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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and hospital environments.

picoSAT II SpO2 pulse oximetry module and M3001A Multi-Measurement Server

The provided text is a 510(k) summary for the picoSAT II SpO2 pulse oximetry module. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does NOT contain the detailed information required to fill out the table regarding acceptance criteria and the specific study proving the device meets those criteria.

Here's what can be extracted and what information is missing:

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

• Acceptance Criteria: Not explicitly stated in the provided text. Pulse oximeter performance is typically measured by accuracy (Arms) over a specified SpO2 range.
• Reported Device Performance: Not explicitly stated. The document mentions "clinical validation studies were also conducted" but does not provide the results of these studies or any performance metrics.

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 (Test Set): Not mentioned.
• Data Provenance: Not mentioned.

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)

• Number of Experts: Not applicable, as this is a pulse oximetry device, not an image-based diagnosis device usually requiring expert interpretation for ground truth. The "ground truth" for a pulse oximeter would likely be arterial blood gas measurements (co-oximetry).
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable for a pulse oximetry device where direct physiological measurements usually serve as the reference.

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

• MRMC Study: Not applicable. This is not an AI-assisted diagnostic device for human readers.

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

• Standalone Performance: The core of a pulse oximeter is a standalone algorithm. The document mentions "clinical validation studies were also conducted," which would imply testing the device's accuracy in measuring SpO2. However, no specific performance results (like Arms) are provided.

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

• Type of Ground Truth: Not explicitly stated, but for pulse oximeters, the gold standard for ground truth is typically arterial blood gas analysis (co-oximetry).

8. The sample size for the training set

• Sample Size (Training Set): Not mentioned. "Training set" is generally more relevant for machine learning algorithms. While the device uses a "FAST pulse oximetry algorithm," the document doesn't detail how this algorithm was developed or if it involved a distinct "training set" in the modern machine learning sense. Clinical validation would be a more direct performance test.

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

• Ground Truth (Training Set): Not mentioned.

Summary of what is present and what is missing:

The provided text serves as a 510(k) summary, which generally focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory requirements. It confirms that "clinical validation studies were also conducted" and "all verification and validation activities were successfully completed," but it explicitly lacks the detailed results, acceptance criteria, sample sizes, and ground truth methodologies that would typically be found in a detailed study report or a more comprehensive technical document.

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