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The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.

The PreSep Oligon Oximetry Catheters (K060093) are used with Edwards oximetry monitors to continuously measure oxygen saturation. The catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples. The PreSep Oligon Oximetry Catheters can be used with an uncoated stainless steel guidewire or a PTFE-coated Nitinol core guidewire, which are included in kits or as separately packaged components.

This 510(k) summary describes a medical device, the PreSep Oligon Oximetry Catheters, and demonstrates its substantial equivalence to a predicate device, rather than providing a study proving performance against defined acceptance criteria in the typical sense of an AI/algorithm-driven device.

Therefore, many of the requested categories regarding AI-specific studies and ground truth establishment are not applicable. I will extract the relevant information from the provided text.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly present a table of quantitative acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) with corresponding reported device performance values. Instead, it describes a comparative analysis to a predicate device for safety and effectiveness.

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

The document states "side-by-side comparative bench and pre-clinical performance testing."

• Sample Size: Not explicitly stated. The term "pre-clinical animal studies" implies a test set of animals, but the number is not provided. "Bench" studies typically involve physical device testing, not data samples in the same way an AI algorithm uses data.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies are described as "pre-clinical animal studies," indicating they were conducted in a controlled, non-human environment. The nature (retrospective/prospective) is not explicitly given, but "pre-clinical" and "bench" studies are typically prospective tests designed for device evaluation.

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

Not Applicable. This device is a physical catheter, not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" would be objective measurements and observations from the bench and animal studies to assess the catheter's physical performance, safety, and functionality.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in human-AI studies involving subjective interpretations. For this device, the "adjudication" would be based on direct measurement, observation, and comparison to the predicate device's measured performance in the bench and animal studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

Not Applicable. This is not an AI/software device whose performance depends on human-in-the-loop interaction. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

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

Not Applicable. This is a physical medical device (catheter) with associated oximetry monitors. It is not an algorithm, so a standalone algorithm performance study is not relevant. The device itself performs the function.

7. The Type of Ground Truth Used

For a physical device like this, the "ground truth" for the test (verification and validation) would be based on:

• Physical Measurements and Observations: Direct measurements of catheter dimensions, material properties, flow rates, pressure readings, oxygen saturation readings, and observations of device interaction within the test environment (bench models, animal models).
• Biocompatibility Testing: Results from standardized tests to ensure the material is safe for contact with biological tissues.
• Predicate Device Performance: The established and legally marketed performance and safety profile of the predicate device serves as the benchmark against which the new device is compared to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set for an AI algorithm, no ground truth was established for a training set in this context.

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The PreSep Oligon Oximetry Catheters are intended to provide the means for infusion of solutions, measuring pressure and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor.
The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.

The PreSep Oligon Oximetry Catheters are used with Edwards oximetry monitors to continuously measure oxygen saturation. These catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples.

This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish de novo performance criteria. Therefore, the traditional concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as would be seen in a clinical trial for a novel device, is not explicitly present in the provided text.

Instead, the submission focuses on demonstrating that the PreSep Oligon Oximetry Catheters are as safe and effective as the predicate devices through comparative analysis and functional/safety testing.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document
does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or durability). The acceptance is based on demonstrating equivalence to the predicate devices.

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

The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission states "functional testing" was performed, but no specifics about the testing methodology or data are given.

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

This information is not provided in the document. Given that this is a 510(k) for an oximetry catheter, "ground truth" would likely refer to established methods for measuring oxygen saturation or relevant physiological parameters, and not typically involve a panel of experts reviewing images or clinical cases in the way an AI-based diagnostic device might.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. MRMC studies are typically used to assess the impact of medical imaging devices or AI algorithms on human reader performance, which doesn't directly apply to an oximetry catheter for continuous physiological monitoring. The comparative analysis focused on device characteristics and performance against predicate devices.

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

This concept is not applicable to this device. The PreSep Oligon Oximetry Catheter is a physical medical device for continuous physiological monitoring, not an algorithm, and therefore does not have "standalone" algorithmic performance in the context of AI.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. For an oximetry catheter, "ground truth" would generally refer to established, validated methods for measuring oxygen saturation (e.g., co-oximetry of blood samples) or other physiological parameters measured by the catheter (pressure, blood sampling). The functional testing would compare the device's measurements against these established methods or against the performance of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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