(210 days)
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:
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- CRI™ algorithm
- Nonin pulse ox sensor (8000AA K080255) 2.
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- 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.
| Metric | Acceptance Criteria (Implied / Stated) | Reported Device Performance (CipherOx CRI M1) |
|---|---|---|
| Compensatory Reserve Index (CRI) | Identical to DEN160020 | 0-1.0 numeric with graph |
| SpO2 Accuracy | ± 2 digits (as per predicate) | ± 2 digits |
| Pulse Rate Accuracy | 18-321 BPM ± 3 digits (as per predicate) | 18-300 ± 3 digits |
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.
§ 870.2200 Adjunctive cardiovascular status indicator.
(a)
Identification. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:
(i) Full characterization of technical parameters of the software, including any proprietary algorithm(s);
(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;
(iii) Specification of acceptable incoming sensor data quality control measures; and
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.
(2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must be provided in support of the intended use and include the following:
(i) 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;
(ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;
(iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and
(iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of compatible sensors for data acquisition;
(ii) A description of what the device measures and outputs to the user;
(iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;
(iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;
(v) Key assumptions made in the calculation and determination of measurements;
(vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and
(vii) A detailed description of the patients studied in the clinical validation (
e.g., age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.