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The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes.

The GHI algorithm is intended for use in surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter.

The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

The Global Hypoperfusion Index (GHI) parameter provides the clinician with physiological insight into a patient's likelihood of a global hypoperfusion event on average 10-15 minutes before mixed venous oxygen saturation (SvO2) reaches 60%. The GHI feature is intended for use in surgical or nonsurgical patients. The product predictions are adjunctive for reference only and no therapeutic decisions should be made based solely on the GHI parameter.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with all the requested information. It primarily presents the FDA's 510(k) clearance letter and a summary of the device, its indications for use, and a comparison to predicate devices, stating that performance testing was executed and that no clinical trial was performed for the 510(k) submission.

However, based on the available information, here's what can be extracted and inferred:

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

The document mentions that the GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes and alerts the clinician on average 10-15 minutes before SvO2 reaches 60%. It also states that the GHI algorithm provides an index from 0 to 100 where the higher the value, the increased likelihood that a global hypoperfusion event will occur.

While specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or AUC) and their corresponding achieved performance values are not explicitly stated in the provided text, the overall conclusion is that the algorithm "has successfully passed functional and performance testing" and "meets the predetermined design and performance specifications." This implies that internal acceptance criteria were met, even if they are not detailed here.

Example (Hypothetical, as not provided in text):

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

• Sample Size: The text states, "Prospective analyses of retrospective clinical data from multiple independent datasets, comprised of data from a diverse set of patients over the age of 18 years undergoing surgical procedures with invasive monitoring, were analyzed to verify the safety and performance of the subject device." However, the exact sample size (number of patients or data points) for the test set is not specified.
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: "Prospective analyses of retrospective clinical data" implies that existing (retrospective) data was collected and then analyzed in a forward-looking (prospective) manner for the purpose of the study.

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

The text does not provide any information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set.

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

The text does not provide any information regarding an adjudication method for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The text explicitly states: "No clinical trial was performed in support of the subject 510(k)." This indicates that an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted for this submission.

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

Yes, a standalone performance evaluation was conducted. The text states:

• "Algorithm performance was tested using clinical data."
• "The algorithm was tested at the algorithm level to ensure the safety of the device. All tests passed."
• "Prospective analyses of retrospective clinical data... were analyzed to verify the safety and performance of the subject device."

This confirms that the algorithm's performance was assessed independently.

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

The ground truth for a "global hypoperfusion event" is explicitly defined in the Indications for Use as: "SvO2 ≤ 60% for at least 1 minute." This is an objective physiological measurement (outcomes data) rather than expert consensus or pathology.

8. The sample size for the training set:

While the text mentions that "patient waveforms were collected in support of the development and validation of the GHI algorithm," the sample size for the training set is not specified.

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

Given that the ground truth for the device's output is based on SvO2 measurements, it is highly probable that the ground truth for the training set was established using the same objective physiological measurement: SvO2 ≤ 60% for at least 1 minute. The text implies that clinical data (patient waveforms) were used for both development and validation.

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