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The Mission® Plus Hemoglobin (Hb) Testing System is for the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA ( K2, K3, Na2) or sodium heparin. The testing system is designed for point-of-care use in primary care settings. Estimation of hematocrit is only for hemoglobin values from 12.3 to 17.5 g/dL (123 to 175 g/L).

The Mission® Plus Hemoglobin (Hb) Control Solution is intended to validate hemoglobin testing using the Mission® Plus Hemoglobin (Hb) Testing System.

The Mission® Plus Hemoglobin (Hb) Testing System is for professional in vitro diagnostic use only.

The Mission® Plus Hemoglobin Testing System consists of The Mission® Hemoglobin (Hb) Testing Meter, Test cartridge, Control Solutions, and Optical Verifier.

The Test cartridges are used with the Meter for monitoring Hemoglobin (Hb) and estimate the Hematocrit (Hct) within normal range of hemoglobin in capillary or venous whole blood. Red blood cells in the specimen are lysed to release Hb, which is converted into MHb. The shade of the color produced depends on the concentration of Hb.

The Mission® plus Hemoglobin Testing System is a small, portable, battery-powered meter to measure total hemoglobin in combination of disposable test cartridge and requires no sample preparation or reagents. The portable meter analyzes the intensity and color of light reflected from the reagent area of a Test cartridge and provides results in less than 15 seconds. The test only requires a single drop of whole blood. The meter can store up to 1,000 results data and the data can be transferred to a computer for further analysis using the USB port. The meter can be powered by 4 AAA (1.5V) batteries or an optional AC adapter.

The Mission® Plus Hemoglobin (Hb) Testing System contains an optical verifier which works with the Meter to ensure the optical detection is working properly.

The Mission® Plus Hemoglobin (Hb) Control Solution is provided with 3 levels (0, 1, 2, ) of control solutions with known concentration of hemoglobin. It is used to confirm that the test meter and Test cartridges are working together properly. The product is a liquid, stable control prepared from bovine hemoglobin with added chemicals, preservatives (0.06%) and stabilizers (14.5% of sorbitol and sugar). The control does not contain products of human origins.

The provided text describes the Mission® Plus Hemoglobin (Hb) Testing System and its comparison to a predicate device. Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing pass/fail acceptance criteria with numerical targets. However, the comparison table and discussion of tests performed imply the following performance aspects were evaluated for equivalence. The "Reported Device Performance" column synthesizes information from the various sections describing the device and its studies.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a numerical value for the clinical study. It mentions clinical studies were conducted at "total 4 clinical sites." For non-clinical tests, specific sample sizes for linearity, precision, etc., are not provided.
• Data Provenance:
  • Clinical Studies: Conducted at "4 clinical sites" with "Health professionals at each site" operating the device. This suggests a prospective study involving patient samples. The country of origin is not specified but is likely the US given the FDA submission.
  • Laboratory Testing: Performed as part of the "Non-Clinical Tests." The types of samples (e.g., patient, control) are not detailed for each test but generally involve various types of blood and control materials.

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

• The document does not provide details on the number or specific qualifications of experts involved in establishing ground truth for the clinical studies. The "Health professionals at each site" operated the device, implying they are qualified to perform such tests, but their specific expertise in establishing ground truth or their experience levels are not mentioned.

4. Adjudication Method for the Test Set:

• The document states that the "study data were presented for evaluating the system accuracy... compared to the results obtained from predicate device." This indicates a comparison study, but it does not specify an adjudication method (e.g., 2+1, 3+1). The "ground truth" was likely derived from the predicate device's readings or a reference method.

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

• Was a MRMC study done? This type of study (MRMC) typically refers to evaluating multiple human readers' performance with and without a diagnostic aid on a set of cases. While the "clinical study" involved health professionals at multiple sites, it appears to be a direct comparison of the new device to the predicate device, with users' satisfaction also assessed. It is not presented as a MRMC study comparing human reader improvement with AI assistance. The device in question is a standalone hemoglobin testing system, not an AI-assisted diagnostic tool for interpretation by humans.
• Effect Size of Human Readers with/without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, a standalone performance was done. The entire submission describes the performance of the Mission® Plus Hemoglobin (Hb) Testing System itself, which operates independently to measure hemoglobin. The clinical studies compare its results to a predicate device, and the laboratory tests evaluate its intrinsic analytical performance. The device is intended for "professional in vitro diagnostic use," meaning healthcare professionals utilize the device to get a result, but the device's reading is a direct measurement, not an AI output requiring human interpretation.

7. The Type of Ground Truth Used:

• Clinical Studies: The ground truth for comparative accuracy in clinical studies was established by the predicate device (Hemopoint H2 Hemoglobin Measurement System, K032482). The study aimed to show "comparable blood Hemoglobin readings" to this predicate.
• Non-Clinical (Laboratory) Tests: For calibration, it states "Factory calibrated against CLSI H15-A3 reference method," indicating a reference method was used for ground truth. For other analytical performance tests like linearity, precision, and analytical sensitivity, the ground truth would typically be derived from highly accurate reference measurements or known concentrations of control materials.

8. The Sample Size for the Training Set:

• The document does not explicitly mention a "training set" in the context of device development. This is a point-of-care medical device, not a machine learning or AI algorithm that typically has a distinct training phase with a specific dataset. Its calibration and performance are established through traditional analytical and clinical validation.

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

• As there's no mention of a "training set" for an AI/ML algorithm, this question is not applicable. The device's foundational accuracy is rooted in its design, chemical reaction, and calibration against established reference methods (e.g., CLSI H15-A3).

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