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The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K2-EDTA, sodium citrate, lithium heparin, or sodium heparin). The testing system is designed for point-of-care settings, hospitals, and medical lab facilities.

Estimation of hematocrit, as a function, is only for normal hemoglobin values, 12.0 to 180 g/dL) and in patients ≥ 6 months old.

The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration.

The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. The hemochroma PLUS System is for in vitro diagnostic only.

The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglobin concentration in terms of g/dL.

The hemochroma PLUS Analyzer is a battery powered, hand-held device to measure the concentration of total hemoglobin in blood in 3 seconds with 15uL of whole blood. Whole blood may be collected by fingerstick (capillary) or venipuncture and analyzed without preprocessing. The hemochroma PLUS Analyzer uses hemochroma PLUS Microcuvettes with dual ports where the user applies samples either through capillary action or direct volume pipetting.

The hemochroma PLUS Analyzer determines hemoglobin concentration in whole blood samples using a dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer. The optical distance between the hemochroma PLUS 3 Microcuvette walls is fixed and permits photometric determination of hemoglobin in undiluted blood samples. The computed end result is displayed on the LCD display and can be printed on an external printer (optional).

The hemochroma PLUS System consists of a hemochroma PLUS Analyzer, single-use hemochroma PLUS Microcuvettes, hemochroma PLUS ID Chip, optical System Check Microcuvette and hemochroma PLUS Controls.

Here's a breakdown of the acceptance criteria and the study details for the hemochroma PLUS System, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by meeting specific performance metrics determined by the manufacturer, often guided by CLSI (Clinical and Laboratory Standards Institute) guidelines, to ensure accuracy, precision, and reliability. The document details analytical performance studies. The results from the repeatability, reproducibility, linearity, detection limits, and method comparison studies demonstrate that the device meets the defined acceptance criteria, often by being "within the defined acceptance criteria" or showing "comparable performance."

Study Details:

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

   • Repeatability: 5 test samples (ranging from 5.6 g/dL to 23.7 g/dL) were tested 84 times each (total of 420 measurements per study). Data Provenance: In-house (presumably Republic of Korea, where the sponsor is located) and retrospective (prepared samples).
   • Reproducibility: 3 control levels (low, middle, high) were tested with 160 results per control level per site (total 480 results per control level across all 3 sites). Data Provenance: Three point-of-care clinical sites in the United States. Prospective.
   • Linearity/Assay Reportable Range: 11 hemoglobin concentration levels tested in triplicate. Data Provenance: Not explicitly stated, but in-house testing. Retrospective.
   • Detection Limit (LoB, LoD, LoQ):
     • LoB: 5 blank samples, 5 replicates, 3 days, 3 microcuvette lots, 3 analyzers (total 75 results per microcuvette lot).
     • LoD: 6 Hgb-low samples, 5 replicates, 3 days, 3 microcuvette lots, 1 analyzer (total 90 results per microcuvette lot).
     • LoQ: 6 low Hgb samples, 5 replicates, 3 days, 3 microcuvette lots, 1 analyzer (total 90 results per microcuvette lot).
       Data Provenance: Not explicitly stated, but in-house testing. Retrospective/prepared samples.
   • Analytical Specificity (Interference): 3 hemoglobin levels of human whole blood samples, tested in 5 replicates. Data Provenance: Not explicitly stated, but in-house testing. Retrospective/prepared samples.
   • Method Comparison: 60 capillary finger-stick blood samples and 70 venous blood samples (including 10 spiked extreme range samples). Data Provenance: Three point-of-care clinical sites in the United States. Prospective.
   • Matrix Comparison: 80 study participants (venous and capillary whole blood). Data Provenance: Not explicitly stated, likely clinical sites in the United States. Prospective.
   • Sample Stability: 37 fresh venous blood samples. Data Provenance: Not explicitly stated, but in-house testing. Prospective.
   • Anticoagulant Comparison: Venous blood collected from 50 study participants. Data Provenance: Not explicitly stated. Prospective.
   • Disease Conditions Comparison: 3 specimens from Polycythemia, 2 from hypochromia, 3 from high WBC count, 2 from sickle cell donors. Each tested 5 times. Data Provenance: Not explicitly stated. Retrospective.

