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The Nonin Medical 3250 Finger Pulse Oximeter is a small, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of individuals who are well or poorly perfused under no motion conditions for medical use without a prescription. It is intended for spot-checking of individuals 18 years and older with finger thickness between 0.8-2.5 cm (0.3-1.0 inch). It is not intended for the diagnosis or screening of lung disease, for use in treatment decisions, and should only be used for making heathcare decisions under the advice of a healthcare provider.

Model 3250 Pulse Oximeter is a small, lightweight, portable, battery operated, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate and is intended for over-the-counter use.

The device measures the absorption caused by the pulsation of blood in the vascular bed, which are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LCD display of the device. The LCD also provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate poor pulse quality that may affect the readings. All associated electronics and the microcontrollers are within the sensor, which is activated by inserting a patient's digit. This simple operation activates the internal circuitry automatically upon application.

The Model 3250 includes a Bluetooth radio to send real time oximeter readings to a host device. The Model 3250 features a Bluetooth LE version 4.0 radio to ease the connectivity setup configuration with options to implement secure connections for the point-to-point data connection. This oximeter uses ISP3, Nonin's core signal processing technology software.

Acceptance Criteria and Device Performance Study for Nonin OTC Pulse Oximeter Model 3250 (K211498)

The Nonin OTC Pulse Oximeter Model 3250 is intended for measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate in individuals under no motion conditions for over-the-counter medical use. The device's performance was evaluated through clinical and non-clinical testing to ensure compliance with relevant standards and demonstrate substantial equivalence to predicate and reference devices.

1. Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the pulse oximeter's accuracy is based on the ISO 80601-2-61:2017 standard, which specifies an ARMS (Accuracy Root Mean Squared) of ≤ 3.0%. The device's performance was assessed across different SaO2 ranges and skin pigmentations.

The reported device performance consistently falls within the 3.0% ARMS guidance, demonstrating the device meets the accuracy acceptance criteria across various SaO2 ranges and skin pigmentations. The bias values also indicate no clinically significant bias.

2. Sample Sizes and Data Provenance

The clinical performance testing utilized data from two studies:

• Leeb Study:
  • Sample Size (Test Set): 34 participants.
  • Data Provenance: Not explicitly stated, but it is an "independent study." Controlled desaturation study.
• UCSF Study:
  • Sample Size (Test Set): 26 participants.
  • Data Provenance: Conducted at UCSF (University of California, San Francisco). Controlled desaturation study.

Both studies involved "controlled desaturation studies with arterial oxygen saturation (SaO2) plateaus between 70% and 100%," suggesting a prospective clinical study design where participants' oxygen levels were intentionally varied under medical supervision. The text emphasizes "diverse skin pigmentation" in both studies, indicating an effort to include a representative demographic.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. For pulse oximeter accuracy studies using controlled desaturation, the ground truth for arterial oxygen saturation (SaO2) is typically established through co-oximetry measurements of arterial blood samples, which are analyzed by laboratory professionals using specialized equipment. This process does not usually involve subjective expert interpretation in the same way, for example, a radiology image would.

4. Adjudication Method

The document does not describe an adjudication method for the test set. In pulse oximetry accuracy studies, the direct comparison is between the device's SpO2 readings and the established SaO2 ground truth (from co-oximetry). There isn't typically an expert panel review or adjudication process for interpreting the ground truth data itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being performed for the Nonin Model 3250 or its reference device. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. Pulse oximetry device validation focuses on the accuracy of the device's direct measurement against a physiological gold standard.

6. Standalone (Algorithm Only) Performance

The study primarily evaluates the standalone performance of the pulse oximeter device, which integrates the sensor and the algorithm. The text states: "Nonin oximeters utilize the same oximeter technology thus the accuracy of Model 3250 is identical to the results of the reference device, Model 3230" and "The optical path and algorithm for the Model 3250 is equivalent to the Model 9590." This indicates that the performance data presented directly reflects the algorithm's capability as integrated into the device, without a human-in-the-loop component for interpreting the raw signal.

7. Type of Ground Truth Used

The ground truth used for the clinical accuracy studies (Leeb and UCSF studies) was arterial oxygen saturation (SaO2) measured from arterial blood samples (co-oximetry). This is considered the gold standard for determining actual arterial oxygen saturation. The studies are described as "controlled desaturation studies," confirming the use of direct physiological measurement for ground truth.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. The clinical data presented is for validation (test set) of the device's accuracy. For pulse oximeters, the core signal processing technology (ISP3 for Nonin) is likely developed and refined over time using extensive proprietary datasets, but specific "training set" details for a machine learning model are not typically disclosed or relevant in the same way as for AI software devices. The statement "Nonin oximeters utilize the same oximeter technology" and "The optical path and algorithm for the Model 3250 is equivalent to the Model 9590" suggests leveraging existing, established technology rather than a newly trained AI model.

9. How Ground Truth for the Training Set Was Established

As with the training set sample size, the document does not detail how the ground truth for any presumed "training set" for the underlying "ISP3" signal processing technology software or core algorithm was established. Given the nature of pulse oximetry, it's highly probable that any developmental data would similarly rely on arterial oxygen saturation (SaO2) measured from arterial blood samples (co-oximetry), following the established methodology for validating pulse oximeter accuracy.

