(106 days)
The LNCS/M-LNCS Sensors are indicated for the continuous nonitoring 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 hospitals, hospital-type facilities, mobile, and home environments.
The LNCS/M-LNCS Oximetry Sensors are fully compatible for use with instruments which include or compatible with the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
- Nellcor technology
- · Philips FAST-SpO2 technology
The main difference is that the sensors in this filing have a lower profile in comparison to the predicates, for optimal fit and comfort for patients. The design is optimized or improved by the removal of excess inner wrap materials and an alternate molding compound in LED assemblies.
Here's an analysis of the acceptance criteria and supporting study for the Masimo LNCS/M-LNCS Oximetry Sensors based on the provided document:
This document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full de novo clinical trial for device acceptance. Therefore, the "study that proves the device meets the acceptance criteria" is primarily by demonstrating equivalence to the previously cleared predicate device's performance through non-clinical testing.
The acceptance criteria are essentially the specifications of the predicate device, which the new device aims to meet or exceed. The "reported device performance" refers to the new device (LNCS/M-LNCS Oximetry Sensors) meeting these specifications.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are the specifications of the predicate device (K051212) which the new device aims to match or improve upon. The "reported device performance" indicates that the new device meets these criteria.
| Category | Specific Criterion (Predicate Device Specification) | Reported Device Performance (New LNCS/M-LNCS Oximetry Sensors) |
|---|---|---|
| Masimo Technology | ||
| SpO2, no motion | 70-100%, ± 2% (Adult/Pediatric/Infant) | Same (70-100%, ± 2%) |
| 70-100%, ± 3% (Neonatal) | Same (70-100%, ± 3%) | |
| SpO2, motion | 70-100%, ± 3% | Same (70-100%, ± 3%) |
| SpO2, low perfusion | 70-100%, ± 2% (Adult/Pediatric/Infant) | Same (70-100%, ± 2%) |
| 70-100%, ± 3% (Neonatal) | Same (70-100%, ± 3%) | |
| Pulse rate, no motion | 25-240 bpm, ± 3 bpm | Improved: 25-300 bpm, ± 3 bpm |
| Pulse rate, motion | 25-240 bpm, ± 5 bpm | Improved: 25-300 bpm, ± 5 bpm |
| Pulse rate, low perfusion | 25-240 bpm, ± 3 bpm | Improved: 25-300 bpm, ± 3 bpm |
| Nellcor/Philips Fast Technology | ||
| SpO2, no motion | 70-100%, ± 2% (Adult/Pediatric/Infant) | Same (70-100%, ± 2%) |
| 70-100%, ± 3% (Neonatal) | Same (70-100%, ± 3%) | |
| Pulse rate, no motion | 25-240 bpm, ± 3 bpm | Same (25-240 bpm, ± 3 bpm) |
Note: The primary "acceptance" here for the 510(k) is demonstrating that the modified device performs at least as well as the predicate device, with some improvements noted.
2. Sample Size Used for the Test Set and Data Provenance
The document states "The following non-clinical testing was conducted to verify that the LNCS/M-LNCS Oximetry Sensors met all design specifications: biocompatibility testing, performance testing including bench accuracy testing and visual and validated functional testing."
- Sample Size for Test Set: The document does not specify a sample size for the "bench accuracy testing" or "visual and validated functional testing." These would typically involve laboratory measurements on a various number of sensors or test setups, but the exact count isn't provided.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective. As this is a non-clinical, bench testing submission, the data would originate from internal Masimo Corporation testing facilities (likely Irvine, CA, USA, based on their address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. The "ground truth" for sensor accuracy in this context would be established through:
- Reference instrumentation: For SpO2, this typically involves a co-oximeter measuring arterial blood gas samples. For pulse rate, a reference ECG machine or other highly accurate heart rate monitor.
- Standardized test methods: Following established protocols for evaluating oximetry sensors (e.g., ISO standards, AAMI standards).
There are no human experts "adjudicating" the ground truth for sensor performance; it's based on objective measurements against a reference standard.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
None. Adjudication by human experts is not relevant for objective performance measurements like sensor accuracy.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an oximetry sensor, not an AI-assisted diagnostic tool requiring human interpretation. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The "performance testing including bench accuracy testing and visual and validated functional testing" (Test Summary, page 2) represents the standalone performance evaluation of the device. The sensor itself is a standalone measurement device; its reported accuracy ranges (e.g., ± 2% SpO2) are its standalone performance characteristics.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for oximetry sensor performance (SpO2 and pulse rate) is typically established through:
- Co-oximetry (blood gas analysis): For oxygen saturation (SpO2), actual arterial blood samples are taken and analyzed by a laboratory co-oximeter, which is considered the gold standard for arterial oxygen saturation.
- Reference ECG/physiologic monitoring: For pulse rate, a highly accurate physiological monitor (e.g., ECG) provides the reference pulse rate.
This is objective, quantitative data, not based on expert consensus, pathology, or outcomes data in this context.
8. The sample size for the training set
Not applicable. The Masimo LNCS/M-LNCS Oximetry Sensors are hardware devices, not AI/ML algorithms that require a "training set." Their performance is based on physical design, materials, and signal processing, validated through engineering and clinical testing, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable. As stated above, 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).