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The Etiometry Platform™ software features the Data Aggregation software module version 5.4 and the Risk Analytics Engine software module version 9.2.

The Data Aggregation & Visualization software module is intended to record and display multiple physiological parameters of adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes:

To remotely consult regarding a patient's status and

To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner.

The Data Aggregation & Visualization software module can display numeric physiologic data and waveforms captured by other medical devices:

Airway flow, volume, and pressure Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) Bispectral index (BIS, signal quality index, suppression ratio) Cardiac Index Cardiac output Central venous pressure Cerebral perfusion pressure End-tidal CO2 Heart rate Heart rate variability Intracranial pressure Left atrium pressure Oxygen saturation (intravascular, regional, SpO2) Premature ventricular counted beats Pulmonary artery pressure (systolic, diastolic, and mean) Pulse pressure variation Pulse Rate Respiratory rate Right atrium pressure Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) Umbilical arterial pressure (systolic, diastolic, and mean) Electrocardiogram Plethysmograph

The Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.

The Data Aggregation & Visualization software module can display information captured by the Risk Analytics Engine software module.

The Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia.

The IDO2 Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care and patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the IDO2 Index is increasing, it means that there is an increasing risk of inadequate oxygen delivery, and attention should be brought to the patient. The IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The IVCO2 Index is indicated for use by healthcare professionals with invasively ventilated patients 0 to 12 years of age under intensive care. The IVCO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation and Visualization software module. When the IVCO2 Index is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation, and attention should be brought to the patient. The IVCO2 Index presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The ACD Index is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation and Visualization software module. When the ACD Index is increasing, it means that there is an increasing risk of acidemia, and attention should be brought to the patient. The ACD Index presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The HLA Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation software module. When the HLA Index is increasing, it means that there is an increasing risk of hyperlactatemia, and attention should be brought to the patient. The HLA Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Etiometry Platform allows ICU clinicians and quality improvement teams to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. The platform features include:

• Adjunctive status indicators
• Customizable display of physiologic parameters over the entire patient stay
• Configurable annotation
• . Web-based visualization that may be used on any standard browser
• Minimal IT footprint
• . Software-only solution – no new bedside hardware required
• . Highly reliable and robust operation
• . Auditable data storage

Here's an analysis of the acceptance criteria and study information for the Etiometry Platform (DAV 5.4 RAE 9.2), based on the provided text:

Based on the provided text, the Etiometry Platform (DAV 5.4 RAE 9.2) was evaluated against "the same acceptance criteria as the predicate device," which are explicitly listed as: discriminatory power, range utilization, resolution/limitation, and robustness.

Unfortunately, the document does not provide specific quantitative acceptance criteria values (e.g., "discriminatory power > X, range utilization between Y and Z") nor does it provide the reported device performance values for each of these criteria. It only states that "All results met the same acceptance criteria as the predicate device."

Therefore, the table below will list the acceptance criteria as described, but the "Reported Device Performance" column cannot be filled with specific numbers from this document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 4721 data points (referred to as "points") from 779 patients.
• Data Provenance: "data from different clinical sites in the US." The study was retrospective, as stated by "The adjunctive status indicators were retrospectively computed on all de-idents."

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 or their qualifications for establishing ground truth for the test set. It mentions that the "adjunctive status indicators" were "designed based on principles of physiology, with parameters chosen to reflect those specified in the medical literature," implying a foundation in expert knowledge, but not a direct expert review of the test set for ground truth.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study.

6. Standalone (Algorithm Only) Performance

The study primarily describes the performance of the integrated "Risk Analytics Engine software module" which calculates the indices based on manipulated physiological data and laboratory measurements. This indicates a standalone (algorithm only) performance evaluation as it assessed the indices themselves against predetermined criteria. The "Data Aggregation & Visualization software module" also has standalone functions of displaying data.

7. Type of Ground Truth Used

The ground truth for evaluating the adjunctive status indicators (IDO2, IVCO2, ACD, HLA Indices) was based on their ability to predict "risk of inadequate oxygen delivery," "risk of inadequate carbon dioxide ventilation," "increasing risk of acidemia," and "increasing risk of hyperlactatemia." The indices were "derived by mathematical manipulations of the physiologic data and laboratory measurements" and validated against acceptance criteria related to discriminatory power, range utilization, resolution/limitation, and robustness.

