(183 days)
The PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 sensors labeled for patients ranging from neonates to adults.
The PM-50 is a flexible, portable, battery powered Pulse Oximeter. The PM-50 Pulse Oximeter acquires the physiological signals - oxygen saturation (SpO2) and pulse rate (PR). The signals are converted into digital data and processed, and the SpO2 and pulse rate values are calculated and displayed on LCD screen.
PM-50 uses a two-wavelength pulsatile system - red and infrared light - to obtain SpO2 based on the different light absorption of oxygenated and reduced hemoglobin. The light source in the finger sensor emits red and infrared light, which are partially absorbed and modulated by the arterial blood pulsation at the sensor site. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The electronic signals are sent to the oximeter and processed by the oximeter's circuitry. Thereafter, the SpO2 and pulse rate are obtained and indicated on the LCD screen.
Here's the breakdown of the acceptance criteria and study information for the PM-50 Pulse Oximeter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable clinical acceptance criteria for all aspects. However, some performance metrics and accuracy statements are made in comparison to the predicate.
| Metric / Parameter | Acceptance Criteria (Implied / Predicate) | Reported Device Performance (PM-50) |
|---|---|---|
| Pulse Rate Range | Predicate: 40-255 bpm | PM-50: 25-254 bpm |
| Pulse Rate Accuracy | Predicate: ±2 bpm at 40-100 bpm, ±2% at 100-255 bpm | PM-50: ±2 bpm (presumably across its full range, as no other range is specified) |
| SpO2 Saturation (Neonate, 70-100%) Accuracy | Predicate: ±2 digits | PM-50: ±3 digits |
| Compliance with Standards | N/A (General expectation to meet relevant standards) | IEC60601-1, IEC60601-1-2, IEC60601-1-4, EN865, EN475, ISO14971 (all met) |
| Safety | Comparable to predicate device, addressing risks like electrical shock, misdiagnosis. | Hazard analysis performed, device "as safe as" predicate. |
| Effectiveness | Comparable to predicate device. | Device "as effective as" and "performs as well as or better than" predicate. |
Note: The submission states that despite the difference in SpO2 accuracy for neonates, "the specification of the PM-50 meets with the EN865 standard," which would serve as the acceptance criteria for that specific parameter.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical and laboratory testing" but does not specify the sample size for any clinical test set.
Data Provenance: The document does not explicitly state the country of origin for any clinical data, nor does it specify if the data was retrospective or prospective. It only mentions "clinical and laboratory testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth in any clinical study. Given the nature of a pulse oximeter (measuring physiological signals directly), ground truth would typically be established through highly accurate reference instruments or arterial blood gas analysis, rather than expert consensus on images or interpretations.
4. Adjudication Method
The document does not mention any adjudication method for a test set. This is consistent with a device that provides direct physiological measurements, where "ground truth" is typically an objective measurement from a reference device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. The device is a diagnostic tool for measuring SpO2 and pulse rate, not a device that involves human interpretation of complex medical images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. Standalone Performance Study
Yes, a standalone performance study was done. The document states:
- "Laboratory testing was conducted to validate and verify that the PM-50 Pulse Oximeter met all design specifications..."
- "Additional testing was performed to demonstrate compliance with the Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation."
- "The PM-50 Pulse Oximeter has also been tested to assure compliance to the requirements of various published standards, including IEC60601-1, IEC60601-1-2, IEC60601-1-4, EN865, EN475, and ISO14971."
This testing confirms the device's performance characteristics (e.g., accuracy, ranges, safety) without human intervention in the interpretative loop.
7. Type of Ground Truth Used
While not explicitly detailed, for a pulse oximeter, the ground truth would typically be established through:
- Reference Instrumentation: Comparison against highly accurate, gold-standard pulse oximeters or CO-oximeters.
- Arterial Blood Gas Analysis (ABG): Directly measuring arterial oxygen saturation (SaO2) from blood samples for comparison with SpO2 readings.
The document refers to "clinical and laboratory testing," which would imply the use of such objective measurements as ground truth.
8. Sample Size for the Training Set
The document does not specify any sample size for a training set. Pulse oximeters generally rely on physiological models and signal processing algorithms derived from established principles, not typically machine learning that requires a "training set" in the conventional sense (e.g., for image recognition). If any adaptive algorithms are used, the training data and methods are not described.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of machine learning, there is no information provided on how ground truth for a training set was established. The device's operation is described based on "two-wavelength pulsatile system - red and infrared light - to obtain SpO2 based on the different light absorption of oxygenated and reduced hemoglobin," which is a physics-based approach rather than a data-driven machine learning approach requiring a labeled training set.
§ 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).