(124 days)
The UniProbe Adapter Cable allows specified Nellcor brand reusable and patient-dedicated oxygen sensors to be used with specified Ohmeda and Ohmeda-compatible Marquette Tram pulse oximetry monitors, to provide noninvasive measurement of oxygen saturation and pulse rate.
The intended patient population for the UniProbe includes adult, pediatric and neonatal patients. Use with any particular patient requires selection of an appropriate Nellcor brand oxygen sensor.
The UniProbe may be used in any hospital or hospital-type environment where the specified compatible monitors may be used. The UniProbe is contraindicated for use during MRI scanning. The UniProbe is NOT intended for use in the home care environment. The UniProbe is a prescription device and is to be used by qualified health care professionals only.
The UniProbe Adapter Cable allows specified Nellcor brand reusable and patient-dedicated oxygen sensors to be used with specified Ohmeda and Ohmeda-compatible Marquette Tram pulse oximetry monitors, to provide noninvasive measurement of arterial oxygen saturation and pulse rate.
That is, the UniProbe Adapter Cable allows the user to substitute Nellcor brand sensors for Ohmeda brand sensors when measuring SpO2 with the specified Ohmeda and Ohmeda-compatible Marquette Tram pulse oximetry monitors.
The UniProbe has been designed and tested to be compatible with the following monitors:
Ohmeda Models: 3700, 3700e, 3740, 3760, 3800
Marquette Tram® Models (Ohmeda compatible): 200, 200A, 200SL, 400A, 400SL, 600, 600A, 600SL, 800A, 800SL
The major components of the UniProbe are a molded plastic housing that contains a pair of printed circuit boards sandwiched together. The circuit consists primarily of analog components with no software driven circuitry. The UniProbe's body is approximately 6 inches long with a 10 foot sensor cable attached at one end and a power cable and monitor cable attached at the other end.
The sensor cable is approximately ten feet long and terminates in a 9-pin sensor connector that accepts a Nellcor brand oximetry sensor.
The power cable and monitor cable emerge together from the opposite end of the housing and are approximately eighteen inches long.
The power cable terminates in a coaxial barrel connector (power plug) that connects to one of three possible power connectors, depending on the model of monitor it is used with.
The monitor cable has a Hypertronics connector (monitor connector) that plugs into the sensor (Patient or SpO2) port of the oximeter.
The UniProbe is supplied in 3 different configurations depending on the Ohmeda or Ohmeda-compatible Marquette Tram monitor used. Power must be supplied to the UniProbe using one of three different power connectors as listed in the following table:
| Compatible Monitor | UniProbe Configuration Model Number | Power Connector |
|---|---|---|
| Marquette Tram Monitors | UP12A | Front Panel Power |
| Ohmeda 3740, 3760 | UP12B | Rear Panel Power |
| Ohmeda 3700, 3700e, 3800 | UP12C | AC Wall Power |
The Front Panel Power Connector (part of configuration UP12A) is designed to plug into the "DISPL" socket on the front panel of the Marquette Tram. The UniProbe's power plug plugs into a mating connector mounted within the Front Panel Power Connector.
The Rear Panel Power Connector (part of configuration UP12B) connects between the oximeter's own power cord and rear panel power inlet. The UniProbe's power plug plugs into a mating connector mounted within the Rear Panel Power Connector.
The AC Wall Power Connector (part of configuration UP12C) consists of a switching power supply that connects to the power plug of the UniProbe.
A UniProbe Adapter Cable is shipped with one power connector, Velcro strips and a DFU in a carton.
The provided document describes the Nellcor Puritan Bennett UniProbe Adapter Cable, which allows Nellcor brand sensors to be used with specified Ohmeda and Ohmeda-compatible Marquette Tram pulse oximeters. The primary purpose of the device is to provide noninvasive measurement of arterial oxygen saturation and pulse rate.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of numerical acceptance criteria (e.g., specific SpO2 accuracy ranges with corresponding pass/fail thresholds) or a side-by-side comparison with reported performance values. Instead, it states that the device's accuracy and performance were demonstrated to be equivalent to existing predicate devices.
