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Solaris NT1 and NT1A Handheld Pulse Oximeters with sensor accessories are non-invasive spot-check, oxygen saturation and pulse rate monitors. They operate on battery power using SOLARIS reusable Sp02 sensors for pediatric and adult patients.

The subject SOLARIS NT1 and NT1A Handheld Pulse Oximeters measure pulse rate and oxygen saturation. The signals are converted into digital data and processed; the pulse oximeter examines the data and displays the data. The subject pulse oximeters also provide operating control for the user. The pulse oximeters are intended for use in spot checking; the NT1A model is intended to both spot check and perform continuous monitoring. The pulse oximeters can be used in hospital clinical areas such as general wards to provide additional information to the medical and nursing staff about the physiological condition of the patient. The subject devices are intended to be used under supervision by clinical personnel. The intended location of use is clinics.

The subject pulse oximeters provide a rapid indication of a patient's level of oxygenation which reflects the effective ventilation. The NT1A Pulse Oximeter with alarm allows continuous and instantaneous monitoring of SpO2 and both the NT1 and NT1A Pulse Oximeters reduce the need for arterial puncture and bloodgas analysis.

The subject pulse oximeters are composed of two boards, a main control board and a physiological singal processing board. The main control board is composed of a LED display and its control and driver, data memory, audio circuit, UART communication interface, and DC/DC circuits. The physiological processing board is composed of a SpO2 sensor control and IR/RED LEDs driver, data collection, signal processing algorithm execution, UART communication interface and DC/DC circuits.

The oximeter is housed in a single package. The main components of the assembly are listed as following

• Main Board .
• SpO2 Module .
• Key Pad .
• Batterv ●

The provided text describes a 510(k) summary for the SOLARIS NT1 and NT1A Handheld Pulse Oximeters. It states that laboratory testing was conducted to validate and verify that the device met all design specifications and was "substantially equivalent" to a predicate device, the Datex-Ohmeda TuffSat 3000 Pulse Oximeter.

However, the summary does not contain a specific table of acceptance criteria or reported device performance metrics in the format requested. It generally states that the device "met all design specifications" and demonstrated that it is "as safe, as effective, and performs as well as the legally marketed predicate device."

Here's a breakdown of the information that can be extracted or inferred from the provided text, along with what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document mentions "clinical and laboratory testing" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the text. The document refers to "laboratory testing" and "clinical testing" but does not detail how ground truth was established for these tests, or the involvement/qualifications of experts.

4. Adjudication Method for the Test Set

The adjudication method (e.g., 2+1, 3+1, none) is not mentioned in the provided text.

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

A MRMC comparative effectiveness study was not conducted or reported. The device is a "standalone" medical device (pulse oximeter) that provides direct readings, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.

6. Standalone Performance

Yes, a standalone performance assessment was effectively done. The device's primary function is to measure and display SpO2 and pulse rate directly. The testing conducted aimed to show the device's inherent performance and its substantial equivalence to the predicate device without human-in-the-loop assistance influencing the device's measurement outputs. The "laboratory testing" and "clinical testing" would have assessed the device's accuracy and reliability as a standalone unit.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. For a pulse oximeter, ground truth typically involves comparing the device's readings against a gold standard method, such as arterial blood gas analysis for oxygen saturation. While "clinical testing" is mentioned, the specific method for establishing ground truth is not detailed.

8. Sample Size for the Training Set

This information is not applicable/relevant in the context of this device and testing described. Pulse oximeters operate based on well-established physiological principles and optical measurements. They do not typically involve "training sets" in the sense of machine learning algorithms. The device's core functionality is hardware-based signal processing.

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

This information is not applicable/relevant as there is no mention or implication of a "training set" for an AI or machine learning model.

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