characteristics for the Radius T. It does not explicitly state these as "acceptance criteria" in a dedicated section with pre-defined pass/fail thresholds for clinical efficacy, but rather as "specifications" and the results from a clinical validation study in accordance with a standard.

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

• Sample Size: The document states that a "clinical validation study was performed" to support the performance of the Radius T and evaluated its clinical performance to a reference clinical thermometer in accordance with ISO 80601-2-56. However, the exact sample size for this clinical study (test set) is not provided in the supplied text. It only mentions the "indicated population of the subject device was narrowed to align to the clinically tested population, age group C (older than 5 years) in accordance with ISO 80601-2-56."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the nature of a clinical validation study for a wearable thermometer implies a prospective collection of data from enrolled subjects.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer measurement, not necessarily expert radiologist interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: This information is not applicable/not provided as the ground truth for a clinical thermometer study would be objective measurements from a reference device, not expert consensus 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 comparative effectiveness study was not done. This type of study design is typically used for AI/ML diagnostic imaging devices where human interpretation is a key component. This document describes a clinical electronic thermometer, where the device itself provides the measurement. AI assistance for human "readers" (in this context, users) is not relevant for a direct temperature measurement device.

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

• Standalone Performance: Yes, the core clinical validation study described is a standalone performance study of the Radius T Wearable Thermometer. It evaluates the device's ability to measure body temperature itself against a reference clinical thermometer. The specifications provided (clinical bias and limits of agreement) are measures of this standalone performance. The device provides a direct measurement, and its "algorithm" refers to its internal logic for deriving body temperature from skin surface temperature.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical study was established using a reference clinical thermometer in accordance with ISO 80601-2-56. This is a form of objective, gold-standard measurement.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This information is not applicable/not provided. This device is a traditional medical device (thermometer) and does not appear to employ machine learning that would require a separate "training set" for an algorithm in the way an AI/ML imaging device would. Its "principle of action" is based on established biophysical principles (heat flux, skin surface temperature correlation to body temperature) and uses a thermistor. Any internal calibration would be based on engineering design rather than a large data-driven training set.

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

• Ground Truth for Training Set: This information is not applicable/not provided as there is no mention of an ML training set.

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