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The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.

· For %SpO2 and pulse rate, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients who are well or poorly perfused, during both motion and non-motion conditions in professional healthcare facilities, mobile, and EMS settings.

· For %rSO2, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients in professional healthcare facilities, mobile, and EMS settings.

· For %COHb and %MetHb, the H500 System is intended for spot-checking, multiple spot-checks to observe change, and/ or measuring during clinician assessment of adult and pediatric patients in professional healthcare facilities, mobile, and EMS settings.

The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is a small handheld wireless device intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2) of adult, pediatric and neonate patients. It is intended for professional use only, in healthcare facilities, mobile and EMS environments. The system is not provided sterile and is not a reprocessed single-use device. The H500 System consists of three components which are the display, the signal processor and associated sensors. It is intended to be used with specific parts, accessories and compatible sensors which are outlined in Table 1 below.

The Nonin Medical CO-Pilot Model H500 Multi-Sensing Oximetry System is intended for non-invasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). The device underwent comprehensive testing to establish its accuracy and substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are based on the root-mean-squared (Arms) value, calculated per ISO 80601-2-61, for each physiological parameter. While the specific numerical acceptance criteria (e.g., maximum allowable Arms value) are not explicitly stated in the provided text, the document indicates that the device "meets all testing acceptance criteria." The described performance is the result of applying the stated methods and the device passing these criteria.

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

• COHb, MetHb, SpO2 (no motion), SpO2 (with COHb and MetHb):
  • Sample Size: "healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older." The exact number of subjects is not specified, but the testing was "for all subjects."
  • Data Provenance: Prospective, conducted at an "independent research laboratory." The country of origin is not specified but it's an FDA submission, implying a US-based or internationally recognized standard for testing.
• rSO2 (8004CA/8204CA sensors):
  • Sample Size: "healthy, non-smoking, light- to dark-skinned subjects that were 18 years of age and older." The exact number of subjects is not specified, but the testing was "for all subjects."
  • Data Provenance: Prospective, conducted during "induced hypoxia studies." The location is not specified, but implicitly an independent research laboratory.
• rSO2 (8004CB/8004CB-NA sensors):
  • Sample Size: "sick, male and female, pediatric patients ranging in age from 4 days to 10 years with light- to dark-skin." The exact number of subjects is not specified, but the testing was "for all subjects."
  • Data Provenance: Prospective, conducted in "cardiac catheterization laboratories." The location is not specified but implicitly an independent research laboratory.

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

The ground truth for all clinical accuracy testing was established using laboratory CO-oximetry for COHb, MetHb, and SpO2, and arterial/venous blood gas analysis for rSO2. This method relies on validated laboratory equipment rather than human expert consensus. Therefore, the concept of "number of experts" is not directly applicable in the same way it would be for image interpretation tasks. However, the operation and interpretation of these laboratory gold standard devices would have been performed by qualified laboratory personnel. Specific qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

Not applicable as the ground truth was established by objective laboratory measurements (CO-oximetry and blood gas analysis), not via human expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on the measurement accuracy of the device itself against established reference methods, not on how human readers' performance might improve with or without AI assistance from this specific device. The device is a multi-sensing oximetry system, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC reader study to assess human-AI symbiosis.

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

Yes, the clinical accuracy testing described for COHb, MetHb, SpO2, and rSO2 are standalone performance studies. The device's measurements were directly compared against the "gold standard" laboratory methods (CO-oximetry and blood gas analysis) to determine its accuracy without human interpretation influencing the measurement outcome. The device itself is an algorithm-driven measurement system.

7. The Type of Ground Truth Used

• For %COHb, %MetHb, %SpO2, and %SpO2 in presence of COHb and MetHb: The ground truth was objective laboratory measurements from arterial blood samples as assessed by CO-oximetry.
• For %rSO2: The ground truth was objective laboratory measurements from venous and arterial blood samples as assessed by blood gas analysis, modeling blood in the brain as 70% venous and 30% arterial.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set sample size. This suggests the device's underlying signal processing algorithms were developed and validated independently or through proprietary methods not detailed in this 510(k) summary. The clinical accuracy studies described are test set evaluations for regulatory submission.

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

Information on how the ground truth for any potential training set was established is not provided in this document.

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The Nonin® Model 9591Onyx® 3 Finger Pulse Oximeter is a small, lightweight, portable and reusable spot-check device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute.

For %SpO2, and pulse rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services. It is intended for adult and pediatric patients who are well or poorly perfused, with digits that are between 0.3 – 1.0 inch (0.8 –2.5 cm) thick, under non-motion conditions.

For Respiration rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, and home healthcare services. It is intended for adult who are well perfused, with digits that are between 0.3 – 1.0 inch (0.8 - 2.5 cm) thick, under non-motions. It is not intended for use in high-acuity environments, such as ICU or operating rooms where continuous monitoring is expected.

The Model 9591 Finger Pulse Oximeter is a small, lightweight, portable, reusable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. The SpO2, pulse rate, and respiration rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate of poor pulse quality that may affect the readings. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. It is intended for spot-checking of adult and pediatric patients who are well or poorly perfused with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.

