(31 days)
The PRO2® Pulse Reflectance Oximeter System is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The PRO2 is intended to monitor arterial saturation on the back and forehead locations in pediatric and adult populations. The PRO2 is for use in hospital, hospital-type facilities, and intra hospital transport environment.
The Pro 9 Pulse Reflectance Oximeter System consists of a reusable sensor that emits and detect red and infrared light, a flexible disposable sensor holder to attach the sensor to the skin, a connecting cable, and a monitor incorporating control, processing, and display units.
The Pro2® Monitor contains an internal battery to power the unit when AC power is not available. The monitor displays the percentage of oxygen saturation in the blood, pulse rate, signal quality, and alarms.
The Proo Sensor geometry includes light sources that emit light in three different wavelengths, and detection areas defined by two photodetector rings arranged concentrically with the light sources in the center. The rings constitute an annular shape. which allow a multi-path acquisition of signals from a larger tissue area. The measurement of SpO2 is dependent upon specific wavelengths of light detected by its sensor.
The Pro2 device has a disposable sensor holder; Model # AHL-200 for adults and pediatric use. The Pro Sensor Holder provides optical isolation for external light and is attached to the skin via adhesive that is incorporated as part of the Sensor Holder.
The provided documentation for the ConMed PRO2 Pulse Reflectance Oximeter System (K061112) is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device. While it states that "The Pro2® Pulse Reflectance Oximeter System performance was tested with clinical data and the results met the acceptable criteria," it does not provide the specific acceptance criteria or detailed results of the study.
Therefore, I cannot fulfill all parts of your request with the information provided.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
- Not explicitly stated in the provided document. The document only mentions that the "results met the acceptable criteria" without detailing what those criteria were.
Reported Device Performance:
- Not explicitly quantified in the provided document. The document states that the system's performance "was tested with clinical data and the results met the acceptable criteria," but no numerical performance metrics (e.g., accuracy, bias, precision) are given.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: "Clinical data" is mentioned, implying human subjects, but the country of origin and whether the study was retrospective or prospective are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable / Not Provided. The document is for an oximeter, where "ground truth" for SpO2 is typically established by co-oximetry (blood gas analysis), not expert review of images or other data. The information about how ground truth was established for the clinical data is not included.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. This concept is more relevant for studies where human review or interpretation is being assessed. For an oximeter, ground truth is typically established by a gold standard measurement technique.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is typically for evaluating observer performance in interpreting medical images or other diagnostic tests. This is not relevant for an oximeter, which provides direct physiological measurements.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device is an oximeter, which directly measures and displays physiological data (SpO2 and pulse rate). Its performance would be evaluated as a standalone device against a reference standard, not as an algorithm assisting human interpretation. However, the specific details of this standalone performance evaluation are not provided.
7. The Type of Ground Truth Used
- Implicitly, a reference oximetry method (e.g., co-oximetry). While not explicitly stated, the gold standard for SpO2 measurement in clinical studies typically involves invasive blood sampling and co-oximetry. The document states "functional oxygen saturation of arterial hemoglobin (SpO2)," which aligns with this type of ground truth.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. Oximeters are generally based on established physiological principles of light absorption by oxygenated and deoxygenated hemoglobin. While calibration might occur, the concept of a "training set" like in machine learning models is not typically applied in the same way to traditional medical devices like oximeters. The document does not mention any machine learning or AI components that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided. (Refer to point 8)
Summary of Missing Information:
The provided 510(k) summary is very high-level regarding the clinical performance study. Crucial details such as:
- Specific quantitative acceptance criteria (e.g., A_rms value, bias, precision).
- Actual numerical performance results (e.g., reported accuracy, bias, or A_rms from the study).
- Sample size of subjects for the clinical study.
- Details of the clinical study design (e.g., patient population, induced hypoxia protocol, comparison method).
- How ground truth (reference SpO2) was specifically established in the clinical trials.
These details are typically found in the full 510(k) submission, not usually in the publicly available 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).