(259 days)
The AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L and AS-311) is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult in hospital-type facilities, and home environments.
The AS-301/AS-302/AS-301-L/AS-302-L/AS-303/AS-304/AS-304-L/AS-311 Fingertip Pulse Oximeter manufactured by ACURIO provides noninvasive blood oxygen measurement by the dual-wavelength spectrophotometric technique, and shows the results by the OLED. The oximeter is easy to operate, small in volume, light in weight, convenient in carrying, low consumption in design and with strong resistance to ambient light interference. 2pcs of AAA batteries can be continuously used for 20 hours, and the battery voltage can be indicated. The fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adults in hospitals, hospital-type facilities, and home environments.
The components of the oximeter include the body part and a hanging rope.
Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous, non-invasive method based on the different spectra absorption of hemoglobin and oxyhemoglobin. It measures how much light, sent from light sources on one side of the sensor, is transmitted through patient tissue (such as a finger), to a receiver on the other side. Two beams of different wavelength of lights (660nm red and 895nm near infrared light) can be focused onto a human nail tip through c clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in electronic circuits and microprocessor.
The provided text describes the 510(k) summary for the AS-3XX Series Fingertip Pulse Oximeter. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the SpO2 accuracy are implicitly defined by the ISO 80601-2-61 standard, stating that the error should be "far less than the scope specified in the STANDARD." The reported performance is summarized by the "root-mean-squared (Arms value) for all subjects." The standard typically requires an Arms value of ≤ 3% for SpO2 in the range of 70-100%. While the exact Arms value is not explicitly stated, the text indicates compliance.
| Metric | Acceptance Criteria (per ISO 80601-2-61) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (Arms value) | ≤ 3% in SpO2 range of 70-100% | "error is far less than the scope specified in the STANDARD" |
| Agreement between Methods (Bland-Altman) | "vast majority of data is within ±95% limit of agreement" | "the data points beyond or below this scope were regarded as outliers" (implying the majority were within limits) |
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 for test set: 10 healthy, nonsmoking, light-to-dark-skinned subjects.
- Data provenance: The study was a prospective clinical hypoxia accuracy testing (controlled desaturation study) conducted in an "independent research laboratory." The country of origin is not explicitly stated, but the submission is from a Chinese company (Xiamen Acurio Instruments Co., Ltd).
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)
No experts were used to establish the ground truth in the traditional sense of medical image interpretation. The ground truth for oxygen saturation (SaO2) was established objectively through blood samples analyzed by a CO-oximeter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
There was no adjudication method involving multiple human readers, as the ground truth was based on objective measurements from a CO-oximeter.
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
No such MRMC comparative effectiveness study was done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was conducted. The device's measured SpO2 values were compared directly against the SaO2 values obtained from blood samples via a CO-oximeter. The study evaluates the algorithm's (device's) accuracy independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used was objective laboratory measurement: arterial hemoglobin oxygen (SaO2) values determined from blood samples with a CO-oximeter.
8. The sample size for the training set
The document does not explicitly mention a "training set" or "training data" in the context of an algorithm or AI development. Pulse oximeters operate on established physical principles (dual-wavelength spectrophotometry). Any internal calibration or parameter optimization would typically be part of the device's design and engineering, rather than a distinct "training set" as understood in machine learning.
9. How the ground truth for the training set was established
As there is no explicit mention of a training set in the AI/machine learning sense, this information is not provided. The device's operation is based on physical principles of light absorption by hemoglobin, not on a machine learning model that requires a labeled training dataset in the same way.
§ 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).