This document describes the premarket notification (510(k)) for the Nonin Onyx 3, Model 9591 Finger Pulse Oximeter. The device measures functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate, and also provides a non-invasive measurement of respiration rate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Nonin Onyx 3, Model 9591 are primarily based on demonstrating substantial equivalence to predicate devices and compliance with recognized standards such as ISO 80601-2-61:2011 for pulse oximeters. The performance values are compared against those of the predicate devices.

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

• Respiration Rate Accuracy Verification Clinical (QATR10912):
  • Sample Size: A total of 30 subjects were enrolled.
  • Data Provenance: Single-center, randomized study. The country of origin is not specified, but given the FDA submission, it is likely the US. The study is described as "clinical," implying a prospective data collection approach for this specific test.
• SpO2 Accuracy Testing:
  • Sample Size: Healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older. The exact number of subjects is not specified beyond "all subjects" when referring to ARMS calculation.
  • Data Provenance: Conducted at an independent research laboratory. The country of origin is not specified, but likely the US. This also implies a prospective clinical study where arterial blood samples were taken.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test sets.

• Respiration Rate: Ground truth was established by Capnography based respiratory rate. This is an objective measurement, not directly relying on human expert interpretation for ground truth.
• SpO2 Accuracy: Ground truth was established by co-oximetry analysis of simultaneous arterial blood samples. This is a gold standard, objective measurement and does not involve human expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth for both Respiration Rate and SpO2 accuracy was established through objective, clinical gold standard measurements (Capnography and co-oximetry), rather than subjective expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance assessment focused on the device's accuracy against recognized clinical standards/predicate devices, not on how human readers' performance might improve with or without AI assistance from this device. This device is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic tool for image interpretation.

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

Yes, the studies described (Respiration Rate Accuracy, SpO2 Accuracy) evaluate the standalone performance of the device itself (the Model 9591 Pulse Oximeter) against established ground truth methods. It measures and displays the parameters, and its accuracy is assessed in isolation from human interpretation.

7. The Type of Ground Truth Used

• Respiration Rate: Capnography based respiratory rate. (Objective, physiological measurement)
• SpO2 Accuracy: Co-oximetry of simultaneous arterial blood samples. (Objective, laboratory gold standard)

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. For a device like a pulse oximeter that relies on physiological principles and signal processing, a distinct "training set" in the context of machine learning (where algorithms learn from large datasets) is typically not applicable in the same way as it would be for an AI-based image analysis tool. The device's algorithms are likely developed and validated through engineering design, signal processing, and testing against known physiological responses, rather than deep learning from a "training set" of patient data.

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

Not applicable, as a distinct "training set" in the context of machine learning is not mentioned or implied for this device's development as described. The performance validation relies on the clinical studies mentioned above, comparing the device's output to objective physiological measurements.

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The Model 8006CA reusable, non-sterile, regional oximetry sensor is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation (rSO2) of blood underneath the sensor of adult and pediatric patients weighing ≥ 88 pounds (≥ 40 kilograms). The sensor and/or the patient interface may be repositioned or replaced with another 8006CA sensor without baseline re-establishment.

Nonin's Model 8006PI single patient use, non-sterile disposable patient interface is designed for use with Nonin's Model 8006CA sensor.

The sensor and patient interface is in hospitals, long-term care, medical facilities, sleep laboratories, and subacute environments.

The Model 8006CA Reusable Regional Oximetry Sensor and Model 8006PI Disposable Patient Interface work together for use with the Nonin Medical SenSmart Model X-100 Universal Oximetry System (Model X-100).

The Nonin Medical, Inc. Model 8006CA Reusable Regional Oximetry Sensor and Model 8006PI Disposable Patient Interface have undergone testing to establish substantial equivalence to predicate devices (Model 8004CA and Model 8204CA Regional Oximetry Sensors).

Here is a summary of the acceptance criteria and performance based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "prior clinical testing provided in K102715 is applicable for the proposed Model 8006CA sensor and Model 8006PI patient interface" because "The critical sensor optics technology of the proposed devices remains unchanged from the predicate devices." Therefore, the clinical test set data for Regional (rSO2) Accuracy testing is from the K102715 submission for the predicate Model 8004CA Sensor. The specific details of the sample size, data provenance (country of origin, retrospective/prospective), etc., for that original clinical study are not provided in this document (K190560).

The current submission (K190560) relies on "detailed device comparison, analysis and testing" and the equivalency of the critical sensor optics.

For the Functional and Safety Testing, the tests were performed on the proposed devices (Model 8006CA and Model 8006PI) and are likely prospective tests conducted specifically for this submission. The sample sizes for these engineering tests are not specified but are typically small (e.g., a few units) sufficient to demonstrate compliance with standards.

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

This information is not provided in the document. The regional oximetry accuracy is derived from clinical testing, but the specifics of expert involvement in establishing ground truth (e.g., from an arterial blood gas reference for SpO2) are not detailed within this 510(k) summary. It refers back to a previous submission (K102715).

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is an oximeter, which provides a direct measurement, not an interpretative tool that requires human readers.

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

Yes, the functional, safety, and performance tests assess the standalone performance of the device (Model 8006CA/8006PI) in conjunction with the Nonin Medical SenSmart Model X-100 Universal Oximetry System. The regional oximetry accuracy cited from the predicate device's clinical testing also represents standalone algorithm performance in measuring rSO2.

