Search Results
Found 1 results
510(k) Data Aggregation
(408 days)
Mecun SpO2 sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg. The sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.
Mecun SpO2 Sensor consists of a connector, cable and patient sensor terminal. The optical components of sensor contain a LED emitter and a LED detector assembled into the non-woven housing. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.
The provided document describes the Mecun SpO2 sensor and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Guidance) | Reported Device Performance (Mecun SpO2 sensor) | Comment |
|---|---|---|
| ISO 80601-2-61: 2017 SpO2 Accuracy (70-80% SpO2) | ±3% | Meets requirement. The predicate device's accuracy was ±3% for 70-100%, implying the subject device also meets this, specifically within this range. |
| ISO 80601-2-61: 2017 SpO2 Accuracy (80-100% SpO2) | ±2% | Meets requirement. Better accuracy in this range compared to the predicate device's ±3% for 70-100%, but still within acceptable limits as per ISO 80601-2-61 and FDA guidance. |
| ISO 80601-2-61: 2017 SpO2 Accuracy (< 70% SpO2) | Undefined | Consistent with the predicate device and standard practice for pulse oximeters, which typically do not define accuracy below 70%. |
| Pulse Rate Accuracy | ±3 (20-250bpm) | Similar to predicate device (±3 for 30-250bpm). The subject device's lower limit for pulse rate accuracy is better (20bpm vs 30bpm), indicating no new safety or effectiveness issues. |
| Biocompatibility Testing (ISO 10993-1) | Cytotoxicity, Skin Sensitization, Skin Irritation | Performed and passed. This demonstrates the device's materials are safe for patient contact. |
| Electrical Safety (IEC 60601-1) | Compliant | Indicates the device meets general requirements for basic safety and essential performance of medical electrical equipment. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliant | Ensures the device operates safely in its electromagnetic environment without causing or being susceptible to undue electromagnetic disturbances. |
| Performance Effectiveness (ISO 80601-2-61) | Compliant | Comprehensive compliance with this standard indicates the device meets particular requirements for basic safety and essential performance of pulse oximeter equipment, which includes SpO2 and PR accuracy. |
| Guidance: "Pulse Oximeters - Premarket Notification Submissions" | Clinical testing performed | Clinical studies were conducted according to this FDA guidance, ensuring the rigor and relevance of the clinical performance evaluation for market approval. |
2. Sample size used for the test set and data provenance
- Sample Size for Test Set: The document states that "Clinical studies were conducted to verify the accuracy of subject device" but does not specify the exact sample size used for the clinical test set.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the nature of clinical studies for SpO2 accuracy (desaturation studies involving human subjects) strongly suggests a prospective design where subjects are enrolled and monitored specifically for the study.
3. Number of experts used to establish the ground truth for the test set and their qualifications
The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. For SpO2 accuracy studies, the "ground truth" is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus on visual interpretation. However, medical personnel would be extensively involved in performing the study according to protocol and ensuring data quality.
4. Adjudication method for the test set
The document does not specify an adjudication method. For pulse oximetry accuracy studies using arterial blood gas analysis, an adjudication method in the traditional sense (e.g., 2+1 reader consensus) is generally not applicable, as ground truth (SaO2 from co-oximetry) is a direct physiological measurement, not an interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
This is a standalone device (SpO2 sensor), not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance evaluation for the Mecun SpO2 sensor is standalone (device-only performance). The clinical study evaluated the direct accuracy of the SpO2 sensor in comparison to a reference standard (arterial blood gas analysis/co-oximetry) without human interpretation being a variable in the device's output.
7. The type of ground truth used
The ground truth for the SpO2 accuracy validation in clinical studies is typically established by arterial blood gas analysis (co-oximetry). This is the physiological reference standard for measuring functional oxygen saturation (SaO2).
8. The sample size for the training set
This device is a hardware sensor, not a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. Therefore, the concept of a training set sample size is not applicable. The device's internal algorithms for processing optical signals to derive SpO2 and PR are designed and validated through engineering principles and testing against physiological models and clinical data, distinguishing it from adaptive AI models that train on vast datasets.
9. How the ground truth for the training set was established
As mentioned, a "training set" is not applicable for this type of hardware device. The internal algorithms and calibration are established through engineering design, physiological modeling, and validation against known physical and physiological parameters, rather than based on labeled training data as used in machine learning.
Ask a specific question about this device
Page 1 of 1