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HemoCue HemoTrol control is compared to the HemoCue Whole Blood Control, manufactured for HemoCue by Streck Laboratories, Inc., 14306 Industrial Road, Omaha, Nebraska, 68144. Product descriptions, intended use and assay values for this product are included for comparison.

These two products are similar in matrix, chemical composition, technological characteristics, intended use, and packaging specifications.

This document describes a 510(k) submission for the HemoCue HemoTrol control solution. It focuses on demonstrating substantial equivalence to an existing device, not on the performance of a diagnostic device that detects a disease or condition. Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable.

However, I can extract and interpret the available information in the context of demonstrating substantial equivalence for a control solution.

Here's an adaptation of your requested format based on the provided text:

Acceptance Criteria and Study for HemoCue HemoTrol Control Solution

The objective of the studies described is to demonstrate "substantial equivalence" of the HemoCue HemoTrol control solution to the predicate device, HemoCue Whole Blood Control (manufactured by Streck Laboratories). The acceptance criteria are implicitly related to the predicate device's performance and established norms for control solutions (e.g., stability, precision, compatibility).

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a control solution and the provided text, the "acceptance criteria" are implied by the comparison to the predicate device. The performance is reported in terms of demonstrating comparability rather than meeting specific clinical thresholds for diagnosing a condition.

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

• Sample Size for Test Set:
  • Shelf Life Studies: "a variety of production lots" were used over periods ranging from 0 to 876 days. The exact number of lots or individual units within each lot is not specified.
  • Precision Study: Three (3) levels of HemoTrol were tested, and each level was subjected to "replicates of 10" measurements. This implies a total of 30 measurements per analyzer type for HemoTrol (3 levels x 10 replicates). The same would apply to the predicate device for comparison. The study was conducted on three (3) different HemoCue B-Hemoglobin analyzers.
• Data Provenance: The document implies the studies were conducted by HemoCue or their contractors. The predicate device's manufacturer (Streck Laboratories, Inc.) is located in Omaha, Nebraska, USA. The data provenance (country of origin) for the studies themselves is not explicitly stated but would likely be where HemoCue (originating from Sweden) or its US operations conducted the testing. The data is prospective in nature, as these are controlled laboratory tests conducted to evaluate the product.

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

This question is not applicable to a control solution's substantial equivalence submission. "Ground truth" in this context would generally refer to the established assay values for the control solution, which are determined by the manufacturer through precise analytical methods, not by expert consensus in the typical sense of clinical image interpretation or diagnosis. The predicate device's assay values serve as the comparative ground for demonstrating equivalence.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1) are typically used in clinical studies where human interpretation of medical images or patient data is involved to resolve discrepancies. For analytical performance studies of a control solution, the results are quantitative measurements, not subjective interpretations requiring adjudication.

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

No, an MRMC study was not done. MRMC studies are relevant for evaluating diagnostic devices where human readers interpret medical cases. This submission is for a control solution, which is used to verify the performance of an analytical instrument, not a diagnostic device interpreted by human readers.

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

This question is not directly applicable. The "device" in this submission is a chemical control solution, not an algorithm or an AI system. The performance evaluated is that of the control solution itself when measured by an analytical instrument (HemoCue B-Hemoglobin analyzers), which operates without human interpretation in the measurement process. The studies focused on the performance of the material (HemoTrol) itself, such as its stability and its ability to produce consistent, comparable results on the analyzers.

7. The Type of Ground Truth Used

The "ground truth" for these studies is the established analytical values or expected performance characteristics of both the HemoCue HemoTrol and its predicate device, HemoCue Whole Blood Control (manufactured by Streck Laboratories).

• For shelf-life and open-vial stability, the ground truth is the expected stability profile and maintenance of established assay values over time.
• For precision, the ground truth is the inherent variability and reproducibility of the measurements, compared to the known precision of the predicate device.
• For accuracy, the ground truth is the proximity of the HemoTrol's measured values to its established target values and consistency with the predicate device's established values.

This is based on analytical laboratory data and pre-defined specifications, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The HemoCue HemoTrol is a chemical control solution.

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

Not applicable, as there is no training set for this type of device.

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

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This document is a 510(k) summary for the HemoCue GlucoTrol, a control solution for glucose meters, and does not describe a clinical study for a medical device that measures a physiological state or disease. Therefore, much of the requested information (acceptance criteria for a device's performance, sample sizes for test/training sets, expert involvement, MRMC studies, standalone performance, ground truth types) is not applicable in the context of this submission, which focuses on demonstrating substantial equivalence of a control solution to an existing control solution.

However, I can extract the relevant information from the provided text regarding the demonstration of substantial equivalency for the HemoCue GlucoTrol control solution.

Here's the breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:

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

The document does not specify formal "acceptance criteria" in the sense of performance thresholds for a diagnostic device (e.g., sensitivity, specificity). Instead, it focuses on demonstrating comparability to an existing predicate device (HemoCue Whole Blood Control) in terms of various characteristics for a control solution.

