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The Nellcor OxiMax SoftCare adult oxygen sensor, model SC-A, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adults weighing more than 40 kg.

The Nellcor OxiMax SoftCare preterm infant oxygen sensor, model SC-PR, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 1.5 kg.

The Nellcor OxiMax SoftCare neonatal oxygen sensor, model SC-NEO, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing 1.5 kg to 5 kg.

The Nellcor OxiMax SoftCare neonatal oxygen sensor, model SC-N, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 3 kg.

The OxiMax SoftCare Sensors are indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required.

The OxiMax SoftCare sensors are sterile, latex-free, single patient use, non-adhesive Sensors. These sensors have a noon and soft and soft as a more is eliminated.

These sensors contain a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in-sensor data, Advanced Signal Evaluation, lot code and data set revision, and sensor model. The OxiMax SoftCare sensors are compatible with OxiMAX monitors.

The provided text is a 510(k) summary for the Nellcor OxiMax SoftCare Sensors. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the typical format for a medical device's performance study.

Based on the information provided, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." However, it does not provide a specific table of acceptance criteria or the reported device performance metrics (e.g., accuracy, precision values, specific thresholds for SpO2 or pulse rate) during these evaluations. This is common for 510(k) summaries which often refer to conformance to established standards or predicate device performance without detailing the exact numbers.

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

• Sample Size for Test Set: Not specified. The document only mentions "Human oxygenation evaluations."
• Data Provenance: Not specified, but likely from a clinical setting, given "human oxygenation evaluations." It does not clarify if it was retrospective or prospective.

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

This information is not provided. For oxygen saturation sensors, ground truth for human oxygenation evaluations is typically established by arterial blood gas analysis performed by trained medical professionals, but the document does not elaborate on this.

4. Adjudication Method for the Test Set:

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:

This is not applicable to this device. The OxiMax SoftCare Sensors are an oxygen sensor (hardware) designed for continuous noninvasive arterial oxygen saturation and pulse rate monitoring, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

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

This is not applicable in the context of device performance as typically understood for AI/software devices. The device itself is a sensor that outputs data, not an algorithm that interprets complex inputs for diagnosis. Its performance is measured by its accuracy and precision in measuring SpO2 and pulse rate. The document states "human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," implying a standalone performance assessment against a clinical reference standard.

7. The Type of Ground Truth Used:

For "human oxygenation evaluations," the most common ground truth for pulse oximeters is arterial blood gas (ABG) analysis. The document does not explicitly state this, but it is the standard method for establishing ground truth for SpO2 accuracy.

8. The Sample Size for the Training Set:

This information is not provided. The device is a physical sensor, and while it contains a "memory chip carrying information about the sensor" and uses "Advanced Signal Evaluation," the document doesn't discuss a "training set" in the context of a machine learning algorithm. If there are internal calibration or signal processing algorithms, the training data for those are not described.

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

This information is not provided and likely not applicable in the context of device training as understood for AI systems. Any internal calibration data or signal processing optimization would have associated ground truth, but this is not detailed.

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