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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.

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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.

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Lyphochek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

This is a lyophilized product prepared from human whole blood containing preservatives and stabilizers.

The Bio-Rad Laboratories Lyphochek Diabetes Control is a quality control material, not a diagnostic device that measures patient outcomes or makes clinical decisions. Therefore, the typical acceptance criteria and study designs involving diagnostic performance metrics like sensitivity, specificity, or reader studies are not applicable.

Instead, the "acceptance criteria" for this type of device revolve around its stability and its ability to consistently monitor the precision of laboratory testing procedures for specific analytes over time. The "study" that proves the device meets these criteria is a stability study.

Here's a breakdown of the information requested, adapted for a quality control material:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided summary does not detail the specific metrics used to define "acceptable precision" for the analytes (e.g., specific coefficients of variation or acceptable biases) or the raw data from the stability studies. These would be found in the full submission to the FDA.

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

This is not applicable in the traditional sense for a quality control material's stability study.

• "Test Set": In a stability study for a QC material, the "test set" would be various lots of the manufactured control material that are subjected to different storage conditions and timepoints. The number of vials/aliquots tested at each time point would constitute the "sample size" for that specific test run. The document does not specify the number of lots or aliquots used in the stability studies.
• Data Provenance: Not specified, but generally, such studies are conducted internally by the manufacturer (Bio-Rad Laboratories in Irvine, California, USA) according to established quality system procedures and regulatory guidelines. It would be prospective, as the stability of newly manufactured batches is monitored over time.

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

This is not applicable. For a quality control material, the "ground truth" for its analyte values is established through reference methods or highly accurate assays performed in a controlled laboratory setting by qualified analytical chemists or laboratory scientists during the manufacturing and characterization process. It's not based on expert consensus for interpretation like in diagnostic imaging.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations of diagnostic data. For a stability study, the data points are quantitative measurements of analyte concentrations, and any discrepancies would be resolved through re-testing, statistical analysis of replicates, or investigation of assay performance, not expert adjudication of qualitative interpretations.

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. This type of study is relevant for diagnostic devices, particularly those involving human interpretation, often assisted by AI. The Lyphochek Diabetes Control is a reagent used to monitor the precision of laboratory instruments, not a device that humans directly interpret for diagnostic purposes.

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

This is not applicable. This device is a physical control material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the analyte values (e.g., the target values for Hemoglobin A1C, Total Hemoglobin, etc.) in the Lyphochek Diabetes Control would be established through a combination of:

• Reference Methods: Highly accurate and precise analytical methods (e.g., HPLC, mass spectrometry) that are traceable to international reference materials.
• Certified Reference Materials (CRMs): The control material would be assayed against CRMs to assign accurate target values for the analytes.
• Internal Characterization Studies: Extensive testing during manufacturing to determine the mean and acceptable range for each analyte in each lot.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of a quality control material stability study. The control material's characteristics are determined through analytical testing, not machine learning or algorithmic training.

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

This is not applicable, as there is no training set. The "ground truth" for the control material's characteristics (analyte values and stability) is established through rigorous analytical testing using reference methods and comprehensive stability studies, as described in point 7.

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R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.

Sickle QC is a control for solubility tests used to detect Hemoglobin S. Sickle QC is compatible with other manufacturer's solubility kits. The control contains human red blood cells that are processed and are suspended in an anti-microbial solution that completes the simulation of fresh whole blood.

Here's an analysis of the provided text regarding the R&D Sickle QC Hematology Control, presented according to your requested format:

Acceptance Criteria and Device Performance Study for R&D Sickle QC Hematology Control

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "3 validation lots" were used for testing. The specific number of individual samples within these lots is not provided.
• Data Provenance: The data appears to be prospective as it describes "laboratory testing" that was conducted to validate the product. The country of origin is implicitly the United States, as the submission is to the U.S. FDA by R&D Systems, Inc., based in Minneapolis, MN.

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

• This information is not provided in the given text. The "ground truth" for the performance metrics (assay range, precision) would likely be established by the product specifications and analytical methods of the lab conducting the validation, rather than expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable and therefore not provided in the text. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of diagnostic cases where there might be disagreement (e.g., in medical image analysis). This is a laboratory control product, and its performance is evaluated against predefined analytical metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that impact human interpretation of cases. The R&D Sickle QC Hematology Control is a laboratory control material, not a diagnostic device that humans interpret in conjunction with AI.

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

• Yes, a form of standalone performance evaluation was done. The "laboratory testing of 3 validation lots" directly assessed the performance characteristics (precision, stability within range) of the Sickle QC product itself, independent of human interpretation or assistance. It's important to note this isn't an "algorithm" in the typical AI sense, but rather the performance of the control material in a laboratory setting.

7. The Type of Ground Truth Used

• The ground truth for this device's performance is established by analytical specifications and established laboratory methods/standards. For example, the "assay range" would be a pre-defined range within which the control is expected to perform, and "precision" would be measured against statistical benchmarks for variability. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• This information is not applicable and therefore not provided. The R&D Sickle QC Hematology Control is a physical control material, not an AI/machine learning algorithm that requires a training set.

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

• This information is not applicable as there is no training set for this type of device.

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Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

This is a liquid product prepared from human whole blood containing preservatives and stabilizers.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Open vial Stability: 14 days at 2°C to 8°C	14 days at 2°C to 8°C
   Shelf Life: 3 years at -10°C to -70°C or 6 months when stored tightly capped at 2°C to 8°C	3 years at -10°C to -70°C or 6 months when stored tightly capped at 2°C to 8°C

2. Sample Size for the Test Set and Data Provenance:
   The document does not explicitly state the sample size used for the stability studies. The data provenance is "retained on file at Bio-Rad Laboratories," indicating it is internal company data, likely retrospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
   Not applicable. This device is a quality control material, and its performance is assessed against predefined stability parameters, not through expert interpretation of data.