The "performance" is implicitly demonstrated through stability, precision, and compatibility studies. There are no numerical performance metrics provided in this summary that would typically be associated with a diagnostic device.

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:
  • For the precision study comparing GlucoTrol to the predicate: "five (5) levels of HemoCue GlucoTrol as compared to three (3) levels of HemoCue Whole Blood Control (manufactured by Streck Laboratories), measured on five different HemoCue B-Glucose analyzers, in replicates of six (6)."
    • This means for the GlucoTrol: 5 levels * 5 analyzers * 6 replicates = 150 measurements.
    • For the predicate: 3 levels * 5 analyzers * 6 replicates = 90 measurements.
  • For other studies (open vial, closed vial stability, day-to-day precision), specific sample sizes are not detailed in this summary, other than generally being "test data."
• Data Provenance: Not specified in the summary. Given the companies (HemoCue, Streck Laboratories) and the submission to FDA, it is highly likely the data were generated in the US or Europe, but this is not explicitly stated.
• Retrospective or Prospective: Not specified, but typically, stability and precision studies for a control solution like this would be conducted prospectively in a lab setting.

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)

• N/A. This is a control solution, not a diagnostic device requiring expert interpretation of results to establish ground truth about a patient's condition. The "ground truth" for a control solution is its specified analyte concentration, and the validation focuses on stability and precision around that concentration.

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

• N/A. Adjudication methods are relevant for studies involving human interpretation or complex disease diagnosis, not for the analytical performance of a control solution in a laboratory setting.

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

• N/A. This submission is for a control solution, which does not involve human readers interpreting cases or AI assistance.

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

• N/A. This is for a control solution, not an algorithm or a diagnostic device, so the concept of "standalone performance" in this context is not applicable. The performance described is the analytical performance of the control solution itself.

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

• The "ground truth" in this context refers to the assigned values or target concentrations for glucose levels in the control solution. These values would have been established through a highly accurate reference method during the manufacturing process of the control solution. The testing then verifies that the control solution maintains these values over time and exhibits acceptable precision when measured by the intended analyzer.

8. The sample size for the training set

• N/A. Control solutions generally do not have a "training set" in the machine learning sense. The studies described are validation and characterization studies.

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

• N/A. See point 8.

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Not Found

Not Found

The provided document is a 510(k) notification for HemoCue HemoLin, a control solution used for HemoCue B-Hemoglobin analyzers. It primarily focuses on demonstrating substantial equivalence to a predicate device (HemoCue Whole Blood Control manufactured by Streck Laboratories) rather than presenting a study of a medical device's performance against specific acceptance criteria for a diagnostic claim. Therefore, much of the requested information about device performance, ground truth, expert involvement, and reader studies is not applicable or cannot be extracted from this document.

However, I can extract the information related to the control solution's performance where applicable.

Here's the information that can be extracted or deduced:

1. A table of acceptance criteria and the reported device performance
   This document focuses on demonstrating comparable precision and accuracy to a predicate control device rather than stating specific acceptance criteria for "device performance" in terms of diagnostic accuracy. The performance mentioned is for the control solution itself.

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

   • Test Set Description: "A precision study of five (5) levels of HemoCue HemoLin as compared to three (3) levels of HemoCue Whole Blood Control (manufactured by Streck Laboratories), measured on three (3) different HemoCue B-Hemoglobin analyzers, in replicates of 10."
   • Sample Size (Test Set): For the precision study, 5 levels of HemoLin x 10 replicates each = 50 measurements. 3 levels of predicate control x 10 replicates each = 30 measurements. Total of 80 measurements for precision on each of the 3 analyzers. (The total number of individual vials used isn't specified, but it implies multiple readings from multiple vials across different levels).
   • Data Provenance: Not explicitly stated, but clinical data for this type of control solution is typically generated in a laboratory setting. There is no mention of country of origin of data or whether it's retrospective or prospective. Given the nature of a 510(k) for a control, it would be prospective laboratory testing.

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 applicable. This is for a control solution, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for control solutions usually refers to the manufacturer's assigned reference values, which are established through extensive analytical testing using reference methods.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   Not applicable (see point 3).

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 is for a control solution, not an AI-assisted diagnostic device or a study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   Not applicable. This is for a control solution. The HemoCue B-Hemoglobin analyzer is the "device," and the HemoLin is a control material for it. The performance evaluated here is the analytical performance of the control itself and its comparability to a predicate control using the analyzer.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   For control solutions, the "ground truth" (or reference values) for the control levels would be established by the manufacturer (Direct Solutions/HemoCue) through established analytical methods and traceable standards. The document states that "assay values for HemoLin" are established and attached for comparison.

8. The sample size for the training set
   Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
   Not applicable.

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