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The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings.

The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting.

The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting.

The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.

The HemoCue® Hb 301 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer. The system can be used by non-laboratory personnel.

The HemoCue® Hb 301 System consists of the following parts:

• An analyzer supporting the following features:
  • Photometric determination of hemoglobin
  • Presentation of results on a display
• Power supply by power adapter or four AA batteries
• Single use microcuvettes (test consumable)
• Labeling:
  • Operating Manual
  • Package Insert
  • Quick reference Guide
  • Labels

The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 µL is drawn into the cavity in the microcuvette by capillary action.

The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/ HbO2 isosbestic point. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample.

The HemoCue® Hb 301 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.

Here's the breakdown of the acceptance criteria and the study for the HemoCue® Hb 301 System, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 71 pediatric blood samples.
   • Data Provenance: Tested at one European clinical laboratory site. The data appears to be prospective as it describes a specific evaluation done to compare the device to the reference method and predicate device.

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

   • The document does not specify the number or qualifications of experts used to establish ground truth.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method. The ground truth was established by a reference method (ICSH), which inherently has its own established protocol for measurement, rather than relying on expert consensus adjudication in this context.

4. 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, this is not applicable. The HemoCue® Hb 301 System is an automated hemoglobin analysis device, not an AI-assisted diagnostic tool that human readers would interpret. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this device.

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

   • Yes, in essence. The study described is a direct comparison of the device's measurements (algorithmically determined hemoglobin concentration from photometric readings) against a reference method and a predicate device. The HemoCue® Hb 301 System itself performs the analysis without human interpretation of the final result. While "human-in-the-loop" isn't strictly defined for this type of device, the performance presented is of the automated system.

6. The type of ground truth used:

   • The primary ground truth used was the hemiglobincyanide (HiCN) method (ICSH reference method) for the determination of hemoglobin concentration.

7. The sample size for the training set:

   • The document does not explicitly state a sample size for a "training set" in the context of machine learning, as this device uses spectrophotometric measurements and an algorithm for translation into hemoglobin concentration, rather than a deep learning model that requires a distinct, large training set. The system is described as "factory calibrated."

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

   • The document states that "The HemoCue® Hb 301 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood." This implies that the factory calibration (which is analogous to what might be considered a "training" or calibration phase for the device's internal algorithm) was established using the ICSH reference method as the gold standard. Specific details on the establishment of this ground truth for the factory calibration are not provided in this specific excerpt, beyond stating its traceability.

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Hemo Control is intended to be used for the quantitative determination of hemoglobin (Hb) concentrations in human blood.

The Hemo Control Hemoglobin Microcuvettes are intended to be used with the Hemo Control photometer for the quantitative determination of hemoglobin (Hb) concentrations in human blood.

For in-vitro diagnostic use only.

Hemo Control consists of the Hemo Control photometer / analyzer and the Hemo Control Hemoglobin Microcuvettes, its accessories and consumables (i.e. Control Solution Hb-con).
The Hemo Control photometer / analyzer is a semi-automated, spectrophotometric instrument, which provides instant quantitative total hemoglobin results.
Using the reagent filled microcuvette a small amount of arterial, venous or capillary blood is taken up by capillary action. The filled microcuvette is inserted into the Hemo Control photometer. The color produced by chemical reaction in the microcuvette is measured and the Hb value is displayed.
The measurement accuracy of the Hemo Control Hemoglobin Measurement System can be verified by use of Hb-con control solution, a quality control material with pre-determined hemoglobin concentration.
As a second quality control measurement, the control cuvette as a physical standard is used for a comfortable and cheap check of the device.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Hemo Control device:

Device: Hemo Control (automated hemoglobin system)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents performance characteristics of the device. The reported performance is the demonstration that the device meets the implicit acceptance criteria for substantial equivalence to its predicate device. For example, the low %CV values for precision demonstrate acceptable reproducibility. The regression equations with r-values close to 1 and slopes close to 1 for method comparison studies demonstrate agreement with reference methods and predicate devices.

