Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device