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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 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.

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.

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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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The Reprocessed LNCS 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 no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The Reprocessed LNCS Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The Reprocessed LNCS Oximetry Sensors , are also compatible with Nellcor compatible pulse oximeter monitors.

The provided 510(k) summary describes the acceptance criteria and testing for Reprocessed LNCS Oximetry Sensors.

The central focus of the submission is to demonstrate substantial equivalence to existing predicate devices (Reprocessed LNCS Oximetry Sensors, 510(k) No. K083719), emphasizing that the new devices have the "same specifications."

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are the claimed accuracy ranges for SpO2 and pulse rate under various conditions, which are stated to be "the same specifications as the predicate devices." The device performance is implicitly stated to meet these criteria, as the conclusion is that the devices are "equivalent" and "met all design specifications."

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

The document indicates "performance testing including bench accuracy testing." However, the specific sample sizes for these tests are not provided. The data provenance (e.g., country of origin, retrospective/prospective) is not specified.

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

This information is not provided in the summary. The tests described are non-clinical (bench accuracy, biocompatibility, etc.), which typically do not involve human experts to establish ground truth in the same way clinical trials for diagnostic algorithms would. For oximetry devices, ground truth for SpO2 is usually established by a co-oximeter in controlled desaturation studies, which are not detailed here.

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

Not applicable. The testing described is non-clinical performance and bench testing, not a clinical study involving human reviewer adjudication of cases.

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 oximeter sensor, not an AI-powered diagnostic tool that assists human readers.

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

Yes, "bench accuracy testing" falls under standalone testing, demonstrating the device's inherent performance. The results "demonstrated that the Reprocessed LNCS Oximetry Sensors are equivalent to the predicate devices" and "met all design specifications."

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

For "bench accuracy testing" of oximeter sensors, the ground truth for SpO2 measurements would typically be established using a co-oximeter in a controlled calibration or desaturation study setting. For pulse rate, a calibrated physiological simulator or ECG would typically be used. This specific detail is not explicitly stated but is the standard for such devices.

8. The sample size for the training set

Not applicable. This device is a reprocessed sensor, and the testing described is verification against specifications and predicate device equivalence, not the training of an algorithm.

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

Not applicable. There is no algorithm training set discussed for this device.

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The 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 and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The LNCS Oximetry Sensors are to be reprocessed. They are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The LNCS Oximety Sensors are also compatible with Nellcor compatible pulse oximeter monitors. There is no change in the sensor design or performance. The only change is that the sensors are to be reprocessed and subjected to ethylene oxide (EO) sterilization, and are to be supplied as sterile sensors by Masimo.

The provided document is a 510(k) summary for the Masimo LNCS Oximetry Sensors. It focuses on the substantial equivalence of reprocessed and sterilized sensors to previously cleared sensors. Therefore, the information typically found in acceptance criteria and detailed study reports for new device performance (like specific accuracy metrics, sample sizes for test/training sets, expert qualifications, etc.) is not present in this summary.

Here's a breakdown of what can be extracted based on the request, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., accuracy, precision errors for SpO2). The primary acceptance criterion here is "substantial equivalence" to previously cleared predicate devices. This means the reprocessed sensors must perform at least as well as the original, non-reprocessed sensors.
• Reported Device Performance: The document only states: "The results of the performance data demonstrate that the LNCS Oximetery Sensors, after reprocessed and sterilized are as safe and effective as the legally marketed predicate devices." No specific numerical performance values (e.g., SpO2 accuracy, pulse rate accuracy) are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: The testing was "in-house and laboratory validation testing." No information on country of origin or whether it was retrospective or prospective is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable/not specified. For oximetry sensors, ground truth typically comes from a reference device (e.g., CO-oximeter for SpO2) rather than expert consensus on images.
• Qualifications of Experts: Not applicable/not specified.

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

• Adjudication Method: Not applicable/not specified. Oximetry sensor performance is typically evaluated against reference instruments, not expert adjudication in the way image analysis algorithms are.

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

• MRMC Study: No. This device is an oximetry sensor, not an AI-powered diagnostic tool requiring human reader studies.

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

• Standalone Performance: Not applicable in the context of an "algorithm only" device, as this is a physical sensor. The "performance data" mentioned would be for the sensor itself.

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

• Type of Ground Truth: Not explicitly stated in this summary. For oximetry devices, ground truth for SpO2 accuracy is typically established using a reference CO-oximeter with arterial blood samples. The document refers to "in-house and laboratory validation testing," which would imply such rigorous reference methods.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a sensor, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of available information as per request:

This 510(k) summary is for a device modification (reprocessing and sterilization) of an existing device type, not a new technology introduction. Therefore, the focus is on demonstrating that the reprocessing and sterilization do not negatively impact the established performance and safety of the device, rather than establishing original performance criteria from scratch. Detailed performance metrics and study designs, if required, would typically be found in the full 510(k) submission, not necessarily in the public summary.

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The 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 and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The LNCS Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The LNCS Oximetry Sensors are also compatible with Nellcor and Nellcor compatible pulse oximeter monitors.

There is no change in the sensor design or performance. The only change is that the sensors are to be subjected to ethylene oxide (EO) sterilization and are to be supplied as sterile sensors by Masimo.

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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

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.