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

   • For most analytical performance studies (precision, linearity, detection limits, interference), the "ground truth" is typically established by the carefully prepared samples/controls according to standardized procedures (e.g., using reference materials or precise spiking methods) rather than expert consensus on individual case interpretation.
   • For Method Comparison and Anticoagulant Comparison, the predicate device (HemoCue Hb 301 System) serves as the reference ("ground truth") for comparison. The document does not mention the use of human experts to establish ground truth for individual cases, but rather relies on the established accuracy of the predicate device.
   • For Reproducibility at clinical sites, data was collected by "three operators (one at each site)," but their qualifications are not specified beyond being operators.

3. Adjudication Method for the Test Set:

   • No adjudication method (like 2+1 or 3+1 consensus) is described, as the studies primarily involve quantitative measurements and comparison to a reference method (predicate device) or internally established values for controls/calibrators, rather than subjective interpretations by multiple experts.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. The studies described are primarily analytical performance studies comparing the device's measurements to a reference method (the predicate device) or established laboratory standards. There is no mention of a human-in-the-loop study assessing improved reader performance with or without AI assistance. This device is an automated hemoglobin analysis system, not an AI interpretation tool for imaging or other diagnostic data that typically involves human readers.

5. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done:

   • Yes, all the described analytical and clinical performance studies (precision, linearity, detection limits, interference, method comparison, matrix comparison, stability studies, anticoagulant comparison, disease conditions comparison) are conducted to assess the performance of the device itself (algorithm + hardware) in a standalone manner, without explicit human interpretive involvement in the result generation or assessment beyond operating the device.

6. The Type of Ground Truth Used:

   • Reference Method: For method comparison, the HemoCue Hb 301 System was used as the reference method.
   • Prepared Samples/Controls: For precision, linearity, detection limits, and interference studies, ground truth was implicitly established through the careful preparation of samples with known hemoglobin concentrations or the use of quality control materials with assigned values.
   • Natural Samples: Many studies utilized "natural human whole blood samples" or "fresh venous blood samples," for which the "ground truth" would be the measured value by the hemochroma PLUS in initial readings, or by the predicate device for comparative studies.

7. The Sample Size for the Training Set:

   • The document primarily describes validation studies for a device, not the development of an AI algorithm which requires a separate training set. The device itself uses a "pre-programmed calibration" and an "ID chip" with "calibration data/information." The "Value Assignment" section for the hemochroma PLUS Controls used 15 replicates for each control level to set the mean values, and then 10 replicates on each of three analyzers with three microcuvette lots to verify these values. This isn't a "training set" in the context of machine learning, but rather establishing performance characteristics for physical controls used with a calibrated instrument.

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

   • As noted above, this device is not an AI/machine learning system that requires a "training set" in the conventional sense. Its "ground truth" for calibration and control value assignment is established through standard laboratory practices, including testing in multiple replicates, using multiple lots of reagents/devices, and setting mean values through statistical analysis. The device uses "pre-programmed calibration" and calibration data from its ID chip, which would have been established by the manufacturer using reference methods and standard calibration procedures.

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The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K.2-EDTA, sodium citrate, lithium heparin, or sodium heparin) of adults. The testing system is designed for point-of-care use in primary care settings, hospitals, and medical lab facilities. Estimation of hematocrit, as a function, is only for normal hemoglobin values from 12.0 to 18.0 g/ dL (120 to 180 g/L).

The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration.

The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. This device has not been evaluated for pediatric samples. The device has been evaluated for individuals ranging in age from 18 to 96 years old. The hemochroma PLUS System is for in vitro diagnostic only.

