Search Results

HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and the HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.

HemoTrol® Duo is an assayed hemoglobin quality control material intended for professional use in the verification of the performance characteristics of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® Duo contains stroma-free bovine hemolysate with hemoglobin in cyanmethemoglobin (CNMetHb) form and a bioburden-controlling agent. For daily quality control, three physiological relevant levels are available.

HemoTrol® Duo solutions are filled in reclosable plastic primary containers. Each bottle contains 1.0 ml of HemoTrol® Duo solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a formal table separate from the performance results. Instead, for "Expected values and Value Assignment," it details "Production acceptance range on Hb301" for batch release and "Label range" calculated from the measured mean. For precision/reproducibility and stability, the acceptance criteria are implied by the reported results being "within the defined acceptance criteria."

Implicit Acceptance Criteria and Reported Device Performance:

• Low: Mean 70.2 g/L, SD 2.0 g/L, CV 2.9%
• Normal: Mean 129.8 g/L, SD 3.2 g/L, CV 2.4%
• High: Mean 168.6 g/L, SD 3.8 g/L, CV 2.2%
  HemoCue Hb801 System:
• Low: Mean 65.0 g/L, SD 1.1 g/L, CV 1.7%
• Normal: Mean 117.0 g/L, SD 1.5 g/L, CV 1.2%
• High: Mean 154.5 g/L, SD 1.6 g/L, CV 1.0% |
  | Open Vial Stability | Duration (days) at 30°C | "is stable for 31 days when stored at 30℃." (This is both the criterion and the result based on the study). | 31 days stable when stored at 30°C. |
  | Closed Vial Stability | Duration (days) at 2-8°C | "is stable for 336 days when stored at 2-8ºC." (This is both the criterion and the result based on the study). | 336 days stable when stored at 2-8°C. |
  | Value Assignment (Batch Release for Hb301) | Mean value (g/L) | - Low: 70.0 ± 2.5 g/L
• Normal: 130.0 ± 2.5 g/L
• High: 170.0 ± 2.5 g/L | Not explicitly reported as device performance for new batches, but the method for achieving this is described. The batch "can be released for value assignment" if it meets these ranges. |
  | Value Assignment (Label Range for Hb801) | Label range (g/L) | - Low: Measured mean ± 12
• Normal: Measured mean ± 21
• High: Measured mean ± 27 | Not explicitly reported as a performance metric, but rather a calculation method for the assigned value and range. |

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

• Precision/Reproducibility:

  • Sample Size: Three batches of control material for each of the three levels (Low, Normal, High), tested with five replicates per day over five operating days on 3 sites. This totals to 3 batches * 3 levels * 5 replicates * 5 days * 3 sites = 675 individual measurements per analyzer system (Hb301 and Hb801).
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study was conducted to demonstrate device performance, implying a prospective study design for this submission.

• Open Stability:

  • Sample Size: Nine batches (3 batches of each level), monitored at three time points for a total of 34 days.
  • Data Provenance: Not explicitly stated.

• Closed Stability:

  • Sample Size: 21 batches of control material (3 batches of the three HemoTrol Duo levels "9 in total" suggests 9 batches tested, 3 per level, which were then monitored to determine shelf life, potentially across different production runs?). The phrasing "21 batches of a quality control were monitored" and then "Three (3) batches of the three HemoTrol Duo levels (9 in total)" is a bit conflicting. It safely confirms at least 9 batches (3 per level) were used, monitored up to 337 days.
  • Data Provenance: Not explicitly stated.

• Value Assignment (Batch Release):

  • Sample Size: Three samples of control materials (presumably from a batch being assessed) evaluated on three HemoCue Hb301 Systems, with three batches of microcuvettes. Each sample is measured once per microcuvette batch, providing 27 replicates per analyzer being qualified. This is a batch release process, not a test set for the device's overall performance.
  • Data Provenance: Not explicitly stated; refers to ongoing production processes.