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The LNOP x Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infam, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The LNOP x and LNOP X Oximely Sellsols are indicated for the ventinated by an SpO2 sensor) for use with ault, oxygen saturation of areflal nemogroum (3002) and motion and for patients who are well or pediative, intaint, and neonally darking overling over, and home environments. poorly perfused in hospital-type facilities, mobile, and home environments.

The LNOPx and LNOP x Oximetry Sensors are fully compatible disposable and reusable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors.

The LNOP x and LNOP x disposable sensors are similar in construction to the predicate devices except that the SPO2 COM sensors are cable based while the LNOP sensors including the LNOP x sensors are flex circuit based. The emitter and detector are connected to the flex circuit. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masmo's LNOP series of disposable sensors. Two sizes of disposable LNOPy sensors are available for use with infant and neonatal patients. Two sizes of disposable LNOP x sensors are available for use with adult and pediatric patients. The four sensors are essentially identical except for the emitter and detector spacing and size and orientation of the bandage material The patient contacting materials in the LNOP x disposable sensors are the same that is used in Masimo's SPO2.COM sensor line. The LNOP x disposable sensors are supplied non-sterile for single patient use.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance

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The LNCS Sensors and Cables are indicated for the continuous nonitoring of functional oxygen saturation I he LNCS Sellsons and Cables are multided for and continued by an SpO2 sensor) for use with adult, pediatric, infant, and of arterial nemogroum (op(0)) and pare (motion conditions, and for patients who are well or poorly perfused 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 compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors.

The LNCS DC-I/DC-IP reusable sensors are essentially identical to Masimo LNOP-DC-I/DC-IP sensors except for the connector at the end of the cable which interfaces with the LNCS patient cable. The emitter and detector are mounted in opposing halves of the molded clothespin style sensor with contoured pads to maintain contact with the patient's fingers. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) and detector are used in both the LNCS DC-I/DC-IP and LNOP-DC-I/DC-IP sensors. The patient contacting materials in the LNCS DC-I/DC-IP and LNOP-DC-IP sensors are the same. The LNCS DC-I/DC-IP sensors are supplied non-sterile.

The LNCS TC-I and TF-I reusable sensors are essentially identical to Masimo LNOP-Ear and TF-I sensors except for the connector at the end of the cable which interfaces with the LNCS patient cable. The same emitter (with Red wavelength of 653/659 nm and Infrared wavelength of 880 nm respectively) and detector are used in both the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors. The patient contacting materials in the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors are the same. The LNCS TC-I and TF-I sensors are supplied non-sterile.

The LNCS disposable sensors are similar in construction to the predicate devices except that the LNCS sensors are cable based while the LNOP sensors are flex circuit based. The emitter and detector are connected to the cable assembly. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masimo's LNOP series of disposable sensors. Four sizes of disposable LNCS sensors are available for use with adult, pediatric, infant and neonatal patients. The four sensors are essentially identical except for the emitter and detector spacing and size and orientation of the bandage material. The patient contacting materials in the LNCS disposable sensors are the same that is used in Masimo's LNOP sensor line. The LNCS disposable sensors are supplied non-sterile for single patient use.

The LNCS patient cables are similar in construction to the predicate device enabling the LNCS Oximetry Sensors to be connected to Masimo and Masimo compatible pulse oximeter monitors.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary indicates that the accuracy of the LNCS oximetry sensors is equivalent to the predicate devices. The summary explicitly states:

Note: The document states that the "LNCS oximetry sensors are substantially equivalent...and performance to predicate sensors" and that "The accuracy of the LNCS oximetry sensors is equivalent to those of the predicate devices." The specific accuracy values presented in the "Clinical Testing" section are attributed to "SPO2.COM Disposable and Reusable sensors." While these are listed as predicate devices in the 510(k) (K033298), the document implies that the LNCS sensors achieve equivalent performance to these predicate devices, thus meeting these implied acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "healthy adult volunteer subjects" and "adults, pediatrics and infants and neonates" were included. However, the exact number of subjects or data points is not provided.
• Data Provenance: The study was conducted on "healthy adult volunteer subjects" and involved "induced hypoxia." This indicates a prospective clinical study. The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable in this context. The ground truth for SpO2 measurements is not established by human experts in the typical sense of image or diagnostic interpretation.
• Qualifications of Experts: Not applicable. The ground truth relied on a CO-Oximeter to measure arterial hemoglobin oxygen from arterial blood samples.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement from a CO-Oximeter, not through human interpretation requiring adjudication.

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

• MRMC Study: No, an MRMC study was not done. This device is an oximeter sensor, not an AI-powered diagnostic tool that assists human readers.

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

• Standalone Performance: Yes, the clinical testing describes the standalone performance of the oximetry sensors against a reference standard (CO-Oximeter). The device itself is the 'algorithm' in this context, directly measuring and reporting SpO2.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. This is an objective, gold-standard measurement for blood oxygen saturation.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a medical device (sensor) and its performance, not a machine learning model that would typically have a distinct training set. The device's design and parameters are established through engineering and previous device iterations rather than a "training set" in the AI sense.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable. As mentioned above, this is not an AI/ML device where a training set with established ground truth would be relevant in the same way. The device's operating principles are based on established physiological and photometric principles.

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