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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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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 HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) count in capillary or venous whole blood. The HemoCue WBC system is for In Vitro Diagnostic use only. The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes. The HemoCue WBC system is indicated for use in clinical laboratories and for point-of-care settings.

The system consists of the HemoCue WBC Analyzer together with specially designed microcuvettes, the HemoCue WBC Microcuvettes. The microcuvette serves both as a sample container and a reaction chamber. A blood sample of approximately 10 uL is drawn into the cavity by capillary action. A hemolysing agent lyses the red cells in the microcuvette and a staining agent colors the white blood cells. An image is taken of the stained white blood cells and the number of cells is counted by image analysis. The result is presented within 3 minutes on the analyzer's display. The system reports results in the measuring range 0.3 - 30.0 x107/L. The system is factory calibrated and needs no further calibration.

The HemoCue WBC Analyzer is a portable device. The main parts are the cuvette holder (in which the microcuvette is placed), the cuvette moving arm (brings the microcuvette into correct measuring position), a magnifying optic unit, a camera, image processing software, a display and a power adapter.

The HemoCue WBC Microcuvette is made of polystyrene plastic and contains saponin that hemolyzes the red blood cells, methylene blue that stains the white blood cells and nonactive reagents. A blood sample of approximately 10 µL is drawn into the cavity by capillary action. The microcuvette serves as a sample container and a reaction chamber. No dilution of the sample is required.

The provided text for HemoCue WBC System (K071652) is a 510(k) summary and approval letter, which serves to establish substantial equivalence to predicate devices rather than fully detailing acceptance criteria and studies demonstrating performance. The document states that "Studies were conducted in-house, in clinical laboratory settings and point of care settings to demonstrate the performance with intended specifications of the HemoCue WBC system and to validate that the intended user can easily operate the system and obtain results as expected." However, it does not provide specific details on the acceptance criteria, reported performance, or the methodologies of these studies.

Therefore, much of the requested information cannot be definitively extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not explicitly provided in the given text. While it states that studies were conducted to "demonstrate the performance with intended specifications," it does not list these specifications or the corresponding results in a table format or any other detailed manner.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not explicitly provided. The text mentions "in-house, in clinical laboratory settings and point of care settings" for studies but does not specify sample sizes or data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The text describes the device's technical characteristics and its indications for use, but it does not detail how ground truth was established for its validation studies.

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

This information is not provided.

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

This is not applicable as the HemoCue WBC System is an automated cell counter, not an AI-assisted diagnostic tool for human readers. The comparison is against predicate devices (Sysmex XS-1000i and manual light microscopy), not human readers.

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

Yes, the HemoCue WBC System is described as a "semi-automated device" that performs its analysis via "image analysis" and presents a result. Therefore, the performance described would inherently be standalone performance of the device's algorithm without a human in the loop for the actual WBC count determination. The process involves filling a microcuvette, placing it in the analyzer, and receiving a result.

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

This information is not explicitly provided. The comparison is made against a "Sysmex XS-system" and "manual light microscopic WBC method." It's highly probable that these predicate methods served as the ground truth or reference methods, but the text doesn't explicitly state how discrepancies were resolved or what constituted the ultimate "ground truth."

8. The sample size for the training set

This information is not provided.

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

This information is not provided. The text focuses on the device's operation and regulatory equivalence, not the specifics of its development and training data.

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The HemoCue Glucose 201 RT system is used for quantitative determination of glucose in whole blood supplementing the clinical evidence in the diagnosis and treatment of patients with diabetes. The HemoCue Glucose 201 RT system is for In Vitro Diagnostic use only. The HemoCue Glucose 201 RT Analyzer is only to be used with HemoCue Glucose 201 RT Microcuvettes. For professional use only.

The HemoCue Glucose 201 RT system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The HemoCue Glucose 201 RT Microcuvette contains reagents deposited on its inner walls and serves both as a pipette and as a measuring cuvette. A blood sample of approximately 4 uL is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Glucose 201 RT Analyzer. The measurement takes place in the analyzer in which the transmittance is measured and the absorbance and glucose level is calculated.