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

• Precision: The document provides Coefficient of Variation (CV) values for "Within Run," "Total," and "Single Observation 20 days" at low (107 g/L), normal (129 g/L), and high (173 g/L) hemoglobin concentrations. The specific number of samples or measurements for each of these precision studies is not explicitly stated in this summary, but typically, precision studies involve repeated measurements of control materials or patient samples.
• Method Comparison (NCCLS Reference Method): n = 174 samples
• Method Comparison (HemoCue hemoglobin measurement system): n = 286 samples
• Method Comparison (Hemo Control Cuvettes in HemoCue): n = 286 samples
• Matrix Comparison (Capillary samples): n = 275 samples
• Matrix Comparison (Arterial samples): n = 10 samples

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that this is a 510(k) submission from a German company (EKF-diagnostic GmbH) and involves comparison to established reference methods and other commercially available devices, it is highly likely these were prospective studies conducted in a clinical or laboratory setting.

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

This device is an automated hemoglobin system that measures a quantitative value (hemoglobin concentration). It does not rely on expert interpretation for its output. Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation or diagnostic classification (e.g., radiologists) is not relevant here.

The "ground truth" for method comparison studies is established by:

• NCCLS Reference Method: This refers to a standardized laboratory method (likely cyanmethemoglobin method, which is a gold standard for hemoglobin measurement). The reference method itself is the "ground truth."
• Predicate Device (HemoCue hemoglobin measurement system): This is another commercially available, cleared device that serves as a comparison standard.

4. Adjudication Method for the Test Set

Not applicable. Since the device produces a quantitative numerical output for hemoglobin concentration, there is no need for an adjudication method among experts. The "ground truth" is determined by the reference method or comparison device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) to assess the impact of AI assistance on their performance. The Hemo Control is an automated quantitative device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the analytical performance and method comparison studies described are inherently standalone performance studies. The Hemo Control device (photometer and microcuvettes) itself performs the measurement and provides the hemoglobin value. There is no "human-in-the-loop" interaction for interpreting the result, only for operating the device, taking the sample, and understanding the output.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation included:

• NCCLS Reference Method: A highly standardized, accepted laboratory method for hemoglobin measurement.
• Predicate Device Performance: Comparison against the performance of another legally marketed device (HemoCue hemoglobin measurement system).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This device operates based on spectrophotometric principles and chemical reactions, not on complex machine learning algorithms that require large training data sets in the typical sense. The fundamental physical and chemical principles are well-established.

The studies described (precision, linearity, method comparison, matrix comparison) are typically considered verification and validation studies performed after the device design is largely finalized, not for "training" an algorithm.

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

Not applicable, as a "training set" in the machine learning sense is not mentioned or implied for this device's operation. The device's calibration and performance are established against physical standards, reference methods, and quality control materials, which form its inherent "ground truth." Specifically, the device is calibrated against the NCCLS reference method, and its accuracy can be verified using Hb-con control solutions (quality control material with pre-determined hemoglobin concentration) and a control cuvette as a physical standard.

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The HemoCue® Hb 801 System is intended for the quantitative determination of hemoglobin in capillary or venous whole blood (K2EDTA and Li-Heparin) in point-of-care settings. The HemoCue® Hb 801 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old. The HemoCue® Hb 801 System is for professional in vitro diagnostic use only.

The HemoCue® Hb 801 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer. The system can be used by non-laboratory personnel.

The HemoCue® Hb 801 System consists of the following parts:

• An analyzer supporting the following features: .
  • O Photometric determination of hemoglobin
  • Presentation of results on a display O
  • O Wired and wireless communication (USB and Bluetooth)
• Power supply by power adapter, chargeable or non- chargeable batteries ●
• Single use microcuvettes (test consumable)
• Labeling: ●
  • O Operating Manual
  • o Package Insert
  • Quick reference Guide o
  • o Labels

The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 uL is drawn into the cavity in the microcuvette by capillary action.

