(58 days)
EnviteC Reusable Multi-site Y SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Not recommended for use on the ear.
Prescription device.
The EnviteC Reusable Multi-site Y SpO2 Sensors are a family of oximeter sensors validated for compatibility with the predicate oximeter manufacturers listed above.
EnviteC's Reusable Multi-site Y SpO₂ Sensors consist of a connector and a cable which divides at the distal end into two sensor housings. One housing contains a dual LED light source, and the other contains a light sensitive photodetector. The housings may be positioned on various sites including the finger, thumb, toe, or foot, and are affixed by a medical grade tape.
A unique Y sensor exists for each manufacturer above, and each Y sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, CSI, etc.).
Each sensor type includes the following unique features:
- Connector pin-outs specific for the manufacturer type .
- Component specifications specific for the manufacture type
Each sensor also specifies the manufacturer type with two compatibility statements:
- One printed on or attached to the sensor .
- One on the instructions for use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EnviteC Reusable Multi-site Y SpO2 Sensors:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical results of the device's performance against such criteria. The clinical testing section broadly states:
- Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2.
This suggests that the device's accuracy within the 70% to 100% SaO2 range was deemed acceptable. However, specific performance metrics like Root Mean Square (RMS) difference, bias, or precision are not provided in this summary.
Detailed Study Information
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A table of acceptance criteria and the reported device performance:
As mentioned above, a quantitative table is not present in this summary. The performance is broadly stated as supporting accuracy claims within 70-100% SaO2. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the sample size (number of subjects/patients) used for the clinical testing.
- Data Provenance: The testing was "performed under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry" and "All testing was performed at a single institutionally approved protocol." This indicates the data was prospective and collected specifically for this study. The country of origin is not explicitly stated, but given the manufacturer's location (Germany) and the submission to the FDA (USA), the testing likely occurred in one of these regions or a location approved for such clinical trials.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth was established by "arterial oxygen saturation as determined by co-oximetry." Co-oximetry is a laboratory method, not typically relying on expert interpretation for its raw result. Therefore, there's no mention of experts needed to establish this specific ground truth. Clinical staff would have performed the blood draws and laboratory analysis.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- There is no mention of an adjudication method in the context of expert review for the test set. Given the ground truth method (co-oximetry), expert adjudication of the ground truth itself wouldn't be applicable in the same way it would be for an imaging study.
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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:
- This is not applicable. The device is an SpO2 sensor, not an AI-powered diagnostic tool that assists human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical testing describes the standalone performance of the SpO2 sensors in measuring oxygen saturation compared to co-oximetry (the "ground truth"). The device itself outputs a reading without a human interpreting an image or complex data for diagnosis.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was arterial oxygen saturation as determined by co-oximetry. This is a direct, objective physiological measurement.
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The sample size for the training set:
- The document does not provide information on a "training set" in the context of an algorithm. SpO2 sensors are typically calibrated during manufacturing and their performance is verified through clinical testing, rather than "trained" in the machine learning sense.
- If by 'training set' it refers to the data used during the R&D phase to refine the sensor's algorithms and hardware, this information is not disclosed in the 510(k) summary. The summary focuses on the formal verification and validation (V&V) testing.
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How the ground truth for the training set was established:
- Not applicable as no "training set" in the machine learning context is described. For sensor calibration and development, manufacturers typically use a variety of controlled conditions and known oxygen saturation levels, often verified by co-oximetry or other reference methods, but this is part of the internal design and development process, not usually detailed in a 510(k) summary.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).