The HemoCue Glucose 201 RT system is designed for quantitative determination of glucose in whole blood.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., accuracy, precision targets in mg/dL or %). Instead, it generally states that the device provides "clinical results comparable to other test methods." This implies that the acceptance criteria are met if the new device's performance is demonstrably equivalent or non-inferior to the legally marketed predicate device (HemoCue Glucose 201 system, K020935) and other established test methods.

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

The document does not specify the exact sample size used for the test set. It mentions:

• "Studies were conducted in-house, in clinical laboratory settings and point of care centers..."

This indicates that the data was collected from various settings, suggesting a prospective data collection approach from potentially multiple sites. The country of origin is not explicitly stated, but given the submitter is HemoCue AB in Sweden, and the contact is HemoCue, Inc. in the US, it's plausible the studies were conducted in both Europe and the US.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth for the test set. Given it's a glucose measurement device, the "ground truth" would likely be established by a reference method rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. For a glucose measurement device, the primary validation involves comparison to a reference standard rather than human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

An MRMC study is not applicable to this type of device (a glucose measurement system). MRMC studies typically involve human readers interpreting images or data, which is not the primary function of a glucose meter. Therefore, no effect size of human readers improving with AI vs without AI assistance is reported.

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

Yes, this device inherently functions in a standalone (algorithm only) manner. The HemoCue Glucose 201 RT system, consisting of the analyzer and microcuvettes, performs the measurement and calculates the glucose level without direct human interpretation of raw data. The user only provides the blood sample and
reads the displayed result. The description of the device operation and the fact that "the transmittance is measured and the absorbance and glucose level is calculated" within the analyzer confirms its standalone operation.

7. The Type of Ground Truth Used

The ground truth used for this device is based on a traceable reference method:

• "The calibration of the HemoCue Glucose 201 RT system is traceable to the ID GC-MS method."

ID GC-MS (Isotope Dilution Gas Chromatography-Mass Spectrometry) is a highly accurate and precise reference method for glucose determination, often considered a "gold standard."

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. For an in vitro diagnostic device like this, the "training" (calibration) is typically part of the manufacturing process or device design. The device is "factory calibrated" and "needs no further calibration."

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

Given that the device is "factory calibrated" and its calibration is "traceable to the ID GC-MS method," the ground truth for establishing the device's inherent measurement characteristics and calibration was likely established using samples analyzed by the ID GC-MS reference method. These known concentrations would have been used during the manufacturing and calibration process of the analyzers.

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The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.

The HemoCue Hb 301 system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The microcuvette serves both as a pipette and as a measuring cuvette. A blood sample is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Hb 301 Analyzer. The measurement takes place in the analyzer, which measures the absorbance of whole blood at a Hb/HbO.isobestic point. The system is factory calibrated and needs no further calibration.

The provided text describes the HemoCue Hb 301 system, its intended use, and its technological characteristics. It mentions that studies were conducted to demonstrate the performance of the system and that the intended user can easily operate it and obtain expected results. However, the text does not contain specific acceptance criteria or detailed study results that prove the device meets said criteria.

Here's a breakdown of what can be extracted and what information is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The document claims "The HemoCue Hb 301 system is a convenient method for measuring whole blood hemoglobin and can be used by typical users and provide clinical results comparable to other test methods in current clinical laboratory and point-of-care practices." This is a general statement, not a quantifiable acceptance criterion (e.g., accuracy within X%, precision within Y%).
• Reported Device Performance: No specific numerical performance data (e.g., accuracy, precision, correlation coefficients, sensitivity, specificity) is provided. The text only states that the system "provide clinical results comparable to other test methods."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Studies were "conducted in-house, in clinical laboratory settings and point of care centers." Country of origin is not explicitly stated, although the submitter is in Sweden and the contact is in the USA. The text does not indicate whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not specified. The ground truth is described as being established by the hemiglobincyanide (HiCN) method, which is an international reference method. This implies a method-based ground truth rather than expert consensus on individual cases.

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

• Not applicable/Not specified. The ground truth method (HiCN) does not suggest an adjudication process as typically seen in image or subjective interpretation studies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an automated hemoglobin system; it doesn't involve human 'readers' interpreting results in the way an AI medical imaging device might. The comparison is between the automated system and other test methods, not human performance with/without AI assistance.