The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/ HbO2 isosbestic point. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample.

The HemoCue® Hb 801 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.

Here's a summary of the acceptance criteria and study details for the HemoCue® Hb 801 System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document largely focuses on demonstrating equivalence to a predicate device and established reference methods, with direct explicit acceptance criteria only mentioned for linearity and anticoagulants. Performance is reported in terms of precision, linearity, and correlation with reference methods.

• Hb 2.0-3.0 g/dL: Mean 2.43 g/dL, SD 0.05
• Hb 6.0-7.0 g/dL: Mean 6.55 g/dL, SD 0.07
• Hb 9.5-10.5 g/dL: Mean 9.96 g/dL, CV 0.68% (Repeatability), 0.71% (Within Lab), 1.11% (Reproducibility)
• Hb 13.5-14.5 g/dL: Mean 14.07 g/dL, CV 0.71% (Repeatability), 0.82% (Within Lab), 1.16% (Reproducibility)
• Hb 16.5-17.0 g/dL: Mean 16.87 g/dL, CV 0.60% (Repeatability), 0.73% (Within Lab), 0.95% (Reproducibility)
• Hb 23.0-24.0 g/dL: Mean 23.39 g/dL, CV 0.67% (Repeatability), 0.77% (Within Lab), 0.97% (Reproducibility)

Overall precision (Multi-site):

• Hb 2.0-3.0 g/dL: Mean 2.30 g/dL, SD 0.03 (R), 0.04 (WL), 0.05 (R)
• Hb 6.0-7.0 g/dL: Mean 6.55 g/dL, SD 0.07 (R), 0.07 (WL), 0.08 (R)
• Hb 9.5-10.5 g/dL: Mean 10.24 g/dL, CV 1.04% (R), 1.17% (WL), 1.63% (R)
• Hb 13.5-14.5 g/dL: Mean 13.91 g/dL, CV 0.71% (R), 0.75% (WL), 1.00% (R)
• Hb 16.5-17.0 g/dL: Mean 16.75 g/dL, CV 0.52% (R), 0.63% (WL), 0.66% (R)
• Hb 23.0-24.0 g/dL: Mean 23.35 g/dL, CV 0.74% (R), 0.74% (WL), 0.89% (R) |
  | Precision (Quality Control) | SD and CV calculated for repeatability, between-run, between-day, and within laboratory precision for each level were within the defined acceptance criteria. | Overall precision (Multi-site, multi-lots, operators, days): All reported SD and CV values (e.g., Low control: Mean 6.34 g/dL, SD 0.05 (R), 0.04 (WL), 0.06 (R)) were within the defined acceptance criteria. |
  | Linearity | "fulfilled acceptance criteria for the non-linear error" (for range 1.0-25.6 g/dL). | System determined to be linear in the range 1.0-25.6 g/dL. |
  | Detection Limit (LoB) | Not explicitly stated (calculated to be 0.26 g/dL). | LoB for the HemoCue® Hb 801 System was determined to be 0.26 g/dL. |
  | Detection Limit (LoD) | Not explicitly stated (calculated to be 0.3 g/dL). | LoD for the HemoCue® Hb 801 System was determined to be 0.3 g/dL. |
  | Quantification Limit (LoQ) | Total Error (TE) for each sample ≤ 0.5 g/dL. | LoQ for the HemoCue® Hb 801 System was determined to be 0.5 g/dL, meeting the TE goal. |
  | Analytical Specificity | No significant interference at tested concentrations. | Most tested substances (Acetaminophen, Ascorbic acid, Creatinine, HbCO, HbO2, Hemolysis, Ibuprofen, MetHb, Platelets, Total protein, Salicylic acid, Simvastatin, Tetracycline, Triglycerides, Urea, Uric acid, Warfarin, Normal blood pH) showed no interference at respective concentrations.

