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510(k) Data Aggregation
(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.
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(268 days)
The AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is intended for body temperature measurement from the auditory canal for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
The AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. It uses infrared probe to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object. The infrared probe (Thermopile) can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and the associated circuit. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal. Pressing the activation button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
The provided 510(k) summary describes the acceptance criteria for the AT-6XX Series Infrared Thermometer (models AT-601 and AT-606) in terms of its accuracy and the study conducted to prove it meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device's accuracy are directly inherited from the international standard ISO 80601-2-56:2009 for clinical electronic thermometers.
| Acceptance Criteria (Accuracy) | Reported Device Performance (Accuracy) * |
|---|---|
| ± 0.2°C (35°C~42°C) | ± 0.2°C (35°C~42°C) |
| ± 0.3°C (outside of 35°C~42°C) | ± 0.3°C (outside of 35°C~42°C) |
Note: The document states "Clinical test results demonstrated that the subject device performs substantially equivalent to the predicate device." and lists the same accuracy specifications for the subject device as the predicate device. Therefore, the reported device performance is inferred to meet or exceed these specifications.
2. Sample Size and Data Provenance
The document states that a "clinical accuracy evaluation has been conducted according to clause 201.102 of ISO 80601-2-56:2009." However, the specific sample size used for the test set and the data provenance (e.g., country of origin, retrospective or prospective) are not detailed in this 510(k) summary.
3. Number and Qualifications of Experts for Ground Truth
This information is not provided in the 510(k) summary. For a clinical accuracy evaluation of a thermometer, "ground truth" typically refers to core body temperature measured by a highly accurate reference method (e.g., rectal or arterial catheter temperature). The involvement and qualifications of experts to establish this ground truth are not mentioned.
4. Adjudication Method
The 510(k) summary does not mention an adjudication method. This is usually not applicable for basic device performance studies like thermometer accuracy, where the ground truth is established by a direct measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This type of study is more relevant for diagnostic imaging AI algorithms where human interpretation is involved. The AT-6XX Series Infrared Thermometer is a direct measurement device without human interpretation of complex data.
6. Standalone Performance (Algorithm Only)
The performance described for the device is its standalone performance. The device is an infrared thermometer, and its accuracy (± 0.2°C / ± 0.3°C) refers to the algorithm's ability to convert infrared radiation into a temperature reading without human input in the measurement process itself.
7. Type of Ground Truth Used
The "clinical accuracy evaluation" for a thermometer typically establishes ground truth by comparing the device's readings to a highly accurate and validated reference thermometer or core body temperature measurement method. While the document doesn't explicitly state the exact ground truth method, given the standard followed (ISO 80601-2-56:2009), it would involve comparison to a traceable temperature standard. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
The 510(k) summary does not provide information on the sample size for a training set. For a simple device like an infrared thermometer, there might not be a "training set" in the sense of machine learning. The device's calibration and potentially some internal lookup tables are likely based on engineering and design specifications rather than a distinct training dataset for an algorithm.
9. How Ground Truth for the Training Set Was Established
This information is not provided. As mentioned above, it's unlikely a "training set" with ground truth in the machine learning sense was used. The ground truth for device calibration would have been established through a metrology process using precise temperature standards.
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