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

• Yes. The HemoCue Hb 301 system is an automated device, described as an "analyzer" for quantitative determination. The performance studies would inherently be standalone, comparing the device's output to a reference method, rather than involving human interpretation or modification of results.

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

• Method-based ground truth: The HemoCue Hb 301 System is calibrated against the hemiglobincyanide (HiCN) method, which is explicitly stated as "the international reference method for the determination of the hemoglobin concentration in blood."

8. The sample size for the training set

• Not applicable/Not specified. The device is "factory calibrated and needs no further calibration." This suggests that the calibration was done during manufacturing, likely using a set of samples, but the text does not refer to it as a "training set" in the context of machine learning, nor does it provide a sample size.

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

• Not applicable/Not specified as a "training set." The system is "calibrated against the hemiglobincyanide (HiCN) method." This method would have been used to establish the true hemoglobin values for the samples used in the factory calibration process.

In summary, while the document confirms performance studies were conducted, it lacks the specific quantitative details (acceptance criteria, numerical performance results, sample sizes, and expert qualifications) that would be needed to fulfill many of your requested points. The focus of this 510(k) summary is on establishing substantial equivalence to a predicate device (HemoCue Hemoglobin 201 system), rather than providing a detailed breakdown of validation study results with specific performance metrics against pre-defined acceptance criteria.

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The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed system, the HemoCue Albumin 201 analyzer. The system is designed to be used for the quantitative determination of low levels of albumin in urine at the point-of-care for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes. For professional use only.

The HemoCue Albumin 201 analyzing system consists of an analyzer and specially designed microcuvettes. The microcuvette contains reagents deposited on its inner walls. The plastic microcuvette is filled with a urine sample and inserted into the analyzer. Within the analyzer, the contents of the cuvette are mixed through vibration. The immunochemical reaction is completed and the turbidity is measured. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L.

The HemoCue Albumin 201 analyzing system is intended for the quantitative, rapid, turbidimetric immunoassay of albumin in human urine. It is designed for screening, diagnosing, monitoring, and supplementing clinical evidence in the treatment of microalbuminuria.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the device's performance (e.g., a specific correlation coefficient, accuracy range, or precision metric). It broadly states that studies were conducted "to demonstrate the performance of the HemoCue Albumin 201 System and that the intended user can easily operate the system and obtain urinalysis results as the predicate device."

Therefore, the table below will reflect the stated performance goal (equivalence to the predicate device) rather than specific numerical criteria.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions that "Studies were conducted in-house and in clinical settings."

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

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. The system is an automated urinalysis system, which typically relies on laboratory methods or comparison to a reference standard rather than expert interpretation of images or other subjective data.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. Given it's an automated quantitative immunoassay, an adjudication method in the traditional sense (e.g., for diagnostic imaging interpretation) is unlikely to be applicable. Performance is usually assessed by comparison to a reference method or predicate device.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is an automated system; therefore, an MRMC study comparing human readers with and without AI assistance is not relevant in this context.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done. The "Assessment of Performance" section describes studies conducted to "demonstrate the performance of the HemoCue Albumin 201 System." This indicates testing of the algorithm/device itself to show it produces results comparable to the predicate device.

7. Type of Ground Truth Used

Based on the information, the ground truth was established by comparison to a predicate device, the Clinitek 50 Urine Chemistry Analyzer. The statement "obtain urinalysis results as the predicate device" strongly suggests that the Clinitek 50 served as the reference standard for evaluating the HemoCue Albumin 201's performance.

8. Sample Size for the Training Set

The document does not mention the sample size for the training set. Modern immunoassay devices, particularly those relying on established turbidimetric principles, often leverage extensive historical data and chemical principles during development and calibration rather than a distinct "training set" in the machine learning sense. The device is "factory calibrated."

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

The document does not explicitly describe how ground truth for a training set was established. It states the system is "factory calibrated," which implies internal calibration procedures typically using known concentration standards, but details are not provided. The development process likely involved using reference methods (like those used for the predicate device) to establish the accuracy of the system's measurements against known albumin concentrations.

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