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The Lactate test, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

The epoc Lactate Test is being added as an additional sensor to the existing single use test card that is used with the epoc Blood Analysis System. This test card is inserted into the epoc Reader and all analytical steps are performed automatically. Patient and user information may be entered into the mobile computing device (epoc Host) during the automated analysis cycle.

The epoc Blood Analysis System is an in vitro analytical system comprising a network of one or more epoc Readers designed to be used at the point of care (POC). The readers accept an epoc single use test card containing a group of sensors that perform diagnostic testing on whole blood. The blood test results are transmitted wirelessly to an epoc Host, which displays and stores the test results.

Here's a summary of the acceptance criteria and study information for the epoc Lactate Test, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (Lactate only)

2. Sample Size and Data Provenance

• Test Set for Method Comparison:
  • Sample Size: 373 patient samples for overall method comparison; broken down into 126 venous, 73 arterial, 174 capillary samples for matrix effects.
  • Data Provenance: Field trials at several hospitals on "patient samples of whole blood at various locations." This indicates prospective, real-world data from multiple sites (likely within North America given the FDA submission).
• Test Set for Blood Precision:
  • Sample Size: 15 samples per user at Site 1, and unspecified number at Site 2 (likely similar).
  • Data Provenance: Field trials at two (2) hospitals on "volunteer samples of whole blood by potential end users." This indicates prospective, real-world data from multiple sites.
• Test Set for Aqueous Precision:
  • Sample Size: 15 samples per user per QC level at Site 1, and unspecified number at Site 2 (likely similar).
  • Data Provenance: Field trials at two (2) hospitals on commercially available control fluids by potential end users.
• Test Set for Anticoagulant Effect:
  • Sample Size: 60 samples (43 from hospital POC sites, 17 from in-house studies).
  • Data Provenance: Patient samples from hospital POC sites and in-house studies.

3. Number of Experts and their Qualifications (for Test Set Ground Truth)

• The document describes the predicate device as the "gold standard" for comparison. The ground truth for the method comparison studies was established by the predicate device (i-Stat™ Lactate Test using i-Stat™ Model 300 Portable Clinical Analyzer).
• No specific number of human experts or their qualifications for establishing ground truth are mentioned, as the comparison is against another established device. However, the predicate device itself would have undergone its own validation with expert input.

4. Adjudication Method

• Given that the ground truth is established by a predicate analytical device, there is no human adjudication method (like 2+1 or 3+1) described or applicable in this context. The comparison is quantitative against readings from the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• A formal MRMC comparative effectiveness study, as typically performed for diagnostic imaging devices involving human readers, was not conducted or described.
• The studies involved different "users" (phlebotomists, RNs, Anesthesia Techs, Resp Therapists) performing tests, which is a form of multi-reader study, but it's focused on device precision/reproducibility across different operators rather than assessing AI assistance for human diagnostic performance. Therefore, there is no effect size reported for human readers improving with/without AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire document describes the standalone performance of the epoc Lactate Test (algorithm and device combined) against a predicate device and established analytical standards. The reported device performance metrics in the tables (precision, linearity, method comparison slope, intercept, R², bias) are all measures of the device's standalone performance. There is no human-in-the-loop component for result interpretation.

7. Type of Ground Truth Used

• The primary ground truth for the clinical and non-clinical studies is:
  • Readings from a legally marketed predicate device (i-Stat™ Lactate Test using i-Stat™ Model 300 Portable Clinical Analyzer) for method comparison studies.
  • NIST traceable standards for calibration, quality control, and linearity studies.
  • Pooled human serum and blood samples (spiked with known interferents or aged to increase lactate) for analytical specificity and blood precision studies.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set for the epoc Lactate Test development. This type of submission (510(k) for an IVD) typically focuses on validation data rather than internal development/training data for the algorithm.

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

• As the training set size is not disclosed, the method for establishing its ground truth is also not explicitly described in this document. However, given the nature of the device (a quantitative sensor measurement system), the training/development likely involved:
  • Controlled reference materials with known lactate concentrations.
  • Comparison to reference laboratory methods known to be accurate and traceable to NIST standards.

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