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The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.

It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.

The Oxitone 1000 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a part of the body, in this case the wrist.

This Oxitone 1000 contains the electronics, interface and sensor. The Oxitone pulse oximeter is mounted on a watch-like device and measures oxygen saturation at the wrist location. The Oxitone pulse oximeter exploits a reflectance sensor that includes the photodetector located at the wearer's Ulnar Bone near the Ulnar Bulge and a bi-color light source (LED's) that are located around the top of the wearer's Ulnar "Bulge", to align the light source properly to the Ulnar Bulge the LEDs surrounded by elastic concave shape surface. The Red and infrared light being transmitted through the tissue is partially absorbed by the blood oxyhemoglobin and is sensed by the photodetector. The blood oxygen saturation is measured using the well-established technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood that enables to calculate the blood functional pulse oximetry.

The Oxitone 1000 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the Oxitone 1000 displays digital values for both the SpO2 and Pulse.

Pulse amplitude is not displayed. The Oxitone 1000 is powered by an integral rechargeable Lithium Ion battery pack. The wavelength of red LED is 640nm and Infrared LED is 940 nm with maximum optical output power of less than 1 mW.

The device incorporates a battery state indicator and provides a visual indication of low battery.

Here's a breakdown of the acceptance criteria and study information for the Oxitone 1000, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to standards rather than directly listing acceptance criteria with detailed outcome metrics for each. The key performance metric explicitly stated is SpO2 accuracy.

Study Details

The document refers to clinical testing to ensure the clinical accuracy of the device.

1. Sample size used for the test set and the data provenance:

   • Sample Size: 10 patients.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "clinical testing... performed on 10 patients," suggesting a prospective study, likely conducted for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The document states "Testing to insure clinical accuracy of the device in accordance with ISO 80601-2-61 was performed." ISO 80601-2-61 outlines methods for evaluating the accuracy of pulse oximeters, which typically involves comparing the device's readings to arterial blood gas measurements (co-oximetry) as the gold standard. It doesn't usually involve physician interpretation as ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. For pulse oximetry accuracy testing according to ISO standards, the "ground truth" is typically established by laboratory co-oximetry measurements, which are objective and do not require expert adjudication in the same way image-based diagnoses might.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human interpretation is involved. The Oxitone 1000 is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance evaluation conducted (clinical accuracy testing, bench testing) represents the standalone performance of the Oxitone 1000 device algorithm in measuring SpO2 and pulse rate. There is no human-in-the-loop aspect for the core measurement functions.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the clinical accuracy testing, the ground truth would typically be established by arterial blood gas measurements (specifically co-oximetry), which is an objective laboratory gold standard for oxygen saturation. This is implied by the reference to ISO 80601-2-61.

7. The sample size for the training set:

   • Not applicable/Not specified. The Oxitone 1000 is described as using "well-established technology" and "Photoplethysmography (PPG) signals." While algorithms are used to process these signals, the document does not suggest a machine learning model that would require a distinct "training set" in the modern AI sense. It's a measurement device based on established physiological principles and signal processing.

8. How the ground truth for the training set was established:

   • Not applicable, as there's no mention of a "training set" for a machine learning model in the context of this device's approval. The device's calibration and performance would be based on physiological models and established oximetry principles.

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Nonin's Models 6500MA and 6500SA Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

The 6500MA (wrap-around model) and 6500SA (interlocking model) are fingertip single-patient use disposable, transmittance sensors. They are comprised of a lamination of two foams (patient contact side and external side) with the optical components and a malleable wire within the lamination. The optical components are identical to the currently marketed Model 7000 single-patient use disposable sensor. The sensors are compatible with all Nonin-branded pulse oximeters.

This is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report for a new device's absolute performance. Therefore, many of the requested details about specific study methodologies (like sample size for training sets, adjudication, or MRMC studies) are not present in this type of document.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Nonin's Model 6500 sensor series have successfully undergone both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data, Clause 102 section 102.2 Labeling, and IEC 60601-1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility."

The table above demonstrates that the subject device (Model 6500 Sensor Series) meets or exceeds the performance criteria of the predicate device (Model 7000 Sensor Series) for SpO2 accuracy, and matches it for pulse rate accuracy. This forms the basis of the substantial equivalence claim.

Missing Information (Based on the Provided Text):

The following information is not detailed in the provided 510(k) summary:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "clinical testing" but does not provide details on the sample size of the test set, its provenance, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established by comparing the oximeter readings to arterial blood gas measurements (co-oximetry) in induced hypoxia studies, often without "experts" in the traditional sense for reading images, but rather with clinical staff performing procedures and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified.
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 is a pulse oximeter sensor, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is an algorithm (oximeter) and sensor, so its performance is standalone in the context of its function. However, the exact methodology for this standalone performance (e.g., how the clinical test dataset was used to derive the accuracy metrics) is not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For SpO2 accuracy, the ground truth is typically arterial blood gas analysis with co-oximetry, under controlled desaturation conditions, which is considered the gold standard for SpO2. This is implied by the standard ISO 9919:2005 for oximeters, but not explicitly stated as the method for this specific study.
8. The sample size for the training set: Not applicable or not specified. Pulse oximeters generally use established algorithms based on optical properties of blood, rather than machine learning training sets in the modern sense.
9. How the ground truth for the training set was established: Not applicable or not specified.

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