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

N/A. This device is a quality control material for an analyzer system (HemoCue Hb 301 and Hb 801). The "ground truth" (or target values) for the control material is established through objective laboratory measurements on the respective analyzer systems, not through expert consensus on qualitative data or imaging. Therefore, no experts in the conventional sense (e.g., radiologists) are involved in establishing the ground truth of the control material itself.

4. Adjudication Method

N/A. As the ground truth is established by objective measurements on the specified analyzer systems, there is no need for an adjudication method by human experts. The process for "Value Assignment" described (mean of 27 measurements) serves a similar purpose of establishing a reliable target value.

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

No. An MRMC study is typically used for diagnostic devices that involve human interpretation (e.g., medical imaging). This device is a quality control material, which is measured objectively by an automated or semi-automated analyzer.

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

Yes, implicitly. The performance data for precision/reproducibility and stability are measurements of the control material's characteristics when analyzed by the HemoCue Hb 301 and Hb 801 systems, which are objective measurement devices. Human involvement is primarily in operating the system and recording results, not in interpreting qualitative data, making this essentially a standalone performance assessment of the control material with the specified analyzers.

7. Type of Ground Truth Used

The ground truth for HemoTrol® Duo is established through objective, quantitative measurements of hemoglobin concentration using the HemoCue® Hb 301 and HemoCue® Hb 801 Systems. This is akin to a reference measurement or instrument-generated data, where the analyzer itself defines the 'truth' for the control material within its operational parameters.

8. Sample Size for the Training Set

N/A. This device is a quality control material and is not an AI/ML algorithm that requires a training set. The descriptions of "batches" refer to manufacturing lots of the control material, not data used for training an algorithm.

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

N/A. As above, this device does not involve an AI/ML algorithm or a training set.

Ask a specific question about this device

The Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered.

MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission.

MDW values greater than 20.0 should be interpreted in association with other clinical information and diagnostic testing, as a proportion of patients without sepsis may have an elevated MDW value at baseline.

MDW values less than or equal to 20.0 cannot rule out sepsis or the development of sepsis within 12 hours of hospital admission. The Early Sepsis Indicator should not be used as the sole basis to determine the absence of sepsis.

The predictive value of the Early Sepsis Indicator for identifying sepsis in patients with hematological abnormalities has not been established.

The Early Sepsis Indicator (ESI) requires the use of the UniCel DxH 800 Coulter Cellular Analysis System (DxH 800) and its reagents, controls and calibrators last cleared under 510(k) K140911.

The UniCel DxH 800 Coulter Cellular Analysis System contains a quantitative, automated hematology analyzer (DxH 800) designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). This submission adds a new parameter, Monocyte Distribution Width (MDW) to those mentioned above. This parameter has been shown to aid in the early detection of Sepsis in emergency room patients.

The system consists of two primary components, the workstation and the DxH 800 analyzer as shown in Figure 1. DxH 800 System Configuration. The primary function of the DxH 800 analyzer is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing and storage and external communications. The analyzer runs embedded code and the workstation runs Microsoft Windows 7 Operating System (OS).

Here's the breakdown of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance for UniCel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

The device is intended for the quantitative measurement of Monocyte Distribution Width (MDW) to aid in identifying adult patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission. The key acceptance criterion for clinical accuracy revolves around sensitivity and specificity at a specified MDW cut-off.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the study demonstrated that an MDW cut-off of 20.0 units provided an optimum diagnostic ability by balancing the ability to detect positive patients (sensitivity) and negative patients (specificity), and thus this cut-off was selected. Detailed numerical values for sensitivity and specificity at this cut-off are not explicitly provided in the table, but the text assures they met the acceptance criteria.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated for the "test set" in a distinct way, but the "Clinical Accuracy" study states it was a "multi-center prospective cohort study."
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Primarily prospective. The clinical accuracy study was a "multi-center prospective cohort study."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Note: The document mentions "clinical information and diagnostic testing" and "other laboratory findings" were used in conjunction with MDW values, implying expert judgment in establishing the ground truth for sepsis diagnosis.

