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The V8 Nexus Hemoglobin UltraScreen method is designed for the separation of normal hemoglobins (A, A2, and F) in human blood samples, and for the detection of major hemoglobins variants (S and C) by using a capillary zone electrophoresis (CZE) buffer with the V8 instrument. The V8 Nexus Hemoglobin UltraScreen test is indicated for use in patients 2 years of age and older. This test is designed for in-vitro diagnostic use only in conjunction with other laboratory and clinical findings.

The V8 instrument is an automated analyzer which performs a complete hemoglobin profile for quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S and C. The assay is performed on the hemolysate of venous whole blood collected in tubes containing K2EDTA as the anticoagulant. The V8 Nexus Hemoglobin UltraScreen method uses capillary zone electrophoresis (CZE) buffer with the V8 instrument for the separation of normal hemoglobins (A, A2, and F) and detection of major hemoglobin variants (S and C). The V8 AFSA2 Hemo Control is a control material derived from whole blood used as a quantitative and/or qualitative control for the Hemoglobin UltraScreen on the V8 Capillary Electrophoresis (CE) system.

The V8 Nexus Hemoglobin UltraScreen is a medical device for the separation of normal hemoglobins (A, A2, and F) and the detection of major hemoglobin variants (S and C) in human blood samples. The device uses capillary zone electrophoresis (CZE) and is indicated for in-vitro diagnostic use in patients 2 years of age and older.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the precision/reproducibility and comparison studies. For the precision studies, the acceptance criteria would be the measured standard deviation (SD) and coefficient of variation (CV) of the hemoglobin fractions. For comparison studies, the acceptance criteria are generally an R-value close to 1, a slope close to 1, and an intercept close to 0, along with acceptable confidence intervals.

Linearity Acceptance Criteria and Performance:

Limit of Detection (LOD) and Limit of Quantitation (LOQ) Acceptance Criteria and Performance:

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

The "test set" in this context refers to the clinical samples used for the comparison studies with the predicate device.

• Sample Size for Comparison Studies (Test Set): A total of 439 patient samples were used across three external sites.
  • Hb A quantitation: 320 samples
  • Hb A2 quantitation: 412 samples
  • Hb F quantitation: 175 samples
  • Presumptive Hb S: 143 samples
  • Presumptive Hb C: 33 samples
• Data Provenance: The data comes from three external sites, suggesting a multi-center study setup. The samples were "fresh venous K2-EDTA-anticoagulated whole blood," indicating that these were prospective or recently collected samples for analysis. The country of origin is not explicitly stated, but given the submitter's address (Beaumont, Texas, USA) and FDA submission, it is likely the studies were conducted in the USA.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the "ground truth" for the comparison studies was the results obtained from the predicate device, the Sebia CAPILLARYS Hemoglobin(E) Test (K112491).

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The comparison studies directly compared the performance of the V8 Nexus Hemoglobin UltraScreen to the predicate device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement

No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic assay for analyzing blood samples, not an image-based diagnostic that involves human readers.

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

Yes, the studies presented are standalone (algorithm only) performance assessments of the V8 Nexus Hemoglobin UltraScreen instrument. These are bench-top studies and comparison studies demonstrating the device's analytical performance on its own, without direct human intervention in the interpretation of the capillary electrophoresis data beyond routine laboratory procedures. The instrument is described as an "automated analyzer."

7. The Type of Ground Truth Used

• For the precision/reproducibility studies, the ground truth was the known composition/percentages of hemoglobin fractions in the controls (AFSA2 and AFSC hemoglobin controls) and patient samples.
• For the comparison studies, the ground truth was the results obtained from the predicate device, the Sebia CAPILLARYS Hemoglobin(E) Test (K112491). This is a common approach for 510(k) submissions, where substantial equivalence to a legally marketed predicate device is demonstrated.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of a machine learning algorithm. This device is a quantitative assay using capillary zone electrophoresis (CZE), a well-established analytical technique. While the term "training" might apply to calibration or method development, a distinct "training set" with established ground truth as would be used for AI/ML validation is not detailed here. The studies focus on analytical validation (precision, linearity, LOD/LOQ, analytical specificity) and comparison to a predicate.

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

As no specific "training set" for an AI/ML algorithm is described, the method for establishing its ground truth is not applicable in this document. The device's performance is validated against established laboratory standards, controls, and a predicate device.

