(97 days)
The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spotchecking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device is normally applied to infants, children, adolescents and adult in hospitals, hospital-type facilities and homecare.
The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), OLED/LED display screen, user interface and button control circuit.
The document provided is a 510(k) Premarket Notification from the FDA for a Pulse Oximeter. It describes the device, its intended use, and a comparison to a predicate device, including non-clinical and clinical data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Acceptance Criteria Table and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| SpO2 Accuracy (for FS20P model) | |
| Measurement Accuracy: 70%~100%: ±2% (Implied from "Accuracy: 70% | FS20P Pulse Oximeter: |
ARMS (Accuracy Root Mean Square) of 1.70% over the range of 70-100%. This value 1.70% is less than or equal to the implied acceptance criteria of ±2% as defined by the predicate device and the new device's listed specification for accuracy. | |
| SpO2 Accuracy (for FS20C model) | |
| Measurement Accuracy: 70%~100%: ±2% (Implied from "Accuracy: 70% | FS20C Pulse Oximeter: |
ARMS (Accuracy Root Mean Square) of 1.71% over the range of 70-100%. This value 1.71% is less than or equal to the implied acceptance criteria of ±2% as defined by the predicate device and the new device's listed specification for accuracy. | |
| Biocompatibility | |
| Must conform to the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. | The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". (Statement of compliance, not a numerical performance metric). |
| Bench Testing / Electrical Safety | |
| Conform to specified IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61). | The Pulse Oximeter has been tested according to the following standards: |
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012
- IEC 60601-1-2:2014
- IEC 60601-1-11 Edition 2.0 2015-01
- ISO 80601-2-61: 2017
(Statement of compliance, not a numerical performance metric, beyond the clinical accuracy which is detailed elsewhere). Electrical safety explicitly stated: "Conformed to IEC60601-1, IEC 60601-1-11". |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- FS20P: 10 healthy female adult volunteer subjects.
- FS20C: 13 healthy adult volunteer subjects.
- Data Provenance: The studies involved volunteer subjects, implying prospective data collection. The document does not specify the country of origin of the study data, but the submitting company is based in China, so it is highly likely the studies were conducted there. The subject skin tones (Fitzpatrick 1-6) suggest a diverse population, but this is a characteristic, not a location.
3. Number of Experts and Qualifications for Ground Truth
- The document describes a clinical study for SpO2 accuracy compared to arterial blood CO-Oximetry. This is a direct physiological measurement, implying that no human expert adjudication was used to establish the ground truth for SpO2. The CO-Oximeter itself is the "expert" or gold standard.
- Therefore, the concept of "number of experts" for ground truth establishment, as typically applied to image-based diagnostic AI, is not directly applicable here.
4. Adjudication Method for the Test Set
- None, as the ground truth was established by direct physiological measurement using a CO-Oximeter, which is considered a gold standard for SpO2. No human adjudication process (like 2+1 or 3+1) was necessary or mentioned for the SpO2 values.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance.
- For a pulse oximeter, the device directly measures physiological parameters (SpO2 and PR). The clinical study focused on validating the device's accuracy against a gold standard (arterial blood CO-Oximetry), not on improving human reader performance.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The clinical studies directly measured the device's (i.e., the pulse oximeter's algorithm/measurement system) SpO2 accuracy (ARMS) against a gold standard (arterial blood CO-Oximetry). The reported ARMS values (1.70% for FS20P and 1.71% for FS20C) are metrics of the device's standalone performance.
7. Type of Ground Truth Used
- The ground truth used was outcomes data / physiological measurement, specifically arterial blood CO-Oximetry. This method provides a direct, highly accurate measurement of arterial oxygen saturation, serving as the gold standard for SpO2.
8. Sample Size for the Training Set
- The document does not specify a separate training set or its sample size. For a traditional medical device like a pulse oximeter, particularly one based on well-established principles of optical measurement, there isn't typically an "AI training set" in the sense of machine learning. The device's calibration and design would be based on engineering principles and potentially internal validation data, but not typically a labeled "training set" like an AI performs. The studies described are for validation/testing the accuracy of the final device.
9. How Ground Truth for the Training Set Was Established
- This question is not applicable as there is no mention of an "AI training set" or a separate training set in the context of this device's submission. The described clinical studies are for performance validation (test set), not for training an algorithm.
§ 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).