4. Adjudication Method

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device measures a quantitative biomarker (MDW) from a blood sample, not something interpreted by human readers from images or complex data.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the fundamental performance assessed is the standalone diagnostic ability of the MDW parameter as an aid in identifying sepsis. The clinical accuracy study directly evaluated the MDW parameter's performance in detecting sepsis.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for sepsis diagnosis was established based on "other laboratory findings and clinical information" and "diagnostic testing." This suggests a comprehensive clinical diagnosis of sepsis, likely involving a combination of clinical assessment, laboratory parameters (beyond MDW), and potentially culture results or other confirmatory tests, as determined by clinicians.

8. Sample Size for Training Set

• Sample Size for Training Set: Not explicitly stated as a separate "training set" in the context of machine learning model development. The document focuses on the validation of the MDW parameter and its cut-off.

Note: The MDW parameter itself is a quantitative measurement derived from hematology analyzer data, not a machine learning model that would typically have a distinct training set in the conventional sense. The "training" or development of the algorithm to calculate MDW would have occurred prior to this validation study, but details are not provided here.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not specified, as a distinct training set for a machine learning model is not explicitly mentioned or implied for the MDW parameter's development in this document. The MDW value is a quantitative measurement from the analyzer, not a diagnosis itself.

Ask a specific question about this device

HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.

HemoTrol® WB is an assayed hemoglobin quality control material intended for professional use in the verification of the precision and accuracy of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® WB contains bovine red blood cells with hemoglobin lysates in MetHb and additional stabilizers. For daily quality control, three physiological relevant levels are available.

HemoTrol® WB solutions are filled in reclosable plastic primary containers. Each bottle contains 1.1 g of HemoTrol® WB solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.

The provided text is a 510(k) summary for a medical device (HemoTrol® WB) and focuses on establishing substantial equivalence to a predicate device. It describes performance data related to stability testing of the quality control material itself, rather than a clinical study evaluating the performance of an AI-powered diagnostic device in a patient population.

Therefore, the information required to answer your query about acceptance criteria and study proving a device meets acceptance criteria, specifically for an AI/diagnostic device, is not present in the provided text. The document describes:

1. Device: HemoTrol® WB (a quality control material for hemoglobin measurement, not an AI diagnostic device).
2. Purpose: To demonstrate substantial equivalence to a predicate quality control device (Eurotrol HemoTrol).
3. Performance Data: Focuses on stability of the quality control material (open-vial and closed-vial stability), not diagnostic performance metrics like sensitivity, specificity, or reader improvement in an MRMC study.

Here's a breakdown of why I cannot fulfill your request based on this document:

• Acceptance Criteria for AI/Diagnostic Performance: The text does not mention any acceptance criteria for sensitivity, specificity, AUC, or other typical metrics for an AI or diagnostic device. The "acceptance criteria" presented here implicitly relate to demonstrating stability within acceptable ranges for a quality control material.
• Study Proving Acceptance Criteria: The studies described ("Open Stability" and "Closed Stability") are designed to show how long the quality control material remains stable, not to evaluate the performance of an AI or diagnostic device against a ground truth in a clinical setting.
• Sample Size (Test Set): Not applicable in the context of an AI/diagnostic test set. For stability testing, the sample size was "n=6" for open stability and "n=8" for closed stability.
• Data Provenance: Not relevant for these stability tests. The "samples used were produced according the regular production process of HemoTrol® WB."
• Experts for Ground Truth: Not applicable. Ground truth for stability is measurement against a known reference method for hemoglobin on specific analyzers (HemoCue® Hb 301 and HemoCue® Hb 801 systems).
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Study: Not performed, as this is a quality control material, not a diagnostic device for human interpretation.
• Standalone (Algorithm Only) Performance: Not applicable.
• Type of Ground Truth: For stability, the ground truth is the measured hemoglobin value on the specified HemoCue systems.
• Training Set Sample Size: Not applicable, as this is not an AI/machine learning device requiring a training set.
• Ground Truth for Training Set: Not applicable.

To answer your detailed questions, you would need a document that describes the clinical performance evaluation of an AI-powered diagnostic device in a patient population.

