(128 days)
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.
| Acceptance Criteria Category | Reference Standard / Method | Reported Device Performance | Comments |
|---|---|---|---|
| Functional & Safety Testing | Pass | ||
| Electrical Safety | IEC 60601-1 | Pass | All models met requirements. |
| Temperature and Humidity | IEC 60601-1, EN 1789 | Pass | All models met requirements. |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass | All models met requirements. |
| Electromagnetic Immunity and Emissions | IEC 60601-1-2 | Pass | All models met requirements. |
| Performance | ISO 80601-2-61, IEC 60601-1, IEC 60601-1-6, IEC 60601-1-12, IEC 62304, ANSI/AAMI EC13, ISO 14155 | Pass | All models met requirements. Specific to SpO2 and Pulse Rate accuracy during motion/non-motion, and low perfusion where applicable. |
| Ingress Protection | ISO 80601-2-61 | Pass | All models met requirements. |
| Diaphoretic related ingress | Internal performance characterization | Pass | All models met requirements. |
| Mechanical Durability | IEC 60601-1, ISO 80601-2-61 | Pass | All models met requirements. |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10 | Pass | All models met requirements. |
| Clinical Testing | Pass (Accuracy demonstrated) | Specific ARMS values are not provided, only that accuracy data was calculated and met criteria. | |
| SpO2 Accuracy (Non-motion) | ISO 80601-2-61:2011 | Calculated ARMS value for all subjects (met criteria) | For infant/neonatal sensors (6100CN, 6101CN, 6102CN) and ear clip sensors (8100Q2, 8101Q2, 8102Q2). |
| SpO2 Accuracy (Motion and Non-motion) | ISO 80601-2-61:2011 | Calculated ARMS value for all subjects (met criteria) | For adult/pediatric disposable (6100CA, 6101CA, 6102CA, 6100CP, 6101CP, 6102CP, 6100Cl, 6101Cl, 6102Cl) and finger clip (8100AA, 8101AA, 8102AA, 8100AP, 8101AP, 8102AP) sensors. |
| Pulse Rate Accuracy (Motion and Non-motion) | ISO 80601-2-61:2011 | Verified change in motion claims and addition of non-motion claims (met criteria) | For 6100C, 6101C, 6102C Series. Specific ARMS values are not provided. |
| SpO2 and Pulse Rate Low Perfusion | ISO 80601-2-61:2011 | Verified addition of these claims (met criteria) | For 8100Q2, 8101Q2, 8102Q2 Series. Specific ARMS values are not provided. |
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.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).