Search Results

PM601 Finger pulse oximeter is intended for spot-checking oxygen saturation in blood (SpO2) and pulse rate. The pulse oximeter is used on adults at hospital, clinics, and/or home. Not for continuously monitoring.

The proposed device, Finger Pulse Oximeters PM601 is a fingertip device, which can display % SpO2. pulse rate value and pulse strength. It is based on digital blood oxygen. Power consumption of the proposed device is low and the two originally-equipped AAA alkaline batteries can be operated continuously for 24 hours. It will automatically turned off when no signal is detected for more than 8 seconds. And low voltage warning will be displayed and battery symbol flash when battery voltage is low.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 10 healthy volunteers
• Data Provenance: Not explicitly stated, but the study was conducted according to a European standard (ISO9919:2005 Annex EE.2), which might suggest it was conducted outside the US, possibly in China where the manufacturer is located, or by a contract research organization adhering to international standards. The text does not specify if it was retrospective or prospective, but the description of "performed according to Annex EE.2 Procedure for invasive laboratory testing" suggests a prospective study.

3. Number of Experts and Their Qualifications for Ground Truth

• The document does not mention the use of experts to establish ground truth for the test set. For a pulse oximeter, "ground truth" for SpO2 accuracy is typically established through direct measurement of arterial blood oxygen saturation (SaO2) via co-oximetry, which is considered the gold standard. The text mentions "invasive laboratory testing," which is consistent with this method.

4. Adjudication Method

• Not applicable. The ground truth for pulse oximetry accuracy is established by a co-oximeter directly measuring SaO2, not by expert consensus or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This device is a directly measuring medical device, not an AI-assisted diagnostic tool that would typically involve human readers.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was done. The clinical trial focused solely on the accuracy of the PM601 Finger Pulse Oximeter in measuring SpO2 and pulse rate against a 'gold standard' (implied by "invasive laboratory testing" for SaO2), without human interpretation in the loop.

7. Type of Ground Truth Used

• The ground truth used was established through "invasive laboratory testing" according to ISO9919:2005 Annex EE.2. In the context of pulse oximetry, this procedure involves inducing varying levels of hypoxia in volunteers and simultaneously measuring arterial blood oxygen saturation (SaO2) using a co-oximeter (the gold standard) and the device under test.

8. Sample Size for the Training Set

• Not applicable. This device is a hardware-based medical instrument that directly measures physiological parameters, not a machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device