Ask a specific question about this device

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.

Ask a specific question about this device

XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

RBC(106/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F*(103/μL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/pL), LYMPH#(103/pL), MONO# (103/pL), BASO#(103/pL), IG#(103/ μL), IPF(%), IPF# (103/pL), RET#(106/μL), RET%, IRF%, RET-HE(pg), NRBC#* (100 WBC)

*Not Available on the XN-L.

XN CHECK™ is a three level hematology control the following: stabilized red blood cell component(s), stabilized white blood cell component(s) stabilized platelet component(s), and stablic on onnonent(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

The provided text is a 510(k) Summary for the XN CHECK™ hematology quality control mixture. It details the device's intended use, comparison to a predicate device, and conclusions from tests. However, it does not fully elaborate on the detailed acceptance criteria for each claimed parameter or explicitly describe the "study that proves the device meets the acceptance criteria" in terms of specific statistical analyses, sample sizes for test sets with ground truth, expert qualifications, or multi-reader studies.

Therefore, many of the requested details cannot be extracted directly from this document. The information provided is at a high level, focusing on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "XN CHECK is used for control and calibration verification... and that the product is stable for the entire product dating." It also mentions "reproducible" and "stable" in the conclusions. However, it does not provide specific numerical acceptance criteria (e.g., maximum allowable coefficient of variation for precision, or specific stability limits for each parameter) nor quantified performance data for each of the numerous assayed parameters. It only describes the types of studies conducted.

Ask a specific question about this device

XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include:

RBC (10^6/uL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10^3/uL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10^3/uL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10^3/uL), LYMPH# (10^3/μL), MONO# (10^3/μL), EO# (10^3/μL), BASO# (10^3/μL), IG# (10^3/μL), RET# (10^6/uL), RET%, IRF%, RET-He (pg).

XN-L CHECK™ is an in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology product that contains the following stabilized red blood cell component(s), stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vias with screw caps with a 3 ml fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

The provided document is a 510(k) premarket notification for a medical device called "XN-L CHECK™", a hematology quality control mixture. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria, study details, or results in the format requested.

The document broadly states:

• "The resultant data set established that XN-L CHECK is safe and effective for its intended use and that the product is stable for the entire product dating."
• "Study results show XN-L CHECK to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating."

It mentions the following types of studies were conducted:

• Multi-Site Precision Study
• Single-Site Precision Study
• Open-Vial Stability
• Closed-Vial Stability

However, it does not provide any quantitative acceptance criteria or the reported device performance measurements for these studies. Therefore, I cannot generate the requested table or answer most of the specific questions about sample sizes, ground truth, expert involvement, or MRMC studies.

Based on the information available, here's what can be inferred or explicitly stated:

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

• Cannot be provided. The document states that performance data was collected and the device was found safe, effective, and stable, but it does not specify the numerical acceptance criteria (e.g., specific thresholds for precision or stability over time) or the actual reported performance values.

2. Sample size used for the test set and the data provenance

• Cannot be provided. The document mentions "Multi-Site Precision Study, Single-Site Precision Study, Open-Vial Stability and Closed-Vial Stability" but does not specify the sample sizes (number of samples, runs, instruments, or sites) used for these studies, nor the provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable / Cannot be provided. This device is a quality control mixture and not an interpretive AI device that would require expert adjudication for a diagnostic ground truth. The "ground truth" for a quality control device typically involves reference methods or established performance specifications of the analyzer it controls. The document does not mention any experts in the context of establishing ground truth for testing.

4. Adjudication method for the test set

• Not applicable / Cannot be provided. As explained in point 3, this is a quality control material, not a diagnostic device requiring expert interpretation and adjudication of results for a reference standard.

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

• No. This device is a hematology quality control mixture, not an AI-assisted diagnostic tool, so an MRMC study is not relevant or mentioned.

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

• Not applicable / Cannot be provided. This is not an algorithm or AI device. It's a physical control material used to assess the performance of a hematology analyzer.

