(161 days)
The Nonin® Model 2500A Pulse Oximeter with Alarms is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate for adult, pediatric, and neonatal patients. It is intended for spot-checking and / or continuous monitoring of patients during motion and no motion conditions, and for patients who are well or poorly perfused.
The Model 2500A PalmSAT® with Alarms is a digital handheld pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate using one of a range of Nonin compatible oxygen sensors. It features an easy-to-read display that presents patient data and status information. The display features light-emitting diodes (LED) that show the SpO2, pulse rate values, tricolor pulse quality indicator, alarm bar, alarm silence indicator, and low battery indicator.
New Features
• Patient-specific audible and visual high priority alarms.
• Equipment-specific audible and visual medium priority alarms.
User selectable high and low alarm limits for SpO2 and pulse rate. The ability to review and recall previous alarm limits and volumes. Variable pitch audible pulse beep indicator with an adjustable volume Visual and audible (adjustable volume) alarms. An alarm silence feature: silences audible alarms for the first 2 minutes of normal operation and on-demand. Enhanced signal processing
The Model 2500A will typically operate for 60 hours continuously between alkaline battery replacements, or for 40 hours with the Model 2500B Rechargeable NiMH (Nickel Metal Hydride) Battery Pack (optional). The 2500A requires no routine calibration or maintenance other than replacement of the alkaline batteries or recharging the optional battery pack.
The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared 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.
This K050056 510(k) submission for the Nonin Model 2500A PalmSAT® Pulse Oximeter details the device's accuracy and performance.
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," but does not explicitly state specific numerical acceptance criteria or detail the reported device performance against those criteria. It generally concludes that the device is "substantially equivalent to the predicate devices in terms of accuracy."
However, based on typical pulse oximeter accuracy standards and the context of a 510(k) submission for a Class II device, common acceptance criteria would likely be related to the root mean square deviation (ARMS) of oxygen saturation measurements compared to a co-oximeter, across a specified saturation range. Without further details in the provided text, a precise table cannot be constructed.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for the Test Set: Not explicitly stated in the provided document. The document only mentions "Human oxygenation evaluations were conducted."
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but clinical trials involving human deoxygenation are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not explicitly stated in the provided document.
4. Adjudication Method for the Test Set:
Not explicitly stated in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance:
This device is a pulse oximeter, not an AI-powered diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned in the document.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document refers to "human oxygenation evaluations" to confirm accuracy. For pulse oximeters, the "standalone" performance refers to the device's ability to accurately measure SpO2 and pulse rate without human interpretation of the algorithm's direct output (other than reading the displayed values). The accuracy studies for pulse oximeters intrinsically assess this standalone performance against a "gold standard" reference. Therefore, a standalone performance assessment was effectively conducted.
7. Type of Ground Truth Used:
The ground truth for pulse oximeter accuracy studies is typically established by co-oximetry measurements of arterial blood samples. While not explicitly stated as "co-oximetry" in the provided text, the phrase "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications" strongly implies this method, as it is the gold standard for SpO2 accuracy assessment.
8. Sample Size for the Training Set:
This device does not appear to utilize machine learning or AI in a way that requires a distinct "training set" in the conventional sense for a diagnostic algorithm. The pulse oximeter's algorithms are based on established biophysical principles of light absorption by oxyhemoglobin and deoxyhemoglobin. Therefore, a specific "training set" for an AI model is not applicable and not mentioned.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of an AI algorithm, this question is not applicable. The underlying scientific principles for pulse oximetry are well-established.
§ 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).