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The ODYSSEY Instrumentation System is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the ODYSSEY Instrumentation System to verify proper characteristics of the water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and adjusting to maintain safe and effective hemodialysis systems.

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The provided documents (K981294) are a 510(k) clearance letter and an Indications for Use statement for the "ODYSSEY Instrumentation System." This system is intended for measuring physical parameters of dialysate solution (conductivity, temperature, pH, and pressure) and water for hemodialysis. It is not a device that processes or analyzes medical images, clinical data, or makes diagnostic/AI predictions.

Therefore, the concepts of "acceptance criteria," "study," "sample size," "ground truth," "experts," "adjudication method," "MRMC study," and "standalone performance" do not apply in the context of this device. These terms are relevant for evaluating devices that generate or interpret clinical information, especially those incorporating AI or complex algorithms for diagnosis or prediction.

The ODYSSEY Instrumentation System is a measurement device. Its "performance" would typically be established through metrology studies, calibration, and validation against known standards to ensure accuracy, precision, and reliability of its measurements (conductivity, temperature, pH, pressure). The "acceptance criteria" for such a device would relate to the maximum permissible error, stability, response time, and other metrological specifications in comparison to established industry standards or a predicate device.

To provide an answer in the requested format, but acknowledging the mismatch in the nature of the device and the questions, I will state that the information requested is not applicable given this device's function.

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

• Not Applicable. The provided documents do not contain acceptance criteria or reported device performance data in the context of a clinical study for diagnostic accuracy or algorithmic performance. As a measurement instrumentation system, its performance would be defined by metrological specifications (e.g., accuracy, precision, linearity for conductivity, temperature, pH, and pressure), which are not detailed in these regulatory documents.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This device is a physical measurement system, not one that processes clinical data or involves a "test set" in the sense of clinical samples or imaging data for diagnostic evaluation.

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)

• Not Applicable. The device measures physical parameters. "Ground truth" for such a device would be established through calibrated standards and reference methods, not by expert consensus on clinical data.

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

• Not Applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies where human interpretation is involved. This device does not generate such data.

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, nor does it involve human readers interpreting clinical cases.

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

• Not Applicable. There is no "algorithm only" performance or human-in-the-loop component in the diagnostic sense for this device. It is a measurement instrument.

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

• Not Applicable. For a measurement instrument, "ground truth" would refer to NIST-traceable standards, certified reference materials, or highly accurate reference measurement systems for conductivity, temperature, pH, and pressure. These details are not provided in the submitted documents.

8. The sample size for the training set

• Not Applicable. This type of device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable. As above, no training set is relevant for this device.

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