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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.

N/A

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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

Note: The document only explicitly states accuracy for SpO2. While biocompatibility and environmental testing were performed and passed, specific quantitative acceptance criteria for these were not provided in the summary. The "less than 2% Apys" and "less than 3% Apys" values likely represent the accuracy specifications (e.g., RMS error or similar statistical measure) used by the manufacturer as acceptance criteria for their devices.

Study Information:

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

• Test Set Sample Size: Not explicitly stated. The document mentions "healthy adult volunteer subjects" but does not quantify how many unique subjects were included in the clinical studies. It also states the studies were done for "adults, pediatrics and infants and for neonates," implying different cohorts, but again, no numbers are given.
• Data Provenance: The study was conducted clinically with human subjects. The country of origin is not specified but generally, such studies are conducted within the country of the submitting company or in regions with comparable regulatory standards. It was a prospective study, as subjects were "subjected to a progressive induced hypoxia."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth method involved a "CO-Oximeter," which is an instrument, not human experts. Human oversight of the CO-Oximeter operation would be assumed, but their qualifications are not detailed.

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

• Adjudication Method: Not applicable. The ground truth was established by an objective instrument (CO-Oximeter) measuring arterial blood samples, not by human expert consensus or adjudication of subjective data.

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 oximetry sensor, which is a measurement device, not an AI diagnostic tool that assists human readers in interpreting images or other data.

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

• Standalone Performance: Yes, the clinical testing describes the "accuracy of the LNOP x Oximetry Sensors" against direct arterial blood gas measurements, which is a standalone performance assessment of the sensor's accuracy in measuring SpO2. The device functions independently to provide a physiological measurement.

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

• Ground Truth Type: Objective measurement from a CO-Oximeter analysis of arterial blood samples. This is considered a highly accurate, direct physiological measurement.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This document describes a medical device (sensor) that performs physical measurements, not an AI/ML algorithm that requires a training set. The "design change" refers to hardware and material changes, not algorithmic learning.

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 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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