While not explicitly stating a direct "ground truth" label like "expert consensus" or "pathology," the nature of the indices suggests they are evaluated against an expected physiological response or correlation based on established medical understanding and literature, rather than a definitive "true positive/negative" diagnosis from a gold standard. The validation against "discriminatory power" implies an ability to differentiate between states, which would require some form of reference for those states.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It only mentions "Test datasets were used to evaluate the impact of the changes during the development process. Validation datasets were used after development was complete to validate performance using independent data." The 4721 data points / 779 patients explicitly refer to the validation dataset.

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

The document does not explicitly describe how the ground truth for the training set was established. It states that the models (indices) were "designed based on principles of physiology, with parameters chosen to reflect those specified in the medical literature." This implies an expert-driven design process informed by medical knowledge rather than a label-based "ground truth" derived for a training set in a traditional supervised machine learning context. Without details on specific training data, further information on its ground truth establishment cannot be provided.

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The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 9.0.

The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes:

• To remotely consult regarding a patient's status, and
• To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner.

The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices:

• · Airway flow, volume, and pressure
• · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
• Bispectral index (BIS, signal quality index, suppression ratio) .
• Cardiac Index
• Cardiac output .
• Central venous pressure .
• . Cerebral perfusion pressure
• End-tidal CO2 .
• · Heart rate
• Heart rate variability .
• Intracranial pressure .
• . Left atrium pressure
• Oxygen saturation (intravascular, regional, SpO2) .
• Premature ventricular counted beats .
• Pulmonary artery pressure (systolic, diastolic, and mean) .
• Pulse pressure variation
• · Pulse Rate
• · Respiratory rate
• Right atrium pressure .
• Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
• · Umbilical arterial pressure (systolic, diastolic, and mean)

The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module.

The T3 Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia.

The IDO2 Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the patient. The IDO2 Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age under intensive care. The IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The ACD Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the ACD Index™ is increasing, it means that there is an increasing risk of acidemia and attention should be brought to the patient. The ACD Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The HLA Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the HLA Index™ is increasing, it means that there is an increasing risk of hyperlactatemia and attention should be brought to the patient. The HLA Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include:

• Adjunctive status indicators ●
• Customizable display of physiologic parameters over the entire patient stay
• . Configurable annotation
• Web-based visualization that may be used on any standard browser
• Minimal IT footprint ●
• Software-only solution no new bedside hardware required ●
• Highly reliable and robust operation
• . Auditable data storage

The T3 Platform™ software calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia. The document specifies that studies were performed to validate the IVCO2 Index.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the acceptance criteria for the IVCO2 Index™ are: discriminatory power, range utilization, resolution/limitation, and robustness. It is stated that "All results met the same acceptance criteria as the predicate device".

However, specific quantitative values for these criteria (e.g., a specific threshold for discriminatory power, or a defined range utilization percentage) and the exact performance metrics obtained are not provided in the given text. The document confirms that the device met these criteria without detailing the quantitative results of the performance.

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

• Test Set 1 (Neonatal ICU patients):
  • Sample Size: 180 patients, contributing 1108 PaCO2 measurements from arterial blood gases.
  • Data Provenance: Retrospective, obtained from two Level IV regional NICUs in the US.
• Test Set 2 (Non-NICU patients):
  • Sample Size: 2090 patients, contributing 29,841 PaCO2 measurements from arterial blood gases.
  • Data Provenance: Retrospective, from clinical sites in the US.
  • Demographics: 42% neonates, 32% infants, and 26% children. 46% female and 54% male.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. It mentions "PaCO2 measurements from arterial blood gases," which implies that the ground truth was based on laboratory measurements rather than expert review.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set. Given that the ground truth appears to be objective laboratory measurements (PaCO2 from arterial blood gases) and not subjective expert interpretations, a traditional adjudication process (like 2+1 or 3+1) would not be applicable or necessary.

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

No MRMC comparative effectiveness study was mentioned. The study described focuses on the device's performance against objective physiological measurements, not on its impact on human reader performance.

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

Yes, a standalone performance study was done. The IVCO2 Index™ was "retrospectively computed on all de-identified patients" and "evaluated against the same acceptance criteria as the predicate device." This indicates an algorithm-only evaluation, without human-in-the-loop assistance.

7. Type of Ground Truth Used

The ground truth used was objective physiological data/laboratory measurements, specifically PaCO2 measurements from arterial blood gases.

8. Sample Size for the Training Set

The document mentions "Development test sets are used to evaluate the impact of the development changes during the development process." However, it does not specify the sample size for the training set(s) used to develop the IVCO2 Index™ model. It only provides details for the validation sets.