The key statement regarding performance is:
"Test results confirmed that the oxygen saturation accuracy performance of the UniProbe/D25 combination was equivalent to the OxyTip A/P across the recommended device line." (Page 4, Section 6)
And, "The results of the Co-oximeter Correlation Study clearly demonstrate that the UniProbe, when used with the specified Ohmeda or Ohmeda compatible Marquette monitors, meets the stated accuracy specifications." (Page 5)
While specific numerical acceptance criteria are not provided, the "stated accuracy specifications" likely refer to the established accuracy specifications of the predicate devices. The study aimed to show equivalence or compliance with these existing specifications rather than defining new ones for the adapter cable itself.
Summary of "Acceptance Criteria" (Inferred from Equivalence Claim) and Reported Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance Statement |
|---|---|
| Oxygen saturation accuracy performance must be equivalent to the Ohmeda 3740/OxyTip A/P combination. | "Test results confirmed that the oxygen saturation accuracy performance of the UniProbe/D25 combination was equivalent to the OxyTip A/P across the recommended device line." |
| The device (UniProbe with specified monitors) must meet stated accuracy specifications. | "The results of the Co-oximeter Correlation Study clearly demonstrate that the UniProbe, when used with the specified Ohmeda or Ohmeda compatible Marquette monitors, meets the stated accuracy specifications." This was specifically tested in a "blood study over the specified saturation range of 70% - 100%," suggesting the "stated accuracy specifications" refer to performance within this range. |
| Compliance with environmental and EMC requirements. | "Environmental and EMC testing has been conducted as recommended by the applicable sections of the Reviewer's Guidance for Premarket Notification Submissions. November 1993. Testing results demonstrated that all applicable requirements have been met." |
2. 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 explicitly state the sample size (number of subjects or data points) for the "in vivo clinical testing" or the "Co-oximeter Correlation Study." It mentions "blood study over the specified saturation range of 70% - 100%," which implies a certain number of measurements were taken to cover this range.
- Data Provenance: The document does not specify the country of origin of the data. It indicates the studies were "in vitro and in vivo clinical testing," which implies prospective data collection, especially for the "Co-oximeter Correlation Study."
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 section is not applicable to the evaluation of this device. The ground truth for oxygen saturation measurements in the Co-oximeter Correlation Study would typically be established by a reference co-oximeter (a laboratory instrument that measures oxygen saturation directly from blood samples), not by human expert consensus or clinical expert review in the way it would be for image-based diagnostic devices. The document refers to it as a "blood study," confirming this method. Therefore, no human experts were involved in establishing the ground truth directly for the test set in the conventional sense of expert review for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The nature of the device (adapter cable for a pulse oximeter) and the type of evaluation (comparison against a reference co-oximeter for oxygen saturation accuracy) do not involve human adjudication of results in the way a diagnostic imaging study would.
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
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. This type of study is typically relevant for interpretative diagnostic devices (e.g., AI for radiology images) where human readers are involved in interpreting results, and the AI's role is to assist or improve their performance. The UniProbe Adapter Cable is a measurement device, not an interpretive one, and its evaluation focuses on measurement accuracy rather than human interpretation performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The "Co-oximeter Correlation Study" and the comparison against the Ohmeda 3740/OxyTip A/P combination represent standalone performance evaluations of the device combination (monitor/UniProbe/Nellcor sensor). The performance of the device system itself was assessed against a presumed gold standard (co-oximeter) for its accuracy in measuring SpO2 and pulse rate. The human user is operating the device but not interpreting its primary output in a way that requires human-in-the-loop performance assessment where the human is the variable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the "Co-oximeter Correlation Study" was established through blood samples analyzed by a co-oximeter. This is the standard method for determining the true arterial oxygen saturation (SaO2) in such studies, against which the pulse oximeter's estimated SpO2 is compared.
8. The sample size for the training set
The document does not mention a "training set" in the context of machine learning or AI. The UniProbe is described as having "analog components with no software driven circuitry" (Page 2), indicating it is not a software-based device that would require machine learning training. Its design and testing were likely based on engineering principles and established physiological models for pulse oximetry, rather than data-driven statistical training.
9. How the ground truth for the training set was established
As there is no mention of a "training set" or machine learning components for this device, this question is not applicable.
§ 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).