7. The Type of Ground Truth Used

For the regional oximetry accuracy (rSO2), the ground truth typically involves a reference method for measuring regional oxygen saturation, often arterial blood gas analysis or other established physiological measurements, in a controlled hypoxemic study. However, the specific type of ground truth used for the predicate device's clinical testing (K102715) is not explicitly stated in this document. Given the nature of oximetry, it would likely be a direct physiological measurement.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. Since the validation relies on the "critical sensor optics technology... remains unchanged" from predicate devices and the device is a measurement sensor rather than an AI/machine learning algorithm that requires extensive training data, the concept of a "training set" in the context of machine learning is not directly applicable here.

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

As no training set is discussed or implied for an AI/ML model, this information is not applicable here. The device's performance is based on its physical and optical design, not on learned patterns from a dataset.

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The Multi-Sensing Oximetry System when used with Model 8330AA sensor, is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.
• For %SpO2 and pulse rate, the multi-sense system is intended for use in professional healthcare facilities, mobile, and EMS settings in adult and pediatric patients (> 66 lbs/30 kg).
• For %COHb, the multi-sense system is intended for use in professional healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This device should not be used to screen, diagnose or make treatment decisions related to suspected carbon monoxide poisoning.

Nonin Medical's Multi-Sensing Oximetry system, when used with Model 8330AA reusable finger clip sensor, is based on Nonin's SenSmart™ technology platform, displays (%COHb), pulse oxygen saturation (%SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of a signal processor to the monitor. The model 8330AA sensor provides real time data output of COHb, SpO2, and PR.

Here's a breakdown of the acceptance criteria and study details for the Nonin Medical Inc. Multi-Sensing Oximetry System with Model 8330AA Sensor, extracted from the provided text:

This FDA 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are largely in the context of demonstrating performance comparable to the predicate and compliance with relevant medical device standards, rather than an AI-specific set of metrics. The study described is a clinical accuracy study for a medical device (oximeter), not an AI algorithm. As such, many of the typical AI-specific sections (experts establishing ground truth, MRMC study, training set details) will not be applicable.

Acceptance Criteria and Reported Device Performance

The device's performance is primarily evaluated against its ability to accurately measure %SpO2, %COHb, and pulse rate, in comparison to a gold standard (co-oximetry) and in demonstration of equivalence to its predicate device. The Acceptance Criteria are implicitly defined by the stated accuracy specifications and the results demonstrating compliance ("Pass") with various international standards for medical electrical equipment.

Table 1: Key Performance Metrics & Compliance (Based on Text)

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The text states clinical accuracy testing for COHb and SpO2 was conducted on "healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older." The exact number of subjects is not specified in the provided text.
   • Data Provenance: The studies were "conducted at an independent research laboratory." The country of origin is not explicitly stated, but given the FDA submission, it is typically presumed to be from the US or a country with comparable regulatory and ethical standards. The studies were prospective as they involved induced conditions (COHb, hypoxia) and direct comparison to simultaneously collected arterial blood samples.

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

   • This is not an AI/imaging study requiring expert radiologist consensus. The ground truth for oximetry is established through objective laboratory measurements: specifically, arterial blood samples assessed by co-oximetry. Therefore, the concept of "experts establishing ground truth" in the sense of clinical interpretation (like radiologists for an AI model) is not applicable here. The "experts" would be the trained laboratory personnel performing the co-oximetry and blood sampling, whose qualifications are essential for the validity of the lab measurements.

3. Adjudication Method for the Test Set:

   • Not applicable in the context of this device and study type. Ground truth for blood gas measurements is established by a direct analytical method (co-oximetry) on blood samples, not by human interpretation or consensus.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC comparative effectiveness study was not done. This is a medical device (oximeter) accuracy study comparing device readings to a gold standard (co-oximetry), not an AI diagnostic aid study involving human readers interpreting images.

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

   • Yes, in essence. The accuracy testing (%COHb, %SpO2, Pulse Rate) described is the direct performance of the device's sensing and processing capabilities (its "algorithm") compared to the scientifically accepted gold standard (co-oximetry). There isn't a "human-in-the-loop" aspect to the device's direct measurement of these physiological parameters.

6. The Type of Ground Truth Used:

   • The ground truth used was objective laboratory measurements from arterial blood samples, specifically assessed by co-oximetry. This is a direct, quantitative biochemical measurement.

7. The Sample Size for the Training Set:

   • This is not an AI/machine learning model where a distinct "training set" is typically used in the same way. The device's underlying technology (Nonin's SenSmart™ platform) is likely developed and validated through extensive internal research and development, which implicitly involves a large amount of raw data to refine the algorithms for signal processing and parameter estimation. However, the document does not specify a "training set" in the context of an AI model being submitted for pre-market review. The clinical accuracy studies described are specifically for performance validation (test set equivalent).

8. How the Ground Truth for the Training Set Was Established:

   • As above, the concept of a "training set" with established ground truth as understood for AI models is not directly applicable to this type of medical device submission. The underlying principles for determining SpO2 and COHb involve spectrophotometry, which relies on known absorption characteristics of different hemoglobin species. The "ground truth" for developing such a device would be derived from fundamental physiological and optical principles, corroborated by empirical data from controlled studies using reference methods like invasive co-oximetry, but it's not described as a separate, labeled "training set" with ground truth in this document.

