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The Glucose 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 or venous whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, and idiopathic hypoglycemia, and of pancreatic islet cell tumors.

The EPOC glucose 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 detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: EPOC Glucose Test (part of the EPOC Blood Analysis System)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EPOC Glucose Test are not explicitly stated as quantitative targets in the document. Instead, the studies demonstrate the device's performance characteristics (precision, linearity, hematocrit effect, and analytical specificity) and then conclude equivalence to the predicate device. The performance data itself acts as the evidence to satisfy implicit acceptance criteria generally expected for such a device (i.e., that it performs reliably and comparably to a legally marketed device).

Therefore, the table below summarizes the reported performance characteristics from the provided studies. The acceptance criteria are inferred as demonstrating comparable or acceptable performance for each metric.

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

• Aqueous Precision: Not specified for each level, but "a twenty day precision study performed on 4 lots using aqueous controls at two levels L1 and L3."

• Blood Precision:

  • For each of five glucose concentrations (20, 120, 200, 300, 500 mg/dL): "over 100 cards/blood sample on 50 different readers." (e.g., 102 for 20 mg/dL, 98 for 120 mg/dL, 101 for 200 mg/dL, 105 for 300 mg/dL, 103 for 500 mg/dL).

• Linearity/Reportable Range: "A total of nine blood samples were prepared."

• Hematocrit Effect: Not explicitly stated for each measurement, but "six glucose level blood linearity studies performed at four different hematocrit levels." These are detailed in a large table.

• Analytical Specificity: Not explicitly stated (number of replicates for each interferent tested).

• Method Comparison with Predicate Device:

  • Overall: N = 160 patient samples.
  • Anticoagulant Effect: N = 58 patient samples (29 heparinized, 29 unheparinized).
  • Venous versus Arterial Blood: N = 214 patient samples (100 arterial, 114 venous).
  • Altitude Effect: N = 81 patient samples.

• Data Provenance:

  • In-house: Aqueous precision, blood precision, linearity/reportable range, hematocrit effect, analytical specificity.
  • Field trials: Method comparison with predicate device, anticoagulant effect, venous versus arterial blood (at several hospitals/POC locations).
  • Altitude Effect: Performed at an altitude of over 2000m (~6600 ft).
  • Retrospective/Prospective: The text does not explicitly state "retrospective" or "prospective" for the clinical/field trials, but "patient samples" in method comparison studies typically implies prospective collection for the study.

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

The document does not mention the use of "experts" to establish ground truth in the context of diagnostic interpretation. Instead, for quantitative analytical devices like this, ground truth is established using:

• Reference instruments: For precision, linearity, and hematocrit studies, internal reference instruments (e.g., YSI, ISTAT, ABL) with traceability to NIST standards were used.
• Predicate device: For method comparison, the i-Stat™ Model 300 Portable Clinical Analyzer served as the reference.
• Other reference instrument: For the altitude study, the ABL800 Flex Radiometer whole blood instrument was used as the reference.

Therefore, the "ground truth" is established by these reference methods, not by human experts interpreting results.

4. Adjudication Method for the Test Set

Not applicable. This device is a quantitative diagnostic test for glucose. Ground truth is established by chemical reference methods and comparison to predicate devices, not by interpretation that requires adjudication (e.g., 2+1, 3+1).

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 a standalone quantitative glucose measurement device, not an AI-assisted diagnostic imaging or interpretation tool. There are no "human readers" in the context of MRMC studies for this type of device.

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

Yes, the entire evaluation is for the standalone performance of the EPOC Glucose Test. The studies described (precision, linearity, method comparison, etc.) assess the accuracy and reliability of the device's glucose measurements directly, without involving human interpretation or integration into a diagnostic workflow for performance assessment. The device provides a quantitative numerical result.

7. The Type of Ground Truth Used

The ground truth for the device's performance evaluation was established using:

• Reference instruments/systems:
  • For in-house studies (precision, linearity, hematocrit), the device measurements were compared against "in-house reference instruments with traceability to NIST standards" (e.g., YSI, ISTAT, ABL).
  • For calibration and quality control, the system uses materials with traceability to NIST standards (National Institute of Standards and Technology).
• Predicate device: For the primary method comparison studies, the i-Stat™ Model 300 Portable Clinical Analyzer was used as the comparative "ground truth."
• Other legally marketed device: For the altitude study, the ABL800 Flex Radiometer was used as the comparison "ground truth."

8. The Sample Size for the Training Set

The document does not explicitly mention a distinct "training set" in the context of an algorithm's development. This device likely relies on established electrochemical principles, sensor design, and calibration algorithms rather than a machine learning model that requires a separate training data set of patient samples. The "training" in this context would refer to the development and refinement of the sensor and software using internal laboratory samples and calibrators, leading to the final product validated in the studies mentioned.

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

As noted above, a distinct "training set" for an algorithm in the machine learning sense is not mentioned. However, the development and calibration of the EPOC Glucose Test, which could be considered akin to "training" for a traditional analytical device, involved:

• On-board calibration material: Prepared gravimetrically and assayed on reference systems calibrated with traceability to NIST standards.
• Calibration verification fluids: Commercially available with concentration values traceable to NIST standards.
• Quality control materials: Commercially available fluids with concentrations traceable to NIST standards.

These NIST-traceable reference materials and systems would have been crucial for establishing the accuracy and performance characteristics of the glucose sensor and measurement system during its development and manufacturing.

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