(134 days)
The M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Reprocessed M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The M-LNCS and Reprocessed M-LNCS Oximetry Sensors are fully compatible disposable sensors for use with instruments which include or compatible with the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
- · Nellcor technology
The M-LNCS series has been validated with Masimo SET Oximetry Technology and on Nellcor's N-200 Pulse Oximeter. The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for properties of fetal hemoglobin.
Here's an analysis of the provided text regarding the acceptance criteria and study data for the Masimo M-LNCS Oximetry Sensors:
Important Note: The provided document is a 510(k) summary, which often summarizes the results of studies rather than detailing the full study methodology. As such, some specific details like exact sample sizes for each test, data provenance in terms of country of origin for all tests, specific ground truth establishment for all parameters, and multi-reader multi-case study details are not fully elaborated in this summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are presented as the accuracy specifications for SpO2 and pulse rate under different conditions (no motion, motion, low perfusion) and for different patient populations (adult/pediatric/infant, neonatal). The study's reported performance is implied by the statement that the sensors "met all design specifications" and "are as safe and effective as the legally marketed predicate devices." Therefore, the reported performance aligns with the specified accuracy ranges.
| Parameter | Accuracy Range | Acceptance Criteria (Adult/Pediatric/Infant) | Reported Device Performance (Adult/Pediatric/Infant) | Acceptance Criteria (Neonatal) | Reported Device Performance (Neonatal) |
|---|---|---|---|---|---|
| Masimo Technology | |||||
| SpO2, no motion | 70-100% | ± 2% | Meets ± 2% | ± 3% | Meets ± 3% |
| SpO2, motion | 70-100% | ± 3% | Meets ± 3% | ± 3% | Meets ± 3% |
| SpO2, low perfusion | 70-100% | ± 2% | Meets ± 2% | ± 3% | Meets ± 3% |
| Pulse rate, no motion | 25-240 bpm | ± 3 bpm | Meets ± 3 bpm | ± 3 bpm | Meets ± 3 bpm |
| Pulse rate, motion | 25-240 bpm | ± 5 bpm | Meets ± 5 bpm | ± 5 bpm | Meets ± 5 bpm |
| Pulse rate, low perfusion | 25-240 bpm | ± 3 bpm | Meets ± 3 bpm | ± 3 bpm | Meets ± 3 bpm |
| Nellcor Technology | |||||
| SpO2, no motion | 70-100% | ± 2% | Meets ± 2% | ± 3% | Meets ± 3% |
| Pulse rate, no motion | 25-240 bpm | ± 3 bpm | Meets ± 3 bpm | ± 3 bpm | Meets ± 3 bpm |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers. However, it does not specify the sample size for this validation or for other tests. The provenance is implied to be human subject testing for some aspects (adult volunteers) but no geographical location is specified. The studies are non-clinical, implying they were prospective tests conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of "experts" to establish ground truth in the context of radiologists or similar medical specialists. For oximetry, ground truth is typically established by reference devices or methods (e.g., co-oximetry for SpO2, ECG for pulse rate).
4. Adjudication Method for the Test Set
Not applicable. Adjudication is typically used for subjective diagnoses or interpretations by multiple readers. For oximetry accuracy, the comparison is to a definitive reference standard, not expert consensus requiring adjudication.
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 relevant for diagnostic imaging or subjective interpretation tasks where the performance of human readers, with and without AI assistance, is evaluated. Oximetry sensor evaluation focuses on the accuracy of the device itself against physiological parameters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described appears to be standalone performance of the device. The "performance testing including bench accuracy testing" and the validation on "adult volunteers" for saturation accuracy are tests of the device's ability to measure physiological parameters independently.
7. The Type of Ground Truth Used
For saturation accuracy, the ground truth for neonatal/preterm sensors was established by validation on adult volunteers, where a "1% was added to account for properties of fetal hemoglobin." This implies that the ground truth for SpO2 was likely established using a reference co-oximeter on the adult volunteers. For pulse rate, the ground truth would typically be from an ECG or similar gold standard. The other tests, such as "bench accuracy testing," would use simulated physiological signals or phantoms.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. Oximetry sensors traditionally rely on algorithms based on physiological principles and empirical data, not typically large-scale machine learning training sets in the modern sense. The validation studies mentioned would be more akin to "test sets" for verifying the device's performance against established criteria.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set for an AI algorithm is mentioned, the method for establishing ground truth for a training set is not applicable based on the provided text. The device's underlying technology (Masimo SET, Masimo Rainbow SET, Nellcor technology) already incorporates established algorithms for signal processing and SpO2/pulse rate calculation.
§ 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).