7. The type of ground truth used

• Inferred: For a quality control mixture, the "ground truth" or reference values are typically established through extensive testing against highly accurate reference methods or by comparison to another established quality control material (the predicate device in this case) on the target analyzer. The document doesn't explicitly state the "type of ground truth" but implies it involves demonstrating "consistent reproducibility" and "substantial equivalence to the predicate products."

8. The sample size for the training set

• Not applicable / Cannot be provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

• Not applicable / Cannot be provided. As explained in point 8, there's no training set for this type of device.

Ask a specific question about this device

XN CHECK BF is used for control and calibration of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (10^3/μL), RBC-BF (10^6/μL), MN# (10^3/μL), PMN# (10^3/μL), MN%, PMN%, TC-BF# (10^3/uL)

XN CHECK™ BF is an in-vitro diagnostic, two level, control. It contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. Product storage conditions are 2 - 8° C.

The provided document is a 510(k) premarket notification for a medical device called "XN CHECK BF." This device is a hematology quality control mixture, and the submission is for a new iteration of an already marketed product (K141957). The primary change in the new device is the addition of compatibility with the Sysmex XN-L analyzer.

The document does not contain the information requested regarding acceptance criteria for an AI/ML device, the study to prove it meets those criteria, sample sizes, expert involvement, or MRMC studies. This is because XN CHECK BF is a quality control material for laboratory analyzers, not an AI/ML diagnostic or image analysis device.

Therefore, I cannot extract the requested information from the provided text. The document focuses on performance testing relevant to a quality control material, such as precision and stability studies, which are different from the types of studies performed for AI/ML diagnostic tools.

To answer your request, I would need a document describing the regulatory submission for an AI/ML-driven medical device.

Ask a specific question about this device

The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of sodium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of electrolyte balance.

Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Chloride (Cl-) measurements are used in the diagnosis and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

GEM System Evaluator is a three-level assayed quality control material for evaluating performance characteristics of pH, pCO2, pO2, Electrolytes, Metabolites, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 and GEM Premier 5000 analyzers.

GEM Hematocrit Evaluator is a three-level assayed quality control material intended for evaluating performance characteristics of hematocrit on the GEM Premier 4000 and GEM Premier 5000 analyzers.

GEM CVP 5 tBili is an external Calibration Valuation Product used to complete the callbration process of the GEM Premier 4000 and GEM Premier 5000 analyzers prior to use with patient samples for total bilirubin (tBili) testing.

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of sodium and ionized calcium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood.

Key Components:
Analyzer: Employs a unique color touch screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox/tBili optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency.
Intelligent Quality Management 2 (iQM2): iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System, Sensor, IntraSpect, Pattern Recognition and Stability Checks.

Here's a summary of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Device: GEM Premier 5000 (Measured Parameters: Sodium, Potassium, Chloride, Ionized Calcium) and associated evaluators.

Clinical Context: Rapid analysis of heparinized whole blood samples in clinical and central laboratory settings for diagnosis and treatment of electrolyte imbalances.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with numerical targets for each performance metric, but rather presents the results of various studies and states that "all results were within specification" or "all parameter levels passed specification," implying that the observed performance met predefined internal acceptance criteria.

Below is a table summarizing the reported device performance from the various studies. The "Acceptance Criteria" column reflects the implied successful performance indicated by the text.

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:

