(62 days)
The LNCS oximetry sensors are intended for the continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by an SpO2 sensor) for use with compatible pulse oximeter monitors. The LNCS oximetry sensors are intended for use on adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The LNCS Oximetry Sensors are fully compatible disposable and reusable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. There is no change in accuracy or intended use and the sensors can also be used with Nellcor and Nellcor compatible pulse oximeter monitors.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the LNCS Oximetry Sensors:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Accuracy in the range of 70%-100% SaO2 for adults, pediatrics, and infants | Less than 2% SpO2 ARMS |
| Accuracy for neonates | Less than 3% ARMS |
| Biocompatibility (non-toxic, non-irritating, non-sensitizing patient contacting materials) | Materials were non-toxic, non-irritating, and non-sensitizing (same as predicate devices) |
| Electrical, mechanical, and environmental testing compliance | All tests passed |
| Intended use equivalence | Equivalent to predicate devices |
| Design, principles of operation, materials equivalence | Equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical count of subjects. The text mentions "healthy adult volunteer subjects," and "adults, pediatrics and infants," and "neonates." However, the exact number of participants in each group is not provided.
- Data Provenance: The study was conducted using "healthy adult volunteer subjects" subjected to "progressive induced hypoxemia." This indicates the data was prospectively collected for the purpose of this study. The geographical origin of the volunteers (e.g., country) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The ground truth was established by "measuring the arterial blood samples with a CO-Oximeter," which implies a laboratory or clinical measurement rather than an expert consensus per se in interpreting images or clinical signs.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the traditional sense of human reader adjudication for diagnostic imaging studies. The ground truth was derived from direct measurement using a CO-Oximeter.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the device against a physiological ground truth, not on how human readers improve with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Yes, a standalone performance study was done. The "accuracy of the LNCS oximetry sensors" was evaluated by comparing its readings directly against arterial blood samples measured by a CO-Oximeter. This assesses the device's algorithmic performance without human interpretation or intervention in the measurement process.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was physiological measurement (arterial hemoglobin oxygen content) obtained via a CO-Oximeter from arterial blood samples. This is a direct, objective measurement for oxygen saturation.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The document describes a medical device (sensor) that functions based on optical assessment, not a machine learning algorithm that requires a training set. The device's design and performance are compared to predicate devices, and its accuracy is validated through clinical testing. No mention of AI/ML training is made.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
§ 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).