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The Infinity Masimo SET® SpO2 Pod is intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Infinity Masimo SET® SpO2 Pod is intended for use with Adult, Pediatric, and Neonatal populations. The Infinity Masimo SET® SpO2 Pod is intended to be used by Healthcare Providers, i.e. Physicians, Nurses, and Technicians in hospital and hospital type facilities.

The Infinity Masimo SET® Pod is intended for use under the direct supervision of a licensed healthcare practioner (i.e. . Physicians, Nurses, and Technicians). It is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

The Infinity Masimo SET® SpO2 Pod is indicated for use with adult, pediatric and neonatal patients.

The Infinity Masimo SET® SpO2 Pod and accessories are indicated for use during both motion and non-motion conditions, and for patients who are well or poorly perfused in hospitals and hospital type facilities.

The Infinity Masimo SET® SpO2 Pod is an addition to Draeger Medical Systems' Infinity patient monitoring series that provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients. The Infinity Masimo SET® SpO2 Pod is manufactured by Draeger Medical Systems, Inc. and contains the Masimo SET OEM circuit board with Masimo's SpO2 measurement algorithm.

The pod works as a component of the Infinity patient monitoring series and does not function on its own. The Infinity Masimo SET® SpO2 Pod is connected externally via RS232 using only the X8 connector on the modular monitors Delta/Kappa (USB connector on Gamma series). The Masimo SET® SpO2 pod is powered by the patient monitor.

An oximetry sensor is attached to a patients finger and one end of a patient cable is connected to the sensor and the other end connected to the Masimo SET® SpO2 Pod. The monitor will begin continuously displaying the patient's pulse rate and SpO2 value. Hi and Low SpO2 and pulse rate alarm limits, alarms, trends and status messages are all controlled by the bedside monitor.

The provided 510(k) summary for the Infinity Masimo SET® SpO2 Pod does not contain details about specific acceptance criteria, a study proving the device meets these criteria, or a detailed breakdown of performance metrics except for its intended purpose of continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to general medical device regulations. It is a 510(k) summary, which often provides an overview rather than granular study details.

Here's what can be extracted and what is missing, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document mentions "testing in accordance with applicable standards and internal design control procedures," implying internal data, but details like country of origin or whether it was retrospective or prospective are absent.

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

• Not specified. The document does not describe the methodology for establishing ground truth for any testing.

4. Adjudication method for the test set

• 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

• No MRMC comparative effectiveness study is mentioned. This device is an oximeter, which provides direct physiological measurements, not interpretations, so an MRMC study comparing human readers with and without AI assistance is not applicable in this context.

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

• The device integrates the Masimo SET® OEM circuit board with Masimo's SpO2 measurement algorithm. The 510(k) process typically evaluates the device's performance as a standalone measurement system (algorithm + hardware) when establishing substantial equivalence. However, the document does not explicitly describe a "standalone" algorithmic performance study with specific metrics, but rather states the device (which includes the algorithm) was tested and deemed "as safe and effective."

7. The type of ground truth used

• Not specified. For oximeters, the "ground truth" for SpO2 accuracy studies typically involves arterial blood gas (ABG) analysis as a reference. However, the document does not describe the methodology that would confirm the use of ABG or any other specific ground truth.

8. The sample size for the training set

• Not applicable/Not specified. This filing is for a medical device that includes an algorithm (Masimo SET® SpO2 measurement algorithm), but it doesn't describe the development or "training" of this algorithm itself, nor does it imply a machine learning model that would have a distinct training set in the typical sense of AI/ML software. The algorithm is embedded within the device for physiological measurement.

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

• Not applicable/Not specified, as no training set for a machine learning model is described.

Summary of what's provided for acceptance criteria and study information:

The document broadly states that "The Infinity Masimo SET® SpO2 Pod was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device." This is the general statement of meeting acceptance, but it lacks specific numerical criteria, performance data, or details about the studies themselves (e.g., sample sizes, ground truth methods, expert involvement). The intent of a 510(k) summary is often to declare equivalence, not to detail the full scientific study. More detailed information would typically be in the full 510(k) submission, which is not publicly available in this summary format.

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