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

The document states that the "adjunctive status indicators are produced by a model-based approach. The model-based approach is designed based on principles of physiology with parameters chosen to reflect those specified in the medical literature." It does not explicitly detail how ground truth was established for the training data beyond implying it was based on physiological principles and medical literature, and presumably also included patient data similar to the validation sets.

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The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 8.0.

The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes:

• To remotely consult regarding a patient's status, and
• To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner.

The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices:

• Airway flow, volume, and pressure
• Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
• Bispectral index (BIS, signal quality index, suppression ratio) .
• Cardiac Index
• . Cardiac output
• Central venous pressure .
• . Cerebral perfusion pressure
• End-tidal CO2 .
• · Heart rate
• Heart rate variability .
• Intracranial pressure .
• . Left atrium pressure
• Oxygen saturation (intravascular, regional, SpO2) .
• Premature ventricular counted beats .
• · Pulmonary artery pressure (systolic, diastolic, and mean)
• Pulse pressure variation
• · Pulse Rate
• · Respiratory rate
• Right atrium pressure .
• Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
• · Umbilical arterial pressure (systolic, diastolic, and mean)

The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module,

The T3 Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia.

The IDO2 Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the patient. The IDO2 Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the internets.

The ACD Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the ACD Index™ is increasing, it means that there is an increasing risk of acidemia and attention should be brought to the patient. The ACD Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The HLA Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the HLA Index™ is increasing, it means that there is an increasing risk of hyperlactaternia and attention should be brought to the patient. The HLA Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include:

• Adjunctive status indicators
• Customizable display of physiologic parameters over entire patient stay
• Configurable annotation
• Web-based visualization that may be used on any standard browser
• Minimal IT footprint
• Software-only solution no new bedside hardware required
• Highly reliable and robust operation
• Auditable data storage

Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided text:

Device: T3 Platform™ software (specifically the T3 Risk Analytics Engine software module version 8.0, which calculates the IDO2 Index™, IVCO2 Index™, ACD Index™, and HLA Index™).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are broadly defined as "discriminatory power, range utilization, resolution/limitation, and robustness." While specific numerical thresholds for these criteria are not provided in the document, the conclusion states that "All results met acceptance criteria for discriminatory power, range utilization, resolution/limitation, and robustness."

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

The document provides sample sizes for the validation of the new indices (ACD and HLA Indexes):

• HLA Index Validation: 58,168 whole blood lactate measurements from 3,496 patients.
• ACD Index Validation: 24,431 arterial blood pH measurements from 1,858 patients.

Data Provenance:

• Country of Origin: United States (data from eleven different clinical sites in the US).
• Retrospective or Prospective: Retrospectively computed on all de-identified patients.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. It states that the indices are "derived by mathematical manipulations of the physiologic data and laboratory measurements" and that the "underlying physiology model" for the indices has been updated. The ground truth for the ACD Index is defined as "arterial pH less than 7.25" and for the HLA Index as "whole blood lactate level concentration above 4 mmol / L." These appear to be objective thresholds based on laboratory measurements rather than expert consensus on interpretations of images or complex clinical states.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or appears to be relevant given the nature of the ground truth (objective laboratory measurements).

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

No MRMC study was done, as the device is a risk analytics engine providing calculated indices, not an imaging AI designed to assist human readers in interpreting medical images. The primary use is for "remotely consult regarding a patient's status" and "remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care." The indices provide "partial quantitative information" and "no therapy or drugs can be administered based solely on the interpretation statements." Furthermore, the warnings state: "Do not rely on the T3 Platform software as the sole source of patient status information." This indicates an adjunctive role rather than one where human interpretation is directly assisted in a comparative effectiveness study.

6. Standalone (Algorithm Only) Performance Study

Yes, the validation of the ACD Index and HLA Index appears to be a standalone (algorithm only) performance study against objective ground truth derived from laboratory measurements. The indices were "retrospectively computed on all de-identified patients" and evaluated against the defined acceptance criteria.

7. Type of Ground Truth Used

The ground truth used is primarily outcomes data / objective laboratory measurements.

• For the ACD Index: Arterial blood pH measurements, with acidemia defined as arterial pH less than 7.25.
• For the HLA Index: Whole blood lactate measurements, with hyperlactatemia defined as whole blood lactate level concentration above 4 mmol/L.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a dedicated "training set." It mentions that the "approach is designed based on principles of physiology, and parameters are chosen to reflect those specified in the medical literature and employed development testing data sets and validation sets." It distinguishes between "Development testing sets" (used to evaluate impact of changes during development) and "Validation sets" (used after development is complete). The sample sizes provided (3,496 patients for HLA, 1,858 patients for ACD) are for the validation sets. The size of the "development testing sets" is not specified.

