(169 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text (e.g., specific accuracy ranges for SpO2 and pulse rate, limits for bias or precision) | Not explicitly reported in the provided text, other than "accuracy and measurement range of the device is not affected by the device re-design." |
Study Details
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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).
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the provided text.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established: Not applicable.
§ 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).