(334 days)
The pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.
The HS10A is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and functional arterial oxygen saturation in arterial blood. The HS10A include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings. The device also has menu features to allow the user to set the time, date and measurement alarm limits.
Here's a breakdown of the acceptance criteria and study information for the Pulse Oximeter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from ISO 80601-2-61, implied) | Reported Device Performance (HS10A) |
|---|---|---|
| SpO2 Accuracy (no motion, 70-100%) | ≤ 2% Arms | 1.391% Arms |
| Pulse Rate Accuracy (no motion) | ± 3 bpm (implied from predicate) | Not explicitly stated for HS10A but similar to predicate |
| General Safety | Conformance to IEC60601-1 | Conformed |
| EMC | Conformance to IEC60601-1-2 | Conformed |
| Biocompatibility | Conformance to ISO 10993-1, -5, -10 | Conformed |
Note: The document directly states the SpO2 accuracy criterion and result. For other specifications like pulse rate, the acceptance criteria are not explicitly detailed for the subject device but are implicitly met through overall equivalence claims and conformance to standards. The predicate also has a SpO2 accuracy of "$70-100% no less than ±2%(No motion)$," which serves as the basis for the acceptance criteria for the new device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 12 healthy adult male and female volunteers.
- Number of Blood Samples: 300 blood samples.
- Data Provenance: The study was conducted on "healthy adult male and female volunteers with light to dark skin pigmentations." The country of origin is not explicitly stated, but the company is based in China. The study appears to be prospective as it's described as "clinical testing" specifically for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth for SpO2 was established using a laboratory CO-Oximeter.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by instrumental measurement (CO-Oximeter), not human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the device against a laboratory reference.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The "clinical testing" described measures the intrinsic accuracy of the pulse oximeter (HS10A) itself against a reference standard.
7. The Type of Ground Truth Used
The ground truth used for the SpO2 accuracy evaluation was an instrumental reference standard, specifically a laboratory CO-Oximeter. This is compared to "outcomes data" in the sense that the CO-Oximeter provides definitive physiological measurements.
8. The Sample Size for the Training Set
The document does not provide any information about a training set. This suggests that the device's underlying algorithms or calibration were developed prior to this validation study, and details about their training are not part of this 510(k) summary. Pulse oximeters typically rely on established physiological models and calibration rather than machine learning training sets in the way AI algorithms do.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set information is provided.
§ 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).