Interference observed with:

• Conjugated bilirubin (>23 mg/dL at 10 g/dL Hb)
• Unconjugated bilirubin (>12 mg/dL at 10 g/dL Hb, >23 mg/dL at 20 g/dL Hb)
• Intralipid (>214 mg/dL at 10 g/dL Hb, >483 mg/dL at 20 g/dL Hb)
• Leucocytes (>260 x 10^9/L at 6.8 – 14.7 g/dL Hb)
  (Note: "May give elevated results in higher substance concentrations".) |
  | Anticoagulant Equivalence | Met the acceptance criteria regarding the correlation and bias between K2EDTA and Li-Heparin. | Both K2EDTA and Lithium Heparin samples fulfilled the acceptance criteria. |
  | Capillary vs. Venous Sample | Met the defined acceptance criteria and showed equivalency. | Both venous and capillary samples were within the defined acceptance criteria and showed equivalency. |
  | Method Comparison (Predicate)| Linear regression analysis demonstrated comparable performance. | Venous (N=264): Slope 1.00, Intercept -0.14, r 1.00 against predicate.
  Capillary (N=233): Slope 1.07, Intercept -0.91, r 0.96 against predicate.

Pediatric samples (N=71):

• HemoCue® Hb 801 vs ICSH: slope 0.95, r 0.99.
• HemoCue® Hb 801 vs HemoCue® Hb 301 System: slope 0.97, r 0.99.

Both samples types were within defined acceptance criteria. |
| Reference Range Verification| Values fall within the expected pediatric and adult reference intervals. | Study results verified that the reference ranges data on the HemoCue® Hb 801 System for the subgroups fall within the defined reference ranges (e.g., Infant 9.4-14.1 g/dL, Adult Male 13.0-17.0 g/dL). |

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

• Precision (Whole Blood):

  • Multi-microcuvette lots study: 6 hemoglobin levels, 5 operating days, 5 replicates per run, 3 microcuvette lots. Total 75 measurements per level. (Implied N = 6 levels * 75 measurements = 450).
  • Multi-site study: 3 sites, 5 operating days, 5 replicates per run, 6 hemoglobin levels. Total 75 measurements per level. (Implied N = 6 levels * 75 measurements = 450).
  • Provenance: Not explicitly stated, but clinical studies for method comparison mention primary care settings in the US and one European clinical laboratory. It is likely these precision studies were conducted in similar clinical laboratory environments. Retrospective/Prospective not specified, but likely prospective.

• Precision (Quality Control Material):

  • Sample size: Three sites, 20 operating days, 1 lot of control material (3 levels), duplicate runs twice daily. Total 240 measurements per level (80 per site). (Implied N = 3 levels * 240 measurements = 720).
  • Provenance: Not explicitly stated, but likely clinical laboratory settings, potentially those mentioned for method comparison (US/Europe). Likely prospective.

• Linearity:

  • Sample size: 9 hemoglobin concentrations, 15 replicates per concentration (5 replicates/analyzer). (Implied N = 9 concentrations * 15 replicates = 135).
  • Provenance: Clinical laboratory, likely prospective.

• Detection Limit (LoB, LoD, LoQ):

  • LoB: 4 individual plasma samples. 3 analyzers, 2 microcuvette lots, 4 operating days. 1 sample analyzed each day, 3 runs per day, 2 replicates/analyzer per run. Total 72 replicates/microcuvette lot (Implied N = 2 lots * 72 replicates = 144).
  • LoD: 4 K2EDTA whole blood samples from different subjects. 3 analyzers, 2 microcuvette lots, 4 operating days. 1 sample analyzed each day, 3 runs per day, 2 replicates/analyzer per run. Total 72 replicates/microcuvette lot (Implied N = 2 lots * 72 replicates = 144).
  • LoQ: 4 K2EDTA whole blood samples from different subjects. 3 analyzers, 2 microcuvette lots, 4 operating days. 1 sample analyzed each day, 3 runs per day, 3 replicates/analyzer per run. Total 108 replicates/microcuvette lot (Implied N = 2 lots * 108 replicates = 216).
  • Provenance: Clinical laboratory, likely prospective.