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Model X-100C
Nonin's Model X-100C CO-Met™ Oximetry System is indicated for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (>66 lbs / 30 kg) using the Model 8300AA sensor. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. The X-100C system is indicated for use by trained personnel in clinical settings, including Emergency Medical Service (EMS). hospitals, medical facilities, and mobile environments. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.

Model 8300AA
The Model 8300AA reusable finger clip sensor is intended for noninvasive measuring of function of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (> 66 lbs / 30 kg). The measurements may be multiple spot-checks to observe change and/or continuous monitoring. It is intended for use in Emergency Medical Service (EMS), hospitals, medical facilities, and mobile environments. This device is not meant for sole use in clinical decision making: it must be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Model X-100C CO-Met Oximetry System displays (COHb), methemoglobin (MetHb), pulse oxygen saturation (SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of the signal processor to the monitor. The monitor receives, displays, provide alarm management, and storage of COHb, MetHb, SpO2, and PR. The device is capable of running on battery power or on AC power via an external power supply. The device is equipped with patient alarms to alert the user to abnormal conditions and shall provide real time data output of COHb, MetHb, SpO2, and PR.

The provided document describes the acceptance criteria and the study conducted for the Nonin Medical, Inc. Model X-100C CO-Met™ Oximetry System (K160231).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document references ISO 80601-2-61 for accuracy calculations (root-mean-squared, Arms value). While specific numerical acceptance criteria (e.g., maximum Arms value for each parameter) are not explicitly stated in a consolidated table, the performance is reported against these implicit criteria derived from the standard.

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

• Sample Size: Not explicitly stated as a number of subjects. The clinical accuracy testing sections mention "healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older." They refer to "all subjects" in the accuracy calculation but do not provide a specific count.
• Data Provenance: Retrospective or prospective is not explicitly stated. However, the description of "COHb accuracy testing was conducted at an independent research laboratory," "MetHb accuracy testing was conducted at an independent research laboratory," and "induced hypoxia studies" suggests a prospective study design where subjects were enrolled and data collected for the purpose of the study. The location is an "independent research laboratory." The country of origin is not specified but is implicitly within the scope of a U.S. FDA submission.

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

Not applicable for this type of medical device. The ground truth for oximetry is established through a co-oximeter analyzing arterial blood samples, not through expert consensus on images or clinical assessments in this context.

4. Adjudication method for the test set

Not applicable. The ground truth is objective measurement from a co-oximeter analysing blood samples.

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 a standalone oximetry system and does not involve human readers interpreting images with or without AI assistance.

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

Yes, the primary performance evaluation described is for the standalone device (Model X-100C CO-Met™ Oximetry System with 8300AA sensors) without an explicit human-in-the-loop component for interpreting the raw measurements; the device generates direct readings. The accuracy studies directly compare the device's measurements to the co-oximeter's measurements of arterial blood.

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

The ground truth for COHb, MetHb, and SpO2 measurements was established using laboratory co-oximetry analysis of simultaneous arterial blood samples.

8. The sample size for the training set

Not applicable. This refers to a medical device for direct measurement, not an AI/machine learning algorithm that requires a training set. The device's performance is based on its sensor technology and signal processing.

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

Not applicable, as there is no training set for this type of device.

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Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors: Nonin's Model 6100C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6100CA: adults > 30 kg / 66 Ib; 6100CP: pediatrics > 10 kg / 22 1b ; 6100CI: infants > 2 kg / 4 1b; and 6100CN: neonates 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments.

Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors: Nonin's Model 6101C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6101CA: adults > 30 kg / 66 lb; 6101CP: pediatrics > 10 kg / 22 1b ; 6101CI: infants > 2 kg / 4 1b; and 6101CN: neonates 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.

Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors: Nonin's Model 6102C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6102CA: adults > 30 kg / 66 Ib; 6102CP: pediatrics > 10 kg / 22 1b ; 6102C1: infants > 2 kg / 4 1b; and 6102CN: neonates 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments.

Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor: The Model 8100AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8100AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.

Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Sensor: The Model 8101AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8101AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments.

Model 8102AA/8102AP Reusable, Finger Clip Pulse Oximeter Sensor: The Model 8102AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8102AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 - 60 kg / 18 - 132 lb) who are well or poorly perfused. during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities. Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.

Model 8100Q2 Reusable, Ear Clip Pulse Oximeter Sensor: The Model 8100Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 1b) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, and mobile environments. The recommended application site is the earlobe.

Model 8101Q2 Reusable, Ear Clip Pulse Oximeter Sensor: The Model 8101Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The recommended application site is the earlobe.

Model 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor: The Model 8102Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or ing of adult and pediatric patients (> 40 kg / 88 1b) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, and mobile environments. The recommended application site is the earlobe.

