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Nonin's stand-alone non-invasive Model 7600 Regional Oximeter System is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Nonin's® Model 7600 non-invasive Regional Oximeter System continuously monitors and records the mixed arterial/venous blood oxygen levels through non-invasive near-infrared spectroscopy sensors placed on the patient's forehead. The stand-alone system is comprised of three subsystems; sensor, patient oximetry device (Pod) and display unit. The sensor allows light absorption measurements at various wavelengths in the near infrared spectrum (approximately 700 to 900 nanometers). The sensor is approximately 1.5 by 3 inches. The sensors plug into the patient oximetry device (Pod) which controls the light emitted from the sensor LEDs and measures the light returning to the sensor photodiodes. From these measurements, the Pod determines specific absorption values and calculates the mixed arterial/venous oxygen saturation values. The Pods then communicate the cerebral oxygen saturation readings and other data to the display unit. The display unit displays real-time cerebral oximetry trend data. It is a battery-backed, mains powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module.

The provided text is a 510(k) summary for the Nonin Model 7600 Regional Oximeter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the format requested.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.

Here's an attempt to answer the questions based only on the provided text, indicating what information is missing:

Acceptance Criteria and Device Performance for Nonin Model 7600 Regional Oximeter System

1. Table of acceptance criteria and the reported device performance

Note: The document primarily asserts substantial equivalence and successful testing, but does not provide quantitative performance metrics or specific, measurable acceptance criteria beyond this high-level claim.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided text. The document only mentions "clinical testing" without detailing the number of participants or cases.
• Data Provenance: Not specified. The text does not mention the country of origin or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The document does not describe the establishment of ground truth or the involvement of experts for this purpose.

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

• Not specified. There is no mention of an adjudication method.

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

• No, an MRMC study was not done. The device described is a regional oximeter system, which is a standalone non-invasive physical measurement device, not an AI-based diagnostic image analysis tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• Yes, implicitly. The device itself is a "stand-alone non-invasive Model 7600 Regional Oximeter System" that "continuously monitors and records the mixed arterial/venous blood oxygen levels." Its performance is inherent to its design and measurements. The 510(k) summary focuses on the device's functional integrity rather than an algorithm's performance in isolation from a human. The system calculates and displays oxygen saturation readings.

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

• Not explicitly stated. For physiological measurement devices like oximeters, ground truth typically involves comparison to a recognized gold-standard measurement (e.g., arterial blood gas analysis for oxygen saturation). However, this specific detail is not provided in the summary.

8. The sample size for the training set

• Not applicable/Not specified. The document describes a medical device, not a machine learning algorithm that requires a distinct "training set" in the conventional sense. The "training" for such a device would be part of its engineering and calibration, rather than a separate data set for an AI model.

9. How the ground truth for the training set was established

• Not applicable/Not specified, as this is not an AI-based system with a training set.

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