• Analytical Specificity:

  • Sample size: K2EDTA whole blood samples with adjusted Hb levels. Number of samples/subjects not explicitly stated for each interferent, but tested at two Hb concentrations (10±0.5 and 20±1.0 g/dL).
  • Provenance: Clinical laboratory, likely prospective.

• Anticoagulant Equivalence:

  • Sample size: 120 subjects provided both K2EDTA and Li-Heparin venous whole blood. Additional 11 subjects contributed samples to adjust Hb values.
  • Provenance: Two sites, likely clinical settings, likely prospective.

• Capillary vs. Venous Sample Equivalence:

  • Sample size: 40 subjects for direct comparison, plus 212 subjects from the method comparison study (total 252).
  • Provenance: Not explicitly stated, but likely related to the multi-site method comparison study in the US. Likely prospective.

• Method Comparison (Predicate):

  • Sample size:
    • US Study: 264 venous samples (28 contrived) and 233 capillary samples. Total 497.
    • European Clinical Lab: 71 pediatric samples.
  • Provenance:
    • US Study: Five primary care settings in the US.
    • European Clinical Lab Study: One European clinical laboratory site.
  • Retrospective/Prospective: Likely prospective.

• Reference Range Verification:

  • Sample size: Whole blood specimens collected. Number of individual samples not specified.
  • Provenance: 5 point-of-care locations in the US. Likely prospective.

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

• No information provided regarding experts establishing ground truth for the test set. Most studies compare the device against a predicate device or the International Council for Standardization in Haematology (ICSH) reference method, which represents a gold standard, not expert consensus.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The studies described are analytical performance studies comparing the device to reference methods or a predicate, not studies involving human interpretation or adjudication of results. For the method comparison studies, duplicates were used for the predicate device, and triplicates for the ICSH reference method, implying a direct comparison of numerical results rather than an adjudication process.

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

• No, an MRMC comparative effectiveness study was not done. The studies are focused on the analytical performance of the device in measuring hemoglobin concentrations, primarily comparing it to a predicate device and a reference method. They do not evaluate human reader performance with or without AI assistance. The device is intended for non-laboratory personnel to use for direct numerical readings.

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

• Yes, a standalone performance study was done. All the analytical performance studies (precision, linearity, detection limits, analytical specificity, anticoagulant/sample type equivalence, and method comparison with predicate/ICSH) represent standalone performance of the HemoCue® Hb 801 System. The "system" includes the analyzer which uses an algorithm for translation into hemoglobin concentration. Users are described as "non-laboratory personnel" who obtain a direct reading from the device.

7. Type of Ground Truth Used

• The ground truth varied depending on the study:
  • Precision, Linearity, Detection Limits, Analytical Specificity: These studies establish the inherent performance characteristics of the device itself. The "ground truth" for the samples was their known or carefully prepared hemoglobin concentrations as measured by highly controlled laboratory methods.
  • Anticoagulant and Capillary vs. Venous Equivalence: The "ground truth" was the comparison between the two sample types from the same subject.
  • Method Comparison: The ground truth was established by:
    • The predicate device (HemoCue® Hb 301 System).
    • The hemiglobincyanide (HiCN) method, which is the International Council for Standardization in Haematology (ICSH) international reference method.
  • Reference Range Verification: Comparison against published reference intervals from authoritative texts (Dacie and Lewis Practical Haematology, Pediatric Reference Intervals).

8. Sample Size for the Training Set

• Not applicable/Not mentioned. This is an IVD device that measures a specific analyte using a spectrophotometric measuring principle with a pre-defined algorithm and factory calibration. There is no mention of a "training set" in the context of machine learning or AI algorithm development as typically understood in the context of image analysis or diagnostic prediction. The algorithm for translating light measurements into hemoglobin concentration is fundamental to the device's design, not something that appears to be "trained" on a large dataset in the sense of modern AI.

