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The Masimo ReSposable SpO2 Series Oximetry Sensors are indicated for the continuous noninvasive 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 motion and no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo ReSposable SpO2 Series Oximetry Sensors are pulse oximetry sensors. They measure tissue oxygenation non-invasively through infrared emitters and detectors. The ReSposable SpO2 Series Oximetry Sensors are fully compatible for use with instruments which include the following technologies:

• · Masimo SET technology
• · Masimo Rainbow SET technology
• · Nellcor technology
• · Philips FAST-SpO2 technology

The provided documentation is a 510(k) summary for the Masimo ReSposable SpO2 Series Oximetry Sensors. This document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use and physical characteristics, along with a list of non-clinical and clinical testing performed.

However, the document does not include specific acceptance criteria or the detailed results of a study that proves the device meets those criteria. The available information states that "The following clinical and non-clinical testing was conducted to verify that the Masimo ReSposable SpO2 Series Oximetry Sensors met all design specifications," but it doesn't elaborate on the "design specifications" (acceptance criteria) or the measured performance against them.

Therefore, I cannot populate the table of acceptance criteria and reported device performance, nor can I fully answer questions about sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone performance) because that detailed information is not present in the provided text.

Based on the available information, here's what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Available: The document mentions "all design specifications" were met but does not specify what these acceptance criteria are or present a table of reported device performance against them.

2. Sample size used for the test set and the data provenance

Information Not Available: The document does not provide details on the sample size used for any clinical or non-clinical tests or the data provenance (e.g., country of origin, retrospective/prospective). It only lists the types of tests conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Information Not Available: The document does not describe any expert-based ground truth establishment as typically seen in image analysis or diagnostic studies. The tests listed are primarily related to physical performance, electrical characteristics, and overall biocompatibility and environmental robustness. For SpO2 accuracy, typically arterial blood gas measurements (Gold Standard) are used, but details are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Information Not Available: Not applicable to the type of tests briefly described.

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

Information Not Available: This device is an oximetry sensor, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study with AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Information Not Available: The document mentions "clinical and non-clinical testing" was done, but it doesn't specify if this included a standalone performance evaluation of the sensing algorithm in isolation. For SpO2 devices, standalone performance typically refers to the accuracy of the device's SpO2 readings against a "gold standard" (like arterial blood gas analysis) under various physiological conditions (motion, low perfusion, different SpO2 levels). While clinical tests were conducted, details about this specific type of assessment are not provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Information Not Available: For the SpO2 device, the gold standard for ground truth in clinical testing of SpO2 accuracy is typically arterial blood gas co-oximetry. However, the document does not explicitly state what ground truth method was used for its "clinical testing." For the non-clinical tests (biocompatibility, light rejection, etc.), the ground truth would be established by relevant scientific standards and measurement techniques.

8. The sample size for the training set

Information Not Available: The document does not describe any machine learning or AI component that would require a "training set." Therefore, this information is not applicable and not provided.

9. How the ground truth for the training set was established

Information Not Available: See point 8. Not applicable as no training set is mentioned.

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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.

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.

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