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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

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