  • Internal Precision (Aqueous Controls): 120 replicates per control level per analyte (3 analyzers x 20 days x 2 runs/day x 1 replicate = 120).
  • Internal Precision (Process Control Solutions D & E): 120 replicates per PCS per analyte (3 analyzers x 20 days x 2 runs/day x 1 replicate = 120).
  • Internal Precision (Whole Blood): 120 replicates per concentration level per analyte (3 analyzers x 5 days x 1 run/day x 8 replicates = 120).
  • Reproducibility (Aqueous Controls - POC): 90 replicates per control level per analyte (3 sites x 3 replicates/run x 2 runs/day x 5 days = 90).
  • External Precision (Whole Blood):
    • POC Sites: 30-54 samples for Na+, 30-54 for K+, 30-54 for Cl-, 27-54 for Ca++ (per site)
    • Central Labs (Lab1, Lab2) / CSL: 30-33 samples for Na+, 30-33 for K+, 30-36 for Cl-, 27-33 for Ca++ (per site/lab)
  • Linearity: 9 or 10 levels per analyte, each analyzed in triplicate (9-10 levels x 3 replicates per level = 27-30 measurements per analyte).
  • Method Comparison (GEM Premier 5000 vs. GEM Premier 4000): 373 samples for each analyte (Na+, K+, Cl-, Ca++).
  • Clinical Testing (Normal Mode Syringe Samples): 485-491 samples per analyte.
  • Clinical Testing (Native Capillary Samples): 171 samples for Na+ and Ca++.
  • Clinical Testing (Pooled Native & Contrived Capillary Samples): 201 samples for Na+, 205 samples for Ca++.

• Data Provenance: The data is a mix of internal studies (Instrumentation Laboratory Co.) and external studies at clinical point-of-care (POC) sites and central laboratories.

  • Internal Studies: Conducted by Instrumentation Laboratory Co. (Bedford, MA, USA). Some CSL (Customer Simulation Laboratory) data included contrived samples.
  • External Studies: Performed at:
    • Three (3) external clinical point-of-care (POC) sites.
    • Two (2) external central laboratories.
    • One (1) internal Customer Simulation Laboratory (CSL) at IL, with POC users.
  • Retrospective/Prospective: The studies appear to be prospective, designed specifically to evaluate the GEM Premier 5000's performance as per CLSI guidelines. The whole blood samples used in precision and method comparison studies include both native patient samples and, in some cases, contrived samples. The native clinical samples would be analogous to retrospective data if collected prior, but the studies describe active collection and testing to compare performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly mention the number or qualifications of "experts" used to establish ground truth in the traditional sense (e.g., radiologists, pathologists). Instead, laboratory reference methods and predicate devices are used as the "ground truth" or reference for comparison.

• Ground Truth for Analytical Studies:
  • Traceability: For Process Control Solutions (PCS), it states "traceable to NIST standards, CLSI procedures or internal standards."
  • Reference Analyzers: For Linearity, results were "compared to reference analyzers."
  • Predicate Device: For Method Comparison and Clinical Testing, the GEM Premier 4000 (K133407) served as the predicate device for comparison.

Since this is a clinical chemistry device for measuring electrolytes, the "ground truth" is typically established by highly calibrated and validated laboratory reference methods or proven predicate devices, rather than expert interpretation of images or clinical assessments.

4. Adjudication Method

Not applicable for this type of device performance study. Adjudication methods (like 2+1 or 3+1 expert consensus) are typically used in studies involving subjective assessments, such as radiology image interpretation, to establish a definitive ground truth when there might be inter-reader variability. For quantitative measurements by clinical chemistry analyzers, the ground truth is established by objective reference methods or well-characterized predicate devices.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are specific to evaluating the impact of an AI system on human reader performance, often in diagnostic imaging. This document describes the analytical and clinical performance of a clinical chemistry device, which does not involve human "readers" interpreting cases in the same way. The studies focus on the device's accuracy, precision, linearity, and comparability to a predicate device.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was conducted for the device. The entire suite of analytical and clinical studies (precision, linearity, analytical specificity, method comparison) evaluates the performance of the GEM Premier 5000 system (which includes its embedded processing/algorithm) as a standalone diagnostic tool without direct human-in-the-loop interpretation of results that would alter the quantitative measurement it produces. The output values are direct physical measurements.

7. Type of Ground Truth Used

The ground truth used for this device includes:

• Reference Methods/Standards: For internal precision and calibration, traceability to NIST standards, CLSI procedures, or internal standards is mentioned for Process Control Solutions. "Reference analyzers" were used for linearity comparisons.
• Predicate Device Performance: For method comparison and clinical testing, the GEM Premier 4000 served as the gold standard or reference for comparison, indicating substantial equivalence.
• Known Concentrations: Contrived samples (e.g., in the CSL) were used to cover medical decision levels, implying that their concentrations were known or precisely measured by a separate method.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. Given that this is a 510(k) submission for an in vitro diagnostic device, the "training" for such devices typically refers to the extensive development and internal testing/calibration cycles that occur before formal validation studies (like those presented in the performance section) are conducted. These early development data sets are generally not disclosed in 510(k) summaries but are part of the design control process. The performance data presented are from validation studies, which serve as the test set.