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

• Not applicable/Not mentioned. As noted above, typical "training sets" and their associated ground truth establishment methods (e.g., expert consensus labeling) are not relevant to the description of this device's development or validation. The device's fundamental measurement principle and algorithm are traceable to the HiCN method (ICSH), meaning its design and underlying calculations are based on established scientific principles for hemoglobin determination.

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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."

• Within Run: SD (0.09-0.11), %CV (0.47-1.68) for Hgb concentrations 5.6-23.7 g/dL.
• Total: SD (0.20-0.25), %CV (1.06-3.67) for Hgb concentrations 5.6-23.7 g/dL.
  Reproducibility (Across sites, operators, and days):
• Site 1: Total %CV (1.08-1.99) for Hgb controls 8.5-15.8 g/dL.
• Site 2: Total %CV (1.08-1.74) for Hgb controls 8.5-15.8 g/dL.
• Site 3: Total %CV (1.14-2.10) for Hgb controls 8.5-15.8 g/dL.
• Combined Sites: Total %CV (1.23-2.30) for Hgb controls 8.4-15.8 g/dL. Performance results were "within the defined acceptance criteria." |
  | Linearity/Assay Range | Linearity across the claimed measuring range | Linear regression demonstrating acceptable correlation. | Linearity: Linear regression performed on eleven hemoglobin concentration levels (2.5-25.6 g/dL) demonstrated linearity over the claimed measuring range of 5.0-25.6 g/dL. |
  | Detection Limits | Limit of Blank (LoB) | Explicit acceptance criteria not given, but a calculated value is provided. | LoB: 0.23 g/dL |
  | | Limit of Detection (LoD) | Explicit acceptance criteria not given, but a calculated value is provided. | LoD: 1.66 g/dL |
  | | Limit of Quantitation (LoQ) | % Total-error smaller than the desired total error for the measurand. | LoQ: 4.5 g/dL (data considered acceptable as % Total-error was smaller than desired total error). |
  | Analytical Specificity | Interference by exogenous and endogenous substances | Non-significant interference up to specified concentrations. | Interference Study: All tested interference substances (endogenous and exogenous) showed non-significant interference up to the specified concentrations. |
  | Method Comparison | Agreement with predicate device (HemoCue Hb 301 System) | Linear regression demonstrating comparable performance (implied acceptance within a certain slope, intercept, and R-value). | Method Comparison: Linear regression analyses showed comparable performance. Example (Site 1 Capillary): Slope = 0.9942 (95% CI: 0.941-1.048), Intercept = 0.1214 (95% CI: -0.650-0.892), r = 0.980. The study demonstrated that analytical performance is "substantially equivalent" to the predicate device. |
  | Matrix Comparison | Comparability between venous and capillary whole blood samples | Results of Bland-Altman plot analysis and % difference meeting acceptance criteria. | Matrix Comparison: Results of Bland-Altman plot analysis and % difference between venous whole blood samples and capillary whole blood samples met the acceptance criteria. |
  | Sample Stability | Stability of blood samples stored at 2-8°C | Not explicitly stated, but based on recovery. | Sample Stability: Supports a stability claim of 24 hours when stored at 2-8°C. |
  | Anticoagulant Comparison | Agreement between K2EDTA and other anticoagulants | Results of Bland-Altman plot analysis and % difference meeting acceptance criteria. | Anticoagulant Comparison: Results of Bland-Altman plot analysis and % difference between K2EDTA and 4 other anticoagulant tubes were "within the defined acceptance criteria." |

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 DiaSpect Tm system is intended for the in vitro quantitative measurement of total hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2EDTA or lithium heparin tubes. The DiaSpect Tm system consists of the DiaSpect Tm analyzer and specifically designed disposable cuvettes, the DiaSpect Tm Cuvettes. The device is intended for use in point-of-care settings. The DiaSpect Tm analyzer is only to be used with DiaSpect Tm Cuvettes.

