Search Results

Nonin's Model 8000SX Reusable Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused. 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 8000SX is a fingertip transmittance sensor comprised of a molded silicone boot that contains identical sensor optics and cable as the currently marketed Model 8000AA. The 8000SX sensor comes in three sizes, Model 8000SL (Large) for finger heights between 0.5 inches and 1.0 inch, Model 8000SM (Medium) for finger heights between 0.4 inches and 0.75 inches, and Model 8000SS (Small) for finger heights between 0.3 inches and 0.5 inch The sensors are compatible with all Nonin branded pulse oximeters.

The provided text describes a 510(k) summary for the Nonin Model 8000SX Oximeter Sensor. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance data in the typical format of a clinical trial report.

Therefore, much of the requested information cannot be directly extracted from the provided text. The document refers to "bench and clinical testing" to demonstrate compliance with ISO 9919:2005 Clause 50 (Accuracy of Operating Data), but it does not provide the specific acceptance criteria or the study results in detail.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be fully provided. The document states that the device "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." However, it does not specify the quantitative acceptance criteria for "Accuracy of Operating Data" or present a table of the device's measured performance against those criteria.

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

• Cannot be provided. The text mentions "clinical testing" but does not detail the sample size, patient demographics, data provenance (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 applicable/Cannot be provided. For oximetry accuracy studies, the "ground truth" for SpO2 is typically established using a co-oximeter measuring arterial blood gas samples (SaO2), not by expert readers. The text does not describe how ground truth was established, but it would not involve experts in this context.

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

• Not applicable/Cannot be provided. As the ground truth for oximeters is typically based on objective blood gas analysis, an adjudication method for conflicting expert opinions would not be relevant.

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, this was not done. The device is an oximeter sensor, which directly measures physiological parameters. It is not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

• Yes (implicitly). The device itself, an oximeter sensor, operates as a standalone measurement tool. Its performance (accuracy of SpO2 measurement) would be evaluated inherently without human intervention in the primary measurement task. The clinical testing mentioned typically assesses the device's ability to accurately measure SpO2 without human interpretation influencing the measurement itself, though human clinicians would use the readings.

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

• Cannot be directly stated, but typically for oximetry, the ground truth is SaO2. While not explicitly stated in the document, for oximetry accuracy according to ISO 9919, the ground truth for arterial oxygen saturation (SpO2) is typically established by simultaneously measuring arterial blood gas samples (SaO2) using a laboratory co-oximeter.

8. The sample size for the training set

• Not applicable. The Nonin Model 8000SX Oximeter Sensor is a hardware device that measures physiological parameters. It does not employ machine learning algorithms that would require a "training set" in the conventional sense. Its design and calibration are based on established optical principles and physiological models.

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

• Not applicable. See point 8.

Ask a specific question about this device