4. Adjudication Method for the Test Set:
   Not applicable. The stability studies involve quantitative measurements against established criteria, not subjective expert review.

5. MRMC Comparative Effectiveness Study:
   Not applicable. This is a quality control material, not a diagnostic device that assists human readers.

6. Standalone Performance:
   Yes, the reported performance is for the device standalone, as a quality control material. Its stability characteristics are assessed independently.

7. Type of Ground Truth Used:
   The ground truth is established based on the intrinsic chemical and physical stability properties of the control material under specified storage conditions. This would typically involve laboratory measurements over time to assess the integrity and performance of the analytes within the control.

8. Sample Size for the Training Set:
   Not applicable. This device is a quality control material, not an AI/ML model that requires a training set.

9. How Ground Truth for the Training Set Was Established:
   Not applicable. As noted above, this device does not involve a training set.

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The Quantimetrix GlycoHemosure is intended for the quality control of laboratory procedures for the quantitation of HbA1c.

The Quantimetrix GlycoHemosure is supplied liquid in glass bottles. It consists of humansource blood that was treated to give a stable liquid formulation of two distinct levels of HbA1c.

The provided text describes a 510(k) summary for the Quantimetrix GlycoHemosure, a quality control material for HbA1c quantitation. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for a medical device that makes diagnostic claims (e.g., sensitivity, specificity, accuracy).

Instead, the documentation focuses on the stability of the control material, which is a key performance characteristic for a quality control device.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The text explicitly mentions "stability studies" were performed to "validate the shelf life claim and the opened vial claim." This implies that the acceptance criteria for these claims would be met if the control material remained within acceptable analytical ranges over these timeframes. However, the specific numerical acceptance limits (e.g., ±X% variation from initial value) are not provided in this summary.

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

The text states "Accelerated stability studies (25°C and 37°C) and real time studies (2-8°C) were performed."

• Sample Size: Not specified. This typically refers to the number of vials or batches tested.
• Data Provenance: Not specified, but implies internal testing by Quantimetrix Corporation. It is prospective testing for stability.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a control material, not a diagnostic device that requires expert interpretation for its "ground truth." Its performance relates to its internal stability and consistency over time, measured against a reference method.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for the performance of a quality control material in this context. The "truth" for its stability is determined by analytical measurements against a defined reference.

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

No. This type of study is not relevant for a quality control material. MRMC studies are designed for diagnostic devices where human readers interpret results, and the study assesses how the device aids human performance.

6. Standalone Performance

Yes, implicitly. The stability studies evaluate the performance of the GlycoHemosure control material itself, without human interpretation or intervention beyond conducting the analytical measurements. The device's "performance" here is its inherent stability over time when measured using a standard HbA1c immunoassay.

7. Type of Ground Truth Used

The ground truth for the GlycoHemosure's stability is established by analytical measurement against a reference method or baseline value. The initial HbA1c concentration of the control material was determined using an immunoassay method (e.g., Dade HbA1c assay), and stability is assessed by comparing subsequent measurements to this initial value (or a derived reference) over time under different conditions.

8. Sample Size for the Training Set

Not applicable. Quality control materials fundamentally operate differently from AI/ML algorithms which require training sets. The GlycoHemosure is a prepared biological material with known concentrations, not an algorithm that learns from data.

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

Not applicable, as there is no training set for this type of device. The quality control material itself serves as a "known" for laboratories to check the performance of their own HbA1c assays. Its own characteristics (concentration, stability) are established through analytical testing and manufacturing specifications.

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R&D Glucose/Hemoglobin™ Whole Blood Control is an assayed whole blood product for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin in whole blood.

R&D Glu/Hgb Control is an assayed whole blood product used to monitor the precision and accuracy of analyzers that measure glucose and hemoglobin in whole blood.

The product is composed of human erythrocytes and glucose in a plasma-like fluid with preservatives.

The provided document is a 510(k) summary for the R&D Glucose/Hemoglobin™ Whole Blood Control, a device used for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin. As such, it is a control solution used to validate other medical devices, not a diagnostic or prognostic device that itself interprets patient data. Therefore, many of the typical acceptance criteria and study components requested in the prompt, which are usually applicable to diagnostic algorithms or medical imaging devices (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details), are not relevant or present in this context.

However, based on the information available, here's a summary tailored to the nature of this device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the traditional sense for a control solution. The "test set" here refers to the actual R&D Glucose/Hemoglobin™ Whole Blood Control product itself, which was tested for its performance attributes.
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective for a control solution's performance testing. The testing was conducted by R&D Systems, Inc.

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

• Not applicable. Ground truth for a control solution isn't established by expert consensus on patient data. Instead, the "truth" is its assayed value, which would be determined through validated laboratory methods and measurements against reference standards, not expert interpretation.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are used to resolve disagreements among human reviewers of patient data, which is not relevant for a control solution.

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 a control solution, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

• Not applicable. This device is a biochemical control solution, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device is its assayed value for glucose and hemoglobin, which is intrinsically determined during its manufacture and verified through laboratory testing. This is analogous to a certified reference material, where the "truth" is established by its chemical composition and precise measurements, not by expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The sample size for the training set

• Not applicable. This device is a control solution, not an algorithm that requires a training set.

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

• Not applicable. See point 8.

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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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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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