The Model 6100C Series, Model 6101C Series and Model 6102C Series Pulse Oximeter Sensors are single-patient use. non-sterile disposable pulse sensors intended for use with the Nonin Medical Model X-100 SenSmart Universal Oximetry System (Model X-100). The Model 8100AA/8100AP, Model 8101AA/8101AP, Model 8102AA/8102AP, Model 8100Q2, Model 8101Q2 and Model 8102Q2 Pulse Oximeter Sensors are reusable, non-sterile pulse sensors intended for use with the Nonin Medical Model X-100 SenSmart Universal Oximetry System (Model X-100).

Acceptance Criteria and Device Performance for Nonin Pulse Oximeter Sensors

The provided document describes the acceptance criteria and study results for Nonin Medical, Inc.'s pulse oximeter sensors, specifically the Model 6100C Series, 6101C Series, 6102C Series, 8100AA/8100AP, 8101AA/8101AP, 8102AA/8102AP, 8100Q2, 8101Q2, and 8102Q2.

1. Table of Acceptance Criteria and Reported Device Performance

The document indicates that the acceptance criteria for these pulse oximeter sensors are based on various functional, safety, and clinical standards. The reported device performance uniformly passes all these criteria, demonstrating substantial equivalence to predicate devices. The specific performance metrics for SpO2 accuracy are given in terms of ARMS values (Root-Mean-Squared) but the exact numerical values for these ARMS values are not explicitly stated in the provided text, only that they were calculated for all subjects.

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

• Sample Size for Test Set: The document states that clinical SpO2 accuracy testing was conducted on "healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older" for adult/pediatric models. For neonatal models (6100CN, 6101CN, 6102CN), testing was conducted on "male and female, light to dark-skinned subjects up to 30 days of age." The specific number of subjects (the sample size) for each sensor type or a combined number is not explicitly stated in the provided text.
• Data Provenance: Clinical testing was conducted at an "independent research laboratory" for adult/pediatric and finger/ear clip sensors, and at a "Children's Hospital" for neonatal sensors. This indicates prospective data collection for the specific purpose of this study. The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting U.S. or internationally recognized standards-compliant data.

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

The ground truth for the clinical SpO2 accuracy testing was established using co-oximetry from simultaneous arterial blood samples. This is an objective measurement from a medical device (co-oximeter) and does not typically involve expert consensus in the same way as, for example, image interpretation. Therefore, the concept of "number of experts" and their "qualifications" for establishing this specific ground truth data is not applicable in the traditional sense. The accuracy of the co-oximeter itself would be subject to its own validation.

4. Adjudication Method for the Test Set

Since the ground truth for SpO2 accuracy was established through direct biomedical measurement (co-oximetry of arterial blood samples), an adjudication method (like 2+1 or 3+1 consensus) for subjective expert interpretation is not applicable. The comparison was directly between the device's SpO2 reading and the co-oximeter's SaO2 reading.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device. This submission concerns pulse oximeter sensors, which are hardware devices for physiological measurement, not AI-powered diagnostic software that assists human interpreters. The testing focused on the device's inherent accuracy against a physiological gold standard.

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

The clinical testing described is effectively a "standalone" performance study for the pulse oximeter sensors, as it evaluates the device's output (SpO2 reading) against a medical gold standard (co-oximetry) without human intervention in interpreting the sensor's measurement. The accuracy data was calculated from the device's measurements directly.

7. The Type of Ground Truth Used

The ground truth used for SpO2 accuracy testing was co-oximetry of simultaneous arterial blood samples (SaO2). This is a highly objective and recognized medical gold standard for determining actual arterial oxygen saturation.

8. The Sample Size for the Training Set

The document describes clinical and non-clinical testing for the purpose of demonstrating substantial equivalence to predicate devices and does not refer to a machine learning or AI model that requires a distinct "training set." Therefore, a sample size for a training set is not applicable in the context of this device submission. The device's "training" would be its design, calibration, and manufacturing processes.

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

As there is no "training set" in the context of an AI/ML model for this device, the question of how its ground truth was established is not applicable. The device's intrinsic accuracy is validated against established medical standards.

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Model 8203CA
The Model 8203CA single-patient use, non-sterile, disposable sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8203CA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.

Model 8204CA
The Model 8204CA single-patient use, non-sterile, disposable sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8204CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.

The SenSmart Model 8203CA Regional Oximetry Sensor (Model 8203CA) and SenSmart Model 8204CA Regional Oximetry Sensor (Model 8204CA) are single-patient use, non-sterile disposable regional (tissue saturation) sensors intended for use with the Nonin Medical Model X-100 SenSmart Regional Oximetry System (Model X-100). The proposed devices are also compatible with the Nonin Model 7600 Regional Oximeter (Model 7600).

Here's an analysis of the acceptance criteria and study information based on the provided text, using the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria for typical performance metrics like sensitivity and specificity. The testing performed is more about compliance with general safety, functional, and performance standards.

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

The document does not specify a distinct "test set" in the context of efficacy for the new devices. Instead, it relies on the fact that "the critical sensor optics technology of the proposed devices remains unchanged from the predicate devices." Therefore, the clinical data proving efficacy is derived from the predicate devices (Nonin SenSmart Model 8003CA and Model 8004CA Regional Oximetry Sensors cleared under K102715).

• Sample Size: Not specified for the current submission, as it defers to the predicate device's clinical testing. The sample size for the predicate's clinical testing would be in K102715.
• Data Provenance: Not explicitly stated for the predicate's clinical data from K102715, but it would have been part of that prior submission. The current submission relies on this existing data.