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

As noted above, a distinct "training set" with established ground truth in the AI/ML sense is not detailed. However, the process for establishing "ground truth" during device development (analogous to training) would involve:

• Calibration Standards: Using certified reference materials and multi-point calibration procedures to ensure the device's sensors and algorithms accurately translate raw signals into quantitative concentrations.
• Inter-Instrument Reproducibility: Extensive internal testing against known values to optimize sensor performance and ensure consistency across multiple manufacturing units.
• Method Development & Optimization: Iterative testing with various samples (potentially including contrived and real patient samples) to refine the measurement algorithms and internal quality control mechanisms (like iQM2) to detect and correct errors. These steps would ensure measurements align with established reference methods or predicate devices.

Ask a specific question about this device

BC-5D is an assayed whole blood control designed for Mindray BC-5390 (Mindray 5000 series) Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD. PLT. and MPV.

The BC-5D Hematology Control consists of three levels of controls (Low, Normal, and High). It is recommended to perform quality control check using these controls established by the laboratory procedures and/or local/national regulations.

BC-5D Hematology Control is an in vitro diagnostic reagent composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives. This control is contains stabilized materials that provide a means of monitoring the performance of hematology blood cell counters. It is sampled in the same manner as a patient specimen.

Here's an analysis of the acceptance criteria and study information for the BC-5D Hematology Controls, based on the provided text, while noting limitations due to the document's nature as an FDA 510(k) summary, which often doesn't contain detailed study protocols:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states, "The BC-5D Hematology Control met the acceptance criteria, as determined during verification, over the life of the product." However, it does not explicitly list the quantitative acceptance criteria for each parameter (WBC, Neu#, Lym#, etc.) nor does it provide a table of the reported device performance values against those criteria. It only indicates that the device met the criteria.

Without the specific numerical ranges for acceptance criteria and the actual performance data, a table like the one requested cannot be constructed from the given text. The relevant section notes that an "assay range" was determined for each parameter, and subsequent validation lots "met the acceptance criteria." This implies that the acceptance criteria revolved around the ability of the control to consistently fall within these established assay ranges.

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

• Sample Size (Test Set): The study involved testing "3 validation lots" of BC-5D Hematology Controls. The document does not specify the number of individual control samples tested within each lot or the number of measurements taken for each parameter.
• Data Provenance: Not explicitly stated, but as a commercial product seeking FDA clearance in the U.S., it's implied that the testing was conducted in a laboratory setting. The data is prospective in the sense that these validation lots were manufactured and tested specifically for the 510(k) submission. No information is given about the country of origin of the data beyond the applicant being R&D Systems, Inc. in Minneapolis, MN, USA.

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

This information is not applicable and therefore not provided in the document because:

• The device is a hematology quality control (QC) mixture, not a diagnostic device that relies on expert human interpretation of results (like an imaging device or a histological slide).
• The "ground truth" for a QC material is its assayed value, typically established by the manufacturer through rigorous testing using a reference method or consensus methods, not by "experts" in the sense of clinicians or radiologists interpreting results.

4. Adjudication Method for the Test Set

This is not applicable and therefore not provided for the same reasons as point 3. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in human expert interpretations, which is not relevant for a quality control material where performance is assessed against pre-defined numerical ranges.

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 (e.g., radiologists, pathologists) interpret data, and the effect of AI assistance on their performance is evaluated.
• The BC-5D Hematology Control is a quality control material for an automated hematology analyzer. It does not involve human interpretation or AI assistance in the diagnostic process itself. Its purpose is to monitor the performance of the analyzer.

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

This question is not directly applicable in the context of this device.