The DiaSpect Tm system consists of an analyzer and cuvettes. The DiaSpect Tm analyzer is a spectrophotometric instrument for the total hemoglobin concentration in unaltered human blood. The DiaSpect Tm Cuvette is injection-molded of poly methyl methacrylate (PMMA) and contains a cavity of 10 uL volume. The cavity is empty.

Here's a summary of the acceptance criteria and the study that proves the DiaSpect Tm system meets those criteria, based on the provided document:

Acceptance Criteria and Reported Device Performance

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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:

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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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The Avie™ Total Hb Test System is for the quantitative measurement of total hemoglobin in whole blood (capillary or venous EDTA,K2). The test system is designed for point-of-care use in primary care settings. The test system is for professional in vitro diagnostic use only.

The Avie™ Total Hb Test System is a point of care (POC) IVD system that utilizes general chemistry reactions to quantify total hemoglobin in fresh capillary blood and venous blood. The test system includes a small instrument (Reader) and disposable reagent strips- the strips are packaged in a reusable canister with desiccant, similar to the packaging of routine urine test strips. The concentration of total hemoglobin is calculated photometrically and is based on the optical intensity of the reaction within the quantitative area of the test strip. The calibration of the Avie™ Total Hb Test is traceable to the same high-order reference method as the HemoCue (hemiglobincyanide [HiCN].

Here's an analysis of the acceptance criteria and study details for the Avie™ Total Hb Test System based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each performance metric (e.g., "Slope must be between 0.98 and 1.02"). Instead, it reports the results of the performed studies, implying that these results were considered acceptable for demonstrating substantial equivalence to the predicate device.

However, we can infer performance goals based on the reported values and the comparison to the HiCN method (a high-order reference method). The reported "r" values (correlation coefficients) close to 1.0 indicate a strong correlation, and slopes near 1.0 with y-intercepts near 0 indicate good agreement with the reference method. Precision %CV values in the low single digits ($

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The Hemo-Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.

The microcuvettes part number 3000-3012-0765 are indicated for use in the Hemo-Control Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.

Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.

For In Vitro Diagnostic Use Only

The Hemo-Control Hemoglobin Measurement System is comprised of a Hemo-Control Hemoglobin Measurement Photometer and Hemo-Control Microcuvettes. The scope of this 510(k) is limited to a modification of the microcuvettes.

The Hemo-Control Microcuvettes are single-use microcuvettes filled with dry reagents. A modified azide methemoglobin method is used. The use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled microcuvette is inserted into the Hemo-Control Hemoglobin Measurement Photometer, the color produced by the chemical reaction in the microcuvette is measured, and the Hb level is calculated and displayed. Light emitting diodes (LED's) are used as light sources with a photodiode to detect the light.

The plastic microcuvette consists of a clear body with a cavity which takes up approximately 10 µL of blood which combines with the dry reagent chemistry. The optical distance between the microcuvette walls is fixed and permits photometric determination of the hemoglobin in undiluted blood samples using the Lambert-Beers Law. The microcuvette optical and chemical characteristics are unchanged by the modification.

The Hemo Control Hemoglobin Measurement System with the microcuvette modification employs the identical fundamental scientific technology as the predicate device(s).

The provided documentation describes the acceptance criteria and a study demonstrating that the modified Hemo_Control Microcuvettes meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The study primarily focuses on precision and correlation with a reference method. The acceptance criteria can be inferred from the reported precision (low CV%) and strong correlation (high R^2).

Note: The acceptance criteria are "implied" as specific numeric thresholds are not explicitly stated as "acceptance criteria" but rather as "results obtained" that demonstrate substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: 100 samples
• Data Provenance: The document does not explicitly state the country of origin. The test used venous blood samples. It is a retrospective analysis in the sense that the samples were already collected and then tested. The study design appears to be a laboratory evaluation (non-clinical test).

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

This study is a non-clinical laboratory test comparing a device's performance to a reference method, not an interpretative study requiring human expert ground truth.