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

Not applicable. The current submission does not involve new clinical trials requiring expert-established ground truth for a test set. It relies on the clinical performance previously established for the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. As no new clinical test set with human interpretation is presented in this submission, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned for these specific devices. The submission focuses on substantial equivalence based on unchanged critical sensor optics technology and functional performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

The device is a regional oximetry sensor, which measures physiological parameters. Its performance is inherent in its measurement accuracy and compliance with physical and electrical standards, not in an "algorithm only" sense like an AI diagnostic tool. The "rSO2 Accuracy testing" mentioned is a standalone assessment of the sensor's measurement capability, concluding it is demonstrated due to the unchanged optics from the predicate.

7. The Type of Ground Truth Used

For the functional and safety testing, the ground truth is established by compliance with recognized international and national standards (e.g., IEC 60601-1, ISO 80601-2-61, ISO 10993-1).

For the rSO2 accuracy and clinical performance, the ground truth is implicitly based on the clinical validation data and reference methods used during the clearance of the predicate devices (K102715). Without access to K102715, the precise nature of that ground truth (e.g., arterial blood gas analysis for oxygen saturation) isn't specified in this document.

8. The Sample Size for the Training Set

Not applicable. This device is a medical sensor, not an AI/ML algorithm that requires a "training set" in the typical machine learning sense. Its design and calibration are based on established engineering principles and physiological models, rather than learned patterns from a large dataset.

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

Not applicable, as a training set for an AI/ML algorithm is not relevant here.

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The Nonin® Model 3231 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients with digits between 0.8 - 2.5 cm (0.3 - 1.0 inch) thick.

Model 3231 Pulse oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate if there is poor pulse quality that may affect the readings. All associated electronics and the microcontroller are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.

The modification of the Model 3230 to the Model 3231, include the removal of Bluetooth LE 4.0 and the addition USB 2.0 for serial communication. This modification includes moving from batteries to the USB 2.0 to power the Model 3231. The oximeter circuitry, software and electro optical elements of the Model 3231 are identical to the Model 3230. There are no technological characteristic changes to the device that affect the measurement or display of SpO2 or pulse rate to the user.

Here's an analysis of the acceptance criteria and study information for the Nonin Model 3231 Finger Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For accuracy specifications, the document states "Identical" to the predicate model (Model 3230), which was cleared by FDA. This implies that the acceptance criteria for these accuracy metrics were met by the Model 3231, as it is stated to have the same performance characteristics.

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

The document mentions "predicate laboratory and clinical hypoxia accuracy testing," but does not specify the sample size for these tests for the Model 3231 or its predicate.

The data provenance is not explicitly stated as retrospective or prospective, nor are specific countries of origin mentioned for the data. However, the testing is done to ensure compliance with international standards (e.g., IEC, ISO), suggesting a general clinical testing environment rather than a specific geographic location.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth, particularly for the clinical hypoxia accuracy testing.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is a standalone pulse oximeter, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance assessment was done. The performance testing for SpO2 and pulse rate accuracy (including under low perfusion) is a standalone evaluation of the device's measurement capabilities. The "Performance" test also indicates compliance with ISO 80601-2-61, which relates to basic safety and essential performance of pulse oximeter equipment.

7. Type of Ground Truth Used

The ground truth for pulse oximeters is typically established through:

• Clinical hypoxia studies: Involving human subjects who are induced into various levels of hypoxia, with arterial blood gas analysis (co-oximetry) serving as the reference standard for actual arterial oxygen saturation (SaO2). The oximeter's SpO2 readings are then compared against the SaO2.
• Controlled laboratory conditions: For assessing performance characteristics like signal processing, optical accuracy, and resistance to interference.

While the document generally refers to "clinical hypoxia accuracy testing," it doesn't detail the precise method of ground truth establishment beyond this. Given the device's nature, the ground truth would be from direct measurements of arterial oxygen saturation using a gold standard method.

8. Sample Size for the Training Set

The document describes the Model 3231 as having identical "oximeter circuitry, software and electro optical elements" as the predicate Model 3230. Since this is a hardware device with embedded software, rather than a machine learning algorithm that is "trained," the concept of a "training set" in the context of AI/ML is not directly applicable. The device's underlying algorithms for SpO2 calculation would have been developed and validated through extensive data, but this wouldn't be referred to as a "training set" in the typical ML sense. The provided text does not specify a training set size.

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

As explained above, the concept of a "training set" for a traditional medical device like a pulse oximeter (which predates widespread AI/ML application) isn't directly applicable. The embedded algorithms would have been developed based on scientific principles of spectrophotometry and validated against gold standard measurements (e.g., co-oximetry in clinical hypoxia studies), but this process isn't typically described as establishing "ground truth for a training set." The document does not provide this information directly.

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Model X-100: Nonin's SenSmart™ Model X-100 Universal Oximetry System is a modular system and is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to six (6) channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor. Patient populations include adult, pediatric, infant, and neonate through the use of SenSmart compatible sensors. The SenSmart system is intended for use in hospitals, long-term care, medical facilities, sleep laboratories, sub-acute environments, and Emergency Medical Services (EMS), including patient transport. The X-100 SenSmart system may be used for spot-checking and continuous monitoring with patient alarms. The SenSmart pulse oximetry (SpO2) functionality is suitable for use in both motion and non-motion conditions, including patients who are well or poorly perfused.

