(272 days)
The Unimed model 2400GN adapter cable is intended to be used as an accessory to connect the Nellcor Oximax 595 pulse oximeter monitor to Dolphin pulse oximetry sensors for the continuous noninvasive monitoring of peripheral functional oxygen saturation (SpO2) and pulse rate (PR) in adult, pediatric, and infant patients in hospitals and hospital-type environments.
The Unimed 2400GN cable is intended to be used with an SpO2 monitoring device. The cable connects SpO2 sensors placed at appropriate sites on the patient to the monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. It allows digital information exchange between the sensor and monitor to accurately read the arterial oxygen saturation (SpO2) and pulse rate of the patient.
Here's a breakdown of the acceptance criteria and study information for the Unimed 2400GN Adapter Cable, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics for SpO2 or heart rate accuracy. Instead, it describes a comparative performance test to establish "relative equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Relative equivalence in SpO2 readings compared to Nellcor SpO2 sensors when both are used on a Nellcor N-595 pulse oximeter. (Range: 70% - 100% SpO2) | Verified relative equivalence between the ConMed (UniMed) 2400GN adapter cable and Dolphin SpO2 sensor to the Nellcor SpO2 sensors for SpO2 readings over the range of 70% - 100%. |
| Relative equivalence in heart rate readings compared to Nellcor SpO2 sensors when both are used on a Nellcor N-595 pulse oximeter. | Verified relative equivalence between the ConMed (UniMed) 2400GN adapter cable and Dolphin SpO2 sensor to the Nellcor SpO2 sensors for heart rate readings. |
| Accuracy of SpO2 readings when the Dolphin/UniMed device combination is used with a Nellcor OxiMax 595 pulse oximeter, compared to SaO2 readings obtained via a CO-oximeter. | "The purpose of this study was to evaluate the accuracy of the Dolphin/UniMed device combination when used with a Nellcor OxiMax 595 pulse oximeter." (No specific quantitative accuracy metric reported in this summary, but the general conclusion implies acceptable accuracy was found for substantial equivalence.) |
Study Details
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Sample size used for the test set and the data provenance:
- Non-Clinical Testing (Hypoxia Study): Volunteers were enrolled. The specific number of volunteers is not stated, but readings were taken from these volunteers. The provenance is likely a controlled laboratory setting (implied by "Hypoxia Study Report #SPR-08-128"). This appears to be a prospective study.
- Clinical Testing: 10 subjects were consented and examined. The study was conducted at the University of California at San Francisco, suggesting prospective data collection.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth in the context of interpretation or adjudication for the performance tests.
- For the non-clinical test, the "ground truth" seems to be derived from a predicate device (Nellcor SpO2 sensors) and induced hypoxia, rather than expert interpretation.
- For the clinical test, SaO2 readings obtained via a CO-oximeter served as the reference standard (ground truth), which is an instrumental measurement, not an expert opinion.
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Adjudication method for the test set:
- Not applicable/Not mentioned. The studies focused on objective measurements and comparisons to a reference device or a medical instrument (CO-oximeter), not on subjective interpretations requiring expert adjudication.
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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:
- No MRMC study was done. This device is an adapter cable for pulse oximeters, not an AI-powered diagnostic tool requiring human interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not entirely applicable in the typical sense for this device. The device itself is an adapter cable. Its performance is evaluated in conjunction with the SpO2 sensors and the monitoring device. The "standalone" performance would relate to the cable's ability to transmit signals accurately, which is inferred by the comparative SpO2 and heart rate readings. The "non-clinical testing" and "clinical testing" effectively evaluate the system (cable + sensor + monitor) performance.
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The type of ground truth used:
- Non-Clinical Testing: The "ground truth" for comparison was the performance of Nellcor SpO2 sensors (a predicate device/established technology) within a specified SpO2 range during induced hypoxia.
- Clinical Testing: The "ground truth" for SpO2 readings was SaO2 readings obtained via a CO-oximeter, which is a highly accurate method for measuring arterial oxygen saturation.
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The sample size for the training set:
- The document describes performance testing for regulatory submission, not the development of a machine learning algorithm, so there is no mention of a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned for this type of device submission.
§ 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).