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The Microgel Alkaline Hemoglobin Electrophoresis test kit is intended for qualitative and semiquantitative determination of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using agarose gel. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglish hemoglobin electrophoresis is necessary. The electrophoretic test is performed at allialine pH and provides a valuable screening method for hemoglobin patterns. Densitometry of the pattern allows the relative quantification of hemogram patism belief allows the pattern allows the relative automated Microod instrument automated Microgel instrument.

The Microgel Acid Hemoglobin Electrophoresis kit is a qualitative test for the identification of both normal and abnomal or variant hemoglobins, and to confirm the identify of clinication of hemoglobins such as A. E. Gand O. Th hemoglobins such as A, F, S and C. The Acid Hemoglobin test kit employs agarose gel at acidic pH and is for in vitro diagnes and of The Rold Hemoglouin test Kit Employs agarose gel at acidid Microgel instrument Microgel instrument.

Not Found

The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. It is a 510(k) clearance letter for the "Microgel Hemoglobin Test Systems by Electrophoresis."

This document primarily states:

• The device name and its regulatory classification.
• That the device has been found substantially equivalent to legally marketed predicate devices.
• The intended use of the device, which includes qualitative and semi-quantitative determination of various hemoglobins using electrophoresis.
• General regulatory requirements.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of detailed performance data is typically found in the full 510(k) submission, not summarized in the clearance letter itself.

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The Interlab Alkaline Hemoglobin Electrophoresis test system is intended for the separation of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using cellulose acetate supported on Mylar®. The test is a screening method for in vitro diagnostic use on the Microtech 672 PC and the Microtech 648 ISO fully automated analyzers. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglobin electrophoresis is necessary.

The InterLab Hemoglobin devices test kits for the electrophoretic separation of hemoglobin in whole blood and are intended for In-Vitro diagnostic use only. The InterLab Alkaline Hemoglobin Electrophoresis Test Devices provide semi-quantitative identification of hemoglobin bands visualized by staining of the fractions. The principle of hemoglobin electrophoresis is based upon the visualization of specific hemoglobin bands following separation by electrophoresis. Dilutions of a patient's specimen are placed on separate tracks (fingers) on a cellulose acetate slide six fingers shaped, and the major hemoglobin groups are separated by electrophoresis. The migration rate depends on the temperature, pH, ionic force of the solution and proportions of the reactants. After electrophoresis, the slide is processed to remove excess soluble materials through a washing step. Fractionated hemoglobins are stained. The excess of stain is removed by a destaining step.

Here's an analysis of the provided text, outlining the acceptance criteria and the study that demonstrates the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the comparison to a commercially available reference method and the statistical results (correlation coefficients, precision metrics) achieved.

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

• Sample Size: 93 samples (from both normal and suspected pathological patients).
• Data Provenance: Retrospective, as samples were "submitted for routine testing to the hospital laboratory." The country of origin is not explicitly stated.

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

The document does not explicitly state the number of experts or their qualifications. It mentions that comparative studies were done against "the laboratory's routine commercially available agarose gel test system following the manufacturers' procedure." This implies that the results from the reference method, presumably interpreted by qualified laboratory personnel, served as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "ground truth" seems to be established by the results of the reference agarose gel test, which implies a single reference result per sample rather than a consensus among multiple readers for the test set itself.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not indicated. This device is an in-vitro diagnostic test system for semi-quantitative identification of hemoglobin bands, not an AI-assisted diagnostic tool that aids human readers. The comparison is between two laboratory testing methods.

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

The device is described as an "electrophoretic hemoglobin analysis system" that performs semi-quantitative identification of bands after processing. While it runs on "fully automated analyzers" (Microtech 672 PC and Microtech 648 ISO), the identification of bands and their comparison to a reference method (agarose gel test) implies that the system outputs results, and these results (band patterns) are then visually inspected and compared. The study data focuses on the performance of the test system itself, suggesting standalone performance in generating the patterns. However, the qualitative assessment ("visually inspected") suggests human interpretation is still involved in confirming results against the reference.

7. The Type of Ground Truth Used

The ground truth for the method comparison and agreement studies was established by a reference method, specifically "the laboratory's routine commercially available agarose gel test system."

8. The Sample Size for the Training Set

The document does not mention the use of a separate training set. The study described uses 93 samples for performance evaluation, compared against a reference method. This appears to be a validation/verification study, not a development study involving a distinct training phase for an algorithm.

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

As no training set is mentioned for an algorithm, this question is not applicable to the provided information.

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