• The BC-5D is a control material, not an algorithm. Its "performance" is its ability to produce consistent and accurate results within its specified assay range when run on the Mindray BC-5390 Hematology Analyzer.
• The analyzer itself (Mindray BC-5390) performs in a "standalone" fashion (algorithm-only processing of samples). The control is used to verify that this standalone analyzer is functioning correctly.
• The study did evaluate the performance of the control material (i.e., its own characteristics like stability and assayed values) without human intervention in the result generation, but this isn't the typical "standalone algorithm performance" evaluation for a diagnostic AI device.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) for a hematology quality control material is its assayed value for each parameter. These values are established by the manufacturer through a combination of:

• Reference methods: Using highly accurate and precise analytical methods.
• Consensus values: Often by analyzing the control material on multiple instruments or by comparing with primary reference standards.
• The document implies that an "assay range" for each parameter was determined during the "manufacture and analysis of three verification lots." This "assay range" essentially defines the expected "ground truth" for the control material when it is functioning correctly.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided.

• "Training set" refers to data used to train a machine learning algorithm.
• The BC-5D Hematology Control is a physical control material, not a machine learning algorithm. Therefore, there is no "training set" in this context.

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

This information is not applicable and therefore not provided for the same reasons as point 8.

Ask a specific question about this device

The i15 Blood Gas and Chemistry Analysis System (including Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge) is a portable, automated system that measures pH and blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca++, Cl-) and hematocrit in arterial and venous whole blood samples with lithium heparin or calcium balanced heparin. The system is intended for in-vitro diagnostic use only by trained health care professionals in a laboratory environment, near patient or point-of-care settings.

pH, pCO2, pO2: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base and/or oxygenation disturbances.
Hct: Whole blood measurements of the packed cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red blood cells)
Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
K+: Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels
Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ca++: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The EDAN i15 Calibrant Fluid Pack is intended for the calibration of pH, pO2, pCO2, Na+, K+ Ca++, Cl-, and Hct as part of the EDAN i15 Blood Gas and Chemistry Analysis System.

The EDAN i15 Blood Gas and Electrolyte Controls are external multi-analyte quality control material intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Electrolyte Analyze, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of pH, blood gases (pCO2 pO2), and electrolytes (Na+, K+, Ca++, and Cl').

The EDAN i15 Hematocrit Controls are intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Chemistry Analysis System, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of hematocrit.

The EDAN i15 Blood Gas and Chemistry Analysis System, including the Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge, and Quality Controls) is a system for in-vitro analysis of whole blood, delivering quantitative results for panels of tests determined by the Test Cartridge type used in the measurement. The Analyzer incorporates a large graphical user interface with a large color touch screen interfacing the analyzer electronic, Test Cartridge (containing the sensors) and Calibrant Fluid Pack. The sensors, flow path and waste are integrated into a single-use Test Cartridge. The calibration solution is contained in the Calibrant Fluid Pack which is available in versions for 50 or 100 tests. The product, consumables, installation instructions and packaging are designed for easy customer installation and operation.

The EDAN i15 Analyzer accepts lithium- or calcium-balanced heparinized whole blood samples from syringes and capillary tube. The minimum volume for samples from both syringe and capillary tube is 140 µL.

As with the predicate device, the EDAN i15 Blood Gas and Chemistry Analysis System is microprocessor-based and incorporates traditional sensor technology for measurement.

• pH, pCO2, Na*, K*, Cl , and Ca** (potentiometric measurement) .
• pO2 (amperometric measurement)
• Hct (conductivity measurement) ●

The Test Cartridge is available in three (3) versions, with different test panels, but with identical sample paths and calibration fluid:
BG8: pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct
BG3: pH, pCO2, pO2
BC4: Na+, K+, Cl-, Ca++, Hct

The Test Cartridge aspirates the sample directly from a syringe, or capillary fitted with an adaptor, and requires a minimum sample volume of 140 µL.

The provided text describes the performance testing and acceptance criteria for the EDAN i15 Blood Gas and Chemistry Analysis System.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device