9. How Ground Truth for the Training Set Was Established

The document implies that the model's development and parameter choices were guided by "principles of physiology" and "medical literature," which would have formed the basis for the ground truth during the development ("training") phase. For the actual performance testing, the ground truth was established by objective laboratory measurements (arterial pH and whole blood lactate levels) with pre-defined thresholds for acidemia and hyperlactatemia. The details of how ground truth was precisely established for the "development testing data sets" are not explicitly detailed, but it would logically follow the same principles of using objective physiological and laboratory data.

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The CipherOx™ CRI MI is indicated for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor),and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia.

For patients with a finger thickness of 0.3'' to 1'' in hospital and pre-hospital settings.

CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

The CipherOx CRI™ M1 is a modification of the predicate device, the CipherOx CRI Tablet (DEN160020). The M1 is a smaller version of the Tablet that is designed for increased portability.

The CipherOx CRITM M1 is a non-invasive, continuous, and multi-parameter monitor that displays SpO2, HR, and the Compensatory Reserve Index (CRI). CRITM is a physiologic parameter that trends changes in intravascular volume, which help to assess a patient's hemodynamic status.

The CRI™ algorithm trends intravascular volume using non-invasive arterial pulsatile waveform signals by continuously comparing extracted waveforms to a reference model. CipherOx™ CRI system operates on the photoplethysmograph (PPG) waveform used in pulse oximetry to estimate CRI.

The CipherOx CRI™ M1 incorporates:

• 1. CRI™ algorithm
• Nonin pulse ox sensor (8000AA K080255) 2.
• 3. M1 User Interface module which is a small, portable, battery powered unit that displays heart rate. SpO2, and CRI™.

The provided document, a 510(k) summary for the CipherOx CRI M1, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with new acceptance criteria for the CRI algorithm itself. The key information regarding the CRI algorithm's performance is explicitly stated to rely on the validation performed for the predicate device, the CipherOx CRI Tablet (DEN160020).

Therefore, the acceptance criteria and study details for the CRI M1 directly reference the previous submission.

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

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

The document does not specify new acceptance criteria or performance derived specifically from the CipherOx CRI M1 for the Compensatory Reserve Index (CRI). Instead, it states that the CRI algorithm is identical to that in the predicate device, the CipherOx CRI Tablet (DEN160020). The performance in terms of "Accuracy" for CRI is listed as "0-1.0 numeric with graph". For SpO2 and Pulse rate, which are standard measurements, the accuracies are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on the clinical validation of the predicate device (DEN160020) for the CRI algorithm. It does not provide details of the sample size or data provenance for a test set specifically for the CRI M1's algorithm, as the algorithm itself is considered identical.

For SpO2 accuracy, the document states: "The clinical study determining the SpO2 accuracy for the Nonin OEM III." The Nonin OEM III board is integrated into the M1. No specific sample size or provenance for this SpO2 study is given in this document, but it refers to the prior clearance of the Nonin OEM III.

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)

This information is not provided in the document. The scientific justification for the CRI algorithm's validity and clinical data requirements are stated as being fulfilled because "The CRI algorithm is identical to that in DEN160020." Therefore, this information would reside within the predicate device's 510(k) submission.

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

This information is not provided in the document. As with point 3, this would be detailed in the predicate device's submission.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is not mentioned. The device provides a Compensatory Reserve Index (CRI) as an adjunct to traditional hemodynamic measures, not a system that assists human readers in interpreting images or complex data in an MRMC study context. The focus is on the device providing a physiological parameter (CRI) for clinicians to use.

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

The document implicitly confirms standalone performance for the CRI algorithm. The CRI algorithm is stated to be identical to the predicate and is responsible for calculating the CRI value based on non-invasive arterial pulsatile waveform signals. The device itself (CipherOx CRI M1) processes these signals and displays the CRI. This is an "algorithm only (without human-in-the-loop performance)" scenario for the calculation and display of CRI. However, the interpretation and use of CRI is explicitly "as an adjunct to rather than as a replacement for traditional hemodynamic measures," requiring a qualified medical provider.