Model 8100S(x): Nonin's Model 8100S(X) reusable soft sensor is indicated for non-invasive spot checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.

SenSmart Download Software: The SenSmart Download Software is an optional accessory for use with Nonin's X-100M SenSmart Monitor only. It is intended for use by healthcare professionals when 1) transferring data from the X-100M to a computer in order to maintain individual records of oximetry data, 2) reviewing data according to user-selected parameters, and 3) generating reports.

The SenSmart X-100 Oximetry System performs both pulse oximetry and regional oximetry measurements. The SenSmart X-100 Oximetry System works with all Nonin Equanox regional oximetry sensors (Model 8004CA, Model 8003CA, Model 8004CB and Model 8004CB-NA). The SenSmart compatible pulse oximetry Soft Sensor Model 8100S(x) is used with the Model X-100 System. The system consists of the sensor, the X-100SP signal processor (up to 6), extensions cables, the X-100H hub for multiple channels, the X-100M SenSmart Monitor which includes display, alarms, and memory. The SenSmart Download software is included for data storage review and reporting on a Windows PC.

The Nonin Medical, Inc. Model X-100 Universal Oximetry System is designed to measure and monitor arterial hemoglobin oxygen saturation (SpO2), pulse rate, and cerebral or somatic hemoglobin oxygen saturation (rSO2). The device underwent several tests to ensure its performance and safety, including functional and safety testing, rSO2 accuracy testing, SpO2 accuracy testing, and a usability study.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• SpO2 Accuracy Testing:

  • Sample Size: 13 healthy, non-smoking, light-to-dark-skinned subjects.
  • Data Provenance: Prospective, conducted in an independent research laboratory. The document does not specify the country of origin, but "Nonin Medical, Inc." is based in Plymouth, MN, USA.

• Usability / Human Factors Study:

  • Sample Size: 20 healthcare professionals.
  • Data Provenance: Prospective, likely conducted within a controlled environment to simulate clinical use. Country of origin not specified, but implied to be in the same geographic region as the manufacturer.

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

• SpO2 Accuracy Testing:

  • The ground truth for SpO2 was established by comparing the device's SpO2 measurements to arterial hemoglobin oxygen (SaO2) values determined from blood samples using four (4) laboratory co-oximeters. The final SpO2 values were paired with the average of three Radiometer CO-oximeters (ALB80Flex OSM). While these are not "experts" in the human sense, the co-oximeters serve as a highly accurate, standardized ground truth instrument for SaO2 measurement. No human experts are mentioned for establishing this specific ground truth.

• Usability Study:

  • The "ground truth" for usability was established through the observations of the study personnel and user feedback captured via questionnaires. No specific number or qualifications of "experts" are provided to establish the ground truth for usability, beyond the general conduct by "Nonin personnel" who provided in-service training and an "observer" during task performance.

4. Adjudication Method for the Test Set

• SpO2 Accuracy Testing: The method involved taking multiple arterial blood samples at different plateaued SpO2 levels and running them on four co-oximeters. The average of three Radiometer co-oximeters was used as the reference against which the device's SpO2 readings were compared. This isn't a traditional "adjudication" in the sense of multiple human readers resolving discrepancies, but rather a robust method of establishing a highly accurate instrumental ground truth.

• Usability Study: An observer was present to document whether tasks were performed appropriately and if the user had difficulty. User responses and body language were also documented. Task effectiveness was the primary objective, suggesting a pass/fail assessment based on predefined criteria, but no formal adjudication process by multiple individuals is 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

• No, an MRMC comparative effectiveness study was not done. This device is an oximetry system and does not involve AI for interpretation or human-in-the-loop performance improvement. The studies described focus on the device's accuracy in measuring physiological parameters and its usability without, or as a replacement for, human interpretation of raw data.

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

• Yes, a standalone performance study was clearly the primary focus for SpO2 and rSO2 accuracy. The SpO2 accuracy testing directly compared the device's measured SpO2 values to the co-oximeter reference, operating independently of human interpretation of the measurement output. The rSO2 accuracy was demonstrated through direct device comparison and testing with the predicate system. The Usability study evaluated human interaction with the device, but the core accuracy measurements were standalone.

7. The Type of Ground Truth Used

• SpO2 Accuracy Testing: Instrumental Ground Truth (Laboratory Co-oximetry for SaO2 values).
• rSO2 Accuracy Testing: Comparison to a predicate device's measured rSO2 values, which would have been established with similar instrumental ground truth methods.
• Usability Study: User feedback and observation of task completion against predefined usability criteria.

8. The Sample Size for the Training Set

• The provided document describes pre-market testing for substantial equivalence. It does not mention a "training set" as would be relevant for machine learning algorithms. The device is hardware-based with embedded software, and its performance is verified through testing, not developed through machine learning. Therefore, this question is not applicable in the context of this device.

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

• As the concept of a "training set" is not applicable to this pre-market submission for a hardware medical device, this question is also not applicable.

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