(252 days)
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)
| Measurement/Test Category | Acceptance Criteria (Implicit from Predicate/Standard) | Reported Device Performance |
|---|---|---|
| COHb Accuracy | ISO 80601-2-61 specified accuracy (Root-mean-squared, Arms value) over specified ranges for the predicate device. | Adults, Pediatrics: |
| • ±3 Arms (COHb range of 0-15%, SaO₂ 95-100%) | ||
| • ±3 Arms (COHb range of 0-5%, SaO₂ 95-100%) | ||
| • ±2 Arms (COHb range of 5-10%, SaO₂ 95-100%) | ||
| • ±2 Arms (COHb range of 10-15%, SaO₂ 95-100%) | ||
| (Note: These match the predicate's stated COHb accuracies, except for 0-15% range which is ±2 Arms for predicate) | ||
| COHb Accuracy with Elevated HHb | ISO 80601-2-61 specified accuracy (Arms value). | Adults, Pediatrics: |
| • ±3 Arms (COHb range of 0-15%, SaO₂ 80-100%) | ||
| • ±3 Arms (COHb range of 0-5%, SaO₂ 80-100%) | ||
| • ±2 Arms (COHb range of 5-10%, SaO₂ 80-100%) | ||
| • ±3 Arms (COHb range of 10-15%, SaO₂ 80-100%) | ||
| (Matches predicate) | ||
| SpO2 Accuracy in Presence of COHb | ISO 80601-2-61 specified accuracy (Arms value) over specified ranges for the predicate device. | Adults, Pediatrics: |
| • ±2 Arms (COHb range of 0-3%, SaO₂ 70-100%) | ||
| • ±3 Arms (COHb range of 0-3%, SaO₂ 70-80%) | ||
| • ±2 Arms (COHb range of 0-3%, SaO₂ 80-90%) | ||
| • ±2 Arms (COHb range of 0-3%, SaO₂ 90-100%) | ||
| (Matches predicate, except for 80-90% range which is ±3 Arms for predicate) | ||
| Pulse Rate Accuracy (non-motion) | ISO 80601-2-61 specified accuracy. | Adults, Pediatrics: ±3 digits (40-250 bpm) (Matches predicate) |
| Electrical Safety & EMC Test Results | Compliance with various IEC, ISO, ANSI/AAMI standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61). | Pass (for all listed tests in Table 1, page 4-5) |
| Functional Testing | Equivalency with predicate, compliance to recognized standards. | Pass (demonstrates equivalency and compliance) |
Study Details:
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
§ 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).