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When used with a compatible patient monitor or a pulse oximeter device, Solaris Medical Technology, Inc. reusable & disposable SpO2 sensors are intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring.

Solaris Medical Technology, Inc. reusable multi-patient use SpO2 Soft Sensors, reusable multi-patient use SpO2 Finger Sensors, and disposable single patient use SpO2 Soft-finger Sensors are for use with adult/pediatric patients weighing greater than 40kg.

Solaris Medical Technology, Inc. disposable single patient use SpO2 Adhesive Sensors are for use with adult patients weighing greater than 40kg, pediatric patients weighing 10 - 40 kg, and infant (non-neonatal) patients weighing 3 - 15 kg.

Prescription device.

Solaris Compatible Reusable and Disposable SpO2 Sensors (Solaris Sensors) are compatible sensors for use with major types of patient monitors and oximeter devices as listed above.

Solaris Sensors employ non-invasive electro-optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in the sensor housing.

Four types of sensor housings are described in this submission:

• Reusable soft finger sensor comprised of an integrated silicone rubber tube.
• Reusable finger clip sensor with rigid halves and silicone pads
• Disposable soft-digit sensor with flexible silicone housing
• Disposable adhesive sensors constructed of a medical tape laminate

Each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, Nonin, HP/Philips, BCI).

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the acceptance criterion for the Solaris SpO2 sensors is "stated accuracy claims over the 70% - 100% range." The reported device performance is that the "Clinical test results indicated that the sensors meet the stated accuracy claims over the 70% - 100% range."

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

• Sample Size: The document does not specify an exact numerical sample size for the clinical test set. It only mentions "clinical testing... with subject informed consent."
• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. It was performed "under an institutionally approved protocol."

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

• The document describes the ground truth as "arterial oxygen saturation as determined by co-oximetry." It does not mention the involvement of human experts for establishing this ground truth, as co-oximetry is a laboratory measurement.

4. Adjudication Method for the Test Set:

• Not applicable as the ground truth was established by co-oximetry, not expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• This is not applicable. The device is a physical SpO2 sensor, not an AI or imaging diagnostic tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• The clinical testing assessed the "performance and accuracy of the Solaris Reusable and Disposable sensors" (algorithm/device only) against co-oximetry. There's no mention of a human-in-the-loop component in this specific accuracy study.

7. The Type of Ground Truth Used:

• Co-oximetry: The ground truth for the clinical study was "arterial oxygen saturation as determined by co-oximetry."

8. The Sample Size for the Training Set:

• The document does not describe a "training set" as this is not an AI/machine learning device that typically requires a separate training phase. The clinical testing was for validation.

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

• Not applicable, as there is no mention of a training set for an AI/machine learning model. The clinical validation directly compared the sensor's readings to co-oximetry.

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The Solaris NT1 Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check, functional arterial oxygen saturation and pulse rate monitor. The device operates on battery power using SOLARIS reusable Sp02 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.

The Solaris NT1A Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check or continuous monitoring, functional arterial oxygen saturation and pulse rate monitor. The device has data storage and data transfer functionality via a USB hub. The device operates on battery power using SOLARIS reusable Sp02 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.

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 provided text describes a 510(k) submission for the SOLARIS NT1 and NT1A Handheld Pulse Oximeters. It outlines the device's intended use, comparison to predicate devices, and general testing. However, it does not contain detailed information about specific acceptance criteria or an explicit study proving device performance against such criteria in the format requested.

The document states "Laboratory testing was conducted to validate and verify that the SOLARIS NT1 and NT1A Handheld Pulse Oximeters with Sensor Accessories met all design specifications and were substantially equivalent to the predicate device." It also mentions "Performance testing for the NT1A device was conducted to show that the accuracy and measurement range of the device is not affected by the device re-design. Performance testing documentation was included in the submission under 'NT1A Sp02 Oximeter Testing Reports'."

Without access to the "NT1A Sp02 Oximeter Testing Reports," it's impossible to fill in the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or expert involvement.

Therefore, the following table and subsequent sections are populated with "Not specified in the provided text" for most items, as the necessary detailed information is not present.

