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The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) is intended for measuring the oxygen saturation of blood.

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) is indicated for the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice. The probe with fluidic seal is also indicated for pressure monitoring, and infusion of fluids.

The Central Venous Oximetry Probes (Heparin Coated) are non-pyrogenic, sterile, single patient use, disposable oxygenation monitoring sets for use with central venous catheters for continuous monitoring of central venous oxygen saturation. The probes are manufactured from medical-grade polymers and incorporate a closed-ended fiber optic lumen at the tip to measure central venous oxygen saturation. The exterior of the proposed device is coated with Heparin using the same Heparin agent and coating method used on Oximetry Catheters being marketed by Hospira today. The method of operation is the same as the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal.

The Fluidic Seal is a non-pyrogenic, sterile, single patient use device that facilitates the introduction of a Central Venous Oximetry Probe into any size-compatible central venous catheter. The Fluidic Seal also maintains the relative insertion of the oximetry probe within the central venous catheter. The Fluidic Seal consists of a lateral flush port for the administration of fluids and/or for pressure monitoring.

The subject devices are modifications of the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal.

The modification is to add Heparin coating to the probe and change the lead tubing material to a PE-lined polyvinyl chloride.

Both the predicate and the proposed devices can be used with marketed central venous catheters for obtaining critical cardiac performance parameters.

The provided 510(k) summary (K062999) describes a device modification rather than a new device and does not include detailed performance studies with acceptance criteria in the manner typically seen for complex diagnostic algorithms. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

Therefore, the information requested for acceptance criteria and a detailed study proving device performance is not present in the provided text.

The document states:

• "The subject devices are modifications of the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal."
• "The modification is to add Heparin coating to the probe and change the lead tubing material to a PE-lined polyvinyl chloride."
• "The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) meets the functional claims and intended use as described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal."

This indicates that the primary method for demonstrating safety and effectiveness was through showing that the modified device is substantially equivalent to the previously cleared predicate device, rather than through a new, comprehensive performance study with specific acceptance criteria.

To directly answer your questions based only on the provided text, most of the information is not available:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission relies on substantial equivalence to the predicate device.
2. Sample size used for the test set and the data provenance: Not provided. No specific test set data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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: Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

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