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The Nonin® Model 7500FO Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot-checking and / or continuous monitoring of patients who are well or poorly perfused.

The Nonin® Model 7500FO Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot-checking and / or continuous monitoring of patients who are well or poorly perfused.

The Model 7500FO display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Model 7500FO can be powered externally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack.

The Model 7500FO includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, sensor alarm, user defined defaults, real-time data outputs, and patient security mode. Nonin's fiber optic sensors and cables contain no conductive components, they can safely be placed on the patient's finger while inside an MR (magnetic resonance) environment.

Here's an analysis of the provided text regarding the Nonin® Model 7500FO Digital Pulse Oximeter, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K071415) does not explicitly state specific numerical acceptance criteria for the device's performance in terms of accuracy (e.g., A_rms values, bias, precision for SpO2 or pulse rate). It broadly states that the device "successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device."

Without explicit acceptance criteria in the document, it's impossible to create a table directly comparing them to reported performance. The document focuses on establishing substantial equivalence to a predicate device (Nonin Model 8604FO Pulse Oximeter and Fiber Optic Sensor, K910001). This implies that the performance of the Model 7500FO is expected to be comparable to that of the predicate device, which would have had its own established performance characteristics.

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

• Sample Size: The document does not specify the numerical sample size (number of patients or data points) used for the clinical testing. It only states "clinical testing."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that Nonin Medical, Inc. is based in Minnesota, USA, it is likely that the clinical study was conducted in the USA and was prospective, as is typical for device approval studies. However, this is an inference, not explicitly stated.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in any clinical testing. For pulse oximeters, the ground truth for SpO2 is typically established through arterial blood gas analysis (co-oximetry), which does not inherently involve expert consensus in the same way as image interpretation.

4. Adjudication Method for the Test Set

The concept of "adjudication method" (e.g., 2+1, 3+1) is primarily relevant for studies involving subjective human interpretation of data, particularly in medical imaging where multiple readers may review cases. For a device like a pulse oximeter, which provides a direct physiological measurement, adjudication methods are not applicable in the traditional sense. The comparison would be between the device's output and the objective ground truth (e.g., co-oximetry).

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. MRMC studies are used to compare the diagnostic accuracy of different methods (e.g., imaging modalities or AI algorithms) when interpreted by multiple human readers, often involving a human-in-the-loop component. This device is a standalone physiological monitor, not an interpretive diagnostic tool that involves human readers in its primary function.

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

Yes, the testing described is inherently a standalone performance study. The Model 7500FO Digital Pulse Oximeter is a device that provides measurements (SpO2 and pulse rate) directly. Its performance is evaluated by comparing its output against a reference standard (ground truth), not by how it aids a human interpreter. The "clinical testing" mentioned would assess the algorithm's ability to accurately measure SpO2 and pulse rate on patients without human intervention in the measurement process itself, beyond proper sensor placement.

7. Type of Ground Truth Used

For pulse oximeters, the universally accepted "ground truth" for oxygen saturation (SpO2) is arterial blood gas analysis (co-oximetry). This involves drawing arterial blood and analyzing it with a co-oximeter to determine the actual arterial oxygen saturation (SaO2). The pulse oximeter's readings (SpO2) are then compared to these SaO2 values. The document doesn't explicitly state "co-oximetry" but this is the standard method for establishing ground truth for oximeters. For pulse rate, the ground truth could be established via ECG or a manual pulse count.

8. Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This suggests one of two possibilities:

• The device's underlying algorithms were developed and validated internally by Nonin using proprietary data, and this information is not typically part of a 510(k) submission unless specifically requested or deemed critical to substantial equivalence beyond the predicate.
• The device's core technology and algorithms are sufficiently similar to the predicate device, or are based on established biophysical principles, such that a separate, explicitly defined "training set" for the purpose of this 510(k) submission was not deemed necessary to describe.

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

Since no training set is mentioned, no information is provided on how its ground truth was established.

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The Nonin® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.

The Nonin® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.

The Model 7500 display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Model 7500 can be powered internally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack.

The Model 7500 includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, sensor fault detection (SPIM), user defined defaults, real-time data outputs, and patient security mode.

This 510(k) summary for the Nonin Model 7500 Digital Pulse Oximeter indicates that human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications. However, the document does not provide explicit acceptance criteria, detailed performance metrics, or specific information about the study design that would allow for a complete answer to all parts of your request.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document does not explicitly state numerical acceptance criteria for accuracy or precision. It generally refers to "conformance to accuracy and precision specifications." In the context of pulse oximeters, these typically relate to the accuracy of SpO2 readings compared to a reference standard (e.g., arterial blood gas analysis), often expressed as an Arms (Accuracy Root Mean Square) value.

Reported Device Performance:
The document does not provide specific numerical performance metrics such as Accuracy Root Mean Square (Arms) for SpO2 or accuracy for pulse rate. It only states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." and concludes that the device is "substantially equivalent to the predicate device in terms of accuracy, functional design and principles of operation."

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

The document states that "Human oxygenation evaluations were conducted," implying a human test set. However, it does not specify:

• The sample size (number of subjects) used in the human oxygenation evaluations.
• The country of origin for the data.
• Whether the study was retrospective or prospective. (Typically, such evaluations for new devices are prospective.)

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

The document does not provide any information about:

• The number of experts involved in establishing ground truth.
• The qualifications of any such experts.
  • For pulse oximetry, the ground truth for SpO2 is usually established via arterial blood gas (ABG) measurements, not through expert consensus on visual interpretation. ABG analysis is usually performed by trained laboratory technicians or medical staff, not "experts" in the sense of radiologists.

4. Adjudication Method for the Test Set

Given that the ground truth for SpO2 is typically established through a direct physiological measurement (ABG), adjudication methods like 2+1 or 3+1 are not applicable in the same way they would be for image-based diagnostic devices where expert consensus is needed. The document does not mention any adjudication method.

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

The document does not mention or imply that an MRMC comparative effectiveness study was conducted. Pulse oximeters are typically standalone measurement devices, and the evaluation focuses on their accuracy against a reference standard, not augmentation of human reading performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the entire evaluation described implies a standalone performance assessment. The "human oxygenation evaluations" were conducted to test the device's accuracy in measuring SpO2 and pulse rate, which is the device's direct output, independent of human interpretation or intervention in the measurement process itself.

7. The Type of Ground Truth Used

Based on common practice for pulse oximeters, the most probable type of ground truth used for SpO2 accuracy is arterial blood gas (ABG) analysis. The document refers to "human oxygenation evaluations," which strongly suggests the use of ABG as the reference standard.

8. The Sample Size for the Training Set

The document does not mention a "training set" or provide any information about its sample size. For traditional medical devices like pulse oximeters, especially in the context of a 2007 submission, there generally isn't a "training set" in the machine learning sense. The device's algorithms for calculating SpO2 and pulse rate are based on established physiological principles and spectrophotometry, often calibrated during development but not typically "trained" on a separate dataset in the way an AI algorithm would be.

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

Since a "training set" in the context of machine learning is not indicated or implied for this device, a description of how its ground truth was established is not provided and not applicable in the conventional sense. The core algorithms would have been developed and validated against physiological models and potentially pre-clinical data during the research and development phase.

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