Acceptance Criteria and Device Performance

Study Details

• Sample size used for the test set and the data provenance:

  • Sample Size: Not specified in the provided text.
  • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.

• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the provided text.

• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement device. However, specific performance metrics from such a standalone evaluation are not presented in the provided text.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in the provided text. For pulse oximeters, ground truth for SpO2 accuracy typically involves co-oximetry measurements from arterial blood samples. This is not mentioned.

• The sample size for the training set: Not applicable to the presented information, as this document describes a hardware device, not a machine learning algorithm requiring a "training set" in the typical sense for AI/ML.

• How the ground truth for the training set was established: Not applicable.

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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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Solaris Medical Technology, Inc. SpO2 sensors are indicated for use in continuous, non-invasive monitoring of arterial oxygen saturation and pulse rate for patients weighing more than 40 kg.

Solaris Compatible Reusable Adult SpO2 Finger Sensors (Solaris Sensors) are compatible reusable sensors for use with major brands of patient monitors and oximeter devices. Solaris Sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in silicon rubber pads.

The provided 510(k) summary for K061931 concerns Solaris Compatible Reusable Adult SpO2 Finger Sensors. According to the document, the device itself is an electro-optical sensor for non-invasive monitoring of arterial oxygen saturation and pulse rate. The study design focuses on establishing substantial equivalence by demonstrating the device meets performance, safety, and accuracy specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Cleaning Instructions Testing: Do not damage sensor labeling or degrade the material after cleaning.	Test results indicated that the cleaning instructions do not damage sensor labeling or degrade the material.
   Biocompatibility Testing (ISO 10993-1:2003): Patient contact materials are non-toxic, non-sensitizing, and non-irritating for skin surface-contact, limited-duration devices.	Test results indicated that the patient contact materials were non-toxic, non-sensitizing, and non-irritating.
   Electrical Safety Testing (IEC 60601-1:1988; Am1:1991; A2:1995, Clauses 3, 5, 6, 48 and 56): Compliance with stated clauses for medical electrical equipment.	Test results indicated that the sensors comply with the stated clauses.
   Electromagnetic Compatibility Testing (IEC 60601-1-2:2001, Clauses 5.1.1, 6.2.1 and 6.3.1): Compliance with stated clauses for electromagnetic compatibility.	Test results indicated that the sensors comply with the stated clauses of the Standard.
   Clinical Testing (Accuracy): Meet published specifications for accuracy over the 70% - 100% SpO2 range, using controlled hypoxia and co-oximetry comparison.	Test results indicated that the sensors meet the published specifications for accuracy over the 70% - 100% SpO2 range. (Specific accuracy metric or threshold is not detailed in the summary.)

2. Sample size used for the test set and the data provenance:
   The document does not explicitly state the sample size (number of subjects) for the clinical testing. It mentions that testing was performed under an "institutionally approved protocol with subject informed consent." The provenance of the data is not specified beyond being generated through "clinical testing." It is implied to be prospective data collected specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable to this type of device and study. Ground truth for SpO2 accuracy is typically established by a recognized reference method like co-oximetry during controlled hypoxia, not by human experts.

4. Adjudication method for the test set:
   Not applicable. The ground truth (arterial oxygen saturation by co-oximetry) is an objective measurement, not subject to expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This device is an SpO2 sensor, not an AI-assisted diagnostic imaging device that involves human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, the clinical testing described is a standalone performance assessment of the sensor against a reference standard (co-oximetry) without human interpretation in the loop. The sensor directly outputs SpO2 values.

7. The type of ground truth used:
   The ground truth for the clinical accuracy testing was "arterial oxygen saturation as determined by co-oximetry" during "controlled hypoxia." This is an objective, gold-standard physiological measurement.

8. The sample size for the training set:
   Not applicable. This device is a hardware sensor, not a machine learning algorithm that requires a training set in the conventional sense. Its performance is based on its electro-optical design and calibration, which would be validated in testing, not "trained."

9. How the ground truth for the training set was established:
   Not applicable, as there is no "training set" for this type of medical device.

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