The hemochroma PLUS Analyzer is a battery powered, hand-held device to measure the concentration of total hemoglobin in blood in 3 seconds with 15ul of whole blood. Whole blood may be collected by fingerstick (capillary) or venipuncture and analyzed without pre-processing. The hemochroma PLUS Analyzer uses hemochroma PLUS Microcuvettes with dual ports where the user applies samples either through capillary action or direct volume pipetting.

The hemochroma PLUS Analyzer determines hemoglobin concentration in whole blood samples using a dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and permits photometric determination of hemoglobin in undiluted blood samples. The computed end result is displayed on a LCD display and can be printed on an external printer (optional).

The hemochroma PLUS System consists of a hemochroma PLUS Analyzer, single-use hemochroma PLUS Microcuvettes, hemochroma PLUS ID Chip, optical System Check Microcuvette and hemochroma PLUS Controls.

1. hemochroma PLUS Microcuvette
   The hemochroma PLUS Microcuvettes are specially designed for use with the hemochroma PLUS Analyzer. The microcuvettes function as measuring devices specifically holding 15 uL of blood and are inserted into the hemochroma PLUS Analyzer by placing it into the cuvette holder. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and by measuring the degree of light absorption permits photometric determination of the hemoglobin in undiluted blood samples.

2. hemochroma PLUS ID Chip
   The hemochroma PLUS ID chip contains encoded memory with the calibration data/information. With the ID chip inserted in the designated port, the hemochroma PLUS Analyzer reads and utilizes the calibration data regarding the lot under consideration and applies appropriate correction to the conversion formula while computing the test result.

3. hemochroma PLUS Optical System Check Microcuvette
   hemochroma PLUS Optical System Check Microcuvette is designed for use with the hemochroma PLUS Analyzer only. The Optical System Check Microcuvette is a special glass filter used to measure the degree of light absorption with the spectrophotometric method. If the result is between 11.7-12.3 g/dL, the optic system is working properly according to specification.

4. hemochroma PLUS Controls
   The hemochroma PLUS Controls: Level 1 (Low), Level 2 (Middle), and Level 3 (High), are external quality controls designed for use with hemochroma PLUS Analyzer only.

Here's an analysis of the provided text, focusing on the acceptance criteria and study proving the device's performance:

The document is a 510(k) Summary for the "hemochroma PLUS System," an automated hemoglobin system. It outlines the analytical performance studies conducted to establish substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" for each study in a table format. Instead, it states for each analytical study that the "results were within the defined acceptance criteria" or "met the acceptance criteria." This implies that internal acceptance criteria were pre-established by the manufacturer for each test (e.g., repeatability, reproducibility, linearity, interference, method comparison, stability, detection limits) and the observed performance successfully satisfied them.

However, based on the provided results, we can infer some performance metrics:

Study Details:

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

   • See table above. The document generally states "met acceptance criteria" without providing the specific numerical cutoffs for most criteria. The reported performance details are extracted from the text where available (e.g., specific %CV values, correlation coefficients).

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

   • Repeatability:

     • In-house study: Five test samples (K2EDTA tubes) with distributed hemoglobin concentrations. Each of 3 analyzers tested 7 times in duplicate (morning/evening) for a total of 84 results per sample level.
     • Between Operator: 5 hemoglobin levels, 3 operators, 7 times in duplicate.
     • Between Lot: 5 hemoglobin levels, 3 microcuvette lots, 7 times in duplicate.
     • Between Instrument: 5 hemoglobin levels, 3 instruments, 7 times in duplicate.

   • Reproducibility:

     • Three intended use sites.
     • Sample size: 160 test results per control level at each site. This implies 3 levels * 160 results/site * 3 sites = 1440 control results in total for the main reproducibility study.

   • Linearity/Reportable Range: Eleven hemoglobin concentration levels. Tested in triplicate.

   • Limit of Blank: 5 blank samples, 5 replicates each, over 3 days (total of 75 results per microcuvette lot).

   • Limit of Detection: 6 low-Hgb samples, 5 replicates each, over 3 days (total of 90 results per microcuvette lot).

   • Limit of Quantitation: 6 low-Hgb samples, 5 replicates each, over 3 days (total of 90 results per microcuvette lot).

