(317 days)
The Fingertip Pulse Oximeter are intended for measuring function of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as not checking in home and professional caring environment. It is designed for fingers between 7mm and 25.4mm in diameter (0.28 inches to 1.0inches). And it is not intended to be used under motion or low perfusion scenarios.
The Fingertip Pulse Oximeter X1609P is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user. Moreover, the X1609P also has the function of low battery voltage indicate and automatically power off. The power source is 2xAAA batteries. Fingertip Pulse Oximeter X1609P is small in volume, light in weight and convenient in carrying. It is composed of light signal driving circuit, preamplification circuit, low pass filtering circuit, DC bias circuit, gain control circuit, display control circuit, and main control circuit. The device is for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterile.
Here's an analysis of the provided FDA 510(k) summary for the Finger Pulse Oximeter, Model: X1906P, organized to address your specific points about acceptance criteria and study proof.
It's important to note that this document is a summary for a 510(k) submission, and therefore provides high-level information. Full details of the protocols, raw data, and statistical analyses would be found in the complete submission documents, which are not provided here.
Acceptance Criteria and Device Performance
The core of the performance evaluation for a pulse oximeter revolves around its accuracy in measuring oxygen saturation (SpO2) and pulse rate (PR). The key standard referenced is ISO 80601-2-61: 2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Fingertip Pulse Oximeter Equipment. The acceptance criteria are typically derived from this standard.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (from ISO 80601-2-61) | Reported Device Performance (Model: X1906P) |
|---|---|---|
| SpO2 Accuracy | 70% to 99% range: ± 2% ARMS (as per ISO 80601-2-61) | "The measure result between the SpO2 measured by subject device and the SaO2 measured by the blood gas analyzer... were conformed with the requirements of this clinical trial and related standards." (Implicitly meets ± 2% within 70-99% range as per standard) |
| Pulse Rate Accuracy | As per ISO 80601-2-61, Clause 201.12.1.104 (typically ± 3 bpm or ± 2% for specific ranges) | "Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104." (Implicitly meets the standard's criteria) |
Note on Acceptance Criteria Interpretation: The document states that "Bench testing was conducted, and the results show that the subject device complies with the ISO 80601-2-61: 2017... standard. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104." This implies the acceptance criteria were the specific performance requirements outlined in that ISO standard for accuracy, which is typically Average Root Mean Square (ARMS) difference for SpO2. The specific numerical ARMS values are not explicitly stated for the device's performance, but rather that it "conformed with the requirements."
Study Details
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 13 adult volunteers.
- Breakdown: 5 males, 8 females.
- Fitzpatrick skin types included: 3 subjects with Fitzpatrick VI, 3 subjects with Fitzpatrick II, and 7 subjects with Fitzpatrick IV. This inclusion of diverse skin tones is crucial for pulse oximetry accuracy.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. Given the manufacturer (Shenzhen Changkun Technology Co., Ltd. from China) and consultant (Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. from China), it is highly probable the study was conducted in China.
- Retrospective or Prospective: The study description "Clinical studies were conducted to verify the accuracy of proposed device" and "There were 13 adult volunteers to validated the accuracy of finger pulse oximeter" indicates a prospective clinical study.
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 in the traditional sense of image adjudication or clinical interpretation, as this is a pulse oximeter accuracy study. The "ground truth" for SpO2 and pulse rate is established through direct, highly accurate physiological measurements:
- SpO2 Ground Truth: Measured by a blood gas analyzer (SaO2).
- Pulse Rate Ground Truth: Measured by a patient monitor (HR).
These are considered gold standards for these physiological parameters. Therefore, the concept of "experts establishing ground truth" as it applies to subjective interpretation (like radiology reads) is not directly applicable here. The expertise lies in the certified laboratory/clinical personnel performing the blood gas analysis and operating the patient monitor, ensuring proper calibration and technique. Specific qualifications of these operators are not detailed but are assumed to be standard for clinical laboratory and patient monitoring practices.
4. Adjudication Method for the Test Set:
Not applicable in the context of this study. This study directly compares the device's numerical output against gold-standard physiological measurements (blood gas analyzer for SaO2, patient monitor for HR). There is no "adjudication" of the device's readings by human experts in the sense of consensus reading or interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. For a pulse oximeter, the study design is centered on direct numerical accuracy against a gold standard, not human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
Yes, the clinical accuracy study described for the pulse oximeter is effectively a standalone study. The device's measurement (SpO2 and PR) is directly compared to the reference measurement (blood gas analyzer and patient monitor) without an explicit "human-in-the-loop" component influencing the device's output or the ground truth measurement. The user of the oximeter reads the displayed value, but the study validates the intrinsic accuracy of the measurement.
7. The Type of Ground Truth Used:
- SpO2 Ground Truth: Physiological measurement via arterial blood gas analysis (SaO2). This is considered a gold standard for true arterial oxygen saturation.
- Pulse Rate Ground Truth: Physiological measurement via a patient monitor (HR). This is also considered a gold standard for heart rate.
8. The Sample Size for the Training Set:
The document does not provide information on a training set size. For a traditional medical device like a pulse oximeter, "training set" is usually not a relevant concept in the same way it is for AI/ML algorithms. The device's underlying principles (Lambert Beer Law, photo-plethysmography) are based on established physics and physiology, not on learning from a dataset. Any internal calibration or algorithm refinement would be part of the engineering design process, not typically referred to as a "training set" in the context of FDA submissions for such devices.
9. How the Ground Truth for the Training Set was Established:
As there is no mention of a "training set" in the context of AI/ML, this question is not applicable. The device's design and calibration are based on established scientific principles and engineering practices, not on a machine learning training dataset. The clinical study validates the final, produced device's performance against established physiological ground truth.
§ 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).