• Number of Experts: Not applicable, as the ground truth was established by a reference method.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison to a reference method, not an interpretative study requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a non-clinical laboratory evaluation of a modified medical device against a reference standard, not an AI-assisted diagnostic tool involving human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The precision and correlation data presented represent the performance of the modified microcuvette with the Hemo_Control device, without human interpretation as part of the measurement process. It's a "device only" performance evaluation.

7. Type of Ground Truth Used

The ground truth was established by a reference method, specifically the CLSI H15-A3 standard for the quantitative determination of hemoglobin in blood.

8. Sample Size for the Training Set

Not applicable. This device is a measurement system, and the study described is a validation study for a device modification, not a machine learning model that requires a training set. The "device" already has its algorithm embedded.

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

Not applicable, as no training set for a machine learning model was used.

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The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.

The HemoPoint H2 Microcuvettes are indicated for use in the HemoPoint® H2 DM Hemoglobin Measurement System. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.

Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.

The DM (Data Management) system allows enhanced data management features.

For In Vitro Diagnostic Use Only

The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes.

A modified azide methemoglobin method is used in the HemoPoint® H2 system.

In the HemoPoint® H2, however, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed.

In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured.

For this purpose, light is directed through the blood sample and the transmission T is measured. From the amount of light absorbed by the sample, the concentration of the hemoglobin in the cuvette can be calculated using Lambert-Beers Law.

Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).

The DM (Data Management) software modification allows the storage and retrieval of data results along with patient information.

Here's an analysis of the acceptance criteria and the study that proves the HemoPoint® H2 DM Hemoglobin Measurement System meets them, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly listed in a separate table, but they can be inferred from the "Comparison to Predicate Device" table and the "Correlation Study" and "Precision" sections.

Study Details

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

   • Precision Test Set: The number of individual samples for the precision study is not explicitly stated as a single "test set" size. However, the study for "Between-Day Imprecision" mentions "Single observation, 20 days," which implies at least 20 measurements for each hemoglobin level (high, low, normal). The "Within-Run Precision" and "Total Precision" are based on NCCLS EP5-A, which typically involves multiple replicates over several days, but the exact number of unique samples is not given.
   • Correlation Study Test Set: For both correlation studies (vs. NCCLS H15-A3 and vs. HemoCue), the sample size was N=100 duplicate measurements.
   • Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective studies conducted by the manufacturer to demonstrate performance.

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

   • The document does not mention the use of "experts" in the sense of human readers adjudicating results for the ground truth.
   • The ground truth for the correlation studies was established using NCCLS H15-A3 reference method and the HemoCue system (predicate device). These are established laboratory methods, not human expert consensus.

3. Adjudication method for the test set:

   • No adjudication method (like 2+1, 3+1) was used as the ground truth was based on laboratory reference methods (NCCLS H15-A3) or comparison to a predicate device (HemoCue), not on human expert interpretation requiring consensus.

4. 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 MRMC comparative effectiveness study was done. This device is a quantitative hemoglobin measurement system, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

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

   • Yes, the studies conducted are standalone performance evaluations of the HemoPoint® H2 system. The device itself performs the measurement and calculation of hemoglobin concentration. The "DM (Data Management) software modification" merely allows for data storage and retrieval, it does not involve an AI algorithm for diagnosis or interpretation that would typically require human-in-the-loop assessment for performance studies.

6. The type of ground truth used:

   • Reference Method: For the accuracy and correlation studies, the ground truth was established by a recognized reference method: the NCCLS H15-A3 reference method for hemoglobin determination.
   • Predicate Device Comparison: The HemoCue system (a legally marketed predicate device) was also used as a comparator/ground truth source in some correlation and precision studies.

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of an algorithm or AI model development. The HemoPoint® H2 System is a photometric device, and its core principle (Lambert-Beer's Law) and calibration are based on established chemical and optical principles, not on a machine learning model requiring a training set in the typical sense. Calibration is performed against the NCCLS reference method.

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

   • Since there's no "training set" for an AI algorithm, this question is not applicable. The device is calibrated against the NCCLS reference method, which serves as the standard for establishing accuracy for the device's measurements.

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