   • Analytical Specificity (Interference): Three hemoglobin levels, control and test samples, tested in 5 replicates.

   • Method Comparison:

     • 60 capillary finger-stick blood samples.
     • 60 venous blood samples (K2EDTA).
     • Additional 10 venous samples in extreme hemoglobin ranges (for venous data only).
     • Total sample size for method comparison appears to be approximately 130 patient samples (60 capillary + 70 venous).

   • Matrix Comparison: 80 study participants (venous and capillary whole blood).

   • Sample Stability: 37 fresh venous blood samples (K2EDTA tubes).

   • Disease Conditions: 10 specimens (3 Polycythemia, 2 Hypochromia, 3 High WBC, 2 Sickle Cell). Each tested 5 times.

   • Anticoagulant Comparison: 50 study participants (venous blood collected in 4 different anticoagulant tubes).

   • Data Provenance:

     • Repeatability and Detection Limits: "in-house"
     • Reproducibility: "at three intended use sites" (implies prospective, real-world conditions).
     • Method Comparison: "at three point-of-care clinical sites in the United States" (implies prospective, real-world conditions).
     • Matrix Comparison, Sample Stability, Disease Conditions, Anticoagulant Comparison: Performed using collected blood samples but location/nature (retrospective/prospective) not explicitly stated for all. The collection of "fresh venous blood samples" and samples from "study participants" suggests prospective.

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

   • Not applicable (N/A) / Not provided. For this type of in vitro diagnostic device (automated hemoglobin system), the "ground truth" for analytical performance studies is typically established by reference methods or validated laboratory measurements (e.g., using a predicate device or a clinical laboratory analyzer as a comparison), not by expert human graders or adjudicators of images.
   • The "HemoCue Hb 301 System" is used as the predicate device for method comparison, which serves as the "truth" or comparison standard in that study. For other studies like repeatability and reproducibility, the device's own measurements against each other, or against controls/calibrators, form the basis of the evaluation.

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

   • None. This concept of "adjudication" (common in image analysis AI models where human readers interpret data) does not apply to the analytical performance testing of a quantitative laboratory device like the hemochroma PLUS System. Measurements are objective numerical values.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that aid human interpretation (e.g., radiologists reading images) to show improvement in diagnostic accuracy or efficiency. The hemochroma PLUS System is a quantitative measuring device, not an AI assistance tool for human interpretation.

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

   • Yes, implicitly. All the analytical performance studies (repeatability, reproducibility, linearity, detection limits, interference, stability studies, and even the method comparison with the predicate) demonstrate the performance of the "algorithm only" or the device itself in producing quantitative hemoglobin results. Human involvement primarily pertains to sample collection, handling, and operating the device, not interpreting its output or providing a diagnosis based on visual assessment that the algorithm then aids.

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

   • The "ground truth" or reference standard for this device is primarily established through:
     • Comparison to a legally marketed predicate device (HemoCue Hb 301 System) for method comparison studies.
     • Validated laboratory methods and samples (e.g., spiked samples, control materials with assigned values, reference measurements) for studies like linearity, detection limits, and interference.
     • Internal consistency and precision metrics for repeatability and reproducibility studies.

8. The sample size for the training set:

   • No specific "training set" is mentioned in the context of device development for this 510(k) submission. The hemochroma PLUS System is described as using a "pre-programmed calibration" and an "ID chip" with "calibration data/information." This suggests that the device's measurement algorithm is based on a fixed, pre-established calibration curve rather than a machine learning model that requires a "training set" to learn from data. Therefore, the concept of a training set as understood in AI/ML development is not directly applicable or described here.

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

   • N/A. As explained above, there is no mention of a "training set" in the context of an AI/ML model for this device. The device operates on optical principles and a pre-programmed calibration curve. The value assignment for controls and the calibration data on the ID chip would have been established through a rigorous internal validation process using reference methods and materials, though the specifics of that process are not detailed as a "ground truth" for a "training set."

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