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

The document states that the "output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner." However, it then reiterates, "The CRI algorithm is identical to that in DEN160020." This implies the ground truth and reference methods were established during the validation of the predicate device. The specific type of ground truth (e.g., invasive hemodynamic measurements, controlled blood loss studies) is not detailed in this submission but would be in DEN160020.

8. The sample size for the training set

This information is not specified in the document for the CRI M1. As the CRI algorithm is entirely referenced to the predicate device (DEN160020), any training set details would be found in that submission.

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

This information is not specified in the document for the CRI M1, for the same reason as point 8.

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The CipherOx CRI Tablet is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia.

For patients with a finger thickness of 0.3" to 1" in hospital and pre-hospital settings.

CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

The CipherOx CRI Tablet consists of a Nonin Onyx II Model 9560 finger pulse oximeter (previously cleared under K081285) that communicates by Bluetooth with a Cybernet CyberMed T10 tablet PC. The CipherOx CRI Tablet is a continuous, multi-parameter monitor that displays SpO2, Heart Rate (HR), photoplethysmograph (PPG) waveform images, and the Compensatory Reserve Index (CRI) value and historical trend-line.

CRI is an index related to the physiologic changes induced by intravascular fluid loss and ranges from 0 to 1, where 1 indicates a normal subject and 0 indicates a subject who has undergone significant physiological effects from loss of fluid volume.

Here's a breakdown of the acceptance criteria and study information for the CipherOx CRI Tablet, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for the CipherOx CRI Tablet appears to be the accurate estimation of CRI values, specifically the root-mean-squared error (RMSE) between estimated and reference CRI.

Study Information

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

• LBNP Verification Study: 20 healthy participants.
  • Data Provenance: The text does not explicitly state the country of origin, but the development and studies seem to be conducted by Flashback Technologies in Boulder, Colorado. The data is prospective, gathered specifically for the study.
• Blood Draw Validation Study: 42 healthy participants (ages 19 to 36).
  • Data Provenance: Similar to the LBNP study, the country of origin is not explicitly stated but implied to be the US. The data is prospective, gathered specifically for the study.

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

The text does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., diagnosis by radiologists). Instead, the ground truth for CRI was established physiologically:

• LBNP Study: Reference CRI values were defined as CRI = 1 - LBNPcurrent / LBNPcollapse, where LBNPcollapse refers to the LBNP pressure level at the point a subject either had a precipitous fall in systolic blood pressure below 80 mmHg and/or voluntary subject termination due to discomfort or expression of presyncopal symptoms (or until completion of -100 mmHg). This relies on objective physiological measurements (blood pressure) and subjective patient reporting (presyncopal symptoms).
• Blood Draw Study: The "ground truth" for the blood draw study was the actual volume of blood removed and the observation of symptoms (e.g., systolic blood pressure <80 mmHg or a 30% drop in mean arterial pressure) during blood loss, indicating hemodynamic decompensation.

There is no mention of experts adjudicating these physiological ground truths.

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

Not applicable. As described in point 3, the ground truth was established by physiological measurements and direct observation of patient responses to induced hypovolemia, not by expert consensus or 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, an MRMC comparative effectiveness study was not conducted for the CipherOx CRI Tablet. The studies focused on the performance of the device itself against physiological reference points.

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

Yes, the core performance testing (LBNP verification and blood draw validation) appears to be standalone algorithm performance. The device calculates CRI based on PPG data. While usability assessment involved users interpreting CRI values, the primary validation of the algorithm's accuracy in calculating CRI was performed independently.

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

The ground truth used was physiologically derived and based on direct physiological measurements and observed patient responses to induced hypovolemia.

• LBNP Study: Direct measurement of LBNP levels and observation of a precipitous fall in systolic blood pressure or patient-reported presyncopal symptoms.
• Blood Draw Study: Direct measurement of blood volume removed and observation of physiological symptoms (systolic blood pressure, mean arterial pressure drop) leading to early termination.

8. The sample size for the training set:

• LBNP Training Dataset: 230 healthy human volunteers.

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

The ground truth for the training set was established through the same LBNP methodology as described for the LBNP verification study:

• LBNP Training: Reference PPG signals were collected on 230 healthy human volunteers undergoing lower body negative pressure (LBNP) to the point of presyncope. Reference CRI values were then defined as CRI = 1 - LBNPcurrent / LBNPcollapse, where LBNPcollapse refers to the LBNP pressure level at which the subject reached objective (BP drop) or subjective (presyncopal symptoms) stopping criteria. This allowed the algorithm to learn the relationship between PPG changes and known levels of induced intravascular volume changes.

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